VIVEK PHARMACHEM (INDIA) LIMITED

SELF INSPECTION AUDIT CHECKLIST

(STERILE AREA) Page 1 of 35

SELF INSPECTION PROTOCOL

STERILE AREA

PROTOCOL NO. VPSI 001-01

DATED

SUPERSEDES VPSI 001-00

PROTOCOL CONTAINS PAGES 35 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 Shashi bala
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 Shashi bala
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
to evaluate the implementation of GMP objectively. The head of the department will be responsible for
implementation of the corrective action.
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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
Reviews Standard Operating Procedures
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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

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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

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 ?
* GMPs
* SOPs
* Sterile manufacturing 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 Is it documented in the form of a Manual ?

__________________________________________________________

__________________________________________________________

4.6 Are job descriptions of individuals laid down ?

__________________________________________________________
____________________________________________________________

4.7 Are all employees attired according to the appropriate garmenting SOP ?
__________________________________________________________

__________________________________________________________

4.8 When necessary, do operators wear masks and gloves ?

__________________________________________________________

__________________________________________________________

4.9 When engaged in clean room operations, are employees correctly attired
according to the relevant SOP ?
__________________________________________________________
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__________________________________________________________

4.10 Observe employees performing the gowning procedure. Are they accurately
following the SOP ?
_________________________________________________________

__________________________________________________________

4.11 Is a fresh set of garments used on each entry into the clean room ?
__________________________________________________________

__________________________________________________________

4.12 Examine a set of garments ready for use.

* Is the package sealed ?

* How was the package sterilised ?
* Is sterilization in accordance with the relevant SOP ?

_________________________________________________________

____________________________________________________________

4.13 Are sterilised dresses being properly hanged in dress cabinet?

__________________________________________________________

__________________________________________________________

4.14 Is dress cabinet properly designed?

__________________________________________________________

__________________________________________________________

4.15 Is U.V. light working ?

__________________________________________________________

__________________________________________________________

4.16 Is integrity of HEPA filter checked at regular intervals ?

__________________________________________________________

__________________________________________________________
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4.17 Does integrity of HEPA filter meet the specifications as per relevant SOP ?
__________________________________________________________

__________________________________________________________

4.18 If not, is there documented evidence of corrective action ?

__________________________________________________________

__________________________________________________________

2.19 Is media plate being exposed in dress cabinet to monitor microbial load ?
__________________________________________________________

___________________________________________________________

4.20 Is the microbial load within limits ?

___________________________________________________________

___________________________________________________________

5.0. Facilities

5.1 Is the department maintained in a good state of repair, neat ,and with sufficient
space for equipment and operations ?
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_________________________________________________________

__________________________________________________________

5.2 Are there written records to indicate that the cleaning schedule is being followed as stated
in the relevant SOP ?
__________________________________________________________

__________________________________________________________

5.3 Are cleaning and sanitizing agents labeled with reference to their
1. Identity
2. Date of receipt ( Catalogue Number )
3. Date of expiry
4. Concentration of use
__________________________________________________________

__________________________________________________________ .

5.3.1 Are the cleaning and sanitizing solutions being used identical to and in
identical concentrations to those listed in the relevant SOP ?
. __________________________________________________________

__________________________________________________________

5.3.2 Are cleaning and sanitizing solutions labeled with an expiration date
according to the relevant SOP ?
__________________________________________________________

__________________________________________________________

5.3.3 Are there records of the preparation of Cleaning and sanitizing solutions ?
__________________________________________________________

__________________________________________________________

5.4 Is there a cleaning and sanitation SOP and schedule?

_________________________________________________________

_________________________________________________________

5.5 Is there adequate space to allow for operations at respective work stations?
_________________________________________________________

_________________________________________________________
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5.6 Is the building and facility suitable for the manufacturing operations ?
_________________________________________________________

_________________________________________________________

5.7 Is there adequate lighting to support operations ?

_________________________________________________________

_________________________________________________________

5.8 Is the temperature and humidity controlled ?

_________________________________________________________

_________________________________________________________

5.9 Are there records to support temperature / RH control ?

_________________________________________________________
____________________________________________________________

5.10 Is the man movement in the production area controlled ?

__________________________________________________________

__________________________________________________________

5.11 Are their adequate staging areas for all equipment / machines / handling Raw
Material etc..........
_________________________________________________________

