6.

C Qualification documentation

6.C.5 SOP Qualification of facilities and equipment

Each company should define their own specific qualification sequence in an SOP.
One of many possible options is shown on the following pages.

Company name Logo

Operating procedure SOP no.

Valid from

6.C
Title Page x of y

Qualification of facilities and equipment Facilities

Replaces SOP no.

Binding for
Purchasing
Production
Quality control
Quality assurance

For information to

compiled by

checked by

approved

Change index
New compilation

C. Wawretschek / M. Lazar GMP Manual (Up04) Maas & Peither AG GMP Publishing (11)
 6 Qualification

1 Introduction

Background/objectives
The qualification should verify that facilities and equipment used for manufactur-
ing and testing are suitable for their intended purposes and that the required
quality of the medicinal products manufactured can be guaranteed. Qualification
is, thus, a basic factor for drug product quality and safety.
The SOP describes the general qualification procedure.

Other relevant rules and regulations

6.C

EU GMP Guideline 3.3.4 equipment must be suitable.

Annex 15 to EU GMP Guideline
PIC/S PI 006 qualification, validation and cleaning validation recommendations
Commission Directive 91/356/EEC of 13 June 1991 to define basic principles and
guidelines of good manufacturing practice for medicinal products for human use,
Chapter II Basic principles and guidelines of good manufacturing practice, Article
8.3 3.
United States 21CFR Parts 210 and 211 (Code of Federal Regulations) and
Guideline on General Principles of Process Validation.

Definition

Note: While the specific definitions vary between the United States and the EU,
the general intent is related closely, and therefore any variations between the
countries or regions are considered insignificant unless otherwise noted for the
purposes of this chapter.

Qualification
Documented evidence that facilities and equipment operate faultlessly and also
produce the expected results is established. Qualification is a multi-stage process
consisting of the following parts:

Design Qualification (DQ)

Documented evidence that the requirements for facilities and equipment
assessed in the planning phase by the future operator (user requirements) are fully
taken into account in the supplier's specification (technical specification).

User requirements
A summary of all contract giver requirements in relation to the scope of supply
and services.

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 6.C Qualification documentation

Technical specifications
A description of the implementation of all user requirements (specifications).

Installation Qualification (IQ)

Documented evidence that facilities and equipment satisfy the requirements of
the design qualification in terms of identity, installation, conformity with the
guidelines and documentation.

Operational Qualification (OQ)

Documented evidence that the equipment/facility is functioning correctly within

6.C
the specified parameters. The operational qualification is carried out without the
product.

Performance Qualification (PQ)

Documented evidence of the correct interaction of all facility and equipment
components with the relevant process. This qualification phase is considered sep-
arately and is carried out by the user.

Scope and responsibilities

Person responsible for qualification

This person ensures the qualification of equipment within his area of responsibil-
ity. He appoints a qualification task coordinator and a qualification team, and also
confirms that each qualification step has been concluded.

Qualification coordinator
This person coordinates the tasks of the qualification team and also compiles qual-
ification protocols and reports.

Qualification team
The team members are staff who have specialist qualifications with regard to the
technical functions; or, where computerized systems are the subject of the qualifi-
cation, have specialist qualifications with regard to the relevant IT function. Exter-
nal companies may also be part of the team.

Quality assurance
Qualification protocols and reports are checked to verify their compliance with the
rules of the quality assurance system and subsequently approved.

C. Wawretschek / M. Lazar GMP Manual (Up04) Maas & Peither AG GMP Publishing (13)
 6 Qualification

2 Implementation

Procurement of the equipment to be qualified is carried out by qualified suppliers.

A prospective qualification must be carried out for all new facilities and equip-
ment. Existing equipment that is already in operation must be qualified retrospec-
tively.
Each qualification is based on a risk analysis during which the critical parame-
ters of the facility and the environmental conditions are observed.
The qualification scope may be confined to the operational qualification in the
case of basic production and analysis equipment (e.g. pH meter or balance) and a
6.C

risk analysis may be omitted.

The contents of the user requirements and technical specification may be used
as the basis for the design qualification.
The technical specifications describe the purpose of the equipment and the
requirements in relation to technical data and conditions
Construction and workmanship,
accessories and spare parts,
physical and chemical parameters,
operation and cleaning,
safety at work,
customer service,
starting materials and products,
sampling
as well as scheduling and regulatory requirements.
Changes to the requirements are monitored by a uniform change control sys-
tem during the process. A requalification is required as a result of quality-relevant
changes.
The required specification describes the conversion of the equipment require-
ments, as defined in the user requirements, into checkable technical specifica-
tions.
The qualification is carried out and documented in the aforementioned
sequence. Each qualification step is followed by a formal confirmation that the
necessary qualification work has been properly completed.
Training and instruction of the operating personnel is carried out in a timely
manner and is documented.
Once the qualification has been successfully completed and the equipment
and facilities approved by the persons responsible for qualification, the handover
is made to the user, who in turn provides confirmation.

Flow chart
(See figure 6.C-8.)

