VIVEK PHARMACHEM (INDIA) LIMITED

SELF INSPECTION AUDIT CHECKLIST

QUALITY-ASSURANCE Page 1 of 35

SELF INSPECTION PROTOCOL

FOR
QUALITY-ASSURANCE

PROTOCOL NO. VPSI 001-01

DATED

SUPERSEDES VPSI 001-00

PROTOCOL CONTAINS PAGES 35 PAGE INCLUDING COVER PAGE

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1.0 APPROVAL:

1.1 Pre-Approval: The approval of this protocol will be joint responsibility of the following function area:

Functional Area Name Sign Date

Quality Assurance J.S. Gour
Engineering Department Nand Lal
Production V.Parashar

1.2 Post-Approval: The approval of this protocol will be joint responsibility of the following function area:

Functional Area Name Sign Date

Quality Assurance J.S. Gour
Engineering Department Nand Lal
Production V.Parashar

1.3 Final-Approval: The final approval of this protocol will be joint responsibility of following function
area:

Designation Name Sign Date

Quality Assurance Manager D.P.Singh
Managing Director Mr. Kuldeep Gupta

2.0 Principal : The purpose of self inspection is to evaluate the section of the manufacturing facility
compliance with GMP in all aspects of production and quality control The self inspection program is
designed to detect any shortcoming in the implementation of GMP. The audit team will be responsible
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to evaluate the implementation of GMP objectively. The head of the department will be responsible for
implementation of the corrective action.

2.1 Item for self-inspections:

(a) Personal
(b) Premises
(c) Maintenance
(d) Storage of the products
(e) Equipments
(f) In-Process control
(g) Quality control
(h) Documentations
(i) Sanitization and hygiene
(j) Validation program
(k) Calibration of Instruments.
(l) Recall procedure
(m) Complaint management
(n) Label control
(o) Results of previous self-inspection and any corrective action taken.

2.2 Self inspection Team:

The person of the self-inspection team should be familiar with GMP and related to the respective field

2.3 Frequency of the Self inspection:

The self inspection required minimum once in a year.

2.4 Self inspection Report:

The report should be made at the completion of a self inspection The report should include:
(a) Self inspection results
(b) Evolution and conclusions
(c) Recommended corrective action.

2.5 Follow up action:

The management evaluate both the self inspection report and corrective action as neccesary.

2.6 Quality audit:

A quality audit consist of an examinations assessment of all part of a quality system with specific
purpose of improving it.

Date (s) of Audit

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Purpose of Audit Routine Other

Rating of Audit Good = G Satisfactory = S Inadequate = I
Reviews Standard Operating Procedures
Personnel
Batch Record Review
Deviation Report
Change Control Records
Annual Review - Product Quality Standards
Self Inspection
Complaints
Goods Destruction Records
Special Release Batches
Rejected Batches
Returned Goods
Recalls
Facilities
Instrumentation and Calibration
Sample Receipt , Storage and Documentation
Test procedures
Recording Result
Standard Solutions
Repeat Testing
Evaluation / Supervision of Results
Method Validation
Stock Cultures
Environment and periodic monitoring (Clean Room)
Based on review of the above mentioned documents and data and the information recorded on the
following pages, the Personnel & Administration , has been audited for compliance with the criteria in this
Self Inspection Audit Checklist. The Evaluations and Conclusions of the audit observations are attached.
Results : Corrective action is / is not required . ( If required, attach list ).

Approval by Audit Team

SIGNATURE

NAME Mr. Kuldeep D.P.Singh Vinod Parasher J.S.Gaur Nand Lal

Gupta
DESIGNATION Director Manager QA Manager Manager Manager
Production Quality Control Engineering
DATE

3. Standard Operating Procedure

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3.1 Is a complete index and a complete set of applicable SOPs available in the
department ?

_____________________________________________________________

______________________________________________________________

3.1.1 Are the index and the SOPs current ?

_________________________________________________________

_________________________________________________________

3.1.2 Is the set of SOPs correctly organized according to the index ?

_________________________________________________________

_________________________________________________________

4. Personnel
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4.1 Select three employees working in the Department. Are their

training records up-to-date ?

