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SOP for Rework/Reprocessing Procedure

OBJECTIVE 
To ensure that all product rework/reprocessing are documented and authorized before being conducted. 

SCOPE 
This procedure applies to all products requiring rework after they have been found not to conform to specifications 


RESPONSIBILITIES 
  • It is the responsibility of the production Manager (Pharmacist) to initiate a rework. 
  • It is the QA Manager’s duty to approve or reject a rework proposal depending on the impact on quality of the rework process 

PROCEDURE 
  • A rework shall be proposed by the Production Manager to take a corrective action when a product has failed to meet the specifications 
  • The reason shall be stated to avoid recurrence of such incidences in future 
  • A step by step procedure on how the rework is to be conducted shall be documented on Attachment 1. 
  • The QA Manager shall assess the risks of the rework process and further impact on product quality 
  • If in agreement he shall approve and if not he shall state reasons and an alternative course is taken 
  • A notification shall be sent to the Finance Department so that the extra cost incurred for the rework is captured and cost benefit analysis conducted to assess viability of rework 
  • Confirmatory test shall be carried out by the QA Department to assess whether the rework process has been a success. 
  • All reworks shall be issued with reference No with following R/Yearly/Serial Number e.g. R/2020/001 first rework for 2020 and shall be entered into a rework register.
  • Considerations when performing a rework: 
  1. Reworking/reprocessing operations must not be used to pass specification by mixing good quality materials or products failing chemical or microbiological specifications or contaminated matter without further processing to address the quality issue 
  2. Where two or more batches have been mixed the date of manufacture of the reprocessed or reworked batch must be the date of manufacture of the oldest input batch 
  3. Where material to be reworked/reprocessed is to be added to a new production batch, the maximum percentage of material allowed in each batch has to be defined 
  4. Reworked material must not be further reworked in the same manufacturing step to avoid a cumulative deviation from the validated method 
  5. A batch can only be reworked a maximum number of three times. 
  • For ongoing rework batch use same Batch Manufacturing Record. Reworking process data recorded have to be attached in the respective BMR.
  • If recalled batch is to be reprocessed, a New Batch Manufacturing Record has to be issued with new batch number of current year which will be enclosed along with the original Batch Manufacturing Record.
  • For recalled batch manufacturing date on the BMR will be given of the reprocessing month and the expiry shall remain same as shown in the old BMR.

ATTACHMENTS 
Attachment 1: Rework Procedure Format
Attachment 2: Rework Register 


ABBREVIATION 
QA: Quality Assurance 

REVISION HISTORY 
Change of format, layout and review period 

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