Pharma Manufacturing Premises – Risk classification guide for drug good manufacturing practices observations
Risk 1 (critical) observations in Pharma Industry
- There was no air filtration system to eliminate airborne contaminants likely to be generated during fabrication or packaging.
- There was generalized malfunctioning of the ventilation system(s), with evidence of widespread cross-contamination.
- Segregation of manufacturing or testing areas from other manufacturing areas was inadequate for higher risk products.
Risk 2 (major) observations in Pharma Industry
- Maintenance and scheduled verification (e.g. air filter replacement and monitoring of
pressure differentials) were not done. (↑).
- The establishment’s heat, ventilation and air conditioning (HVAC) and/or purified water systems were not qualified. (↑).
- Unsealed porous finish in manufacturing areas showed evidence of contamination (e.g.mildew, mould or powder from previous productions). (↑).
- There was insufficient manufacturing space, which could lead to mix-ups. (↑).
- Physical or electrical quarantine areas were not adequately controlled, identified, well marked and/or not respected when used. (↑).
- There was malfunctioning of the ventilation system that could result in localized or occasional cross-contamination.
- Accessory supplies (e.g. steam, air, nitrogen and dust collection) were not qualified.
- Temperature and humidity were not controlled or monitored when necessary (i.e. products were not stored according to labelling requirements).
- Holes, cracks, peeling paint or other damages to walls and/or ceilings were observed immediately adjacent to or above:
- manufacturing areas in which products were exposed.
- equipment that handled products.
- The placement of pipes, fixtures or ducts directly above products or manufacturing
equipment created surfaces that could not be cleaned.
- The finish of surfaces such as floors, walls and ceilings did not permit effective cleaning.
- Unauthorized staff had access to physical and electronic quarantine areas.
- A separate area was not assigned for raw material sampling.
- Proper precautions were not taken to prevent contamination or cross-contamination
during raw material sampling.
Risk 3 (other) observations in Pharma Industry
- Personnel used doors with direct access to the exterior from manufacturing and packaging areas.
- Floor drains were not screened and/or trapped.
- Outlets for liquids and gases were not identified.
- Permanent pipeline installations in production areas were not identified appropriately.
- Damage was noted on surfaces not directly adjacent to or above exposed products.
- Non-production activities were performed in production areas.
- Rest, change, wash-up and/or toilet facilities were inadequate.
Reference: Risk classification guide for drug good manufacturing practices observations (GUI-0023)
Process Validation: General Principles (USFDA)