Auditing Guide

Annex 2 – Aide Mémoire

Company : Auditor(s) :

Location, Country : Date of Audit:

General Remark
Chapters 1 to 19 of this Aide Mémoire refer to the appropriate chapters of ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients).Chapter
20 relates to aspects of Quality Management Systems according to ISO 9001 or ICH Q10 Pharmaceutical Quality System.

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1 Introduction
1.3 Scope
Has the company designated the point at which the
production of the API begins?
Can a rationale be provided for this decision?
Has the decision been discussed with the respective
authority?
Are the quality critical steps identified?
2 Quality Management
2.1 Principles
2.11 A Certified Quality Management System (e.g. ISO
9001) is implemented? (if yes, see chapter 20)
2.12 Is there a quality policy?
How is it brought to the attention of the employees?
Is there a Quality Manual or equivalent
documentation that describes in detail how the
Quality System is implemented?
How does Management review effectiveness of
quality system
2.13 Is the Quality Unit (QA/QC) independent of
production?
2.14 Is there an authorized person(s) for the release of IM
and APIs?
Who is the person(s)?
2.16 Are all deviations documented and explained?
Are critical deviations investigated in a timely
manner?
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Is there a written procedure for handling

investigations (6.53)?
Average days for completion?
2.17 How is it ensured that materials are not released or
used before completion of evaluation by the QU?
If not done by QU: Is an appropriate system in place?
2.18 How is management notified of serious GMP
deficiencies, quality related complaints and/or product
defects?
Average time needed for information?
2.2 Responsibilities of the QU
2.21 Are there procedures that ensure that QU reviews
and approves all quality related documents?

2.22 Non-transferable responsibilities of QU:

- release/rejection of APIs and IM (to be sold)
- establish system to release/reject materials
and labels
- review of critical process steps batch records
- ensure critical deviations are investigated
- approving specifications and master
instructions
- approving all quality related documents
- ensuring conduction of internal audits
- approving contract manufacturers
- approving changes with quality impact
- approving validation documents
- ensure complaints are resolved

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- ensuring calibration system is functioning

according to procedure executed
- ensuring that stability data is generated and
reviewed
- performing product quality reviews
2.3 Responsibilities for Production Activities
- procedure for preparing, reviewing and
approving instructions
- reviewing batch production records
- ensure all deviations and investigations are
handled
- cleaning of facilities
- calibrations performed
- validation documents generated
- evaluation of proposed changes
- ensure that facilities and equipment are
qualified
2.4 Internal Audits
2.40 Are regular audits performed?
Is there an audit schedule?
Is the schedule followed?
2.41 Are audit findings and corrective actions
documented?
Procedure to notify management of audit findings?
Are corrective actions completed within agreed time
(are there significant delays?)

2.5 Product Quality Review

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2.50 Are regular Product Quality Reviews conducted for all

products?
Frequency (dedicated, campaign)?
Content (at least):
- review of critical IPC and API test results
- review of all batches failed
- review of all critical deviations
- review of process changes and impact on
quality
- review of changes to analytical methods
- review of results of ongoing stability
programmes
- review of returns, complaints, recalls
- review of adequacy of corrective actions
defined in previous review
2.51 Evaluation and assessment for need of additional
corrective actions to address recurring issues and/or
need for process or cleaning revalidation
3 Personnel
3.1 Personnel Qualifications
3.10 Adequate number of personnel?
Qualification of personnel sufficient at different
levels?
3.11 Are responsibilities of all personnel engaged in
manufacture in APIs in writing available?
Are responsibilities periodically reviewed to ensure
they are current?
3.12 Is regular training conducted?

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Are records of training maintained?

Is effectiveness of training evaluated?
How?
3.2 Personnel Hygiene
3.21 Do personnel wear clean clothing suitable for activity?
Additional protective apparel where necessary (e.g.
Final Product Packing Rooms)?
3.22 How is it ensured that personnel have no direct
contact with IM and APIs?
3.23 How is it ensured that no smoking, drinking, chewing
and storage of food takes place ?
3.24 How are personnel with infectious diseases or open
lesions identified?
Is there a procedure in place that these persons have
no product contact?
3.3 Consultants
Are consultants used to advise on any GMP related
activities?
Is there an assessment of consultant’s education,
training and experience?
4 Buildings and Facilities
4.1 Design and Construction
4.10 Can cleaning and maintenance be easily performed
based on design of equipment and layout of facility?
Have production and warehouse facilities been
designed to prevent contamination or cross
contamination?
If not, how is contamination prevented?

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4.11 Is there adequate space for placement of equipment

to prevent mix-up or contamination?
4.12 Outdoor equipment raises concerns for
contamination?
4.13 Does flow of materials and personnel raise concerns
for contamination?
4.14 Defined areas or control systems in place for the
following activities:
- receipt, identification, sampling of incoming
materials
- quarantine before release/reject
- Sampling of intermediates or API’s
- holding of rejected materials before further
disposition?
- Packaging and labeling operations?
4.15 Washing facilities and toilets available for personnel?
4.16 Laboratory areas separated from production?
4.2 Utilities
4.20 All utilities that could impact on product quality are
identified and qualified?
Are the utilities monitored and actions taken when
alert limits are exceeded?
4.21 Adequate ventilation, air filtration and exhaust
systems in place?
Are these systems designed and operated to prevent
contamination?
4.22 Control of re-circulated air sufficient to avoid
contamination?

