European Non-Compliance Report due to the Lack of Transparency regarding the Sourcing of Starting Materials

Recommendation

28-30 March 2023

Global Registration and Life Cycle Management of APIs - Live Online Training
Contents of the regulatory information in the ASMF and CEP

On 26 March 2016, the French National Agency for Medicines and Health Products Safety published a non-Compliance Report in the  EudraGMDP database. During an inspection at the Indian API manufacturer Anuh Pharma Ltd., the French monitoring authority discovered in total 24 deficiencies: among them one critical and two "major" ones.

The company purchased pharmaceutical APIs which had been micronized at the production site and then exported to Europe. Anuh Pharma didn't reveal deliberately the origin of the APIs sold to its European customers, i.e. the name of the original manufacturer; the original batch number and the respective certificates of analysis haven't been communicated. The GMP inspectors found out that materials had been processed which came from a facility known as a non GMP-compliant source. All micronized APIs have been delivered to Europe under the name Anuh Pharma which represents a gross violation and confusion for the customers.

Further serious GMP violations ("major") have been observed with regard to the documentation system. The inspectors discovered documents within a pile of rubble of a wall. Among them, they also found the original report on the repacking of a batch as well as several orders of APIs back to 2013.

The inspectors searched in vain for data about the validation of the blending of micronized batches and about equipment cleaning. There were no supporting data for the reduced testing of the recovered Ethyl Acetate solvent available.

The consequences of these inspection results not only affect the Indian company (withdrawal of the GMP certificate) but also all pharmaceutical companies which use those APIs for the manufacture of their medicinal products. They should change the supplier and take into consideration a product recall of the products concerned.

The inspection was part of the EDQM's inspection programme. That's why also the Certificates of Suitability (CEPs) of in total 4 APIs have been withdrawn or suspended.