VIVEK PHARMACHEM (INDIA) LIMITED

SELF INSPECTION AUDIT CHECKLIST

(PRODUCTION- CAPSULE) Page 1 of 18

SELF INSPECTION PROTOCOL

CAPSULE-SECTION

PROTOCOL NO. VPSI 001-01

DATED

SUPERSEDES VPSI 001-00

PROTOCOL CONTAINS PAGES 18 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

Purpose of Audit Routine Other (specify)
Rating of Audit Good = G Satisfactory = S Inadequate = I
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Reviews Standard Operating Procedures

Personnel
Health and Safety
Safety and accident Management
Cleaning and Sanitization
Pest & Rodent Control / Waste Control
Training

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

3.0 STANDARD OPERATING PROCEDURES

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

__________________________________________________________

___________________________________________________________

4.0 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 ?

. cGMPs
. SOPs
. Encapsulation techniques
____________________________________________________________

____________________________________________________________

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

_____________________________________________________

_____________________________________________________

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

_____________________________________________________

_____________________________________________________

4.5 Are all employees attired according to the appropriate garmenting SOP?.

______________________________________________________

______________________________________________________

4.5.1 When necessary, do operators wear masks and gloves?

______________________________________________________

______________________________________________________

45.2 Are beard covers used?

______________________________________________________

______________________________________________________

5.0 FACILITIES
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5.1 Is the department maintained in good state of repair?

______________________________________________________

______________________________________________________

5.2 Is the department neat and orderly with sufficient space for equipment and operations ?

_____________________________________________________

_____________________________________________________

5.3 Examine the area at the end of a day’s work. Is it left neat and tidy?

______________________________________________________

______________________________________________________

5.4 Are all work areas clearly labeled with the name and the batch number
of the product being processed ?

________________________________________________________

________________________________________________________

6.0 PREVENTION OF CROSS CONTAMINATION

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6.1 Are doors closed at all times?

________________________________________________________

________________________________________________________

6.2 Is personnel clothing clean, unstained and dust free, including shoes or sliper ?

________________________________________________________

________________________________________________________

6.4 Is negative pressure maintained in working areas at all times during work?

________________________________________________________

________________________________________________________

6.5 What is the quality of the air in the department (filter designation)?

________________________________________________________

________________________________________________________

6.6 Are there approved SOPs for the maintenance of ceiling filters?

________________________________________________________

________________________________________________________

6.7 Is dirty equipment covered prior to transfer to the washing room?

________________________________________________________

________________________________________________________

7. EQUIPMENT AND FACILITY CLEANING

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7.1 Are pallets and drums brought into the area clean and free from powder / dust ?

________________________________________________________

________________________________________________________

7.2 Is the equipment neat, clean and rust free?

________________________________________________________

________________________________________________________

7.3 When not in use, is equipment covered so as to prevent accidental

contamination?

________________________________________________________

________________________________________________________

7.4 Is the equipment suitably designed for its purpose?

________________________________________________________

________________________________________________________

7.5 Are there specific procedures for the cleaning of major equipment items?

________________________________________________________

________________________________________________________

7.6 Select a Capsule Filling Machine.

________________________________________________________

Examine the following records:

 Machine duty card.
 Cleaning checklist

________________________________________________________

________________________________________________________

7.7 Select one batch recorded on the machine duty card.

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Batch No.:_______________________________________________

7.7.1 Is the cleaning checklist for the equipment complete?

________________________________________________________

________________________________________________________

7.7.3 Is the cleaning correctly recorded on the room duty card as major or minor.

________________________________________________________

________________________________________________________

7.8 Visually inspect one piece of equipment that is not in use.

7.8.1 Is it labeled with respect to its cleanliness status?

7.8.2 Is it clean?

________________________________________________________

________________________________________________________

7.9 Do cleaning procedures include a requirement for the cleaning of small items
(e.g. portable computers, balances, etc.)?

________________________________________________________

________________________________________________________

7.10 Do cleaning procedures specify the detergent type and concentration to be used?

________________________________________________________

________________________________________________________

7.11 Is there an approved protocol for cleaning validation of capsule filling machine?

________________________________________________________

________________________________________________________

7.11 Is there documented evidence that it is being followed?

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________________________________________________________

________________________________________________________

7.12 Is there an SOP for the quarantine of equipment prior to obtaining the
results of cleanliness tests?

________________________________________________________

________________________________________________________

7.12.1 If not, is there a validated cleaning procedure?

________________________________________________________

________________________________________________________

7.13 Is the air suction tubing, used in the department to prevent powder dispersion,
product dedicated?

________________________________________________________

________________________________________________________

8.0 WORKING PROCEDURES

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8.1 Examine the record of the daily check of balances in the department.

