QAS-002 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 182

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

v. All the entries related to temperature,

humidity, and others are recorded and

within the range

vi. Weight variation record of the capsule

filling generated by the machine

operator is present and within

the limits

c. Batch manufacturing record for

compression and 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

vi. Information regarding the identity of

the batch is correct

v. Record is duly signed by the

manufacturing supervisor

vi. Information related to the machine

cleaning is complete with the

signatures of the worker

vii. Yield calculation is correct

viii. All the entries related to the

temperature, humidity, and other

parameters are recorded and within

the range

ix. Weight variation record of the tablet

compression generated by the machine

operator is present and is within limits

x. Batch manufacturing record for

coating is present and all the

information is correct

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