QCS-019 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 110

SOP No. QCS-019.00 Effective date: mm/dd/yyyy
Approved by:
− For parenteral products
− Sterility report (for parenteral products)
− LAL test report
− Air monitoring record of the filling room
− Personnel hygiene monitoring report
− Surface monitoring report
− Water testing report
− Gloves print (operator) report
− Machines swabs report
• The deviation or remarks noted in the batch documents or any deviation related to the
batch manufacturing or packaging shall be rectified prior to the final release.
Final certification of release for each consignee will be issued by the QC manager/designate.
This will be done by issuing a QC number for each consignee on the packaging report and release
of finished product. Separate Certificate of Release will not be issued.
19.4.7 Q uality a SSurance a udit d ocumentS
Annexures VII and VIII are for final batch audit of parenteral products and rest of the products,
respectively. These checklists cover the whole batch documents for their presence, correctness, and
completeness.
19.4.7.1 documentation
• Attachment I (weighing area)
• Attachment II (bulk product manufacturing)
• Attachment III (in-process control—bulk)
• Attachment IV (packaging inished product)
• Attachment V (in-process control—inished products)
• Attachment VI (inished products quality control)
• Annexure VII (QA inal batch documents checklist for injectables)
• Annexure VIII (checklist for inal QA batch document audit)
19.5 reason for revision
First time issued for the ABC Pharmaceutical Company.