_________________________________________________________

5.12 Is the facility for air (HVAC) adequate and validated ?

_________________________________________________________

_________________________________________________________

6.0 Equipment Operation

6.1 Is equipment suitably designed for its purpose ?

.
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__________________________________________________________

__________________________________________________________

.
6.2 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 ?
__________________________________________________________

__________________________________________________________

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

___________________________________________________________

___________________________________________________________

6.3.1 Do they include instructions as to which parts of the machine require

assembly and disassembly for cleaning ?
___________________________________________________________

___________________________________________________________

6.3.2 Are they followed ?

___________________________________________________________

___________________________________________________________

6.4 Select a major piece of equipment.

Examine the following records :

* Machine status label
* Line clearance label
______________________________________________________

____________________________________________________________

6.5 Is equipment suitably identified as to its cleanliness status ?

____________________________________________________________

____________________________________________________________
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6.6 Is there an SOP for the transfer of materials to the clean area via pass-through
windows ?
____________________________________________________________

____________________________________________________________

6.7 Is the sanitizing agents rotated in accordance with relevant SOP to avoid
microbial resistance ?
____________________________________________________________

____________________________________________________________

6.8 Are there approved, validated loading patterns and are they followed for
* Autoclaves ?
* Sterilizing ovens ?
___________________________________________________________

___________________________________________________________

6.8.1 Examine one of the ovens after loading and compare it to the approved
loading pattern.
___________________________________________________________

___________________________________________________________

6.9 Examine the recorder chart for the most recent cycle performed in one of the
autoclaves. Does it meet the required parameters of time and temperature as
defined in the relevant SOP ?
___________________________________________________________

___________________________________________________________

6.10 Are the drains on the autoclaves air-breaked ? Physically verify that the
break is adequate.
___________________________________________________________
___________________________________________________________

6.11 Are there maintenance records of

* Filter replacement on the nitrogen line ?
* Filter replacement on the compressed air line ?
* Integrity testing of the filters ?
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___________________________________________________________

___________________________________________________________

6.11.1 Do the records conform with the requirements of the relevant SOP ?
___________________________________________________________

___________________________________________________________

6.12 Are sterilization charts verified and approved prior to manufacturing the next
production batch ?
___________________________________________________________

___________________________________________________________

6.13 Are log books / sheets maintained for all major equipment ?
___________________________________________________________

___________________________________________________________

6.14 Are maintenance logs and records available?

___________________________________________________________

___________________________________________________________

7.0. Manufacturing Procedures

7.1 Examine the record of the daily, check of balances in the department.
___________________________________________________________
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__________________________________________________________

7.1.1 Is it complete and accurately filled out ?

___________________________________________________________

___________________________________________________________

7.1.2 Are all results within the specifications ?

___________________________________________________________

___________________________________________________________

7.1.3 If not, is there a record of the implementation of corrective action ?

___________________________________________________________

___________________________________________________________

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

___________________________________________________________

7.2.1 Are they in a good state ?

___________________________________________________________

___________________________________________________________

7.2.2 Do they bear a valid calibration sticker ?

___________________________________________________________

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

___________________________________________________________
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7.4 Are all locations where product or product components are exposed protected
by a LAF stream providing air quality of class 100 or better ?
___________________________________________________________

___________________________________________________________

7.5 Are components handled in such a manner as to prevent their accidental

contamination ?
___________________________________________________________

___________________________________________________________

7.6 Are sterilised components removed from the clean area if the time limit is
exceeded ?
___________________________________________________________

___________________________________________________________

7.6.1 Are they re-sterilized?

___________________________________________________________

___________________________________________________________

7.6.2 Has the procedure been validated?

___________________________________________________________

___________________________________________________________

7.6.3 Is validation according to the relevant SOP ?

___________________________________________________________

___________________________________________________________

7.7 Are aseptic processing filters received via the stores and verified that they
are approved for use ?
___________________________________________________________

___________________________________________________________

7.7.1 Is verification according to the relevant SOP ?

___________________________________________________________
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___________________________________________________________

7.7.2 Are aseptic processing filters

* Pre-use integrity tested ?
* Post-use integrity tested ?
____________________________________________________________

____________________________________________________________

7.8 How many post-use integrity test filter failures have there been in the past year ?
____________________________________________________________

____________________________________________________________

7.8.1 What action was taken with respect to the product solution ?
____________________________________________________________

