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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(PRODUCTION- CAPSULE) Page 3 of 18
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.
________________________________________________________
________________________________________________________
