QAS-019 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 338

SOP No. QAS-019.00 Effective date: mm/dd/yyyy
Approved by:

(continued)

responsibility Procedure

Product:
Batch No.:
Valid until:
Date:
Signature:

QA and QC Upon release of the product by the QC department, green (bulk release label) will be pasted on each

container of the bulk product above the yellow label, indicating that this product can be taken up for
packaging. The green label will have the following details:

1. Product name
2. Code No.
3. QC No.
4. Batch No.
5. Mfg. date
6. Expiry date
7. Signature of the person responsible for issuing release label
8. Date
Bulk release label will be printed by the QC and will be pasted on each container by the packaging area
QAI.
Packaging During packing the packaging department will also use different labels (Attachment I) to show the
number of pallet, semifinished product, and incomplete pack carton.
QC In case a lot (raw material, packaging material, bulk, etc.) fails to meet the specification, the rejection
label will be pasted, and the lot will be held in the rejection area till the disposition is decided.
In case QC or QA asks for the sorting of the product or for rework of a portion of a product, “To be
sorted” labels or “To be reworked” label should be pasted on the lot or portion by the QA (in-process).
QA During routine inspection, if any major violation of GMP is observed (material/process) which requires
that the disposition will be put under QA hold, label will be pasted on portion separated or 100% lot,
till the final disposition takes place. The QA hold is removed once the disposition has been decided.
Note: Attachment I refers to the different kinds of labels used by each department, that is, production, packaging, stores,
materials planning, quality control, quality assurance, and maintenance.

38.4 reason for revision
First time issued for the ABC Pharmaceutical Company.