____________________________________________________________

7.8.2 Is the corrective action documented ?

____________________________________________________________

____________________________________________________________

7.9 Are all vessels and utensils labeled as to their cleanliness status ?
____________________________________________________________

____________________________________________________________

7.10 Observe a work station during the production of a batch.

____________________________________________________________

____________________________________________________________

7.10.1 Are manufacturing instructions at hand ?

____________________________________________________________

____________________________________________________________

7.10.2 Are the instructions complete, including special instructions if relevant ?

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___________________________________________________________

___________________________________________________________

7.10.3 Are the instructions accurately followed ?

___________________________________________________________

___________________________________________________________

7.10.4 Are records and signatures made on real time ?

___________________________________________________________

___________________________________________________________

7.11 Are vessels labeled with product, lot number, and stage of processing ?
___________________________________________________________

___________________________________________________________

7.12.1 Is bulk solution held according to the relevant SOP ?

___________________________________________________________

___________________________________________________________

7.13 Are there written records of preparation of solution used for pH adjustment ?
___________________________________________________________

___________________________________________________________

7.13.1 Are the records signed by two individuals ?

___________________________________________________________

___________________________________________________________

7.13.2 Do the records follow a written procedure ?

____________________________________________________________

____________________________________________________________
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7.14 Observe clean room operators performing filling operations, including

machine set-up.
____________________________________________________________

____________________________________________________________

7.14.1 Are they following aseptic practice according to the relevant SOP ?
____________________________________________________________

____________________________________________________________

7.15 Are the manufacturing operations carried out in the supervision of a

manufacturing chemist ?
____________________________________________________________

____________________________________________________________

7.16 Are the identity and weight of ingredients checked to manufacturing.

____________________________________________________________

____________________________________________________________

7.17 Is the in-process bulk storage adequate ?

____________________________________________________________

____________________________________________________________

8.0 Batch Records

8.1 Examine the batch record for a batch that is being processed.
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Product : ___________________________

Batch No : ___________________________

8.1.1 Is the master formula signed as being an accurate copy of the original ?
__________________________________________________________

__________________________________________________________

8.1.2 Have any changes to the master formula been authorized by QA prior to start
of work ?
__________________________________________________________

__________________________________________________________

8.1.3 Has the batch been recorded on the machine status card ?
___________________________________________________________

___________________________________________________________

8.1.4. Is the record completely and accurately filled out up to the appropriate stage
of processing ?
___________________________________________________________

___________________________________________________________

8.1.5 Is the aseptic filtration start and finish time recorded ?

___________________________________________________________

___________________________________________________________

8.1.6 Are in-process results within the defined limits ?

___________________________________________________________

___________________________________________________________

8.1.7 Have all relevant sterilization charts been fully labeled, verified, approved,and
attached to the batch record ?
___________________________________________________________

___________________________________________________________

8.2 Select three recently released batches.

__________________________________________________________
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__________________________________________________________

8.2.1 Are the batch documents readily available and easy to retrieve ?
__________________________________________________________

__________________________________________________________

8.2.2 Is all relevant information included, complete and accurately filled in as follows ?
* Raw materials weighing
* Manufacturing method
* Sterilization charts
* Yield reconciliation at each stage
* In-process tests
* Packaging standard
* Packaging control
* Laboratory results
* Manufacturing deviation report (MDR),if applicable
___________________________________________________________

___________________________________________________________

8.2.3 Do in-process control results meet specifications (e.g.,fill volumes) ?

___________________________________________________________

___________________________________________________________

8.2.4 If not, is there documented corrective action ?

___________________________________________________________

___________________________________________________________

8.2.5 Do yield calculations after each production step conform with the relevant SOP ?
___________________________________________________________

___________________________________________________________

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

___________________________________________________________

___________________________________________________________

8.2.7 Is the yield calculation verified by a second individual ?

___________________________________________________________
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___________________________________________________________

8.2.8 Where required, is there documented evidence of line clearance ?

___________________________________________________________

___________________________________________________________

8.2.9 Are corrections to writing errors made by crossing out and initiating ?
___________________________________________________________

___________________________________________________________

8.2.10 Do environmental monitoring results meet specifications ?

___________________________________________________________
___________________________________________________________

8.2.11 If not, was appropriate corrective action taken?

___________________________________________________________

___________________________________________________________

8.2.12 Do laboratory result for the batches meet specifications ?

___________________________________________________________

___________________________________________________________

8.2.13 If not, was appropriate corrective action taken ?

___________________________________________________________

___________________________________________________________

8.3 Do BPR's allow for recording of correct and complete information as per the
actual production process.
____________________________________________________________

____________________________________________________________

9.0 Critical Systems

7.1 Are there valid calibration labels affixed to the following systems indicating that
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all instruments are within calibration ?

