18th of December 2017

Iran/IFDA, Turkey/TMMDA and Mexico/COFEPRIS are new members of PIC/S

On the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Committee meeting in Taipei (Chinese) from 11-12th of September 2017, three new Authorities were invited to join the Scheme, as released by the Press of PIC/S.

The Iran Food and Drug Administration (IFDA), the Turkish Medicines and Medical Devices Agency (TMMDA), and Mexico’s Federal Commission for the Protection from Sanitary Risks (COFEPRIS) will become Participating Authorities (PA) of PIC/S at 1th of January 2018.

In each case the application was filed years ago and a long-lasting process passed through. After on-site visits the PIC/S Audit team recommended to the Committee to accept the PIC/S membership

for all three authorities. The IFDA will become the 50th , TMMDA the 51st and COFEPRIS the 52nd PA of PIC/S.

As you can read on the PIC/s website, “PIC/S is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It is open to any Authority having a comparable GMP inspection system.”

Common GMP standards and worldwide harmonisation of inspection procedures are the goals of PIC/S. The PIC/s membership is therefore a strong commitment to GMP compliance.

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Our GMP experts execute audit and inspections, risk-based qualification and validation as well as GMP consulting projects worldwide.

Mr. Mohsen Masoumi, one of our Senior GMP consultant, can specially support Iran customers to develop or to review their processes on GMP compliance.

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Dr. Ellen Sons-Brinkmann
Tel: +49 69 153 293 709
Mail.: ellen.sons-brinkmann@valicare.com