News from GMP Area

Opened laptop and a hand

Iran/IFDA, Turkey/TMMDA and Mexico/COFEPRIS are new members of PIC/S, 18th of December 2017

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.

Valicare GmbH,, a 100 % daughter of the Bosch Packaging GmbH, offers extensive GMP consulting services for the Pharma, Biotech and Medical Device industry since over 15 years now.

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.

If you need our support or want to get info about our services, call 0049 69 7909 343, please.


Further information

Dr Claudia Papewalis is giving a GMP for ATMP training


If you want to know more about the regulatory requirements requested for manufacturing ATMPs, contact our experts or take part at one of our internal GMP training courses.

A scientist is looking at t-cells visible at a computer screen

GMP-compliant manufacturing process

Valicare supports start-ups like polybiocept in transferring cell-culturing methods developed at the laboratory into a GMP-compliant manufacturing process. Check the press release and get an overview about our GMP for ATMP services.

cell culture, ATMPs

„Guidelines on Good Manufacturing Practice (GMP) specific to Advanced Therapy Medicinal Products”

On 22th of November 2017 the European Commission adopted the "Guidelines on Good Manufacturing Practices (GMP) specific to Advanced Therapy Medicinal Products".