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Reprocessing Reworking & Redressing of Product

Reprocessing and reworking are considered non-routine events.

Reprocessing: reprocessing is the introduction of an in-process material or drug product including one that does not conform to a standard or specification back into the process and repeating steps that are part of the approved manufacturing process / Primary packaging process. Continuation of a process step after a process test has shown that the step is incomplete considered to be a part of the normal process and is not reprocessing.

Reworking: Reworking is subjecting an in-process material or drug product that does not conform to standard or specification to one or more processing steps that are different from the manufacturing process described in the application to obtain acceptable quality in-process material or drug product.

Re-dressing: Re-dressing is the activity of Secondary/tertiary packaging by way of replacement/addition/ removal of packing materials.

Procedure for Reprocessing Reworking & Redressing

1.0   Objective

    • To lay down a procedure for Reprocessing, reworking & Re-dressing the drug product.

2.0   Scope

    • This procedure is applicable for monitoring of reprocessing / reworking / Re-dressing of the drug products.

3.0   Responsibility

3.1 Production officer/ Executive : To fill the reprocess / rework request form and to assign a batch number.

To send the request to QA Documentation For the Batch record.

3.2 Officer / Executive QA : To issue batch record for Reprocessing/reworking of product.

To ensure the correct batch no. assigned to reprocessing / reworking of product.

3.3 Officer / Executive QC : Timely analysis and release of reprocessing/reworking product. Timely analysis of stability sample collected from reprocessing / reworking of product.
3.4 Chemist  IPQA : Line clearance for reprocessing / Reworking / Redressing product.

Monitoring of reprocessing / Reworking / Redressing of product. Collection of control/stability samples from Reprocessing /Reworking /Re-dressing of   product

3.5 Head manufacturing : To recommend / Reject the Reprocessing / Reworking / Re-dressing of the product.
3.6 Head DRA : To approve / Reject the Reprocessing / Reworking / Redressing of the export product.
3.7 Head QA : To approve / Reject the Reprocessing / Reworking / Re-

dressing of the product.

4.0   Procedure for Reprocessing / Reworking / Re-dressing

    • Reprocessing / Reworking / Re-dressing of the batch shall be initiated by filling reprocessing / reworking request form by production/ Warehouse as per Annexure-I.
    • The reprocessing / reworking / Re-dressing request form shall be reviewed by Head manufacturing and Head -DRA.
    • After getting a recommendation for re-process/ re-work the request form shall be submitted to the head QA for its approval/rejection.
    • The batch number of reprocess/rework batch shall be suffixed as ”R” with the mother batch number whereas the Re-dressed batch number remaining unchanged.
    • The manufacturing and expiry date of the batch to be reprocessed/reworked shall be the same as the mother batch.
    • Collect the samples and send them to the quality control laboratory for analysis, where applicable.
    • Check all the results of the analysis and follow the recommendation of quality assurance to proceed further.
    • If the result of the analysis is approved by quality control then QA shall affix the ‘Approved’ label to the product bin.
    • The Reprocessed / Reworked Batch shall be evaluated by subjecting it to the Stability Study at accelerated condition of 40°C and 75% RH for 3/6 months, as determined by Head QA.
    • Re-dressed batches need not be subjected to stability evaluation.

    • The Reprocessed / Reworked product shall remain on hold, till one month of accelerated stability data found complies with the stated specifications.
    • The new Reprocess / Rework / Re-dress product shall be released only after completion of one month accelerated stability study, but the study shall be continued for the duration as per stability protocol.
    • The batch manufacturing record of the Reprocessed / Reworked batch shall be attached with the batch record of the mother batch record.
    • Reprocess / Reworking shall not be carried out in general, unless it is defined in the manufacturing process however if reprocessing is required in domestic market products,   upon approval of Reprocess / Reworking / Re-dressing form, can be performed subject to meeting the requirements specified above.
    • In the case of export products, reprocessing / reworking / re-dressing form shall be forwarded to DRA.

    • Only upon approval by the concerned regulatory agency (where applicable), approval for reprocessing shall be given by DRA or as per the regulatory requirements.
    • In such cases, Carryout the reprocessing within the purview of commitments given to the agency.
    • Based on the type of rework to be carried, a separate batch processing record (BMR/BMR) shall be prepared.
    • Batch record for reprocessing shall be prepared by Production Executive/Officer; checked by QA Executive, approved by Production head and QA Head.
    • All personnel shall sign in the designated columns.
    • The original batch record shall be stamped with ”MASTER COPY” red in color on the top of the right-hand corner.
    • At the time of issue stamped as “CONTROLLED COPY” in blue ink issued by QA officer.
    • Made the entry in the batch issuance register.
    • The finished goods if stocked/received for redressing/rework in the Warehouse shall be sent to the production area through a delivery challan & excise note for rework/redressing.
    • Carry out the Rework activity as per batch record issued for reworking/ redressing/ reprocessing.
    • The return TT (if applicable) shall be filed in the batch record and reworked material shall be transferred to Warehouse following finished goods storage and dispatch procedure.

Remark: Reprocess, rework during manufacturing and primary packing are not allowed in products manufactured for the export market.

5.0   Reference- Reprocessing / Reworking / Re-dressing

    • Schedule-M, Drug & Cosmetics Act, part-I, GMP for Premises and materials

6.0   Glossary

    • IPQA:           In process Quality Assurance
    • DRA:           Drug Regulatory Affairs
    • GMP:           Good Manufacturing Practices
    • BMR:           Batch Manufacturing Records
    • BPR:           Batch Packaging Records

7.0   Annexure

Annexure I: Reprocess / Rework request form

Part A (filled by Production)
Product Batch No. Mfg. Date Exp. Date Stage Qty.
Nature of reprocessing/rework:
Reasons for reprocess / rework:
Corrective Actions (if applicable)
Part B Recommendation by Head-Production
Reviewed by Head Manufacturing:

Recommended / Not recommended

                                                                                                                     Head Production (Sign. / Date)

Part C Approval / Rejection by DRA
Reviewed by Head DRA:

 

                                                                  Approved / Rejected                      Head DRA (Sign. / Date)

Part D Approval / Rejection by Head-QA
Reviewed by Head QA:

 

                                                   Approved / Rejected                           Head QA (Sign. / Date)

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