____________________________________________________________

_____________________________________________________________

4.2 Have the employees undergone training in the following areas

during the last year ?

* GMPs

* SOPs

* Quality Assurance Systems

* GLPs

____________________________________________________________

_____________________________________________________________

4.3 Question several employees about the operations they are performing. Are they
knowledgeable about their job functions ?

____________________________________________________________

_____________________________________________________________

4.4 Have the employees undergone training according to the relevant SOP ?

______________________________________________________________

_____________________________________________________________

4.5 Are all employees attired according to the appropriate germinating SOP ?

______________________________________________________________

_____________________________________________________________
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4.6 Are detailed , written job descriptions available for all employees ?

_____________________________________________________________

_____________________________________________________________

4.7 Is an up-to date organisational chart of the Quality Assurance Department

available ?

_____________________________________________________________

_____________________________________________________________

5. Batch Record Review

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5.1 Is there an SOP for batch record review prior to release ?

____________________________________________________________

____________________________________________________________

5.2 Is there a comprehensive checklist for batch record review prior to release ?

____________________________________________________________

____________________________________________________________

5.3 Is there a tracking procedure in place to ensure that a batch record with a
deviation report attached to it cannot be released prior to the completion of any
required investigation ?

____________________________________________________________

____________________________________________________________

5.4 Examine three recently released batch records.

Product : _____________ Batch No.: ________________

Product : ______________ Batch No.: _________________

Product : ______________ Batch No.: _________________

5.4.1 Are the records complete with respect to the following?

* The master formula is signed as true copy.
* Any changes to the master formula are QA authorised
prior to manufacturing
 All relevant signatures are present.
 All relevant data are present.

* All relevant data are accurate.

* Yield calculation at each stage of production conforms
to the SOPs
* All calculations are verified by a second individual.
* Any deviations are justified , fully explained and
authorised.
___________________________________________________________

____________________________________________________________

6. Deviation Reports
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6.1 Select three manufacturing deviation report (MDRs) prepared within the last
six months.

Product : _______________ Batch No.: ______________

Product : _______________ Batch No.: ______________
Product : _______________ Batch No.: ______________

6.1.1 Were the MDRs completed prior to release of the Batch ?

__________________________________________________________

__________________________________________________________

6.1.2 Does the relevant SOP require a written investigation and follow-up on
implementation of recommendations ?

__________________________________________________________

__________________________________________________________

6.1.3 Are the MDRs filled out in accordance with the SOP ?

__________________________________________________________

__________________________________________________________

6.1.4 If necessary, is there a fully documented investigation ?

__________________________________________________________

__________________________________________________________
6.1.5 Have recommendations been made to prevent the deviation from recurring ?

__________________________________________________________

__________________________________________________________

6.1.6 Have recommendations for corrective action been implemented ?

__________________________________________________________

__________________________________________________________

6.1.7 Does the SOP require periodic review of MDRs ?

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__________________________________________________________

__________________________________________________________

6.2 Examine the daily deviation reports from the three months preceding the audit.
Is there follow-up to prevent recurrence .

_________________________________________________________

__________________________________________________________

6.2.1 Select three reports at random. Are they filled out in accordance
with the relevant SOP ?

_________________________________________________________

__________________________________________________________

6.3 Review the monthly summaries of all deviations( not product specific) for the
six months preceding the audit. Are there deviations that recur more than once ?

_________________________________________________________

__________________________________________________________

7. Change Control Records

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7.1 Are all changes that may impact product quality authorized by Quality
Assurance prior to implementation ?

_________________________________________________________

__________________________________________________________

7.2 Examine three recent change control forms.

___________________________________________________________

___________________________________________________________

7.2.1 Have the forms been completed and closed ?

___________________________________________________________

___________________________________________________________

7.2.2 Were any required tests performed and the results evaluated prior to closing
the forms ?

___________________________________________________________

___________________________________________________________

7.3 Has all relevant documentation been updated ?

___________________________________________________________

___________________________________________________________

Verify that validation protocols have been revised where appropriate.

