EQPA Tool Box – Checklists for Batch Disposition

Content

1 Examples for Batch Disposition ........................................................................................................ 3

1.1 BATCH RECORD REVIEW CHECKLISTS .......................................................................................................3
1.1.1 Example Checklist 1, Bulk (solid oral dosage form) (basic).........................................................3
1.1.1 Example Checklist 2 ..................................................................................................................5
1.1.2 Example Checklist 3 (comprehensive) .......................................................................................7
1.1.3 Example Checklist 4 (release of IMPs) ........................................................................................9
1.1.4 Example Checklist 5 (release of IMPs - contract manufacture).................................................11
1.1 RECORD OF APPROVAL ........................................................................................................................12
1.1.1 Example 1 ...............................................................................................................................12
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Document History

Date of Publication
Version 2.0 06 June 2018

Comment Form

This Form should be used in order to send comments to the QP Association.

Paragraph Additional Document Alternative Proposal

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1 Examples for Batch Disposition

1.1 Batch Record Review Checklists

1.1.1 Example Checklist 1, Bulk (solid oral dosage form) (basic)

Product Name :
Article Number :
Product Batch Number :
Batch Record Number :
Page: X of n
Explanation: √= oK; ο= missing, not correct; n.a. = not applicable

Incoming
sender: Due date:
date:

Check Result Remarks

Format (Good Documentation Practice –

Conformance):
- Record complete
- Paging correct
- Readable entries and corrections
- additional records attached, paged and readable
- Thermo paper copied and signed
- Fields not used on the form are crossed out
- Entries dated and signed
- All necessary signatures

- Attachments are paged and listed

Content:

- Batch manufacturing procedure approved

- Batch record complete

- Manufacturing information given (dates, yield),

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- Compounding
Ingredients, intermediates and packaging material
with article number and batch number
Quality Control records/ analytical batch records
available

Manufacturing Result Remarks

- Work Preparation (Equipment, Material)

- Initial weight print outs
- Initial weight double check

- Identity samples taken

- Equipment
(equipment used recorded, equipment ready for
use?)
- process data:
→ comply with requirements
→ comply with attachments (cross-reference!)
→ attachments correct
- IPC – Data:
→ comply with specifications
→ if OOS, additional documentation availabel (Doc.-
Nr.)
→ comply with attachments (cross-reference!)

→ attachments correct

- Labels:
→ content correct
→ balancing correct

- Holding times documented

- Yield calculated
- Yield within specification
Deviations
- Deviations documented and evaluated by Head of
Production
- Deviation process initiated (Doc.-Nr.)

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Review of Result Remarks

- equipment cleaning and approval

- room cleaning and approval

- Room temperature, humidity and air pressure data

Delivery receipt
- drum- number/-name or amount of product

- signatures complete
- Product Quality Review:
Data transferred

1.1.1 Example Checklist 2

Product .………........................................................................................................
Batch.no ...........................................................

A. Conformity with Marketing Authorisation / Registration Certificate DA NU NA

Yes No Not
applica
ble
1 The product name is as specified in the Marketing Authorisation / Registration
Certificate
2 Manufacturing formula is the authorized one
3 Expiry data is the authorized one
4 Steps of manufacturing process performed as required

5 All approved controls was performed. Testing was conducted in accordance

with approved specifications for intermediary, bulk and finished product
6 Finished product testing results are compliant with the acceptance limits stated
in the approved Bulk Product Specification/ Finished Product Specification
7 The labeling is consistent with the Marketing Authorisation / Registration
Certificate. On the batch records they are attached samples of printed
packaging materials used
8 Leaflet is the latest version authorized by Marketing Authorisation /
Registration Certificate
B. Conformity with GMP
1 Batch processing/ packaging records are available and provide the history of
batch
2 Batch processing/ packaging records include the dates and times for beginning
and completion of the manufacturing steps
3 Batch processing/ packaging records signed by the responsible personnel and,
where appropriate, for ckeck of major manufacturing steps
4 All manufacturing operations were conducted in accordance with applicable
approved procedures

