QAS-002 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 181

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

Manufacturing/Production Area Documents

Check the:

1. Inspection start-up check list with the release

label (manufacturing side)

2. Batch manufacturing record for

a. Granulation and final mixing: On the

batch manufacturing record for the

granulation and final mixing check that

i. All the information regarding the

identity of the 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. Temperatures and timings

mentioned are as per MFM and are

matching with the Lytzen Oven

Chart (in case if the drying is done

on the tray dryer)

b. Capsule filling (wt. variation chart)

i. Information regarding the identity

of the batch is correct

ii. Record is duly signed by the

manufacturing supervisor

iii. Information related to the machine

cleaning is complete with the

signatures of the worker

iv. Yield calculation is correct

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