QAS-002 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 173

Attachment Vg
SOP No.: QAS-002
Revision No.:
Issued on:
Initiator sign:

Production Area Documents

Check the:

1. Inspection start-up check list with the release

label (manufacturing side)

2. Batch manufacturing record for

a. Suppositories: On the batch manufacturing

record for suppositories check that

i. All the information regarding the

identity of batch is correct

ii. Record is duly signed by the

manufacturing supervisor

iii. Information related to machine

cleaning is complete with the

signatures of the worker

iv. Yield calculation is correct

v. The information and data related to

the temperature, mixing time, and

mixer speed are within the range

specified in the MFM

3. Was there any deviation from manufacturing

formula and method/master packaging

instructions? Was any corrective action taken,

was it properly documented, was corrective

action report raised and made a part of the

batch document?

4. Batch yield final and at various in-process

stage is correct

5. Rejection verification at various stages of

processing and at final stage

Reviewed by:

Remarks:

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