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Pharmaceutical Manufacturing Premises – Risk classification observations

Pharmaceutical Manufacturing Premises – Risk classification guide for drug good manufacturing practices observations

Risk 1 (critical) observations

  • 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

  • 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

  • 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)

 

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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