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APPENDIX-I (Request Sheet)

The document is a reprocessing/rework request sheet from a pharmaceutical company. It provides a process for requesting approval to reprocess or rework a batch of a product that initially failed quality testing. The process involves describing the failure, conducting a trial run of the reprocessing steps, evaluating the trial results, assessing the root cause, and approving the reprocessing request. If approved, a new batch number would be assigned and the reprocessing steps carried out under the appropriate protocols and oversight.

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62 views

APPENDIX-I (Request Sheet)

The document is a reprocessing/rework request sheet from a pharmaceutical company. It provides a process for requesting approval to reprocess or rework a batch of a product that initially failed quality testing. The process involves describing the failure, conducting a trial run of the reprocessing steps, evaluating the trial results, assessing the root cause, and approving the reprocessing request. If approved, a new batch number would be assigned and the reprocessing steps carried out under the appropriate protocols and oversight.

Uploaded by

iloveit52252
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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APPENDIX –I

Healthcare Pharmaceuticals Limited


Rajendrapur, Gazipur Bangladesh

REPROCESSING/ REWORK REQUEST SHEET Page 01 of 02

Ref No.: ________________________ Date: ______________________

Part A Fill up the spaces in writing/tick, as applicable)

Product Name & Strength: ___________________________

Batch No.: __________________ Mfg. Date: ______________ Exp. Date: ________________

Description and probable cause of product failure (attach additional sheets if needed):

Raised by/ Date: ________________ Agreed by (Head of Production)/ Date: ______________

Trial Process Run in brief and reconciliation of materials (attach sheet if any):

Sign/ Date (Production): __________________

QC Report (if trial is done) in trial material:

QC Test Result: Ok Not ok

Sign/ Date (QC): _______________________

Attach Reprocessing steps planned Appendix 2 with approved protocol

New Batch No.: __________________

Fate of already printed materials (if any):

Agreed by Head of Production (Sign/Date): ______________________

Form No.: FGEQA/122.00 Ref. SOP.: GEQA-028


APPENDIX –I

Healthcare Pharmaceuticals Limited


Rajendrapur, Gazipur Bangladesh

REPROCESSING/ REWORK REQUEST SHEET Page 02 of 02

Part B- Assessment by Quality Compliance on root cause identification and finding on


trial:

Name: __________________________ Sign with Date: _______________________

Reprocessing recommended Yes No

Recommended by QA Sign/Date: ________________________

Part C- Requirement for validation and stability (if any)

If not required, specify rationale for that:

Agreed by Head of R&D (Sign/Date): _________________________

Part D- Reprocessing and Reworking Request Approval:

Agreed by (sign with date):

Head of R&D: _____________________________

Head of Production: _____________________________

Approved by (sign with date):

Head of Quality Assurance: _____________________________

Authorized by (sign with date):

Director, Technical Operations: _________________________________

Form No.: FGEQA/122.00 Ref. SOP.: GEQA-028

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