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4.23 Permanently installed pipework appropriately

identified?
Is pipework maintained and located in such a way as
to prevent contamination?
4.24 Are drains designed to prevent back-siphonage or
microbiological contamination in areas where product
is exposed?
4.3 Water
4.30 Water demonstrated to be suitable for intended use?
4.31 Is Process water meeting drinking water quality as a
minimum standard?
Is additional water treatment system in place?
Is quality of all grades of process water monitored at
points of use for physical/chemical attributes, total
microbial counts, objectionable organisms?
Are actions taken when limits are exceeded?
4.32 Tighter specifications needed to ensure quality?
What are the specifications?
4.33 Validation of treatment of (higher) water treatment?
4.34 If claims are made for sterile or parenteral use:
Monitor microbial counts, objectionable
microorganisms and endotoxins

4.4 Containment
4.40 For highly sensitizing materials are dedicated
production areas (facilities, air systems, equipment)
in use?

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4.41 Dedicated production area for high pharmacological

activity
4.42 Are there measures to prevent cross-contamination
from personnel, materials etc. for example moving
from one production area to another?
4.43 Production of highly toxic, non-pharmaceutical
products, for example pesticides excluded from
pharmaceutical production facilities?
4.5 Lighting
Adequate lighting for e.g. cleaning and maintenance
4.6 Sewage and Refuse
4.60 Sewage to be removed timely
4.7 Sanitation and Maintenance
4.70 Buildings to be kept properly maintained, repaired
and cleaned
4.71 Written procedures for cleaning for equipment and
facilities in place
4.72 Procedures for pest control in place?

5 Process Equipment
5.1 Design and Construction
5.10 Equipment suitably located, easy to clean and
maintain?
5.11 Equipment surfaces do not alter product quality
5.12 Equipment only used within the qualified operation
range?
5.13 Major equipment and permanently installed pipework
identified
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5.14 Lubricants not in contact with IM and APIs?

Otherwise food grade lubricants used?
5.15 Precautions (measures) taken where equipment is
opened to prevent contamination? For example
addition of seeds or sampling
5.16 Are current engineering drawings available for
equipment, installations and utility systems?
5.2 Equipment Maintenance and Cleaning
5.20 Preventive maintenance programme in place?
Schedule followed?
5.21 Written procedures for the cleaning of equipment in
place?
Do the procedures give sufficient detail to enable
operators to clean each type of equipment in an
effective and reproducible manner?
5.22 Are equipment and utensils, such as sampling devices
cleaned, stored and where appropriate sanitized or
sterilized to prevent contamination or carry-over of a
material that would affect the quality of the IM or
API?
5.23 Continuous production or dedicated production
facilities: is equipment/ facility cleaned at appropriate
intervals to prevent build-up or carry over of
contaminants for example degradants or
objectionable levels of micro-organisms?
Is the cleaning frequency justified and documented?
5.24 Is equipment cleaned between production of different
products?

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5.25 For multi-purpose equipment is the Maximum

Acceptable Carry Over and other Acceptance criteria
for residues justified and determined?
Are the cleaning procedures validated?
5.26 Equipment identified as to its content and cleanliness
status?
5.3 Calibration
5.30 Instruments critical for IM and/or API quality are
calibrated?
How is critical defined?
Written procedure in place?
Schedule followed?
5.31 Calibration done with standards that are traceable to
certified standards?
5.32 Records of calibration maintained?
5.33 Calibration status of instruments known?
How (label, electronic)?
5.34 How is it ensured that instruments out of calibration
are not used?
5.35 If instruments have been shown out of calibration,
are deviation investigations performed to determine
if this fact has an influence on the release of the
IM/API?
5.4 Computerised Systems
5.40 Are GMP related computer systems validated?
5.41 IQ, OQ for Hard- and Software available to
demonstrate suitability of computer
hardware/software to perform task?

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5.42 Retrospective validation for existing systems if not

validated at time of installation?
5.43 What controls are in place to prevent unauthorized
access?
What controls are in place to prevent changes to
data?
What controls are in place to prevent omissions in
data?
Is there an audit trail / documents available where
changes to data are recorded, who made the change,
when the change was made and of the previous
entry?
5.44 Written procedures for the operation and
maintenance of computerized systems available?
5.45 Is the manual entry of critical data checked by
additional means (second operator or system itself)?
5.46 Are all quality related incidents and deviations
relating to computerized systems investigated
according to defined procedures investigated?
5.47 Changes to the computerized system are made
according to a defined procedure?
5.48 How is data protected in cases of system
breakdowns?
Back-up system provided?
Is Recovery from back-ups tested periodically?

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6. Documentation and Records

6.1 Documentation System and Specifications
6.10 Is there a written procedure in place describing
preparation, review, approval and distribution of all
quality related documents?
6.11 How is revision, superseding and withdrawal of
documents controlled?
Is a revision history maintained?
6.12 Procedure in place for retaining all appropriate
documents?
Retention period specified?
6.13 Retention period for APIs with expiry date: 1 year
after expiry (min.)
Retention period for APIs with retest date: 3 years
after complete distribution (min.)
6.14 Are corrected entries in documents dated and signed?
Original entry still readable?
6.15 Are documents promptly retrievable (copies or
electronic means acceptable)?
6.17 Are specifications for all materials, IM and APIs
established?
6.18 Are electronic signatures authenticated and secure?
6.2 Equipment Cleaning and Use Records
6.20 Are there records for the major equipment used ,
cleaning and maintenance showing the following
- date
- time
- product and batch number of each batch

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- person who performed cleaning

