QAS-002 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 185

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

QA In-Process Documents

Check the:

1. Sampling report (manufacturing side)

2. Sampling report (packaging side)

3. QA in-process record of inspection for

tablet and capsule (compression and/or

encapsulation)

4. For the presence of hourly checks and

confirm that all physical parameters

monitored during the in-process including

weight variation, thickness, hardness, D.T.

friability, temperature, RH, and physical

attributes of tablet and capsules are within

specification limits

5. QA in-process record of inspection for filling

and packaging of the tablet and capsule

6. Was there any sorting of product?

7. For each consignee, QA final packaging

record

8. Inspection start up check list for packaging

with release label (packaging side)

9. First signed coded commodities

(aluminum foil, leaflet, box, labels,

shipping marks etc.)

Reasons:

Results:

* In all in-process documents check for the presence of hourly checks and confirm that all the physical parameters moni-
tored during in-process are within the specification limits.

Reviewed by:

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