QCS-019 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 106

SOP No. QCS-019.00 Effective date: mm/dd/yyyy
Approved by:

19.1 Procedure
To provide a written procedure for the batch documents review using a standard checklist by weigh-
ing area, manufacturing, in-process control (bulk), packaging, in-process control (packaging), QC
laboratory and finally QA batch documents checklist to ensure completeness of records.

19.2 scoPe
The SOP is applicable to all product batches, manufactured in the ABC Pharmaceutical Company.
All related checklists will be attached along with the master manufacturing formula, master pack-
aging instructions, manufacturing in-process, and packaging. For the US market intended products
(ANDA submissions) a final batch audit will be conducted prior to the QC release. The findings for
all parenteral products will be recorded in Annexure VII.

19.3 resPonsibility

1. This is the responsibility of the corresponding departmental supervisors to implement the
procedure.

2. The QA batch auditor is responsible for the audit of the final batch documents.

3. The department managers and directors are responsible for SOP compliance.

19.4 Procedure

19.4.1 w eighing a rea
At the end of weighing, the area supervisor will audit the following weighing records:

• Batch manufacturing record for the presence, correctness, and completeness of informa-
tion regarding the charge quantity and if the purchase order number in the specified col-
umn is duly signed.
• Raw materials requisition for the presence, correctness, and completeness of the deliverd
quantity, and the signatures of the dispensing, issuing, and receiving personnels.
• Raw material weighing records with the printouts of the weighed raw material. Weighing
area clearance complete with the signatures of the weighing area in-charge.

These documents will be forwarded to the manufacturing area supervisor for further processing.
For audit use Attachment I.

19.4.2 B ulk P roduct m anufacturing
After the completion of bulk manufacturing, the area supervisor will audit the following documents.

1. Batch manufacturing record, check that

i. All the information regarding the identity of the batch is correct

iii. Record is duly signed off by the manufacturing area supervisor

iii. Information related to machine cleaning is complete with the signature of the worker

iv. Yield calculation is correct

v. Temperature and timings and other entries mentioned are as per the master formula