- person who performed maintenance
6.3 Records of Raw Materials, IM, API Labeling and Packaging Materials
6.30 Records of each delivery should contain:
- name of manufacturer/supplier
- identity and quantity
- supplier control or identification number
- number allocated on receipt
- date of receipt
- acceptable condition of received goods
assessed
- result of tests and conclusion derived from
this
- trace of use
- review of labels and packaging materials
showing conformity with specifications
- final decision release or reject
6.31 Are master labels maintained?
6.4 Master Production Instructions
6.40 Are Master Production Instructions for each IM/API
- prepared
- dated
- signed
- independently checked by QU
6.41 Do Master Production Instructions contain the
following:
- name of product including document
reference code

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- complete list of raw materials

- accurate statement of quantities needed or
calculation of quantity
- production location and major equipment to
be used
- detailed production instructions including
sequences, ranges of parameters, sampling
instructions, IPC, time limits, expected yield
- instructions for storage
6.5 Batch Production Records
6.50 Are Batch Production Records checked before
issuance for correct version?
6.51 Are the records showing an unique batch number
(not for continuous production)?
6.52 The batch record should contain the following:
- date(s) and times (if appropriate)
- identity of major equipment
- identification of materials used
- actual results
- sampling performed
- signatures of the person(s) performing the
operation
- IPC / laboratory test results
- actual yield, if appropriate
- description of packaging and labels used
- deviation/investigation
- results of release testing

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6.6 Laboratory Control Records

6.60 Laboratory records should contain the following:
- description of sample including name, batch
number or code, date when sample was
taken, quantity
- reference to test method
- cross reference to preparation of reference
standards, reagents and/or standard solutions
- complete record of all raw data
- record of all calculations
- statement of test result if they comply with
specifications
- signature and date of person(s) performing
the testing
- signature of second person demonstrating
review for accuracy, completeness
6.61 Other records to be maintained:
- modification to test method
- calibration of laboratory instruments
- stability testing performed
- OOS investigations
6.7 Batch Production Record Review
6.70 Is a written procedure for the handling of batch
(laboratory) record review available?
6.71 Are batch (laboratory) records of critical steps
reviewed by the QU?
Are they reviewed before the release of the API?

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6.72 Are all deviations, investigations and OOS reviewed

as part of the batch record review?
6.73 Is the QU releasing all IM that are shipped outside
the control of the company?
7 Materials Management
7.1 General Controls
7.10 Are written procedures available for handling of
receipt, identification, quarantine, storage, sampling,
testing, approval or rejection of materials?
7.11 System to evaluate suppliers of critical materials in
place?
Evaluation must show that supplier can consistently
provide material meeting specifications (7.31)
7.12 Materials purchased against agreed specifications?
Purchased from an approved (by QU) supplier?
7.13 If supplier is not the manufacturer, is the original
manufacturer known?
7.14 Change of source/supplier handled according to
Change Control procedures (chap. 13)?
7.2 Receipt and Quarantine
7.20 Upon receipt materials visually examined for
- correct labeling
- container damage
- broken seals
- tampering or contamination
Are materials held under quarantine until released for
use?
How is this done?

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7.21 Incoming materials are released before mixed with

existing stocks?
Are procedures in place to prevent discharging
materials wrongly?
7.22 If deliveries are made in non-dedicated tankers which
assurance is provided to demonstrate no
contamination (one or more of the following):
- certificate of cleaning
- testing for trace impurities
- audit of the supplier
7.24 Is each delivery of materials identified (code or batch
number)?
Is there a system in place to identify the status of
each batch?
7.3 Sampling and Testing of Incoming Production Materials
7.30 Is at least one test conducted to verify the identity of
incoming materials?
If suppliers Certificate of Analysis is used instead of
testing a system for evaluation must be in place.
7.31 (see also 7.11)
Are 3 full analyses conducted before reducing
testing?
Is a full analysis performed at appropriate intervals
and compared with the suppliers certificate of
analysis?
7.33 How is it demonstrated that samples taken from the
material are representative?
Are sampling methods described with at least

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- number of containers to be sampled

- which part of the container
- amount of sample to be taken
7.34 Is sampling done at defined locations preventing
contamination?
7.35 Are containers from which samples are taken
identified?
7.4 Storage
7.40 Is material stored in a manner to prevent degradation
and contamination?
7.41 Are fiber drums, bags and boxes stored off the floor?
Is stored material suitably spaced to permit cleaning
and inspection?
7.42 Do materials met their respective storage conditions?
Is the FIFO principle followed?
7.43 In case materials is stored outdoors:
- do labels remain legible
- are the containers cleaned before opening
- is it described in a procedure
7.44 How are rejected materials held under a quarantine
system?
8 Production and In Process Controls
8.1 Production Operations
8.10 Are weighing and measuring devices of suitable
accuracy for their intended use?
Are the devices periodically calibrated with certified
references?

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8.11 Do containers with subdivided material contain the

following information:
- name of material
- code or control number
- weight, if applicable
- retest date, if applicable
8.12 How are critical weighing, measuring or subdividing
operation witnessed?
Is an equivalent control used? If so what?
8.13 Are all other critical operations witnessed or
subjected to equivalent control?
8.14 Are actual yields compared with expected yields at
designated steps in production?
8.16 How is the processing status of major units of
equipment indicated?
8.2 Time Limits
8.20 Are all specified time limits of the operating
instructions met?
8.21 How are storage conditions for IM held for further
processing determined?
8.3 In-process Sampling and Controls
8.30 Are IPC established to monitor the progress and
control the performance of the processing steps?
8.32 Are critical IPC approved by the QU?
8.33 How is the qualification (training) of the production
personnel documented, if they perform the IPC?
8.34 Are sampling methods for IPC described in writing?

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8.35 Does in-process sampling not cause the

contamination of sample and/or product?
8.4 Blending of Batches of IM or APIs
8.41 Are OOS batches blended with other batches meeting
the specifications?
Are all batches individually tested prior to blending?
And do they all meet specification?
8.43 Is the blending process adequately documented and
the blended batch tested for conformance to
specifications?
8.44 Does the batch record of the blended batch allow
traceability back to the individual batches?
8.45 Are blending operations validated if physical
attributes of the API resulting from this step are
known to be critical?
8.46 How is it demonstrated that the blended batch does
not affect stability?
8.47 Is the expiry/retest date based on the oldest batch in
the blend?
8.5 Contamination Control
8.50 How is it ensured that carryovers (e.g. degradants)
into successive batches of the same IM/API do not
affect the impurity profile of the API?
8.51 What measures are taken in production to prevent
contamination of IM/API?
8.52 What specific precautions are taken to avoid
contamination of the API after purification?

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9 Packaging and Identification Labelling of APIs and IM

9.1 General
9.10 Are written procedures available describing
- receipt
- identification
- quarantine
- sampling
- examination/testing
- release
of packaging materials and labels ?
9.11 Are specifications for all packaging materials and
labels established?
Are suppliers of primary packaging materials in
contact with the product qualified?
9.12 Are records of each delivery of packaging materials
and labels kept?
9.2 Packaging Materials
9.20 Can containers/packaging material used provide
adequate protection against deterioration or
contamination during transportation?
9.21 Are containers cleaned so that they are suitable for
their intended use?
9.22 Are written procedures for cleaning in place for re-
used containers?
Are all previous labels removed or defaced?
9.3 Label Issuance and Control
9.30 Is access to label storage area limited to authorized
personnel?

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9.31 Are procedures in place to reconcile the quantities of

labels issued and used?
Are discrepancies investigated and approved by the
QU?
9.32 Are labels bearing batch numbers not used being
destroyed?
How is it documented?
9.33 Are all out-dated and obsolete labels destroyed?
9.34 Are printing devices checked that the imprint
conforms to the print specified in batch record?
Is an examination done to check if the correct label is
on the packed IM/API? (9.45)
9.36 Is a representative label included in the batch record?
9.4 Packaging and Labelling Operations
9.40 Are written procedures in place ensuring that correct
packaging materials and labels are used?
9.41 Is physical or spatial separation of labels done when
multiple labeling operations are done at the same
time?
9.42 Labels should indicate the following information (at
least):
- name of product
- identifying code and batch number
- storage conditions, when such information is
critical to assure quality
9.43 If the IM/API is transferred outside of the control of
the manufacturer the label as well as requirements of
9.42 contain:

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- name and address of manufacturer

- quantity
- special transport conditions, if applicable
- special storage conditions, if applicable
(10.22)
- legal requirements, if applicable
For APIs with expiry date: date to be included on
label and certificate of analysis
For APIs with retest date: date to be included on
label and/or certificate of analysis
9.44 Are packaging and labeling facilities inspected before
use to ensure that all materials not needed are
removed?
Is this inspection documented?
9.46 Are seals and other security measures used that will
alert the recipient that the material may have been
altered? Please specify.
10 Storage and Distribution
10.1 Warehousing Procedures
10.10 Are facilities for the storage of materials available
supporting the claimed storage conditions (e,g,
temperature, humidity)?
Are records of the storage conditions kept?
10.11 Are separate storage areas provided for quarantined,
rejected, returned or recalled products?
Or is an alternative system used? If so, how is it
designed and qualified?

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10.2 Distribution Procedures

10.20 How is it ensured that APIs/IM are not distributed
outside of the company before the release of the
QU?
10.21 How are transportation conditions ensured so that the
quality of the product will not be adversely affected?
10.23 How does the manufacturer ensure that the
transporter knows and follows the appropriate
transport and storage conditions?
10.24 Are there systems in place to easily permit a recall?
Has its effectiveness been demonstrated?
11 Laboratory Controls
11.1 General Controls
11.10 Are adequate laboratory facilities available?
11.12 Are all sampling plans and testing procedures
reviewed and approved by the QU?
11.13 Do the specifications set for the APIs include a control
of the impurities?
If the API has a specification for microbiological purity
and/or endotoxins what appropriate action limits have
been established?
11.15 Are all OOS results investigated?
Is resampling after OOS described in a procedure?
11.16 Are written procedures in place for preparation of
reagents and standard solutions?
11.17 Are primary reference standards stored under
appropriate conditions?
Is the source of the primary standard documented?

