SOP ON BATCH CONVERSION
PURPOSE: To lay down the procedure for Batch Conversion.
SCOPE: This SOP is applicable for Batch Conversion Procedure.
RESPONSIBILITY:
Preparation of SOP: Officer/ Sr. Officer
Checking and Review of the SOP: Executive/Sr. Executive
Approval of SOP: Head of Department/ Assistant Manger
Authorization of SOP: Head QA/Designee
Head Production shall be responsible for initiating conversion request.
Head Warehouse shall be responsible to ensure transferring of stock as per conversion note.
Head QC shall be responsible to ensure sampling & testing of material. (lf required).
IPQA Persons shall be responsible for compliance the procedure.
ACCOUNTABILITY: Head QA shall be accountable for this SOP.
PROCEDURE:
Product manufactured on generic/branded name shall be packed on different brand name or pharmacopeial status.
If manufacturing master formula is same then batch manufactured on any specific brand name/generic name, shall be packed for different brand name.
lf the product is manufactured and tested as per specific specification, same shall be converted into required specification, if all the raw materials and the finished product shall comply as per required specification.
As per the marketing requirement Production department shall initiate the finished product conversion request & takes the approval from manufacturing, packing and QA.
Based on the conversion request, lPQA shall withdraw the sample (if required) and send it to QC for analysis. After release by QC, batch shall be further packed as per approved request or QC person review the specification and carried out the additional test if required.
Production department shall fill batch record issuance request.
Attached copy of request to the BPR
REFERENCE:
SOP FOR SOP