WHO joins regulators in manufacturing inspections alliance

pharmafile | March 12, 2012 | News story | Manufacturing and Production |  API, EMA, FDA, WHO, manufacturing 

The World Health Organization will join a shared inspection programme for active pharmaceutical ingredient (API) facilities piloted last year by regulators in Europe, the US and Australia. 

The overall aim of the scheme is to better distribute inspection capacity, allowing more API-producing sites to be monitored and reducing unnecessary duplication.

The European Medicines Agency (EMA), US Food and Drug Administration (FDA) and Australian Therapeutic Goods Administration (TGA) were the inaugural partners in the pilot inspections programme, which published findings from a two-year pilot last year. 

The international collaboration initiative allows participants to share information on inspections, including planning, policy and reports, for manufacturers of APIs that are located outside the participating countries. It also allows joint inspections to take place. 

A new document published recently by the partners notes that the WHO is now taking part in the programme via its Prequalification of Medicines programme, which includes inspections of API facilities to ensure they meet the WHO’s Good Manufacturing Practice (GMP) standards. 

Moreover, the terms of reference indicate that other regulatory authorities will be able to join the scheme, providing they meet a set of requirements.

Regulators with a functioning API inspectorate and routine inspection programme, adherence to the International Conference on Harmonisation (ICH) Q7 guideline on GMP for APIs with appropriate guidance and supervision of sterile actives – amongst other requirements – will be eligible. 

“A number of countries have mutual recognition agreements (MRA) or memoranda of understandings (MoU) with other countries which allow them to rely on results from inspections performed by other countries,” says the document. 

“However these MRAs or MOUs are often limited in scope, and subject to certain restrictions,” it notes.

EU Member States and the European Directorate of the Quality of Medicines and Healthcare (EDQM) are also involved in the partnership, according to an EMA statement. 

Phil Taylor