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11.18 If the primary standard is not obtained from an

officially recognized source, is appropriate testing
conducted to fully establish the identity and purity of
the primary standard?
11.19 Are procedures in place to prepare, identify, test
store and approve secondary reference standards?
Is the suitability of the secondary standard
determined prior to use by comparing it against the
primary standard?
Are secondary reference standards periodically re-
qualified?
11.2 Testing of Intermediates and APIs
11.21 Is there an impurity profile established for every API?
11.22 Is the impurity profile compared at appropriate
intervals against the impurity profile in the regulatory
submission or against historical data?
11.3 Validation of Analytical Procedures
See section 12.8
11.4 Certificates of Analysis
11.40 Are authentic Certificates of Analysis issued for each
batch of IM/API?
11.41 Information on the Certificate of Analysis:
- name of IM/API
- batch number and code number?
- date of release
- expiry date, if applicable
- retest date, if desired
-

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11.42 On the Certificate of Analysis, are all tests performed

listed, together with acceptance limits and numerical
results obtained?
11.43 Certificates of Analysis should be
- dated
- signed by authorized personnel of the QU
- show name, address and telephone number of
manufacturer
If Certificate of Analysis is issued by agents (chap.
18) the name, address and telephone number of the
agents must be shown.
11.44 If Certificate of Analysis is issued by agents the
name, address and telephone number of the
laboratory that performed the tests must be shown.
It also should contain a reference to the original
manufacturer and to the original Certificate of
Analysis.
11.5 Stability Monitoring of APIs
11.50 Is an on-going stability testing programme
conducted?
Do the results of the stability programme justify
storage conditions and expiry/retest dates (see also
11.61)?
11.51 Are the test methods used in stability validated and
stability indicating?
11.52 Are the stability samples stored in containers of the
same material as the market containers?

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11.53 Are the first three commercial production batches

placed on stability?
11.54 Thereafter, is at least one batch per year added to
the stability monitoring programme?
Are annually tests performed to confirm stability?
11.55 For APIs with less than 1 year stability:
Is testing performed monthly for the first three
months and at three month intervals after that?
11.6 Expiry and Retest Dating
11.60 Is an expiry/retest date assigned when the APIs are
transferred outside of the control of the company?
11.7 Reserve/Retention Samples
11.71 Are reserve samples stored for 1 year after expiry
date or 3 years after distribution (whatever is
longer)?
For APIs are reserve samples stored for at least 3
years after complete distribution?
11.72 Are reserve samples stored in same packaging
system or more protective than the marketed?
Is the amount of sample sufficient to conduct at least
2 full compendial or internal specification analyses?
12 Validation
12.1 Validation Policy
12.10 Is the company's overall validation policy
documented?
(Could be combined with 2.12)

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12.11 Are all critical parameters defined during the

development (or from historical data)?
Are the operating ranges defined?
12.12 Are all critical operation steps validated?
12.2 Validation Documentation
12.20 Is a validation protocol established?
Is it approved by the QU?
12.21 Is the following specified in the validation protocol:
- critical process steps
- acceptance criteria
- type of validation
- number of process runs?
12.22 Is a validation report prepared summarising the
results obtained, including recommendation of
changes to correct deficiencies?
12.23 Are variations from the validation protocol
documented and justified?
12.3 Qualification
12.30 Is there policy or procedure for
Qualification/Validation?.
Is Validation Master Plan available?
Is appropriate qualification (DQ, IQ, OQ, PQ)
conducted for critical equipment and ancillary
systems?
Is operational qualification completed before
Performance Qualification / process validation
activities?

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12.4 Approaches to Process Validation

12.40 Is process validation (PV) conducted before
commercial distribution of API batches?
12.42 Prospective Validation should normally be performed.
What is the justification of performing other types?
Is the validation completed before commercial
distribution of the drug product?
12.44 If retrospective validation is conducted for well
established processes, are the following requirements
met:
- critical process parameters have been
identified
- appropriate in-process criteria have been
established
- no significant process failures have occurred
- impurity profiles have been established for the
existing API
12.45 Are batches selected for retrospective validation
representative for all batches made during the review
period?
12.5 Process Validation Programme
12.50 Are at least 3 consecutive successful production
batches made for prospective and concurrent
validation?
For retrospective validation are 10 to 30 consecutive
batches examined? If fewer batches are examined,
what is the justification for it?

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12.52 Has process validation confirmed that the process can

be reproducibly controlled within critical operating
parameters and the impurity profile is within the
specified limits?
12.6 Periodic Review of Validated Systems
12.60 Are systems and processes periodically evaluated to
verify that they are still operating in a valid manner
(e.g. through product quality review)?
12.7 Cleaning Validation
12.70 Are cleaning procedures validated?
If not, is there a justification?
Is cleaning validation directed to situations where
contamination or carryover poses the greatest risk?
12.71 If various APIs/IM are produced in the same
equipment and the same cleaning process is used, is
a representative API/IM selected for cleaning
validation (on the basis of solubility, difficulty to clean
and calculation of residue limits based on potency,
toxicity and stability)?
12.72 Does the cleaning validation protocol include
- equipment to be cleaned
- procedures
- materials used
- acceptable cleaning levels
- parameters to be monitored
- analytical methods
- type of samples (swab, rinse)
- how samples are collected and labeled

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12.73 Does the type of sampling detect insoluble and

soluble residues?
Is the sampling method capable to quantitatively
measure levels of remaining residues?
12.74 Are the analytical methods sensitive enough to detect
residues or contaminates?
How are residue limits established (on minimum
known pharmacological, toxicological or physiological
activity or the most deleterious component)?
12.75 If claims on microbiological and/or endotoxin
specifications are made, does the cleaning validation
take this into account?
12.76 Are the cleaning procedures monitored at appropriate
intervals to ensure their effectiveness?
12.8 Validation of Analytical Methods
12.80 Are the analytical methods developed by the
company validated?
How are Pharmacopoeial methods qualified?
12.81 How is the degree of analytical validation (e.g. for
different steps of production) justified?
12.82 Is the analytical equipment qualified?
12.83 Are records of modified validated analytical methods
maintained?
Is the reason for the modification documented?
13 Change Control
13.10 Is a formal change control system in place capable of
evaluating all changes?

