Another Indian API Manufacturer found to be out of GMP Compliance by EU Authorities

Recommendation

23-25 April 2024
Barcelona, Spain

Global Registration and Life Cycle Management for APIs

India continues to be the place were many manufacturing sites are found to be out of GMP compliance. This time it is the manufacturer POLYDRUG LABORATORIES PVT. LTD. , Plot No. 37, Anand Nagar, M.I.D.C., Ambernath (East), Maharashtra, IN - 421 506, India that is affected. There, EU GMP Inspectors from Slovenia found several GMP compliance violations. In total 17 deficiencies were found and caused the suspension of all CEPs. Manufacturers of medicinal products for the European market who use APIs from Polydrug Laboratories should immediately verify the consequences for their medicinal products as medicinal products containing non GMP compliant APIs can no longer be supplied to EU customers. The requested change (according to the report no INSP 2015-002 P01) for the marketing authorisation holder is to choose another API supplier.

The problem at Polydrug Laboratories is mainly caused by 5 major GMP deficiencies. The inspectors found:

- Customer complaints deliberately unregistered in the official logbook
- Storage of quality documents in an uncontrolled location, involving staff from QC, QA, maintenance and production
- Deficient management of paper documents
- Deficient management of the computerised system
- Failure to address risks of cross contamination for APIs sent out to micronisation subcontractor.

According to the Statement of Non-Compliance issued in EudraGMDP this statement is valid for all APIs: "The Plant I produced Metoprolol Tartrate, Metoprolol Succinate, Chlorobutanol Hemihydrate, Chlorobutanol Anhydrous and Fluconazole. The plant II manufactured Ferrous Fumarate. The plant III produced Losartan Potassium and Carisoprodol. All CEPs have been suspended: CEP 2009-112 (Chlorobutanol hemihydrate), CEP 2009-152 (Metoprolol tartarate), CEP 2009-170 (Metoprolol Succinate), CEP 2010-147 (Ferrous fumarate), CEP 2010-247 (Fluconazole), CEP 2011-304 (Metoprolol tartarate), CEP 2011-312 (Metoprolol Succinate).

On March 15 a Chinese API manufacturer was also found to be out of GMP compliance: HUZHOU SUNFLOWER PHARMACEUTICAL CO., LTD. , 692 North Zhiyuan Road, Wukang Town, Huzhou, Zhejiang Province, 313 200, China has been manufacturing POVIDONE and IODINATED for the EU market. Here the EU GMP Inspectors from France found 27 deficiencies. This caused the withdrawal of CEP # 2009-166. The CEP was suspended in June 2012 already because the company refused to accept an EU GMP Inspection planned by EDQM.

Source: EudraGMDP (European Inspection Database for GMP and GDP information)

Recommended reading: EMA publishes several GMP Non Compliance Reports