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US FDA joins PIC/S after 5 year review

By Gareth Macdonald , 03-Jan-2011
Last updated on 03-Jan-2011 at 14:18 GMT

The US FDA has finally become a member of the Pharmaceutical Inspection Convention and Pharmaceutical Co-Operation Inspection Scheme (PIC/S) after a five-year application process.

The PIC/S, which aims to set good manufacturing practice (GMP) standards for the production of pharmaceuticals, formally accepted the US Food and Drug Administration (FDA) in November, enabling it to become a member on January 1.

The acceptance, which follows an inspection in August, makes the FDA the 38th national industry watchdog to join the scheme and, according to regional director Brenda Holman, is the end of an often painful effort to comply with PIC/S standards.

Holman told the Parenteral Drug Association (PDA) that: “We did not know how to approach this as an Agency, so each [division] took the application and filled out [their] separate parts and threw it back over the wall to PIC/S.

It took several years to sort through all of them,” she continued adding that “we answered a lot of questions and communicated extensively with the organization and tried to gain some level of understanding and clarity.”

Impact

Membership of the PIC/S comes with a number of advantages according to Holman, citing its basic set of GMP guides for active pharmaceutical (API) production and guides for the manufacture of sterile medicinal products as some of the most important

She also told the PDA that the group’s “long history of providing seminars and training sessions… relative to APIs, computerized systems, human blood tissues, quality risk management and good distribution practices,” will be important for training future facility inspectors.

The opportunity for membership in PIC/S represents to the Agency and to the industry involved is that we are sitting at the same table with other agencies that are looking at you and your products and your procedures.”

Ukraine

In other PIC/S news, Ukraine’s State Inspectorate for Quality Control of Medicines (SIQCM) also joined the standards scheme after an even longer review process that began in April 2005.

Agency head Oleksii Soloviov, thanked the Ukranian team that took part and offered his country as a host for future PIC/S inspector and agency training programmes.

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