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5 Starting/ packaging materiales used come from approved suppliers

6 Starting materials and packaging materials were tested in

accordance with approved specifications and have been released
for manufacturing by the responsible persons
7 Manufacturing formula is correctly calculated and starting
materials batch numbers used are documented
8 Approved, applicable procedures have been used
9 The manufacturing process has been validated
10 Yields obtained are within the limits set
11 Equipment used is qualified
12 Reports for monitoring the environmental conditions as stipulated in
the approved procedures are attached
13 Sterilization reports of equipment / parts used are attached
14 Testing methods have been validated
15 Deviations were recorded and investigated according to the
applicable procedure
16 OOS results were recorded and investigated according to the
applicable procedure
17 The changes implemented have been approved
18 A program to monitor the stability is implemented and results are
available
19 All reference samples and relevant samples are available at all
times
20 Batch Records have been assessed by Head of Production and Head
of Quality Control

Comments:
...............................................................................................................................................
..................................................
...............................................................................................................................................
..................................................
...............................................................................................................................................
.................

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1.1.2 Example Checklist 3 (comprehensive)

Checklist for Review of Batch Documentation

Product Name: Dosage strength

Batch No.: PL Number:

If “no”, fill in justification/ remarks below

Batch Documents Yes No
Batch documents equivalent to Master Documents
All records comply with the rules of Good Documentation practice (SOP xyz)
All entries have been made in the correct data fields
Batch Manufacturing Instructions Yes No
Line clearances (equipment/ area) carried out
Strat up tests carried out and verified
All challenge tests carried out
All in-process checks (IPC) carried out at correct intervals
Print-outs for IPC are attached and numbered
All IPC within specification
Process yields are correct and within acceptable limits or justified
Identification/ cleaning labels are attached
Time limitation of each production step within acceptable limits
Raw data accurate?
Batch Packaging Instructions Yes No
Line clearances (equipment/ area) carried out
Product and packaging material identification approved
Strat up tests carried out and verified
All challenge tests carried out
All in-process checks (IPC) carried out at correct intervals
Print-outs for IPC are attached and numbered
All IPC within specification
Representative sampling of each pack type and size
Yield and reconciliation correct and within acceptable limits
Correct batch number and expiry date on primary and secondary packaging
PIL/Carton is correct and pertains to product
Transit Temperature Data Report Yes No
Report attached
Deviations/ OOS Yes No
All deviations logged and justified
Deviation reports available
Did OOS results occur?
If yes, check if OOS documentation is available and complete
Change Control Yes No
Did Changes occur?
If yes, check if Change Control documentation is available and complete

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Additional Requirements for Sterile Products:

Checklist for Review of Batch Documentation

Product Name: Dosage strength

Batch No.: PL Number:

If “no”, fill in justification/ remarks below

Additional Documents for Sterile Products Yes No
All necessary reports available like environmental reports, sterilisation cycle
reports, lyophilisation cycle reports, filtration integrity testing reports
All records comply with the rules of Good Documentation practice (SOP xyz)
Was batch included in any stability, environmental program or validation
exercise?
Records for sterility testing available?

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1.1.3 Example Checklist 4 (release of IMPs)

Product:

Description
Investigational
medicinal
product:
* EudraCT * Study protocol
number: code, and Centre

Dosage form: Pack size:

Batch: In charge:

Date of
Expiry date:
manufacture:
Planned o placing o clinical trial o stored until processing
release: o release regular o release quarantined
* If known

No. Request: Result:

