. European Inspector Found Cleaning and Process Validation Deficiencies | IGMPI

  • Institute of Good Manufacturing Practices India
  • Global accredited training & certification provider
  • Approved by Quality Council of India (QCI) & Accredited Vocational Institution of Ministry of HRD, Government of India
  • Approved Training Institute of Food Safety and Standards Authority of India (FSSAI)
  • Recognized by Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, Government of India
  • An ISO 9001:2015 Certified Organisation registered under The Societies Registration Act,1860 Government of India
  • Empanelled under Ministry of Horticulture and Food Processing, Government of Uttar Pradesh
  • Affiliated with Life Sciences and Food Industry Sector Skills Council (SSC) set up by National Skill Development Corporation (NSDC)
  • Conferred with QUALITY COUNCIL OF INDIA (QCI) – D.L. SHAH NATIONAL QUALITY AWARD & ASSOCHAM Services Excellence Award 2017

Trusted by organizations & training participants in over 30 countries
Training | Certification | Education | Research

European Inspector Found Cleaning and Process Validation Deficiencies

US FDA publishes GMP deficiencies in their warning Letter in Form 483. In European Union, there is a European portal, where non-compliance results are published.

In August 2017, an Indian manufacturer of medicinal products received a statement of non-compliance with GMP from Bavarian supervisory agency. The company produces and packages solid dosage forms.

Most critical deficiency was that essential elements of the Pharmaceutical Quality System were not effective.The report cited hundreds of cases in which OOS-results had been invalidated without scientific and traceable root-cause analysis because of human errors. It was further considered a critical deficiency that the deviation and OOS management (including related protocol and review systems) was designed in a way so that discrepancies were systematically not documented.

The cleaning of rooms and equipment were not successfully performed - even though the manufacturing and packing records claimed they were. Overall, the agency states that the integrity of the manufacturing and packing records cannot be guaranteed; therefore, an adequate batch release is not possible. Furthermore, due to the insufficient records, market-complaints cannot be investigated.

Five major deficiencies with corresponding sub-items are:

  1. Deviation management and QP batch certification (e.g. unacceptable high threshold for the investigation of discrepancies, no assessment of the possible impact of equipment break downs on the product quality in the manufacturing and packing records, etc.)
  2. Inadequate design, condition and maintenance of rooms and equipment (e.g. unsuitable doors and surfaces in the manufacturing rooms, etc.
  3. Insufficient cleaning of the rooms and equipment (dirty rooms and equipment, insufficient integrity of cleaning documentation);
  4. Process validation (no suitable root-cause analysis into failed process validation, release of manufacturing documentation in spite of failed process validation, etc.);
  5. OOS investigation (no GMP-compliant handling of OOS results, etc.)

Consequently, theGMP deficiencies mentioned above lead to recalls and a withdrawal of the GMP certificate. Products may not be exported to the EU until a successful re-inspection has taken place.