___________________________________________________________

___________________________________________________________

8. Annual Review -Product Quality Standards

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___________________________________________________________

___________________________________________________________

8.1 Examine three product annual reviews completed at least three months prior to
the audit.

Product : ___________________ Batch No.: ______________

Product : _________________ Batch No.: _______________
Product : _________________ Batch No.: ______________
8.1.1 Does the review comment on any out-of-limit or unusual results ?

____________________________________________________________

____________________________________________________________

8.1.2 Does the review includes special release batches ?

____________________________________________________________

____________________________________________________________

8.1.3 Does the relevant SOP require that management be informed of

problems identified during the review ?

____________________________________________________________

____________________________________________________________

8.1.4 Is there a record of examination of reserve samples for the products reviewed?
Were the samples found to be satisfactory ?

____________________________________________________________

____________________________________________________________

8.1.5 Have recommended corrective actions been implemented ?

____________________________________________________________

____________________________________________________________

9. Self-Inspection
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9.1 Is there an SOP that requires that self-inspection be performed in all Deptt ?
___________________________________________________________

__________________________________________________________

9.2 Is self-inspection performed according to the frequency stated in the SOP ?

___________________________________________________________

__________________________________________________________

9.3 Do all personnel required by the SOP to participate in inspections

actually do so ?

___________________________________________________________

__________________________________________________________

9.4 Are written reports available for all inspections performed during the past year ?
___________________________________________________________

__________________________________________________________

9.5 Is there written evidence of corrective action implemented as a result of the

inspections ?

___________________________________________________________

__________________________________________________________

10. Complaints
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10.1 Is there an SOP for dealing with complaints ?

___________________________________________________________

__________________________________________________________

10.2 Examine three recent complaints files.

Product : _________________ Batch No.: ________________

Product : ________________ Batch No.: ___________________
Product : _________________ Batch No.: ___________________

10.2.1 Do the files contain all the relevant data ?

____________________________________________________________

____________________________________________________________

10.2.2. Have the files been signed by the relevant personnel ?

___________________________________________________________

___________________________________________________________

10.2.3 Could any of the above complaints affect other batches of the product and,
if so , has an investigation been initiated and appropriate action taken ?

___________________________________________________________

___________________________________________________________

10.3 Examine the list of complaints for the year preceding the audit. Are there
products that have several complaints and , if so, has appropriate corrective
action been implemented ?

___________________________________________________________

___________________________________________________________

11. Goods Destruction Records

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11.1 Is there an SOP for destruction of

* Product components and packaging materials ?
* Raw Materials ?
* In-Process material ?
* Finished Product ?

____________________________________________________________

____________________________________________________________

11.2 Examine the goods destruction records file.

11.2.1 Is it identical to that in the warehouse ?

___________________________________________________________

__________________________________________________________

11.2.2 Are all goods destruction forms QA approved prior to destruction ?

__________________________________________________________

__________________________________________________________

11.2.3 Is there written evidence that the destruction order has been carried out ?

___________________________________________________________

__________________________________________________________
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12. Special Release Batches

12.1 Is there an SOP for the special release of batches ?

_________________________________________________________

_________________________________________________________

12.2 Examine the list of special releases for the current year Select three batches.

Product : _______________ Batch No.: ____________

Product : _______________ Batch No.: _____________

Product : _______________ Batch No.: ______________

12.2.1 List the reasons (s) for the special release.

1.
2.
3.

12.2.2 Is there a written investigation, including conclusions and , if appropriate ,

follow - up action for each of the batches ?

____________________________________________________________

____________________________________________________________

12.2.3 Are there any products that have more than one special release , if so, is the
first batch referred to in the decision to release the later batch ?

____________________________________________________________

____________________________________________________________
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13. Rejected Batches

13.1 Examine the list of rejected batches for the current year.
Select three batches.

Product : ______________ Batch No.:__________________

Product : ________________ Batch No.:__________________
Product : _________________ Batch No.: ___________________
13.1.1 List the reason (s) for the rejection.

1.

2.

3.

