SOP for Handling of Rejections at Various Stages of Manufacturing
1.0 OBJECTIVE
To describe the procedure for Handling of Rejects generated at various stages of processing of drug product.
2.0 SCOPE
The scope of this document is to provide the procedure for handling of rejects obtained during various stages of manufacturing, packing , in process testing and holding of drug product at [Company name]
Rejects :
1. Rejects generated during granulation stage.
2. Residue of granules / blend remaining at the end of compression / filling.
3. Tablet rejects / residue generated at compression stage.
4. Tablet rejects / residue generated at coating stage.
5. Rejects / Residue during sorting (If applicable).
6. Rejects / Residue generated at Inprocess testing.
7. Rejects / Residue generated at packing stage.
8. Capsules rejected during filling (Empty, Semi filled, Inprocess).
Recoverable:
1. Recoverable good tablets / capsules generated at packing
Stage. (Sorted after defoiling)
3.0 RESPONSIBILITY
Production Personnel
QA personnel
Head Production (For implementation of SOP)
Head QA (To ensure compliance of SOP)
4.0 PROCEDURE
4.1 Handling of Rejects.
4.1.1 The rejects generated at each stage of manufacturing / packing should be collected separately in respected processing area in a properly labeled S.S container / HDPE container with polythene bag / polythene bags. Label the container as rejected powder / blend / tablets / capsules container. (Put specific status on the container)
4.1.2 The rejects generated during inprocess quality testing / leak test shall be collected in S.S. container / HDPE container previously filled with water / disinfectant solution.
4.1.3 All the containers containing rejects shall be labeled to indicate status with signature and date. (Put product specific label)
4.1.4 In case of rejects at IPQA / Leak test put product name as ‘Mixed Rejects’ and B. No. is ‘Not Applicable’.
4.2 Destruction Of Rejects.
4.2.1 At the end of the day / completion of batch the respective department personnel shall hand over the rejects to engineering personnel in double polythene bags with properly label and enter the details as per Annexure- I. The engineering personnel will dispose the same as per the current version of SOP for “Procedure for storage and disposal of rejected material (Tablets/Capsules/Powder) in ETP” in ETP (Effluent Treatment Plant).
4.2.2 In case of rejects from IPQA / Leak test hand over the mixed rejects (previously dissolved / suspend in water or disinfectant solution) to engineering person by put ‘NA’ in quantity column in Annexure – I.
4.2.3 When the quantity of rejects is more then 0.5 % of the standard B. Size of a particular product and batch then take approval of department head or his designee along with verified by QA in Annexure – I before sending to engineering department.
5.0 ANNEXURE:
Annexure – I Rejects Disposal Record
Product Name: Date
Stage
Batch No.
Mfg.
Exp.
Quantity
Handed Over By
Verified by QA
Received By Engineering