QAS-002 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 193

Manufacturing/Production Area Documents

Check the:

1. Inspection start-up check list with the release

label (manufacturing side)

2. Batch manufacturing record for

a. Ointment and cream: On the batch

manufacturing record check that

i. All the information regarding the

identity of the batch are 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

v. Temperatures (fat phase, water phase),

all the timings of (homogenizer,

agitator), vacuum limits are present

on the record and are within the

range specified in the MFM

3. Was there any deviation from MFM, was

any corrective action taken, was it properly

documented, was PRC raised and made a

part of the batch document?

Remarks:

4. Batch yield in the final and at various

in-process stage is correct

5. Rejection verification at various stages

of processing

Reviewed by: