Biomedical Engineering Reference
In-Depth Information
Attachment II
SOP No.:
Issued on:
Revision No.:
Initiator name:
CHECKLIST FOR THE BATCH DOCUMENT AUDIT
(Manufacturing/Production Area Documents)
1. Batch manufacturing record
On the batch manufacturing record check that
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i. All the information regarding the identity of the batch is correct.
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ii. Record is duly signed by the manufacturing supervisor.
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iii. Information related to machine cleaning is complete with the signatures of the
worker. The equipment cleaning status label “CLEANED” to be made part of the
batch record.
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iv. Yield calculation is correct.
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v. Temperature and timings and other entries mentioned are as per the MFM.
2. Batch Manufacturing record
Compression (weight variation chart)
Capsule filling (weight variation chart)
Ampoule/vials filling (volume variation chart)
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i. Information required for the identity of the batch is correct.
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ii. Record is duly signed by the manufacturing supervisor.
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iii. Information related to the machine cleaning sterilization is complete with the print
outs and signatures. The equipment cleaning status label “CLEANED” to be made
part of the batch record.
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iv. Yield calculation is correct.
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v. All the entries related to temperature, humidity, and other information are recorded
and within the range.
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vi. Weight variation record of the compression and capsule filling generated by
machine operators is present and within the limits.
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3. Batch manufacturing record for coating is present and all the information is correct.
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4. In case there was a deviation from the master formula, any corrective action taken,
process change request raised and made part of the batch documents?
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