QAS-002 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 188

Attachment Vj
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. 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 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. Charts ( if drying on Lytzen dryer ):

Check the presence of the Lytzen dryer

charts if the drying of granules was

carried out in the Lytzen Oven and the

temperature at which the granules were

dried was comparable to the limits

provided in the MFM

3. Was there any deviation from MFM, was

any corrective action taken, was it properly

documented, was PCR raised and made

a part of the batch document?

Remarks:

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:

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