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 [Link]
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 [Link]
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 [Link]
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 [Link] Vinod Parasher [Link] 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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________________________________________________________
________________________________________________________