Batch reprocessing and reworking for API (active pharmaceutical ingredients) - GMP SOP

“Failure to ensure that reprocessed batches of product will conform with all established standards, specifications, and characteristics [21 CFR 211.115(a)] in that there were no written procedures and validation data that support the reprocessing and reworking of products.” This is an FDA 483 observation that could have been avoided by having an internal procedure (SOP) in place that contains clear guidance on the steps that need to be taken before performing reprocessing or reworking.

This Standard Operating Procedure (SOP) is based on Q7A Section XIV, CFR211.115 (a) and (b) and the applicable guidance documents and provides clear and concise guidance for the important steps involved. It also clearly defines the responsibilities for reprocessing and/or reworking investigations, which is a crucial prerequisite for any functional system. This 10-page Standard Operating Procedure (SOP) only needs a small amount of site-specific modification before you can adopt it for your operations.

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Table of Content

1. Regulatory Basis, Reference Documents
2. Purpose
3. Scope
4. Responsibilities and Accountabilities
4.1 Quality Unit
4.2 Manufacturing Unit
4.3 Regulatory Affairs
5. Procedure (of Reprocessing and Reworking)
5.1 Principles
5.2 Procedure
5.2.1 Storage of materials to be reprocessed
5.2.2 Reprocessing Prerequisites
5.2.3 Reprocessing Assessment of Resolution
5.2.4 Validation
5.2.5 Stability
5.2.6 Examples: Reprocessing
5.3 Reworking Principles
5.4 Procedure
5.4.1 Storage of materials to be reworked
5.4.2 Reworking Prerequisites
5.4.3 Reworking Assessment of Resolution
5.4.4 Validation
5.4.5 Stability
5.4.6 Additional Testing
5.4.7 Examples: Reworking
6. Definitions
7. Distribution
8. Attachments

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SKU Batch reprocessing and reworking for API

FDA-EMA

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