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Cleaning and Sanitation:
• Detergent → Rinse → Sanitizer → Final rinse.
• Cleaning frequency defined in SOP.
• Cleaning agents validated for effectiveness and residue removal.

Personnel Hygiene Requirements:
• No jewelry, cosmetics, or loose clothing.
• Gowning procedures and air showers at entry.
• Medical examination before employment and annually.

Warehouse Management:
• Segregation: raw materials, packaging materials, finished goods, rejected materials.
• FIFO (First-In, First-Out) and FEFO (First-Expiry, First-Out) practiced.
• Storage under defined temperature and humidity conditions.

Material Sampling and Testing:
• Random sampling using sampling thief or drum samplers.
• Number of containers sampled as per ANSI/ASQC Z1.4.
• Representative composite sample analyzed.

Release and Rejection Procedures:
• QA releases only if all results comply with specifications.
• Rejected materials identified, recorded, and disposed under supervision.

Deviations and Change Control:
• Any deviation from SOP documented.
• Root cause analysis performed.
• Corrective and preventive action (CAPA) implemented.

OOS (Out-of-Specification) Results:

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