Biomedical Engineering Reference
In-Depth Information
Key performance indicator: FINAL BATCH DOCUMENTS AUDIT FINDINGS
Report for the month of
, year
No. of
Batch Files
Audited 1
Corrective
Actions
Completed 2
No. of
Observations 2
Pending
Points 2
Dosage Form
Remarks 3
Tablets/caplet
Capsule
Granules
Syrup
Suspension
Drops
Suppositories
Spray/inhaler
Sachets (liquid fill)
Cream
Ointment
Ampoules/vials
(liquid fill)
Vials (powder fill)
Sterile powder for
injection
Information provided by:
Name and signature:
Date:
Note:
1. In this column total number of batch files audited for each dosage form will be entered.
2. Add here, if observations were made.
3. Number of observations for which corrective actions have been taken.
4. Number of observations for which corrective actions are pending.
5. Remarks, if any.
 
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