Indian API Manufacturers remain in the Focus of European GMP Inspectors

The EudraGMDP database contains more and more frequently Non-Compliance Reports of API facilities located in India. Three of these reports were published in April and May this year. The companies inspected (Krebs Biochemicals & Industries Ltd, J P Laboratories Private Ltd and Dhanuka Laboratories Ltd) were accused of major violations of the GMP rules (in one case even a critical violation was observed). All in all, the GMP inspectors came to the conclusion that - in their current states - those facilities are not able to manufacture APIs in a GMP-compliant way.

At all three companies, deficiencies against the fundamental requirements for GMP-compliant manufacturing and testing of pharmaceutical APIs were identified - like for example:

  • Poor deviation management and change control

  • Insufficient storage and handling of starting materials, intermediates and finished products with risks of mix-up

  • Technical building defects favouring cross-contaminations

  • Use of non-qualified equipment in production and quality control

  • Inadequate management of electronic documents and data integrity not guaranteed

One critic – which is not specific to those cases but common to many other Non-Compliance Reports regarding facilities in the Far East - refers to inadequate personnel training and their lack of GMP understanding. In two cases, the EDQM has already withdrawn the CEPs for the APIs; in the third case which is currently being examined by the EDQM, a suspension of the CEP seems to be only a matter of time.

 

The Italian National Competent Authority which inspected the companies Krebs and J P Laboratories recommends the prohibition of supply, whereas the Authority of Croatia which inspected the facility Dhanuka even recommends the withdrawal of the GMP certificate as well as the removal from the corresponding marketing authorisation dossier.

Source: EudraGMDP Database

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