Reprocessing of non-confirming products (Formulation)
To establish a procedure for Reprocessing non-confirming products (formulation).
SCOPE:
This SOP is applicable to all sections of the formulation.
RESPONSIBILITY:
Department in charge – Implementation of SOP & Documentation.
Quality Assurance Person – To verify & monitor the activities as per SOP.
R&D Person – Clearance from R&D aspects.
ACCOUNTABILITY:
Production HEAD
PROCEDURE:
In case of non-conformance of a batch of a product in any parameter (Assay, Disintegration Test, Dissolution Rate) as per the specification of the product, the batch is to be reprocessed to meet the required specification.
In case of Non-conformances related to foreign particles, toxicity failure & impurities failure, etc., reprocessing is not permitted.
Take approval for batch reprocessing in a format.
Investigate the reason for non-conformance, if required cause of non-conformance to be verified by conducting the trial.
Review remedial steps and plant expertise guidelines for reprocessing.
Perform R&D trial with suitable change in process/step/quantity of material to attain conformance.
Review the quality and regulatory parameters with respect to reprocessing.
Prepare planned deviation, and get it approved by Q.A. In case of a major change, get it approved by R&D and corporate quality. In case of regulatory deviation get it approved by the technical committee.
Reprocess the batch of the product under close monitoring of Q.A. and/or R&D personnel.
Batch to be kept for stability, if recommended by R&D / Q.A.
Preventive measures are to be taken to avoid the re-occurrence of the non-confirming in the future.
ANNEXURE (S):
List of Critical & Non-critical Non-conformance
ABBREVIATION:
- SOP – Standard Operating Procedure.
- S&E – Safety & Environment.
- R&D – Research & Development.
- QA – Quality Assurance.
CRITICAL
- Failure in the Assay content
- Low hardness & flow problem
- Dissolution results are low
- High Disintegration time of compressed tablets
- Coated tablets failing in Disintegration time
- Weight variation [Individual or Average
NON-CRITICAL
- Collar formation & Damaged corners of the tablet edges
- Poor appearance either of the core or coated tablets