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13.11 Written procedures should be provided for the

identification, documentation, review and approval of
changes.
13.12 Are all changes impacting the quality of the API/IM
approved by the QU?
13.13 Are changes classified (e.g. major, minor)?
If not, how is the impact on the quality of the API
being evaluated?
How is level of testing, validation, documentation
determined (scientific judgement)?
13.14 How is it ensured that after a change all affected
documents are revised?
13.15 Are the first batches evaluated after the change has
been implemented?
13.16 If critical changes have been made, has the impact
on expiry/retest dates and process validation been
evaluated?
13.17 Are medicinal product manufacturers notified about
changes that could impact the API quality (especially
physical attributes)?
14 Rejection and Re-Use of Materials
14.1 Rejection
14.10 Are IM/APIs failing to meet specifications identified?
How?
14.2 Reprocessing
Are all steps where reprocessing is conducted part of
the filing documents?

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14.3 Reworking
14.30 Is an investigation performed before a decision is
taken to rework a batch?
14.31 Have reworked batches been subjected
- to appropriate evaluation
- stability testing
- to show equivalency to original process?
Is concurrent validation performed if more than one
batch is affected?
Is a report issued if only one batch is affected?
14.32 Is the impurity profile of the reworked batch
compared with the one of the established process?
If routine analytical methods are inadequate, are
additional methods used?
14.4 Recovery of Materials and Solvents
14.40 Do procedures exist for the recovery of materials?
Do the recovered materials meet specifications for
their intended use?
14.41 Do recovered solvents used in different processes
meet appropriate standards?
14.42 Are recovered solvents been tested for suitability
before being combined with fresh or approved
solvents?
14.5 Returns
14.50 Are returned APIs/IM identified and quarantined?
14.51 Are returned materials evaluated on their quality
before re-use?

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14.52 Are records of returned goods available containing

- name and address of the consignee
- API/IM, batch number and quantity
- Reason of return
- Use or disposal of API/IM
15 Complaints and Recalls
15.10 Is a written procedure available describing the
handling of complaints?
15.11 Do the complaint records include the following:
- name and address of complaint
- name and phone number of person submitting
the complaint
- complaint nature (including name and batch
number of API)
- date complaint is received
- action taken (including person taking the
action)
- any follow-up, if applicable
- response provided to the originator of
complaint including date of response
- final decision on API
-
15.12 Are the records of complaints retained?
For how long? Are trends or recurring complaints
evaluated?

15.13 Is there a recall procedure in place?

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15.14 Does the recall procedure specify

- who should be involved
- how the recall is initiated
- who should be informed
- how recalled material is treated
16 Contract Manufacturers (including Laboratories)
16.10 Is it ensured that all contract manufacturers engaged
comply with the GMP requirements of ICH Q7?
16.11 How is the contract manufacturer evaluated for GMP
compliance?
16.12 Is there a written contract (agreement) with the
contract manufacturer?
Are the GMP responsibilities defined in detail?
16.13 Does the contract permit to audit the contract
manufacturer?
16.14 Is subcontracting by the contract manufacturer
excluded?
If not, how is it ensured that the contract giver is
involved in prior evaluation of the subcontractor?
16.15 Are all records kept at the contract manufacturers
site?
How is it ensured that these are readily available?
16.16 Does the contract manufacturer have a change
control system?
How is it ensured that the contract giver is informed
about all intended changes of the contract
manufacturer to the process?
Does the contract giver approve all changes?

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17 Agents, Brokers, Traders, Distributors, Repackers, and Relabellers (Agent)

17.1 Applicability
17.10 Is this not the original manufacturer of the API?
(Then this section applies.)
17.11 Does the Agent comply with the GMP requirements as
defined in ICH Q7?
17.2 Traceability of Distributed APIs and IM
17.20 Is the following information retained:
- identity of original manufacturer
- address of original manufacturer
- purchase orders
- transportation documentation
- receipt documents
- name or designation of API
- manufacturers batch number
- distribution records
- authentic certificate of analysis, including
those of the original manufacturer
- expiry/retest date
17.3 Quality Management
17.30 Has the Agent established a system of managing
quality as defined in section 2?
17.4 Repackaging, Relabeling and Holding of APIs and IM
17.40 How does the Agent ensure that during repackaging,
relabeling and holding of APIs/IM no mix-ups and loss
of identity and purity of the API/IM occurs?
Are these operations conducted under conditions
described in Q7?

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17.41 Is repackaging done under conditions to avoid

contamination?
17.5 Stability
17.50 Are stability studies conducted if the API is repacked
in a different type of container?
17.6 Transfer of Documentation
17.60 Does the Agent transfer all quality and regulatory
information from the original manufacturer to the
customer?
17.61 Does the agent provide the name of the original
manufacturer and the batch number to the customer?
17.63 Is the specific guidance for Certificates of Analysis
described in section 11.4 followed?

17.7 Handling of Complaints and Recalls

17.70 Does the Agent maintain records of all complaints
and recalls that were brought to their attention?
17.71 Does the Agent review the complaint together with
the original manufacturer for determining further
action?
17.72 Do the records of the Agents include responses from
the original manufacturer to a complaint?
17.8 Handling of Returns
17.80 Are returns to the Agent handled in the way
described in section 14,52?
Is documentation maintained of returned APIs/IM?