13.1.2 Specify at which stage of production the batches were rejected.

_________________________________________________________

________________________________________________________

13.1.3 Is there a written investigation, including conclusions as to the cause

of the failure and , if appropriate , follow-ups action for each of the batches ?

_____________________________________________________________

_____________________________________________________________

13.1.4 Are there any products that have more than one rejected batch and ,
if so , has corrective action been recommended and implemented ?

___________________________________________________________

___________________________________________________________
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14. Returned Goods

14.1 Is there a written procedure for holding , testing and reprocessing returned
drug products ?

____________________________________________________________

____________________________________________________________

14.2 Examine the list of returned goods for the current year.
Select three batches.

Product : ______________ Batch No.: __________________

Product : ________________ Batch No.:__________________
Product : _________________ Batch No.: ___________________

14.2.1 Is there a record for each batch , including the following details ?
* Name of Customer
* Name and strength of the product
* Batch number
* Reason for return
* Quantity returned
* Date of disposition
* Ultimate disposition

____________________________________________________________

____________________________________________________________

14.2.3 List the reason (s) for the return.

1. _______________________________________________________

2. ______________________________________________________

3. ______________________________________________________

14.2.3 List the disposition of the returned goods.

1. _______________________________________________________
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2. ______________________________________________________

3. ______________________________________________________

14.2.4 Is the disposition adequately justified with a documented

investigation and conclusions authorised by quality assurance

_______________________________________________________

______________________________________________________

14.2.5 Could the reason for any of the returns implicate other batches of the
product and , if so , has an investigation been initiated and appropriate
action taken ?

_______________________________________________________

______________________________________________________
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15. Recalls

15.1 Is there a written procedure for the recall of drug products

that ensures that responsible officials of the firm are notified
in writing of the recall ?

__________________________________________________________

_________________________________________________________

15.2 Have there been any recalls during the current year ?

15..2.1 Specify :

__________________________________________________________

15.2.2 List the disposition of the recalled goods.

_____________________________________________________

15.2.3 Is the disposition adequately justified with a documented

investigation and conclusions authorised by Quality Assurance

______________________________________________________

________________________________________________________

15.2.4 Could the reason for the recall implicate other batches of the product
and , if so , has an investigation been initiated and appropriate action
taken ?

___________________________________________________________

____________________________________________________________
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QUALITY CONTROL LAB

16. Facilities

16.1 Is the laboratory maintained in a good state of repair ?

__________________________________________________________

__________________________________________________________

16.2 Is the laboratory neat and orderly with sufficient space for equipment and
operations ?

__________________________________________________________

__________________________________________________________

16.3 Is there evidence of good housekeeping ?

__________________________________________________________

__________________________________________________________

16.4 Are all reagents and solutions

* Clearly labelled with their proper name ?
* Labelled with date of receipt and / or expiration date ?

__________________________________________________________

__________________________________________________________

16.5 Are prepared solutions labelled with the

* Name of person who prepared them ?
* Date of preparation ?
* Expiration date ?
__________________________________________________________

__________________________________________________________
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17. Instrumentation and Calibration

17.1 Is there an approved preventive maintenance program for all equipment

used in the laboratory ?

__________________________________________________________

__________________________________________________________

17.1.1 Is there evidence that it is followed ?

__________________________________________________________

__________________________________________________________

17.1.2 Is the program based on manufacturer's recommendations ?

__________________________________________________________

__________________________________________________________

17.1.3 If not, is there a documented rationale for the alteration of the

schedule?

__________________________________________________________

__________________________________________________________

17.1.4 Is there documented evidence that the person who performs the
preventive maintenance is qualified to do so ?

__________________________________________________________

__________________________________________________________
17.2 Select three major instruments used in the laboratory.
1. ________________________ ID No. _________________
2. ________________________ ID No. _________________
3. _______________________ ID No. _________________

17.2.1 Are there written procedures for operating the instruments ?

_________________________________________________

_________________________________________________
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17.2.2 Are there written procedures for calibrating the instruments ?

_________________________________________________

_________________________________________________

17.2.3 Is there a valid calibration sticker on each instrument ?

_________________________________________________

_________________________________________________

17.2.4 Examine the calibration records for the instruments.

* Are they up-to-date ?
* Are the results within limits ?
_________________________________________________

_________________________________________________

17.2.5 Is there an SOP for corrective action in the event that an

instrument is found to be out of calibration /
_________________________________________________

_________________________________________________

17.2.6 Where standards are used to calibrated an instrument, in there a

written procedure for their preparation ?

_________________________________________________

_________________________________________________
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18. Sample Receipt , Storage and Documentation

18.1 Is a specific person responsible for the receipt of samples for testing ?

__________________________________________________________

__________________________________________________________

18.2 Is there a written SOP describing sample receipt and recording (logging in) ?

__________________________________________________________

__________________________________________________________

18.3 Where are samples stored before and after testing ?

__________________________________________________________

__________________________________________________________

18.4 Are samples retained after testing is complete ?

__________________________________________________________

__________________________________________________________

18.5 What happens to samples after testing and reporting are completed ?

__________________________________________________________

__________________________________________________________

18.6 Is there a time limit on how long a sample may remain in the laboratory
prior to testing ?

__________________________________________________________

__________________________________________________________
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19. Test Procedures

19.1 Are there approved test procedures available for all tests performed in the
laboratory ?

___________________________________________________________

___________________________________________________________

19.2 Is there a written procedure for ensuring that all pharmacopoeia procedures
are updated when a supplemental monograph is issued ?

___________________________________________________________

___________________________________________________________

19.3 Examine the work currently being performed on one of the HPLCs.
Product Name : ______________________________________________
Batch No. ____________________________________________________
17.3.1 Is the test procedure at hand ?

___________________________________________________________

___________________________________________________________

19.3.2 Is it up-to-date ?

___________________________________________________________

___________________________________________________________

19.3.3 Is it being accurately followed ?

___________________________________________________________

___________________________________________________________

19.3.4 Has the test method been validated for precision and reliability ?
___________________________________________________________

___________________________________________________________

19.3.5 Is the analysis recorded in the analyst's notebook prior to beginning

work , including the physical appearance to the sample ?
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________________________________________________________

________________________________________________________

19.3.6 Has the analyst recorded all the relevant details of the product being
tested , including the attachment of printouts or records of weighings?

________________________________________________________

________________________________________________________

19.3.7 Is there documented evidence that system suitability was determined

prior to use of the chromatography in the analysis ?

________________________________________________________

________________________________________________________

19.3.8 Is there a reference to the test method used in the analyst's notebook?

________________________________________________________

________________________________________________________
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20. Recording Results

20.1 Examine an analyst's notebook.

20.1.1 Is it a bound book with numbered pages ?
20.1.2 Is it neatly filled in and legible ?
20.1.3 Are any cross-outs initialed and dated ?

______________________________________________________________

_______________________________________________________________

20.1.4 Is there an SOP for notebook maintenance ?

________________________________________________________

________________________________________________________

20.1.5 Is there a record of the instrument used for testing together with any
raw data ?

________________________________________________________

________________________________________________________

20.1.6 Are all calculations recorded ?

______________________________________________________

________________________________________________________

20.1.7 Are all charts, graphs and printouts labelled with the
* Product name and batch number ?
* Date of the test ?

______________________________________________________

________________________________________________________

20.1.8 How are raw data transferred from notebook to the final report ?
______________________________________________________

________________________________________________________
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20.1.9 Are numbers rounded in accordance with an approved SOP ?

_________________________________________________________

__________________________________________________________

20.1.10 Do the dates on graphs/charts conform with the dates of analyses ?

_________________________________________________________

__________________________________________________________

20.1.11 Is there a statement in the notebook as to whether or not the

sample passes the test ?

_________________________________________________________

__________________________________________________________

20.1.12 Is the analyst's signature recorded in the notebook ?

_________________________________________________________

__________________________________________________________
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21.Standard Solutions

21.1 Examine a reference standard.

_________________________________________________________

_________________________________________________________

21.1.1 Is it stored appropriately ?

21.1.2 Is a certificate of analysis available from the supplier ?
21.1.3 Is the standard tested internally to confirm its quality?

