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The API manufacturers in India remain in the limelight of European GMP Inspectors

According to The EudraGMDP database, Indian API manufacturers are having more frequent non-compliance reports as observed in three of the reports published in the month of April and May this year.

Three companies inspected include Krebs Biochemicals & Industries Ltd, J P Laboratories Private Ltd and Dhanuka Laboratories Ltd who were observed violating Good Manufacturing Practices norms. All these companies were found deficient in following the fundamental requirements for GMP compliant manufacturing and testing of pharmaceutical APIs.

Some of the violations were:


• 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

In two cases, the EDQM has already withdrawn the CEPs for the APIs and the third case is currently being examined by the EDQM. CEP is the certificate which is issued by Certification of Substances Division of European Directorate for the Quality of Medicines (EDQM), when the manufacturer of a substance provides proof that the quality of the substance is suitably controlled by the relevant monographs of the European Pharmacopoeia.

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.


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