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18 Specific Guidance for APIs Manufactured by Cell Culture / Fermentation

18.1 General
18.10 Are the GMP principles of the other sections complied
with?
18.13 What measures are taken for Biotech processes to
ensure that raw materials (media, buffer
components) are no source of microbiological
contamination?
If applicable, is the bioburden, viral contamination
and/or endotoxins controlled at appropriate stages of
production?
18.14 Which controls are performed for steps prior to this
guide, e.g. cell banking?
18.15 Which equipment and environmental controls are
used to minimize contamination?
Are adequate acceptance criteria for quality and
frequency’s for monitoring set at the various steps of
production?
18.16 Are the following controls taken into account:
- maintenance of WCB
- proper inoculation and expansion of the
culture
- control of critical operating parameters
- monitoring the process for cell growth,
viability and productivity
- harvesting and purification procedures
- monitoring of bioburden
- viral safety concerns (ICH Q5a)

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18.17 Is removal of media components, host cell proteins

process and product related impurities and
contamination demonstrated?
18.2 Cell Bank Maintenance and Record Keeping
18.20 Is the access to the cell banks limited to authorized
personnel?
18.21 Do the storage conditions of the cell banks ensure
that viability is maintained and contamination
prevented?
18.22 Are records of the use of vials from the cell banks
and storage conditions maintained?
18.23 Are cell banks monitored periodically for suitability for
use?
18.24 For handling of cell banks check ICH Q5a
18.3 Cell Culture / Fermentation
18.30 Are closed and contained systems used when aseptic
additions are needed?
If open vessels are used which measures and controls
are used to minimise risk of contamination?
18.31 If use of open equipment can cause microbial
contamination which environmental controls are
done?
18.32 Are personnel handling the cultures appropriately
gowned?
18.33 Are critical operating parameters including cell
growth, viability and productivity monitored?
18.34 Is cell culture equipment cleaned after use?
18.35 Is culture media sterilized before use?
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18.36 Are procedures in place to detect contamination and

to determine necessary action?
Is the impact of the contamination evaluated?
18.37 Are records of contamination maintained?
18.38 Is multi-purpose equipment sufficiently tested to
minimize contamination?
18.4 Harvesting, Isolation and Purification
18.40 Are harvesting steps performed in equipment and
areas designed to minimize risk of contamination?
18.41 Can the harvesting and purification procedures
remove or inactivate organisms in a way that the API
is recovered with consistent quality?
18.42 Is all equipment cleaned properly after use?
18.43 Is purification performed under controlled
environmental conditions if open systems are used?
18.44 If equipment is used for multiple products additional
controls and testing is to be conducted.
18.5 Viral Removal / Inactivation steps
18.50 See ICH Q5a
18.51 Are viral removal and inactivation steps performed
within their validated parameters?
18.52 Are appropriate precautions being taken to prevent
viral contamination from pre-viral to post-viral
removal/inactivation?
Do open processing take place in areas that are
separate from other processing activities and have
separate air handling units?

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18.53 If equipment is used for different purification steps is

it appropriately cleaned?
19 APIs for Use in Clinical Trials
19.1 General
19.11 Are the controls used consistent with the stage of
development?
Are procedures flexible enough to provide changes as
knowledge of the process increases?
If APIs are intended to be used for clinical trials, is
the API produced in suitable facilities with appropriate
controls to ensure the quality?
19.2 Quality
19.20 Is there an appropriate GMP concept in place?
Is a procedure for approval of batches in place?
19.21 Is there an independent QU in place?
19.23 Are raw materials, packaging materials IM and APIs
tested?
19.24 Are process and quality problems evaluated?
19.25 Does the labeling of APIs for use in clinical trials
indicate the material as being for investigational use?
19.3 Equipment and Facilities
19.30 Is it ensured that during all phases of clinical
development the equipment is qualified, instruments
calibrated, clean and suitable for it intended use?
19.31 Are materials handled in a way to minimize
contamination?
19.4 Control of Raw Materials
19.40 Are raw materials evaluated or tested?
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19.5 Production
19.50 Is the production of APIs for use in clinical trials
documented appropriately according to the stage of
production?
Do these documents include information about
materials used, equipment, processing and scientific
observations?
19.6 Validation
19.60 Is the equipment used qualified and the instruments
calibrated?
(Validation is not expected!)
19.61 If batches are produced for commercial use, then
section 12 is to be applied.
19.7 Changes
19.70 Are all changes adequately recorded?
19.8 Laboratory Controls
19.80 Are analytical methods used scientifically sound? (No
analytical validation required)
19.81 Is a system to retain reserve samples in place?
19.9 Documentation
19.90 Is a system in place to document the information
gained during the development?
19.91 Is the development of analytical methods
appropriately documented?

19.92 Is it ensured that all information is retained for an

appropriate length of time?

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20 Quality Management System

20.1 Quality Issues
20.10 Has the organization established, documented,
implemented and maintained a quality management
system in accordance with the requirements of ISO
9000:2000?
20.11 Is the effectiveness of the quality management
system continually improved?
20.12 Does the organization manage these processes in
accordance with the requirements of ISO 9000:2000?
20.13 Does the quality management system documentation
include:
- Documented statement of a quality policy and
quality objectives
- Quality Manual
- Documented procedures required by ISO
9000:2000
- Documents needed by the organization to
ensure the effective planning, operation and
control of its processes
- Records required by ISO 9000:2000
20.14 Are documents required for the quality management
system controlled?
20.15 Has a documented procedure been established
identifying the following controls needed:
- Approval of documents for adequacy prior to
issue
- Review, update as necessary and re-approval

