Role and Benefits of PIC/S (Pharmaceutical Inspection Cooperation Scheme)

C

Cinti

#1
Hi,

I understood from PIC/S website that there are 40 participating authorities that include FDA, MHRA and 4 partners to PIC/S. I assume that PIC/S will conduct inspection to the manufacturing facilities and issue GMP certificates. The manufacturer could submit this GMP certificate to FDA or MHRA for getting approval from them. Kindly correct me if my understanding is wrong.

In addition, I will be very grateful if anyone can explain me the role and benefits of PIC/S to the manufacturing companies.

Cinti
 
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#2
Re: Role and benefits of PIC/S

Does this ring a bell with anyone? If anone can help with this one, my Thanks in advance!
 
#3
Re: Role and Benefits of PIC/S

v9991,

I am not sure for inspections but FDA has accepted the practice of parametric release for drug products terminally sterilized by moist heat.

The Parametric release is described in the International Conference on Harmonisation (ICH) Q6A (ICH 2000),10 is endorsed by regulatory and/or pharmaceutical manufacturing groups in the US (PDA 1999, USP 2009), EU (PIC/S 2007, EMEA 2001), and Japan (Sasaki 2002).

In addiition, as part of International Collaboration,

It is important to note that FDA will seek membership in the Pharmaceutical Inspection Cooperation Scheme (PIC/S), a cooperative arrangement between health authorities whose purpose includes leading the international development, implementation, and maintenance of harmonized CGMP standards and quality systems of world-wide pharmaceutical inspectorates. Membership in the PIC/S provides networking opportunities among participating authorities, the development of mutual confidence among authorities, and mutual training of inspectors, as well as the exchange of information and experience in the field of CGMP and related areas. FDA expects that its involvement with PIC/S will further increase opportunities for information sharing and facilitate steps toward harmonizing the interpretation and application of CGMP requirements.
 
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