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 6.C Qualification documentation

0LACINGOFORDER
BYTHE
PERSONRESPONSIBLE
FORQUALIFICATION

$EFINE
USERREQUIREMENTS

6.C
0ERSONRESPONSIBLE
FORQUALIFICATION

#OMPILE
technical SPECIFICATIONS

1UALIFICATION
The qualification protocol contains:
COORDINATOR Names of the persons responsible
Responsibilities
The objective of the qualification in-
cluding scheduling
&ORMATIONOF
QUALIFICATIONTEAM Description of the equipment to be
qualified and the qualification activi-
ties
0ERSONRESPONSIBLE
FORQUALIFICATION List of the necessary directions
NO

#OMPILE
QUALIFICATIONPROTOCOL

1UALIFICATION
COORDINATOR

2ELEASE
QUALIFICATIONPROTOCOL

0ERSONRESPONSIBLE
FORQUALIFICATION

Figure 6.C-8 Flow chart

C. Wawretschek / M. Lazar GMP Manual (Up04) Maas & Peither AG GMP Publishing (15)
 6 Qualification

!PPROVE
QUALIFICATIONPROTOCOL

1UALITYASSURANCE
6.C

#HECKCONFORMITY
OFtechnicalSPECIFICATIONS
WITHUSERrequirements

0ERSONRESPONSIBLE
FORQUALIFICATION

The testing schedules are based on the

#HECKCONFORMITY user requirements and the technical
WITH1!SYSTEM
REGULATIONS
specification.

Evidence of compliance with the user

1UALITYASSURANCE
requirements and the technical specifi-
cation is provided by the test and calibra-
tion protocols.

NO Technical The test and calibration documents are

SPECIFICATIONS
/+ prepared.

YES

#OMPILE
DETAILEDTESTING
SCHEDULES

1UALIFICATION
COORDINATOR

NO

Figure 6.C-8 Flow chart (cont.)

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 6.C Qualification documentation

#HECKCONFORMITYWITH
USERrequirementsAND
technicalSPECIFICATIONS

0ERSONRESPONSIBLE
FORQUALIFICATION
Necessary documentation:
Risk analysis
User requirements
!PPROVE Technical specifications

6.C
TESTINGSCHEDULES Qualification plan
P&I diagrams, design drawings and
1UALIFICATION bills of materials
ASSURANCE
Description of the components
NO
Spare parts list
Training documentation
4ESTING
SOPs, directions for cleaning, operat-
SCHEDULES/+ ing instructions
Maintenance and calibration instruc-
YES tions
Checks required by law
Qualification report
#ARRYOUTANDDOCUMENT
Handover protocol
$1)1/1AND01
Necessary documentation for equip-
1UALIFICATION ment that is already in operation:
COORDINATOR
User requirements
Qualification plan
Description of the technical equip-
ment
#OMPILE
DOCUMENTATION Training documentation
SOPs, directions for cleaning, operat-
1UALIFICATION ing instructions
COORDINATOR Maintenance and calibration instruc-
tions
Log book
Checks required by law
#HECKCONFORMITYOF Qualification report
DOCUMENTATIONWITH
'-0REGULATIONS

1UALITYASSURANCE

Figure 6.C-8 Flow chart (cont.)

C. Wawretschek / M. Lazar GMP Manual (Up04) Maas & Peither AG GMP Publishing (17)
 6 Qualification

#OMPILE
QUALIFICATIONREPORT

1UALIFICATION
COORDINATOR

2ELEASE
6.C

QUALIFICATIONREPORT

0ERSONRESPONSIBLE Minimum requirement for documenta-

FORQUALIFICATION tion of basic equipment used for produc-
tion and tests:
Risk analysis
#HECKCONFORMITYOF Description of the supply scope
qualificationREPORTWITH Training documentation
'-0REGULATIONS
ANDAPPROVE SOPs, directions for cleaning, operat-
ing instructions
1UALITYASSURANCE Qualification report
Maintenance and calibration instruc-
tions/protocols
&ORMALCONFIRMATION
THATQUALIFICATIONWORK The qualification report should at least
HASBEENSUCCESSFULLY contain the following:
CONCLUDED
Names of the persons responsible
0ERSONRESPONSIBLE Designation of the equipment
FORQUALIFICATION
Overall evaluation of the tests carried
out
List of measures still to be carried out
including designation of responsibil-
(ANDOVERTOTHEUSER
ities and scheduling

0ERSONRESPONSIBLE
FORQUALIFICATION

%ND

Figure 6.C-8 Flow chart (cont.)

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 6.C Qualification documentation

Revision
Once the qualification status has been achieved, it is subsequently checked and
evaluated every three to five years independent of the implementation of neces-
sary requalification measures: the resulting measures and results are documented.
United States regulators expect a documented quality assurance system and pro-
gram to exist, which establishes the circumstances under which a revalidation or
qualification should be performed. There is no specific predetermined period
specified.

Documentation and storage

6.C
Once the qualification report has been approved, the qualification status of the
equipment is labeled by inserting a qualification mark and comment in the log
book.
The documentation should be retained for at least five years after the facility or
equipment has been shut down or for at least the period established by local laws
or regulations.

Summary
The qualification documentation consists of qualification protocols with acceptance
criteria that have been defined and approved in advance, and qualification reports with
the results and a final evaluation.
The qualification master plan is a management instrument used to monitor all qualifi-
cation activities at a company: it lists the tasks to be carried out together with the re-
sponsibilities and schedules.
The general sequence is laid down in a qualification SOP.

C. Wawretschek / M. Lazar GMP Manual (Up04) Maas & Peither AG GMP Publishing (19)