* Pure steam system
* Water for injection system
* HVAC system
* Compressed air system
* Nitrogen system
* RO system
____________________________________________________________

____________________________________________________________

9.2 Examine maintenance records for all of the above systems. Is there a complete
history of maintenance ,including ,where appropriate,
* Filter changes ?
* Filter integrity test data ?
* System sterilization ?
* System cleaning and passivation ?
____________________________________________________________

____________________________________________________________

9.3 Examine records of temperature and conductivity for the water for injection system.
____________________________________________________________

____________________________________________________________

9.3.1 Do they meet the specifications in the relevant SOP ?

____________________________________________________________

____________________________________________________________

9.3.2 If not, is there documented evidence of corrective action ?

____________________________________________________________

____________________________________________________________

9.4 Are all the critical systems validated ?

__________________________________________________________
__________________________________________________________

9.5 Is the quantity of output of all critical systems checked as per a plan.
__________________________________________________________

__________________________________________________________
10.0 Monitoring

10.1 Examine records of air pressure, temperature and relative humidity for the last
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month. Do they meet the specifications stated in the relevant SOP ?

___________________________________________________________

___________________________________________________________

10.1.1 Are any deviations recorded together with corrective action taken ?
___________________________________________________________

___________________________________________________________

10.1.2 Are records according to the relevant SOP ?

___________________________________________________________

___________________________________________________________

10.2 Examine a copy of the air sampling plan for controlled manufacturing areas.
___________________________________________________________

___________________________________________________________

10.2.1 Is sampling of viable particles performed at the locations indicated on the plan
___________________________________________________________

___________________________________________________________

10.2.2 Is sampling of nonviable particles performed at the locations indicated on the plan ?
___________________________________________________________

___________________________________________________________

10.3 Question the person responsible for performing sampling. Is he or she

knowledgeable about exposure time and sampling methods ?
___________________________________________________________

___________________________________________________________

10.4 Examine microbiological results for three months preceding the audit.
___________________________________________________________

___________________________________________________________

10.4.1 Is the frequency of testing in conformance with the relevant SOP ?

___________________________________________________________

___________________________________________________________
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10.4.2 Were all tests performed as required by the SOP ?

___________________________________________________________

___________________________________________________________

10.4.3 If not, is there a documented justification for the deviations?

___________________________________________________________

___________________________________________________________

10.4.4 Where results exceed the limits, was corrective action implemented according to the relevant
SOP ?
___________________________________________________________

___________________________________________________________

10.4.5 Were microorganisms identified ?

___________________________________________________________

___________________________________________________________

10.4.6 What is the overall picture obtained of the state of control of the facility ?
___________________________________________________________

___________________________________________________________

10.5 Examine the results for monitoring air changes from the last year.
___________________________________________________________

___________________________________________________________

10.5.1 Do they meet the specifications in the relevant SOP ?

___________________________________________________________

___________________________________________________________

10.5.2 If not, is there documented evidence of corrective action ?

___________________________________________________________

___________________________________________________________

10.6 Examine the results for monitoring air velocities from the last year.
___________________________________________________________
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___________________________________________________________

10.6.1 Do they meet the specification in the relevant SOP ?

___________________________________________________________

___________________________________________________________

10.6.2 If not, is there documented evidence of corrective action ?

___________________________________________________________

___________________________________________________________

10.7 Examine the results for monitoring airflow patterns from the last year.
____________________________________________________________

____________________________________________________________

10. 7.1 Do they meet the specification in the relevant SOP ?

