SOP For Handling of Reprocessing, Reworking and Recovery

1. OBJECTIVE:

The purpose of this SOP is to lay down a procedure for reprocessing, reworking and recovery of the drug products.

2. SCOPE: 

This SOP is applicable for handling of reprocessing, reworking and recovery of the drug products, at different stages of manufacturing, at the manufacturing facility.    

3. RESPONSIBILITY:

Authorized Designee of Quality Assurance shall be is responsible to prepare and review the SOP.

Manager QA/ Authorized designee shall be responsible for approval and effective Implementation of the SOP.

4. PROCEDURE:
   1. The reprocessing, reworking or recovery of products shall be carried out in case where there is any specific requirement and with prior approval of Manager-Quality Assurance/Customer/RA.
   2. The batch shall be released only, if the quality of the final product is not affected, and the specifications are met.
   3. Risk assessment shall be carried out before starting of the reworked, reprocessed or recoverable batch as per current version of Risk Assessment SOP, No. QA006.
   4. Additional testing shall be carried out if required after justification for any in-processed stage or finished product of reprocessed, reworked and recoverable batch.
   5. Reprocessing: It is defined as “Subjecting all or part of a batch or a lot of in-process stages or a finished product of single batch/lot to a previous step in the validated manufacturing process due to failure to meet predetermined specifications. Reprocessing is normally a repetition of one of the previous step, already in a manufacturing process”.

If such reprocessing is used for three batches, then the same process shall be considered as part of standard manufacturing process after consulting with R&D/Customer/RA and approval of Head-Quality Assurance.

Suffix ‘P’ shall be added in the batch numbering of reprocessed batch in the existing batch numbering system. Reprocessed batches shall be charged for accelerated stability study. Reprocessed batch to be charge on stability shall be stamped on batch record charge on stability as per document control SOP (QA007).

Reprocessed batch shall be released in the market after the verification of data; however the stability data of reprocessed batch shall be monitored for any significant change.

Batch manufacturing record of Reprocessed batch shall be attached with the batch manufacturing record of the original batch.

1. Reworking: It is defined as “subjecting an in-process stages or finished product of a single batch to an alternate process due to failure to meet the predetermined specifications. Reworking is a new step in manufacturing process, which is not defined in standard manufacturing process”.

Investigation shall be carried out to evaluate the reason of non-conformance to the batch before taking a decision of rework of batch.

Reworked batches shall be charged for accelerated stability study. Reworked batch to be charge on stability shall be stamped on batch record charge on stability as per document control SOP (QA007).

Reprocessed batch shall be released in the market after the verification of data; however the stability data of reprocessed batch shall be monitored for any significant change.

Suffix ‘W’ shall be added in the batch numbering of reworked batch in the existing batch numbering system.

Batch manufacturing record of Reworked batch shall be attached with the batch manufacturing record of the original batch.

1. Recovery: Recoverable material shall be stored for NMT 6 months. If not used within 6 months, destroy the recoverable materials.

The Justification (cumulatively) regarding use of 6 month’s recoverable residue is as follows:

Products remain stable up to 6 month’s accelerated condition (worst situation) during stability study.

1. Recoveries shall be collected from various operational cycles of individual batches separately.

0. Batch wise all such recoveries shall be collected in cleaned containers with proper status label indicating Product name, Batch no., Mfg. and Expiry dates, Drum no., Quantity  in individual drum, Signature and Date. 

0. When recovery shall be added to normal standard batch of the same product, the particular batch charge for accelerated stability study. 

0. Recovered batch to be charge on stability shall be stamped on batch record charge on stability as per document control SOP (QA007).

0. The Reprocessable recovery of the particular batch having recovery shall be destroyed after completion of batch.  

Recoverable residue of any stage shall be analyzed as per standard test procedure including impurities (wherever applicable) before adding the same into batch. Results of analysis of recoverable residue shall be compared with initial results. If no significant changes are observed, recoverable residue shall be allowed to use. Production personnel shall inform to QC in case of adding fresh additional raw material, if any

Processing date of recovery batches shall be considered as manufacturing date and the expiry date of oldest recoverable residue shall be considered the expiry date of recovery batch. Recovered material shall be added during dry screening process after milling. The sample of the granules after adding of recovery shall be analyzed prior to processing of next step. Recovered material which is more than 6 months old shall be destroyed with due approval of Manager–Quality assurance and authorization by technical director and the destruction record of the same shall be maintained. No rejected recovered material shall be permitted for adding with regular batches. Suffix ‘R’ shall be added in the batch numbering of recovered batch in the existing batch numbering system

Batch manufacturing record of Recovered batch shall be attached with the batch manufacturing record of the original batch.

1. No “Reprocessing Reworking, Recovery” shall be performed at the site for the product related to PL/MA.

5. TRAINING:

Trainer:   Head – Quality Assurance

Trainees:  Departmental / Sectional Heads of QA / Production 

6. DISTRIBUTION:

Controlled Copy No. 1:  Head of Department – Quality Assurance

Controlled Copy No. 2:  Head of Department – Production

Original Copy             :  Quality Assurance

7. ANNEXURE(S):

Annexure – I   : Reprocessing Approval Form.

Annexure – II  : Reworking Approval Form.

Annexure – III : Recovery Approval Form.

8. REFERENCE(S):

Out of specification test results 

Stability programme 

Failure Investigation 

Document Control 

9. REVISION HISTORY: 

Sr. No.	Revision No.	Change Control Number	Details of Revision	Reasons(s) for Revision
1	00	–	New SOP	New SOP