QCS-019 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 107

SOP No. QCS-019.00 Effective date: mm/dd/yyyy
Approved by:
2. Batch manufacturing records
• Information required for the identity of the batch are correct
• Record is duly signed by the manufacturing supervisor
• Information related to the machine cleaning and sterilization is complete with the print
outs and signatures
• Yield calculation is correct
• All the entries related to temperature, humidity, and others are recorded and are within
the range
• Weight variation record of the tablets compression and capsules illing generated by
machine operators is present and within the limits
• Ampoules/vials illing record are present and are within the limits
3. Batch manufacturing record for coating is present and all the information is correct
4. Record for the presence of any deviation from the master manufacturing formula, if yes,
then any corrective action is taken, the process change request is raised and made part of
the batch documents
5. Final batch yield and yield at various in-process stages is correct
6. Rejection verification at various stages of processing and at the final stage
19.4.2.1 injectables
The following checks are carried out:
• Temperature and pressure differential records are available
• Sterilization record for machine parts, ilters, and gowns
• Ampoule/vials washing and sterilization records
• Filter integrity test report
• Area/equipment clearance (visual inspection)
• Visual inspection request
• Print out for leak test performed
• Print out for terminal sterilization (if applicable)
19.4.2.2 lyophilized Products
• Lyophilization cycle chart
19.4.2.3 Powder-filled vials
• Seals/stoppers sterilization records
• Cramper sterilization record
For audit checklist, refer to Attachment II.
19.4.3 i n -P roceSS c ontrol (B ulk P roduct )
The QA inspector (bulk manufacturing area) is responsible to audit the following documents at the
end of the process before sending the samples and documents to the QC laboratory. The person at
the quality function unit will be an authorized one from the QA department.
19.4.3.1 Weighing area records
• Batch manufacturing record No. 1
• Raw materials weighing record with print out
• Weighing area clearance checklist