____________________________________________________________

____________________________________________________________

10.7.2 If not, is there documented evidence of corrective action ?

____________________________________________________________

____________________________________________________________

10.8 Is bio-burden monitoring of aseptic solutions performed according to the

frequency stated in the relevant SOP ?
____________________________________________________________

____________________________________________________________

10.9 Are the results satisfactory?

____________________________________________________________

____________________________________________________________

10.10 Examine the monitoring results for water for injection from the last year.
____________________________________________________________
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____________________________________________________________

10.10.1 Do they meet the specifications in the relevant SOP ?

____________________________________________________________

____________________________________________________________

10.10.2 If not, is there documented evidence of corrective action ?

___________________________________________________________

___________________________________________________________

10.10.3 What is the overall picture of the microbiological control of the system ?
___________________________________________________________

___________________________________________________________

10.11 Examine the monitoring results for pure steam from the last year.
___________________________________________________________

___________________________________________________________

10.11.1 Do they meet the specifications in the relevant SOP ?

___________________________________________________________

___________________________________________________________

10.11.2 If not, is there documented evidence of corrective action ?

____________________________________________________________

____________________________________________________________

11.0 Equipment Validation

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11.1 Is there an approved annual program for the validation of all production
equipment and critical systems ?
___________________________________________________________

___________________________________________________________

11.1.1 Is the program adhered to and are the validations performed on schedule ?
___________________________________________________________

___________________________________________________________

11.2 Select three items (include at least one critical system) and examine the
IQ/OQ and, if applicable, the PQ reports.
1. ______________________________________________________

2. ______________________________________________________

3. _______________________________________________________

11.2.1 Are the equipment items identified with a distinguishing code number ?
___________________________________________________________

___________________________________________________________

11.2.2 Is all critical instrumentation on the equipment/system identified with a valid

calibration sticker ?
___________________________________________________________

___________________________________________________________

11.2.3 Physically verify that all instruments found on the equipment/system are
included in the validation report.
___________________________________________________________

___________________________________________________________

11.2.4 Cross-check with the calibration records that the instruments have the same
Classification in the validation protocols as in the calibration report.
___________________________________________________________

___________________________________________________________
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11.3 Are the validation reports complete and do they indicate that the equipment or
system is operating in a repeatable and reliable manner ?
____________________________________________________________

____________________________________________________________

11.3.1 Are the validation reports approved by all appropriate personnel ?

____________________________________________________________

____________________________________________________________

11.3.2 Are the reports completely and accurately filled out ?

____________________________________________________________

____________________________________________________________

11.4 Are aseptic media fills performed according to the relevant SOP ?
____________________________________________________________

___________________________________________________________

11.4.1 Is there documented evidence that all operators from all shifts have
participated in successful media fills in the past year ?
____________________________________________________________

____________________________________________________________

11.4.2 Examine media fill results for all fills performed in the past year. Review per
product group, per filling room, and overall for the facility. Do the results
indicate that the processes are under control ?
____________________________________________________________

____________________________________________________________

11.4.3 Where a media fill failure has occurred, is there documented evidence of
corrective action according to the relevant SOP ?
____________________________________________________________

____________________________________________________________

12.0 Cleaning Procedures

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12.1 Is there a written procedure for the cleaning of the packaging facility ?
___________________________________________________________

___________________________________________________________

12.1.1 Is there documented evidence that the cleaning procedure is being followed ?
___________________________________________________________

___________________________________________________________

12.2 Is there a written procedure for the cleaning of packaging equipment

* Between batches of the same product ?
___________________________________________________________

* Between batches of different products ?

___________________________________________________________

12.2.1 Is the procedure specific to a particular machine ?

___________________________________________________________

___________________________________________________________

12.2.2 Does the procedure specify which parts of the machine must be disassembled
for cleaning ?
___________________________________________________________

___________________________________________________________

12.3 Examine the Equipment log for the product currently being filled. Is it
filled out with all the required information ?
___________________________________________________________

___________________________________________________________

13.0 Line Clearance Procedures

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13.1 Watch personnel performing line clearance. Is each stage of the process
performed by one individual and then independently verified by a second
individual ?
___________________________________________________________

___________________________________________________________

13.2 Examine the area prior to the introduction of packaging materials. Is it clean
and free from any material from the previous batch ?
___________________________________________________________

___________________________________________________________

13.3 Do the packaging materials arrive on a covered trolley ?

___________________________________________________________

___________________________________________________________

13.4 Are packaging materials verified against a master set to ensure that they are
most recent edition and the correct materials for the batch ?
___________________________________________________________

___________________________________________________________

13.5 Are the quantities of packaging materials verified against the amounts stated
as dispensed from the store ?
___________________________________________________________

___________________________________________________________

13.6 Is the batch number and expiration date recorded on the packaging materials
standard verified by QA against the batch record ?
___________________________________________________________

