PICS – Pharmaceutical Inspection Cooperation Scheme照片–药品检查合作计划.pptVIP

PIC/S – Pharmaceutical Inspection Cooperation Scheme) Ella van der Merwe 24 February 2004 PIC/S – PIC scheme Established in 1995 as an extension PIC PIC is the Pharmaceutical Inspection Convention PIC founded in 1970 by European Free Trade Association Title of “ The Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products” Initially 10 member companies PIC/S – Cont… Incompatibility between PIC and European law EU law did not permit individual EU countries that were members of PIC to sign agreements with other countries seeking to join PIC Only EU commission allowed to sign agreements with countries outside the EU Commission was not a member of PIC. Consequently PIC Scheme was formed PIC Scheme and PIC operate in parallel, as PIC/S PIC/S – Cont… PIC – legal agreement between countries with treaty status PIC/S – non-legal cooperative arrangement between regulatory authorities PIC/S provides for GMP inspection reports and certificates to be exchanged Unlike PIC not legal obligations for members to accept such reports or certificates PIC/S committee include one senior representative from each member regulatory authority Meet 6 monthly to coordinate activities Main functions Main functions of PIC/S To provide a forum for training of GMP inspectors To facilitate the exchange of information between member authorities To develop guidance documents on GMP To promote uniform interpretation of GMP To encourage international harmonization on GMP To develop and promote quality systems for GMP Inspectorate To provide a forum for networking and confidence building amongst inspectors Members Current members of PIC/S Austria, Denmark, Finland, Greece, Iceland, Liechtenstein, Malaysia, Norway, Portugal, Sweden, Switzerland, UK, Hungary, Ireland, Romania, Germany, Italy, Belgium, France, Australia, Netherlands, Czech Republic, Slovak Republic, Spain, Canada and Singapore Countries currently being assessed Chin