SOP on On – Line Inspection Plan during Labeling & Packaging
1.0 Purpose: This SOP describes the guidelines for inspection to be carried out during manufacture of a drug batch
2.0 Scope: This SOP applies to Production Chemist and Quality Control chemist.
3.0 Responsibility: Quality Control Manager to ensure that procedure is followed.
4.0 Materials and Equipment: As required.
The sampling plan, inspection level, and acceptance criteria is based on product use and performance history. The on line inspection procedures are usually based on classification of inspected items as “defective” or “non-defective”. The aim of system is to identify types of defects that occur so that appropriate action can be initiated to determine and eliminate their cause and enable an objective decision to be made on disposition of each packaged batch.
Defects, any nonconformance with specification, may be classified according to their seriousness:
a. Critical defect: One with a high probability of adversely impacting on effectiveness of product. e.g. incorrect product in container, incorrect label, missing label, incorrect batch number or expiry date, incorrect carton.
Acceptance criteria – 0%
b. Major defect: One with a low probability of adversely impacting on effectiveness of product e.g. low fill volume, partly legible batch number or expiry date, missing carton.
Acceptance criteria – 0.65%
c. Minor defect: One likely to have any impact on product effectiveness e.g. poor printing, off-center or dirty label.
Acceptance criteria – 2.5%