___________________________________________________________

13.7 Is the check required by an SOP ?

___________________________________________________________

___________________________________________________________

13.8 Is the check documented in the batch record ?

___________________________________________________________

___________________________________________________________

14.0 Master Packaging Materials Files

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14.1 Is a complete set of files available in the department with samples of

packaging materials for each product packaged there ?
___________________________________________________________

___________________________________________________________

14.1.1 Is there a written procedure for maintaining and updating of these files ?
___________________________________________________________

___________________________________________________________

14.1.2 Are all samples of printed packaging materials in the files signed and dated
by a QA representative to indicate that they are the correct master materials ?
___________________________________________________________

___________________________________________________________

15.0 Working Procedures

15.1 Is there a procedure for the daily checking of balances used in the department ?
___________________________________________________________

___________________________________________________________

15.1.1 Are there records to indicate that the procedure is being followed ?
___________________________________________________________

___________________________________________________________

15.2 Is all instrumentation in the department labeled with a valid calibration sticker
___________________________________________________________

___________________________________________________________

15.3 Are samples of all printed packaging materials used in the batch attached to
the batch record ?
___________________________________________________________

___________________________________________________________

15.4 Is there a written procedure for the reconciliation of printed packaging materials ?
___________________________________________________________
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___________________________________________________________

15.4.1 Watch the reconciliation being made. Are remaining packaging materials
accurately counted ?
___________________________________________________________

___________________________________________________________

15.4.2 Are rejected packaging materials collected throughout the batch in a manner
that permits accurate counting for reconciliation ?
___________________________________________________________
___________________________________________________________

15.5 Is there a written procedure for clearing and inspecting the packaging area at
the end of the batch ?
__________________________________________________________

__________________________________________________________

15.5.1 Is the inspection documented in the batch record ?

__________________________________________________________

__________________________________________________________

15.6 Is the batch yield calculated immediately upon completion of the packaging
operation and prior to the introduction of a new batch into the area ?
__________________________________________________________

__________________________________________________________

15.6.1 Is the yield calculation independently verified by a second individual ?

__________________________________________________________

__________________________________________________________

15.7 Are any excess overprinted packaging materials destroyed on completion of

the batch ?
__________________________________________________________

__________________________________________________________
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15.7.1 Is there a written procedure for the destruction of printed packaging materials
on completion of the batch or for their return to the store ?
___________________________________________________________

___________________________________________________________

15.7.2 Is it followed ?
___________________________________________________________

___________________________________________________________

15.7.3 Is there a provision in the department for the separation of printed packaging
materials for destruction and rejected product ?
___________________________________________________________

___________________________________________________________

16.0 In-Process Control

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16.1 Examine the records for the batch being processed. Are there written records
of in-process control checks ?
____________________________________________________________

____________________________________________________________

16.1.1 Is the frequency of checks in accordance with the relevant SOP ?

____________________________________________________________

____________________________________________________________

16.2 If the packaging operation continues over more than one shift, is there a
written requirement for re-verification of all electronic controls ?
____________________________________________________________

____________________________________________________________

16.2.1 Is this performed?

____________________________________________________________

____________________________________________________________

16.3 Is there a written procedure for the examination of packaged product during
finishing operations to ensure correct labeling ?
____________________________________________________________

____________________________________________________________

16.4 Is a representative sample of units collected at the end of the operation and
visually examined for correct labeling ?
____________________________________________________________

____________________________________________________________

16.4.1 Are the results of such inspections documented and included in batch records
____________________________________________________________
____________________________________________________________

17.0 Equipment Qualification

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17.1 Is there an approved annual program for the qualification of all packaging
equipment ?
___________________________________________________________

___________________________________________________________

17.2 Select three equipment items and examine the IQ/OQ protocols.
1. __________________________________________________

2.___________________________________________________

3.___________________________________________________

17.2.1 Are the equipment items identified with a distinguishing code number ?
___________________________________________________________

___________________________________________________________

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

__________________________________________________________

17.2.3 Physically verify that all instruments found on the equipment items are
included in the protocols.
__________________________________________________________

__________________________________________________________

17.2.4 Cross-check with the calibration records that the equipment items have the
same classification in the qualification protocols as in the calibration report.
__________________________________________________________

__________________________________________________________

17.2.5 Are all qualification reports completely and accurately filled in ?

__________________________________________________________

__________________________________________________________