EMA Non-Compliance Report for Brazilian Manufacturer of sterile Products

Non-compliance reports are published in the EudraGMDP database of the European Medicines Agency (EMA) by European supervisory authorities. They refer to inspections inside as well as outside of the European Union. The non-compliance reports are independently submitted into the database by National Competent Authorities via a standardised form. For the company concerned, a non-compliance report has severe consequences until the violations are rectified. Amongst other things, a suspension of the marketing authorisation as well as recalls of the products in question could be mandated.

On January 5th, 2017, the EMA published a non-compliance report on the Brazilian manufacturer of antibiotics Antibioticos do Brasil LTDA in Sao Paulo. The API manufacturer was inspected by the Italian supervisory agency "Italian Medicines Agency". During the inspection, four critical and seven major deficiencies were observed. As a consequence, a prohibition of supply for all products produced at the inspected site was suggested, as well as a suspension of the CEP (Certification of Suitability).

Critical deficiencies:

  • An insufficient level of maintenance and cleaning was criticised. Furthermore, the report criticises the inadequate qualification of the personnel, their lack of understanding for GMP, the barely existent supervision of staff members and that non-authorised and fraudulent activities weren't stopped until shortly before the inspectors entered two clean rooms of class D and C;
  • Environmental monitoring (crystallisation in clean room class B) wasn't performed in accordance with the principles of Annex A (probably meaning Annex 1) of the EU GMP Guideline, nor were additional environmental controls implemented;
  • The manufacturer failed to implement a robust pharmaceutical QM system. Procedures had only been followed in parts and further actions were neither investigated, risk assessed, justified nor appropriately documented;
  • The documentation didn't allow for traceability of activities.

Major deficiencies:

  • In some situations, inconsistent answers were given, and some staff members weren't able to give correct answers or show the correct document;
  • In the laboratory, there were no robust policies, procedures or controls implemented in order to ensure the reliability and integrity of analytical data;
  • The material flow in the microbiological laboratory wasn't designed to prevent a potential contamination risk during the testing performance;
  • Some working instructions were found to be inadequate because they were lacking detail or containing false information;
  • There were no procedures implemented in order to prevent contamination in a room for dispensing and sampling;
  • The quality of the purified water and nitrogen used in production hasn't been sufficiently analysed and monitored;
  • The training programme contained no specific training regarding European GMP regulations or training regarding the differences between Brazilian and European GMP regulations.

Source: EMA EudraGMDP Database

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