SOP on Batch Process Record Review
1.0 Purpose: The purpose of this SOP is to describe the procedure of batch processing record review and approval.
2.0 Scope: This SOP applies to the Sr. Production Chemist and the Quality Control Department
3.0 Responsibility:
3.1 Senior Production Chemist to review each batch processing record after the batch has been produced.
3.2 Quality Assurance Manager to review every batch record for completeness and accuracy.
4.0 Materials and Equipment: Batch Processing Records
5.0 Procedure:
5.1 After completing the batch manufacturing, assemble all the records and reviewed by the Sr. Production Chemist, it is submitted to Quality Control department for review and approval.
5.2.0 Review the batch manufacturing records for the following:
5.2.1 Accurate quantities of raw materials, packing materials batch number and analytical report numbers.
5.2.2 Completed form for all blanks filled and signatures on all the forms
5.2.3 All dates agree
5.2.4 Any correction is crossout of original with a single line and signed
5.2.5 All the calculations are correct
5.2.6 All the in-process records completed
5.2.7 All data meet criteria for acceptance
5.2.8 Deviations, if any, is recorded, dated and signed by the production manager.
5.2.9 All pages are attached in the batch processing record
5.3.0 Approval
5.3.1 All the batches are approved before release for distribution
5.3.2 Any unexplained discrepency or failure of a batch, or any of its components, to meet any of the specifications is investigated prior to release.