VIVEK PHARMACHEM (INDIA) LIMITED

SELF INSPECTION AUDIT CHECKLIST

(PRODUCTION- DRY POWDER) Page 1 of 18

SELF INSPECTION PROTOCOL

DRY POWDER-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 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)
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
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

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

4.1 Select three employees working in the department . Are their training records up-to-date ?
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__________________________________________________________

__________________________________________________________

4.2 Have the employees undergone training in the following areas during the last year ?

. cGMPs
. SOPs
. Granulation 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

5.1 Is the department maintained in good state of repair?

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______________________________________________________

______________________________________________________

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

_____________________________________________________

5.3 Are all the raw materials for one batch assembled on a pallet wrapped in
polyethylene?
______________________________________________________

______________________________________________________

5.4 Where more than one pallet is designated for one batch, is each pallet clearly
labeled as one of the total number of pallets?
__________________________________________________

______________________________________________________

5.5 Where the batch is divided into portions, are the raw materials for each
portion assembled on separate pallets?
______________________________________________________

______________________________________________________

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

_____________________________________________________

_____________________________________________________

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

________________________________________________________

________________________________________________________

6.0 PREVENTION OF CROSS CONTAMINATION

6.1 Are doors closed at all times?

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________________________________________________________

________________________________________________________

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

________________________________________________________

________________________________________________________

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

________________________________________________________

________________________________________________________

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

________________________________________________________

________________________________________________________

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

________________________________________________________

________________________________________________________

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

________________________________________________________

________________________________________________________

7.0 EQUIPMENT AND FACILITY CLEANING

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

________________________________________________________

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 Is equipment constructed so that product contact surfaces are not

reactive or absorptive, so that it will not contaminate or in any way affect
the product being manufactured?
________________________________________________________

________________________________________________________

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

________________________________________________________

________________________________________________________

7.7 Select a major piece of equipment.

________________________________________________________

Examine the following records:

 Cleaning checklist
 Log book

________________________________________________________

________________________________________________________
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7.8 Select one batch recorded on the machine duty card.

Batch No.:_______________________________________________

7.8.1 Is the cleaning checklist for the equipment complete?

________________________________________________________

________________________________________________________

7.8.2 Does the checklist describe machine disassembly and assembly

for cleaning purposes?
________________________________________________________

________________________________________________________

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

________________________________________________________

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

7.9.1 Is it labeled with respect to its cleanliness status?

7.9.2 Is it clean?
________________________________________________________

________________________________________________________

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

________________________________________________________

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

________________________________________________________

7.11.1 Are the detergents available in the department identical to those listed
in the cleaning procedures.
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________________________________________________________

________________________________________________________

7.11.3 Are there records of detergent preparation?

________________________________________________________

________________________________________________________

7.12 Is there an approved protocol for cleaning validation.

________________________________________________________

________________________________________________________

7.12.1 Is there documented evidence that it is being followed?

________________________________________________________

________________________________________________________

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

________________________________________________________

7.14 Is there a written procedure for washing the sleeves of fluid bed dryers?

________________________________________________________

________________________________________________________

7.14.1 Is there a use log for sleeves that are not product dedicated?
________________________________________________________

________________________________________________________

7.14.2 Has the cleaning process been validated for sleeves that are not
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 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 authorized 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 Are any in-process results within the defined limits?

________________________________________________________

________________________________________________________

8.3.6 Has the recorder chart for the drying of the granulate been fully
labeled and attached to the batch record?

________________________________________________________

________________________________________________________

8.4 Is there a written procedure for the cleaning of drums after use?
________________________________________________________

________________________________________________________

8.5 Examine the in-process storage area for finished granulates.

8.6.1 Are the granulates properly labeled?

8.6.2 Is the batch assembled on one pallet and wrapped in polyethylene?
8.6.3 Is there an SOP defining the maximum period of time that a granulate
may stand prior to tableting?
________________________________________________________

________________________________________________________

8.6 Examine a sample of granulate to be sent to the laboratory for testing?

8.7.1 Is it labeled in accordance with the relevant SOP?

8.7.2 Does the sample weight conform with the required by the
relevant SOP?
________________________________________________________

________________________________________________________

8.6.3 Do the in-process assay results for the granulate conform with
the relevant SOP?
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________________________________________________________

________________________________________________________

8.6.4 If not, is corrective action implemented according to the relevant

SOP?
________________________________________________________

________________________________________________________

8.7 Do yield calculation after granulation conform with the relevant SOP?
________________________________________________________

________________________________________________________

8.7.1 Is yield calculation performed after each distinct phase of production?

 Milling
 Mixing
 Drying
________________________________________________________

________________________________________________________

8.7.2 Is the yield verified by a second individual?

________________________________________________________

________________________________________________________

8.8 Is there a record of checking the sieve screens after use for signs of damage?

________________________________________________________

________________________________________________________

8.9 Is there an SOP for checking the dryer sleeves for signs of damage prior
to or after use?

________________________________________________________

________________________________________________________

9.0 LUBRICANTS
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9.1 Is equipment designed in such a way that lubricants or coolants can

come into contact with components or drug product?

________________________________________________________

________________________________________________________

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

________________________________________________________

________________________________________________________

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

________________________________________________________

________________________________________________________

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

when maintenance is perfumed?

________________________________________________________

________________________________________________________

9.3 Examine the lubricants available in the department.

Are they clearly labeled and stored in a sanitary manner?

________________________________________________________

________________________________________________________

10.0 EQUIPMENT QUALIFICATION

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

________________________________________________________

________________________________________________________

10.2 Select three equipment items and examine the IQ/OQ and if applicable,
PQ protocols

(1) _____________________________________________________

(2)______________________________________________________

(3)______________________________________________________

10.2.1 Are the equipment items identified with a distinguishing code number?

________________________________________________________

________________________________________________________

10.2.2 Is all critical instrumentation on the equipment items identified with a valid calibration
sticker?

________________________________________________________

________________________________________________________

10.2.3 Physically verify that all instruments found on the equipment

items are included in the protocols.

________________________________________________________

________________________________________________________

10.2.4 Cross-check with the calibration records that the equipment items have the same
classification in the qualification protocol as in the calibration report.
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________________________________________________________

________________________________________________________

10.3 Are the qualification reports approved by all appropriate personnel?

________________________________________________________

________________________________________________________

10.3.1 Are the reports completely and accurately filled out?

________________________________________________________

________________________________________________________

10.4 Do the reports for drying ovens include temperature verification studies?

________________________________________________________

________________________________________________________

10.5 Where compressed air is supplied to machinery, is it oil free and filtered?

10.6.1 Is there an SOP for filter replacement?

________________________________________________________

________________________________________________________

10.6 What filtration is provided to incoming air in fluid bed dryers?

________________________________________________________

________________________________________________________

10.7.1 Is there an SOP for the cleaning and replacement of these filters?

________________________________________________________

________________________________________________________

10.7.2 What measures are taken to prevent cross-contamination of product from these filters when
inlet air is not functioning?
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________________________________________________________

________________________________________________________