01 Application of the sponsor for the conduct of the trial is available o does o does not
o not applicable
02 Manufacture and testing instructions in accordance with IMPD o does o does not
o not applicable
03 Manufacturing and test record are in accordance with o does o does not
manufacturing and testing instruction. o not applicable
04 Randomisation code is correct o does o does not
o not applicable
05 Manufacturing and testing record are dated and signed by the o does o does not
Head of Manufacturing and Head of Quality Control. o not applicable
06 Selected storage and transport conditions are suitable. o does o does not
o not applicable
07 Deviations occurred in the production have been documented, o does o does not
investigated and closed. o not applicable
08 OOS occurred during the testing have been documented, o does o does not
investigated and closed. o not applicable
09 Planned changes are approved and if necessary, reported to the o does o does not
authority. o not applicable
10 Starting materials were only used if released by the QC. o does o does not
o not applicable
11 Raw materials and packaging materials were used, which were o does o does not
obtained by approved, qualified suppliers. o not applicable
12 Critical manufacturing and test methods are validated. o does o does not
o not applicable
13 Relevant manufacturing and testing equipment are qualified . o does o does not
o not applicable

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No. Request: Result:

14A A valid manufacturing license is available. o does o does not
o not applicable
14b A valid GMP certificate is available. o does o does not
o not applicable
15 Contract manufacturer and laboratories are audited/ qualified. o does o does not
o not applicable
16 The current PQR shows no negative trends or other indications of o does o does not
risk to the overall product quality. o not applicable
17 The review of the follow-up stability revealed no indications of o does o does not
deviations from the specification. o not applicable
18 Other factors affecting the quality of the product are not known. o does o does not
o not applicable
19 The required retention and reference samples are stored. o does o does not
o not applicable
20 The batch was entered in the release register. o does o does not
o not applicable

Comments:

Result:
o complies with all the above points, batch can be released

o lack of at the following points:

Measures:
o no release and destruction
o quarantine and the following measures:

Check list __________________________________________________________________

completed by: ______

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1.1.4 Example Checklist 5 (release of IMPs - contract manufacture)

Product (name, strength, dosage form)/

Batch Number

Intermediate product/ Bulk product in original packing material/

Bulk product/ Deliverable/ Finished product
No. Document QA Note QP
review/ review/
Initials Initials
1 Specifications, analytical methods – API,
excipients, packaging materials
2 Specifications-intermediate and finished
product
3 Quality/Technical agreement
4 Approval of clinical trials from the medical
products Agency (the equivalent of
authority) as well as Ethics Committee/
5 Approved Clinical Trial protocol
6 Randomisation list/key
7 Approved receiver of product
8 Manufacturing Standards; Date; Signatures;
Calculations; Process controls/parameters;
Deviations; Labels; Local Conditions; IMPD
9 Packing Instructions: Date; Signatures;
Calculations; Process controls/parameters;
Deviations; Labels; Local conditions/
10 CoA: results from QC: analytical methods;
Validation of methods; Date; Signatures;
Calculations; Deviations; OOS
11 Stability data / Data for shelf life/retest
period and storage conditions
12 Shelf life and storage conditions/
13 Packaged product

Other Notes/ Other comments :

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1.1 Record of Approval

1.1.1 Example 1

Report number: ___________

Name of the product:

Internal code:

Batch size:
Batch number: Date of production:
Expiry date:

Number of the Date of the beginning of the Date of finishing of the

work order: production: production:

Documentation of packaging process

Document Present (√) Date

Filled protocol of packaging

The work order of packaging process

Sample of packaging material

MONITORING

Primary packaging ( t °C i % RH) yes no

Secondary packaging ( t °C i % RH) yes no

Analytical dossier / Documentation of Quality Control

Document Present (√) Date

Aluminum foil

Certificate of analysis of packaging PVC or PVdC foil

material
Boxes

Leaflets

Intermediate

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Certificate of analysis
In Bulk

Report of analysis of a finished product

Certificate of analysis of a finished product

Quality report / OOS yes no

Document Present (√) Date

Documentation of Quality Assurance

Quality report / deviations if any and undertaken preventive
and corrective actions

yes no
Approval of proposed changes yes
no

Notes:

QP responsible for batch realise to the market:

Date:

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