Pharma Manufacturing Premises – Risk classification observations

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)


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