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of documents
- Ensure that changes and the current revision
status of documents are identified
- Ensure that relevant versions of applicable
documents are available at points of use
- Ensure that documents remain legible and
readily identifiable
- Ensure that documents of external origin are
identified and their distribution controlled
- Preventing the unintended use of obsolete
documents, and to apply suitable identification
to them if they are retained
20.16 Have records been established and maintained to
provide evidence of conformity to requirements and
of the effective operation of the quality management
system?
20.17 Has a documented procedure been established to
define the following controls needed
- Identification
- Storage
- Retrieval
- Protection
- Retention time
- Disposition
20.2 Management Responsibility
20.20 Has top management provided evidence of its
commitment to the development and implementation
of the quality management system and for the
continual improvement of its effectiveness?
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20.21 Has top management ensured that customer

requirements are determined and met with the aim of
enhancing customer satisfaction?
20.22 Has top management established a quality policy?
20.23 Has top management ensured that quality objectives
are established at relevant functions and levels within
the organization?
20.24 Has top management ensured that responsibilities,
authorities are defined and communicated within the
organization?
20.25 Has top management appointed member(s) of
management who have responsibility and authority
for quality management?
20.26 Has top management ensured that appropriate
communication processes have been established
within the organization?
20.27 Does the top management review the quality
management system, at planned intervals, to ensure
its continuing suitability, adequacy and effectiveness?
20.28 Do the outputs from the management review include
the decisions and actions?
20.3 Resource Management
20.30 Have the resources for quality management been
determined and provided?
20.31 Is competency for personnel who perform work
affecting product quality based on appropriate
education, training, skills, and experience?
20.32 Has the organization determined the necessary

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competency for personnel performing work affecting

product quality?
20.33 Does the organization identify, provide, and maintain
the facilities including: Buildings, Workspace and
associated utilities, Process Equipment, hardware and
software, Supporting services?
20.34 Has the environment needed to achieve conformity of
product requirements been determined and
managed?
20.4 Product Realisation
20.400 Is planning of the organization’s product realization
consistent with the requirements of the other
processes of the quality management system?
20.401 Has the organization determined requirements
specified by the customer, including the requirements
for delivery and post-delivery activities?
20.402 Prior to the commitment to the customer (e.g.
submission of tenders, acceptance of contracts or
orders or acceptance of change orders) are
requirements adequately reviewed?
20.403 Has the organization determined and implemented
effective arrangements for communicating with
customers?
20.404 Are inputs relating to product requirements defined,
documented and maintained as a record?
20.405 Are outputs of the design and development provided
in a form that enables verification against the design
and development inputs?

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20.406 Are systematic reviews performed in accordance with

planned arrangements at suitable stages of the
design and development?
20.407 Is design and development verification performed in
accordance with planned arrangements to ensure
that the design outputs have met the design and
development input requirements?
20.408 Is design and development validation performed in
accordance with planned arrangements?
20.409 Are design and/or development changes identified
and recorded?
20.410 Are the purchasing processes controlled to ensure
purchased product (or service) conforms to
requirements?
20.411 Does purchasing information describe the product to
be purchased?
20.412 Have the inspection or other activities necessary for
ensuring that purchased product meets specified
purchase requirements been established and
implemented?
20.413 Are the production and service provision planned and
carried out under controlled conditions?
20.414 Have processes where deficiencies may become
apparent only after the product is in use or the
service has been delivered been validated?
20.415 Is the product identified by suitable means
throughout product realization?

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20.416 Does the organization exercise care with customer

property while it is under the organization’s control or
being used by the organization?
20.417 Is conformity of product preserved during internal
processing and delivery to the intended destination?
20.418 Has the organization determined the monitoring and
measurement to be undertaken and the monitoring
and measurement devices needed to provide
evidence of conformity of product to determined
requirements?
20.5 Measurement, Analysis and Improvement
20.50 Have the monitoring, measurement , analysis and
improvement processes been planned, and
implemented?
20.51 Is information relating to customer perception
monitored by the organization as to whether
customer requirements have been met?
20.52 Are internal audits conducted at planned intervals to
determine whether the quality management system:
- Conforms to planned arrangements,
requirements of ISO 9001 and the quality
management system
- Is effectively implemented and maintained
20.53 Are suitable methods applied for monitoring and
where applicable, measurement of the quality
management system processes necessary to meet
customer requirements?

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** Procedure, SOP, OI, memo, notes (personal), Q-manual
 AIDE MEMOIRE
Reference APPLICABILITY COMPLIANT Kind of Documentation** Commentary Question
ICH Q7 TOPICS / ISSUE posed
YES NO YES tbi * No

20.54 Are product characteristics monitored and measured

to verify that product requirements are met?
20.55 Is nonconforming product identified and controlled to
prevent unintended use or delivery?
20.56 Is appropriate data determined, collected and
analysed to demonstrate the suitability and
effectiveness of the quality management system and
to evaluate where continual improvement of the
effectiveness of the quality management system can
be made?
20.57 Does the organization continually improve the
effectiveness of the quality management system?
20.58 Are corrective actions taken to eliminate the cause of
nonconformities and to prevent recurrence?
20.59 Has the organization determined actions to eliminate
the causes of potential nonconformities in order to
prevent occurrence?

This template has been developed by APIC/CEFIC. You may use the templates for your internal auditing purpose but for the purpose of a Third Party Audit,
please note that only APIC Certified Auditors are authorised to perform an official APIC Audit that is coordinated by the API Compliance Institute. While
efforts have been made to assure the accuracy APIC/CEFIC can not be held liable for any errors or omissions. You are not allowed to delete this disclaimer
when using this template.

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** Procedure, SOP, OI, memo, notes (personal), Q-manual