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French Regulators Raise Serious Concerns With Indian API Manufacturer

Posted 10 October 2016 | By Zachary Brennan 

French Regulators Raise Serious Concerns With Indian API Manufacturer

France’s National Agency for Medicines and Health Products Safety (ANSM) on Monday released a new statement of serious good manufacturing practice (GMP) non-compliance for India-based active pharmaceutical ingredient (API) manufacturer Nandu Chemicals Industries.

In an inspection from 20 August, the French regulators uncovered significant deficiencies linked to “the vast majority of inspected areas” at Nandu’s Hubli, India site.

In particular, the inspectors highlighted falsification practices and inadequate control systems.

Major deficiencies observed also included: Risks of contamination, lacking “basic hygiene practices for the packing area / Poor standards for the management of retention samples and stability studies / Failing validation practices, in particular regarding analytical and cleaning validations / Lacking cleaning methods / Poor training practices / Deficient monitoring of the quality of the purified water / For documentation, insufficient recording and archiving practices / Deficiencies in product labelling practices.”

A spokesperson for Nandu told Focus via email: “We are in touch with the concerned authorities to resolve the issues within the time-frame as stipulated. To overcome the non-compliance, we have started working on each point and initiated implementation of CAPA [corrective and preventive action], with the help of experts in this field. We are confident to resolve the issues satisfactorily very shortly.”

As a result of the inspection, ANSM is requesting a recall of products using quality risk management principles. And as long as the non-compliance report remains active, ANSM says the site should not be named in any new marketing authorizations or used in drug compounding activities.

Nandu currently manufactures more than 100 APIs at the site, including zinc sulphate monohydrate for the EU. Other APIs routinely manufactured at the site include calcium chloride dehydrate, potassium chloride, sodium benzoate, sodium gluconate, magnesium sulphate heptahydrate and manganese sulphate monohydrate.

As for its clients, Nandu says it has worked with Pfizer, Merck, Dr. Reddy’s and others.

This isn’t the first time an Indian API manufacturer has been cited for critical issues in 2016. The Italian Medicines Agency in May uncovered major GMP issues at Visakhapatnam, India-based Krebs Biochemicals & Industries and Daund, India-based JP Laboratories. Also in May, the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) issued a statement of non-compliance to Indian active pharmaceutical ingredient (API) manufacturer Dhanuka Laboratories Ltd.

In addition, Hyderabad, India-based Artemis Biotech, which produces multiple products for the EU market, was hit with a statement of non-compliance from a German competent authority, identified as Landesamt für soziale Dienste Schleswig-Holstein in August, while European imports from AstraZeneca’s now-closed terbutaline sulphate API manufacturing facility in Bangalore, India were halted last December by Sweden’s Medical Products Agency after failed validation runs.

EudraGMDP


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