VIVEK PHARMACHEM (INDIA) LIMITED
SELF INSPECTION AUDIT CHECKLIST
(PRODUCTION- PACKING) Page 1 of 14
SELF INSPECTION PROTOCOL
PACKING-SECTION
PROTOCOL NO. VPSI 001-01
DATED
SUPERSEDES VPSI 001-00
PROTOCOL CONTAINS PAGES 14 PAGE INCLUDING COVER PAGE
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SELF INSPECTION AUDIT CHECKLIST
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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- PACKING) Page 3 of 14
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 necessary.
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)
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Rating of Audit Good = G Satisfactory = S Inadequate = I
Reviews Standard Operating Procedures
Personnel
Health and Safety
Safety and accident Management
Cleaning and Sanitization
Past & 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
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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 ?
__________________________________________________________
___________________________________________________________
4.0 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
. Packaging 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?
______________________________________________________
______________________________________________________
4.5.2 Are beard covers used?
______________________________________________________
______________________________________________________
5.0 FACILITIES
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3.1 Is the department maintained in good state of repair?
______________________________________________________
______________________________________________________
3.2 Is the department neat and orderly with sufficient space for equipment
and operations ?
_____________________________________________________
_____________________________________________________
3.3 Examine the area at the end of a day's work . Is it left neat and tidy ?
_____________________________________________________
_____________________________________________________
3.4 Are all work areas clearly labeled with the name and the batch number
of the product being processed ?
________________________________________________________
________________________________________________________
3.5 Is there adequate physical separation between different packaging lines
to prevent mix-ups and/or cross-contamination?
________________________________________________________
________________________________________________________
3.6 Are all parts of the line where product or primary packaging components are
exposed covered to prevent accidental contamination of the product?
________________________________________________________
________________________________________________________
3.7 Is relative humidity control employed in areas where moisture sensitive drugs
are packaged?
________________________________________________________
________________________________________________________
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3.7.1 Examine the records for a moisture-sensitive drugs that was
processed recently. Is the relative humidity recorded in the batch
record.
________________________________________________________
________________________________________________________
4.0 CLEANING PROCEDURES
4.1 Is there a written procedure for the cleaning of the packaging facility?
________________________________________________________
________________________________________________________
4.1.1 Is there documented evidence that the cleaning procedure is being followed?
________________________________________________________
________________________________________________________
4.2 Is there a written procedure for the cleaning of packaging equipment.
Between batches of the same product?
Between batches of different products?
________________________________________________________
________________________________________________________
4.3 Examine the machine duty card for the product currently being filled. Is
it filled out with all the required information?
________________________________________________________
________________________________________________________
5. LINE CLEARANCE PROCEDURES
5.1 Watch personnel performing line clearance. Is each stage of the process
performed by one individual and then independently verified by a second
individual?
________________________________________________________
________________________________________________________
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5.2 Examine the area prior to the introduction of packaging materials. Is it
clean and free from any material from the previous batch?
________________________________________________________
________________________________________________________
5.3 Do the packaging materials arrive on a covered trolley?
________________________________________________________
________________________________________________________
5.4 Are packaging materials verified against a master set to ensure that they
are the most recent edition and the correct materials for the batch?
________________________________________________________
________________________________________________________
5.5 Are the quantities of packaging materials verified against the amounts stated
as dispensed from the warehouse?
________________________________________________________
________________________________________________________
5.6 Is the batch number and expiration date recorded on the packaging materials
standard verified by QA against the batch number?
________________________________________________________
________________________________________________________
6.0 MASTER PACKAGING MATERIALS FILES
6.1 Is a complete set of files available in the department with samples of
packaging materials for each product packaged there?
________________________________________________________
________________________________________________________
6.1.1 Is there a written procedure for maintaining and updating of these
files?
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________________________________________________________
________________________________________________________
6.1.2 Are all samples printed packaging materials in the files signed
and dated by a QA representative to indicate that they are the
correct master materials?
________________________________________________________
________________________________________________________
7.0 WORKING PROCEDURES
7.1 Is there a procedure for the daily checking of balances used in the department?
________________________________________________________
________________________________________________________
7.1.1 Are there records to indicate that the procedure is being followed?
________________________________________________________
________________________________________________________
7.2 Is all instrumentation in the department labeled with a valid calibration sticker?
________________________________________________________
________________________________________________________
7.3 Are all Perspex covers for product protection closed at all times during
the packaging operation?
________________________________________________________
________________________________________________________
7.4 When packaging dry powder suspensions, is there a written procedure for
the refilling of powder when the correct fill weight is not achieved?
________________________________________________________
________________________________________________________
7.5 Are samples of all printed packaging materials used in the batch attached
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to the batch record?
________________________________________________________
________________________________________________________
7.6 Is there a written procedure for the reconciliation of printed packaging materials?
________________________________________________________
________________________________________________________
7.6.1 Watch the reconciliation being made. Are remaining packaging
materials accurately counted?
________________________________________________________
________________________________________________________
7.6.2 Are rejected packaging materials collected throughout the batch
in a manner that permits accurate counting for reconciliation?
________________________________________________________
________________________________________________________
7.7 Is there a written procedure for the issuance of additional packaging
materials if the amount dispensed is not sufficient?
________________________________________________________
________________________________________________________
7.7.1 Does the procedure require
QA Approval prior to the dispensing of the additional quantity?
QA verification of the materials against the master prior to use?
Documentation of the above in the batch record, including samples
of the additional materials?
7.7.2 Is the procedure followed?
________________________________________________________
________________________________________________________
7.8 Is there a written procedure for clearing and inspecting the packaging
area at the end of the batch?
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7.8.1 Is the inspection documented in the batch record?
________________________________________________________
________________________________________________________
7.9 Is the batch yield calculated immediately upon completion of the packaging
operation and prior to the introduction of a new batch into the area?
________________________________________________________
________________________________________________________
7.9.1 Is the yield calculation independently verified by a second individual?
________________________________________________________
________________________________________________________
7.10 Are any excess overprinted packaging materials destroyed on completion of
the batch?
________________________________________________________
________________________________________________________
7.10.1 Is there a written procedure for the destruction of printed packaging
materials on completion of the batch or for their to the warehouse
7.10.2 Is it followed?
________________________________________________________
________________________________________________________
7.10.3 Is there a provision in the department for the separation of printed
packaging materials for destruction and rejected product?
________________________________________________________
________________________________________________________
8.0 IN-PROCESS CONTROL
8.1 Examine the records for the batch being processed. Are there written records of in-process
control checks?
________________________________________________________
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________________________________________________________
8.1.1 Is the frequency of checks in accordance with the relevant SOP?
________________________________________________________
________________________________________________________
8.2 Is there a written procedure for the examination of packaged product during
finishing operations to ensure correct labeling?
________________________________________________________
________________________________________________________
8.3 Is a representative sample of units collected at the end of the operation and
visually examined for correct labeling?
________________________________________________________
________________________________________________________
8.3.1 Are the results of such inspections documented and included
in batch records?
________________________________________________________
________________________________________________________
9.0 EQUIPMENT QUALIFICATION
9.1 Is there an approved annual program for the qualification of all production
equipment?
________________________________________________________
________________________________________________________
9.2 Are the equipment items identified with a distinguished code number?
________________________________________________________
________________________________________________________
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9.2.1 Is all critical instrumentation on the equipment items identified
with a valid calibration sticker?
________________________________________________________
________________________________________________________
9.2.2 Physically verify that all instruments found on the equipment
items are included in the protocols.
________________________________________________________
________________________________________________________
