Standard Operating Procedure (SOP) for Finished Drug Product (Finished Goods) Release for Sale and Distribution including the review of batch documents and checkpoints.
Finished Drug Product (Finished Goods) Release
1.0 Objective :
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- To lay down the Procedure for release of Finished Products for sale & distribution.
2.0 Scope :
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- This procedure is applicable to all products manufactured at pharmaceutical drug manufacturing plant.
3.0 Responsibility :
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For release of Finished Product:
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| Production Chemist | : | Review of batch documents |
| QA Officer /designee | : | For reviewing of batch documents |
| Head QA/Designee | : | To release of batch for sale & distribution |
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For provisional release of Finished Product:
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| Production Chemist | : | To initiate the request for provisional batch release. |
| Head QC | : | To provide comment on the status of testing of the batch. |
| Head QA | : | To provide final authorization of the provisional release of batch. |
| Head QA/Designee | : | To release of batch for depot transfer. |
4.0 Procedure for Finished Product Release:
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- Production chemist and QA officer/designee shall review the Batch Manufacturing /Production Record following SOP “Review of Batch Manufacturing Record”.
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- QA shall review the analytical data and COA of the batch prior to release the batch for sale and distribution.
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- QA officer/designee shall handover the duly reviewed Batch Production Record along with Finished Products Transfer Note and terminal inspection report to Head QA/Designee to release the batch in ECOM.
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Release of Finished Product batch in SAP/Other Software :
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- After verification of all details Head QA/Designee shall release the batch in Software.
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- Follow the SOP for Software operation and select the appropriate section/module of software for batch release.
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- The Head QA/Designee shall sign the Finished Product Transfer Note and handover one copy to Store and take acceptance from
- store personnel on another second copy of Finished Product Transfer Note and file in Batch Production Record.
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- After release of Finished Product handover the Batch Production record to Head QA/Designee for signature.
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- No part release to be done in case of process validation batches.
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Finished Product Batch Release for EU or EEA:
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- Authorized person for batch release shall ensure that the batch has been manufactured in accordance with related MA and by following GMP and EU GMP.
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- Authorized person for batch release shall sign on “Certificate of Conformance” (COC).
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- The details on COC (Annexure-II) can be modified based on the customer requirement / Technical Agreement of MA holder.
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- A photocopy of BMR, BPR, COA, COA of API and COC shall be sent to QP.
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- Final release for sale in EU market shall be the responsibility of QP of a batch release site mentioned on the marketing authorization, after evaluating / assessing the above documents / information as per his in-house SOP.
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Provisional Release of Finished Product up to Main Warehouse / Depots:
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- Production chemist and QA officer/designee shall review the Batch Production Record following “Review of Batch Production Record”.
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- QA officer/designee shall handover the duly reviewed Batch Production Record along with Finished Products Transfer Note to Head QA/Designee to release the batch in software.
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Batch shall be released on provisional basis in the following cases:
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- The product is complying for chemical testing and is under micro testing.
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- Batch shall be released on provision basis based on the results of 3rd day of micro testing.
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- The purpose of provisional batch release is to minimize the urgent market requirement.
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- Production chemist shall initiate the request for provisional batch release as per Annexure-I, with justification.
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- Head QC shall provide the comment on the status of testing of batch on the request.
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- Final approval for provisional batch release shall be given by Head QA/Designee.
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- After approval, Head QA/Designee shall release the batch in software following procedure.
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- Date of distribution of product in market shall be coordinated to concerned customer / depot.
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- Request of provisional batch release shall be enclosed with the respective batch production record.
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- After completion of testing of batch final COA shall be enclosed in Batch Production Record and handover to Head QA/Designee for sign.
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- List of Authorized personnel to release the batch for domestic market shall be prepared as per the Annexure-III.
5.0 Annexure (S)
Annexure – I: Request for Provisional Release of Batch
Date: ………………
From : Production
To.: QA
Please release the below mentioned product on provisional basis.
| Product Name: | Product Code: |
| Batch No.: | Quantity to be released: |
| Justification: Product to be shifted to depot before completion of micro limit test.
Prepared By Production Chemist Sign. & Date |
| Comments of Head QC: Chemical testing has completed and the product complies / does not comply with the laid down specification except the Microbial Limit test. The results of 3rd day of microbial limit test are within / are not within the laid down specification. Hence the batch can be / cannot be transferred to depot.
Head QC Sign. & Date |
Comments of Head QA/Designee: Request is approved / not approved.
Head QA/Designee
Sign. & Date
Release of Product in Software:
Head QA/Designee
Sign. & Date
Annexure – II: Certificate of Conformance
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Certificate of conformance (COC) |
| Product Name | |||
| Product Code | Batch No. | ||
| Pack Style | Quantity | ||
| Mfg. Date | Exp. Date | ||
| BMR No. | BPR No. | ||
| Market | Date of Release | ||
The documentation of manufacturing and packing is completely reviewed and approved.
All deviations, OOS & Change control have been assessed according to procedure and approved, or notified.
During manufacturing, packaging, in process checks and quality control there were
Deviation reported Deviation number ………………..
Change Control reported Change Control number…………..
OOS reported OOS number ………………….
The above batch has been produced in accordance with European Union rules for Good Manufacturing Practice and in compliance with the marketing authorization.
The batch documentation has been reviewed and found to be in compliance with GMP.
This batch is permitted to be released to the market.
Date:
Sign:
(Qualified Person)
Annexure – III: List of Person Authorized for Batch Release
|
S. No. |
Employee Code | Name | Designation |
Signature |
6.0 Glossary – Procedure for Finished Product Release :
| SOP | : | Standard Operating Procedure |
| QA | : | Quality Assurance |
| QC | : | Quality Control |
| BPR | : | Batch Packaging Record |
| COA | : | Certificate of Analysis |
| FPTN | : | Finished Products Transfer Note |
| ECOM | : | Enterprise bite combined operating module |
| BMR | : | Batch manufacturing Record |
| QP | : | Qualified Person |
| MA | : | Marketing Authorization |
| EU | : | European Union |
| EEA | : | European Economic Area |
| GMP | : | Good Manufacturing Practices |
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