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o In-process controls at each stage.
4. Packaging:

o Visual inspection.
o Coding, labeling, and sealing.
5. Finished Product Testing:
o Physical, chemical, and microbiological tests.
o COA (Certificate of Analysis) issued before release.

In-Process Controls – Examples:

Stage Parameter Limit

Mixing Blend uniformity RSD < 5 %

Granulation Moisture content 1–2 %

Compression Weight variation ±5 %

Compression Hardness 5–8 kg

Coating Weight gain 2–4 %

Environmental Control in Production Areas:
• Airlocks between areas of different cleanliness.
• HEPA filters used for air supply.
• Pressure differential: 10–15 Pa between rooms.
• Temperature 20–25 °C, RH 45–55 %.

Compressed Air and Vacuum Systems:
Used for pneumatic transport, cleaning, and coating atomization.
Must be oil-free and filtered to 0.22 µm.

Water Systems:
• Purified water (PW) and water for injection (WFI).
• Conductivity < 1.3 µS/cm at 25 °C.
• Microbial count <100 cfu/mL.
• Regular sanitization and monitoring.

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