SOP on Drug Product Inspection

SOP on Drug Product Inspection
1.0 Purpose: This SOP describes the procedure for Inspection of drug product at various stages of a process in manufacture of a drug batch. 
2.0 Scope: This SOP applies to Production staff and Quality Control Staff.
3.0 Responsibility: Production Chemist to ensure that procedure is followed.
4.0 Materials and Equipment: As required. 
5.0 Procedure:
5.01 Packaged and labeled products are examined during finishing operations to provide assurance that containers and packages in the lot have correct label. 
5.02 A representative sample of units is collected at completion of finishing operations and visually examined for correct labeling.
5.03 Results of these examinations are recorded in batch production record.
5.04 Compliance with the intent that inspection and documentation procedures continue throughout labeling-packaging operation to prevent from utilization of incorrect components or procedures.
5.05 The majority of these on-line inspections are often performed by suitable trained production personnel, with Quality Control confirming compliance with defined inspection procedures and performing periodic audit. Sampling of controlled substances carry special responsibilities as to limitations on number taken, stored and security thereafter.
5.06 The on-line inspection 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 the 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.
5.07 Defects, any nonconformance with specification, may be classified according to their seriousness:
Critical defect: One with a high probability of adversely impacting on the effectiveness of product.  Example includes incorrect product in container, incorrect label, missing label, incorrect batch number or expiry date, incorrect carton.
Acceptance level – 0%
Major defect: One with a low probability of adversely impacting on the effectiveness of product. Example includes low fill volume, partly legible batch number or expiry date, missing carton.
Acceptance criteria – 0.65%
Minor defect: One likely to have any impact on product effectiveness. Example includes poor printing on tablets or capsules, off-center or dirty label.
Acceptance criteria – 2.5%
6.0 Reporting : The number and types of defects found are recorded in batch production record.