QCS-019 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 122

Attachment VI

SOP No.:

Issued on:

Revision No.:

Initiator name:

DOCUMENTS COMPLIANCE DECLARATION

Quality Control

Product :

Code No. :

Batch No. :

CHECKLIST FOR THE BATCH DOCUMENT AUDIT
(Quality Control)

1. Test results as reported by the QC analyst are within the specification

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limits and there is no nonconformance in any of the test.

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2. The information related to the batch identity is there and correct.

For All Products

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a. Analytical report (bulk product)

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b. Microbiological reports

For Parenteral Products

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a. Sterility report (for parenteral products)

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b. LAL test report

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c. Air monitoring record of the filling room

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d. Personnel hygiene monitoring report

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e. Surface monitoring report

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f. Water testing report

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g. Gloves print (operator) report

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h. Machines swabs report

Any other documents

Compliance check by:

Signature:

Date: