QAS-011 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 273

LEVEL 3
SOP No.:
Issued on:
Revision No.:
Initiator Name:

ANNEXURE III

CHECKLIST FOR BATCH DOCUMENTS

ALONG WITH SAMPLES

(FINISHED PRODUCT)

Product: Mfg.:

Code No.: Expiry:

Batch No.: Consignee:

Stage: Finished Status: Partial/Complete

Packaging Area Documents

1. Batch packaging record number 1 ∙

2. Batch packaging record

a. Hand packing ∙

b. Filling and packing ∙

3. Line clearance format ∙

4. First signed coded commodities ∙

5. Reconciliation form (labels/cartons) ∙

6. Packaging report and the release of finished product ∙

7. Packaging material requisition ∙

8. Time sheet ∙

QA In-Process

1. Sampling report (manufacturing side) ∙

2. QA in-process record ∙

a. QA filling chart ∙

b. QA final packaging records (for different consignee) ∙

c. Inspection start-up checklist with release label ∙

Any Other Documents

1. Process change request ∙

2. Memo (sorting or any other) ∙

3. Repacking request/requisition ∙

4.

Remarks:

Checked and sent by: Date:

Original to QC along samples and documents
cc: QA (In-Process)/Packaging/Production/Stores