_________________________________________________________

_________________________________________________________

21.2 Is there a written SOP for the preparation of standards ?

_________________________________________________________

_________________________________________________________

21.2.1 How often are standards prepared ?

_______________________________________________________

_______________________________________________________

21.2.2 What quality of water is used for analyses and for the
preparation of standards ?

_______________________________________________________

_______________________________________________________

21.2.3 What expiration date is given to internally prepared standard?

______________________________________________________

_____________________________________________________

21.2.4 Has the expiration date been validated ?

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______________________________________________________

______________________________________________________

21.2.5 How often are standard solutions tested ?

______________________________________________________

______________________________________________________

21.2.6 Are in-house standards certified against compendia standards ?

______________________________________________________

______________________________________________________

21.2.7 Was the method used to certify the in-house standard specific ?

______________________________________________________

______________________________________________________

21.3 Is there a record of the preparation of volumetric solutions ?

___________________________________________________________

____________________________________________________________

21.3.1 Are volumetric solutions freshly prepared ?

______________________________________________________

______________________________________________________

21.3.2 If stored , what expiration date are they given ?

______________________________________________________

______________________________________________________

21.3.3 Examine a test where a volumetric solution was used. Was the
titre correctly recorded in the notebook ?

___________________________________________________
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__________________________________________________

22. Repeat Testing

22.1 Is there an SOP for repeat testing

* On the same sample ?
* On a new sample ?

____________________________________________________________

___________________________________________________________

22.1.1 Does the SOP require supervisory intervention prior to repeating

any test ?

____________________________________________________________

___________________________________________________________

22.1.2 Does the SOP describe a procedure for invalidating results ?

____________________________________________________________

___________________________________________________________

22.1.3 Does the procedure require a written explanation of the reason for
the retest ?

____________________________________________________________

___________________________________________________________
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23. Evaluation/Supervision of Results

23.1 Is there an SOP for review of test data and calculations ?

______________________________________________________________

______________________________________________________________

23.2 Are raw data reviewed prior to release from the laboratory by a person
other than the analyst who performed the test ?

______________________________________________________________

______________________________________________________________

23.2.1 Are notebooks routinely reviewed by a supervisor ?

_________________________________________________________

_________________________________________________________

23.2.2 Do reviewers sign the notebook to indicate that it has been reviewed ?

_________________________________________________________

_________________________________________________________
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24. Methods Validation

24.1 Have all in-house methods been validated ?

_________________________________________________________

_________________________________________________________

24.2 Does methods validation provide data to demonstrate

* Linearity ?
* System precision ?
* Method precision ?
* Method specificity?
* Method sensitivity ?
* Method ruggedness ?

_______________________________________________________________

_______________________________________________________________
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MICROBIOLOGICAL LABORATORY

25. Stock Cultures

25.1 Is there an SOP for the receipt and handling of ATCC cultures ?

________________________________________________________

________________________________________________________

25.2 Are cultures received with a certificate of analysis ?

________________________________________________________

________________________________________________________

25.3 How often are ATCC cultures transferred ?

________________________________________________________

________________________________________________________

25.3.1 Is there a maximum number of times that ATCC cultures may be

transferred ?
________________________________________________________

________________________________________________________
25.3.2 Is it adhered to ?

________________________________________________________

________________________________________________________
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26. Environment and Periodic Monitoring (Clean Room)

26.1 Is there an SOP for monitoring differential air pressures ?

____________________________________________________________

____________________________________________________________

26.2 Are there written records of air pressures checked and signed ?

____________________________________________________________

____________________________________________________________

26.3 Is there an SOP for environmental monitoring in the clean room ?

____________________________________________________

26.3.1 Do results conform with the limits stated in the SOP ?

____________________________________________________

____________________________________________________

26.3.2 When out-of-limit results were obtained, was corrective action

implemented in accordance with the SOP ?

____________________________________________________

_____________________________________________________

26.4 Examine records of monitoring for the past three months.

26.4.1 Are there records of checking laminar airflow velocities ?

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26.4.2 Are there records of checking air changes ?

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