. European Inspector Found Cleaning and Process Validation Deficiencies | IGMPI

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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.