8.1.1 Is it complete and accurately filled out?

8.1.2 Are all results within the specifications?
8.1.3 If not, is there a record of the implementation of corrective action?

________________________________________________________

________________________________________________________

8.2 Perform a visual examination of the weights with which the check is
performed.

8.2.1 Are they in a good state of repair?

8.2.2 Are they clean?
8.2.3 Do they bear a valid calibration sticker?

________________________________________________________

________________________________________________________

8.3 Examine the batch record for a batch that is being processed.

Product:_________________________________________________

Batch No.:_______________________________________________

8.3.1 Is the master formula signed as being an accurate copy of the

original?

________________________________________________________

________________________________________________________

8.3.2 Have any changes to the master formula been authorised by QA?

________________________________________________________

________________________________________________________

8.3.3 Has the batch been recorded on the machine duty card?

________________________________________________________
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________________________________________________________

8.3.4 Is the record completely and accurately filled out upto the appropriate
stage of processing?

________________________________________________________

________________________________________________________

8.3.5 Does the filling speed conform to the required parameters?

________________________________________________________

________________________________________________________

8.4 Do yield calculations after encapsulation conform with the relevant SOP?

________________________________________________________

________________________________________________________

8.4.1 If not, has an MDR been completed and an investigation conducted?

________________________________________________________

________________________________________________________

8.4.2 Is the yield verified by a second individual?

________________________________________________________

________________________________________________________

8.5 Examine the totes used for collecting capsule.

8.5.1 Are they correctly labeled?

8.5.2 Is the weight recorded on real time (i.e. after the tote is completely
filled)

________________________________________________________

________________________________________________________

8.6 Is there an SOP for monitoring capsule weight during production.

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8.6.1 Is it followed?

________________________________________________________

________________________________________________________

8.7 If necessary, is there an SOP for de-dusting or polishing capsules after filling?

8.7.1 Is it followed?

________________________________________________________

________________________________________________________

9. IN-PROCESS CONTROL
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9.1 Is there an approved SOP for in-process control?

________________________________________________________

________________________________________________________

9.2 Does the SOP state at what frequency tests must be performed by
 Production personnel?
 Quality Control personnel?

________________________________________________________

________________________________________________________

9.2.1 Examine a batch record. Is the test frequency adhered to?

________________________________________________________

________________________________________________________

9.2.2 Do all test results conform to specifications?

________________________________________________________

________________________________________________________

9.2.3 Is the SOP specific with regard to corrective action, in the event
that results do not conform to specifications?

________________________________________________________

________________________________________________________

9.2.4 Are there printouts available for all in-process test results labeled
with the

 Product name?
 Batch number?
 Date and time of testing?
 Signature of the tester?

] 9.2.5 Examine a batch run sheet.

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 Do the recorded specifications conform with the approved product

specification?

________________________________________________________

________________________________________________________

 Are results recorded in the correct units as stated on the form?

________________________________________________________

________________________________________________________

9.3 Is there an SOP for collecting a composite sample for final testing by
Quality Control?

________________________________________________________

________________________________________________________

9.3.1 Is the SOP followed?

________________________________________________________

________________________________________________________

9.4 Is all testing equipment labeled with a valid calibration sticker?

________________________________________________________

________________________________________________________
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10. LUBRICANTS

10.1 Is equipment designed in such a way that lubricants or coolants can

come into contact with components or drug product?

________________________________________________________

________________________________________________________

10.2 Is there an approved list of good-grade lubricants for use where they may
contact product?

________________________________________________________

________________________________________________________

10.2.1 Is there a written procedure for the receipt and approval of such
lubricants?

________________________________________________________

________________________________________________________

10.2.2 Is a record made of the catalogue number of the lubricant used

when maintenance is perfumed?

________________________________________________________

________________________________________________________

10.3 Examine the lubricants available in the department.

Are they clearly labeled and stored in a sanitary manner?

________________________________________________________

________________________________________________________
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11. EQUIPMENT QUALIFICATION

11.1 Is there an approved annual program for the qualification of all production
equipment?

________________________________________________________

________________________________________________________

11.2.1 Is all critical instrumentation identified with a valid calibration sticker?

________________________________________________________

________________________________________________________

11.2.2 Physically verify that all instruments found on the equipment

items are included in the protocol.

________________________________________________________

________________________________________________________

11.2.3 Cross-check with the calibration records that the equipment

items have the same classification in the qualification protocol
as in the calibration report.

________________________________________________________

________________________________________________________