Sentry BioPharma Services provides drug product management, global drug distribution, GMP storage and specialized services like pharmaceutical labeling, packaging and kitting. Sentry plays a critical role in protecting temperature-sensitive product safety, identity, strength, purity and quality (SISPQ) for both clinical trials and commercial drug distribution for a wide range of pharmaceutical and biotechnology clients.
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) Committee met recently on February 9-10, 2017.
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) was established in 1995 as 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. PIC/S presently comprises around 50 participating authorities coming from all over the world (Europe, Africa, America, Asia and Australasia) including the U.S. FDA, Australia’s Therapeutic Goods Administration (TGA), Health Canada, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA), and the EMA is a recognized partner of PIC/S working closely with the group to provide training and develop harmonized guidance documents. A committee of the participating authorities’ representatives (PIC/S Committee) supervises the organization’s activities and all decisions are taken unanimously.
PIC/S intent is to harmonize inspection procedures worldwide by developing common standards in the field of GMP and by providing training opportunities to inspectors. It also aims at facilitating cooperation and networking between competent authorities, regional and international organizations, thus increasing mutual confidence.
At the meeting in February, the PIC/S Committee reviewed a strategic plan (Road Map) for 2017-2019 which includes an objective to and ensure the full implementation of the PIC/S Inspectorates’ Academy (PIA).
The PIA is a PIC/S initiative to set up a web-based educational center under the PIC/S umbrella, which aims at harmonizing and standardizing GMP training at an international level through a certified qualification system. PIA delivers not only general or advanced training but also serves as a platform for discussion and sharing among regulators. It offers a single point of access to all PIC/S training activities and is being implemented in various stages.
The training of GMP inspectors has been at the core of PIC/S activities since its inception, however, PIC/S has also opened some of its training tools to inspectors active in other areas such as Good Distribution (GDP) and Good Clinical Practices (GCP).
In addition to the PIA, PIC/S offers an annual Training Seminar for inspectors, with each Seminar dealing with a specific topic. The Seminars are hosted by a different PIC/S regulatory authority each year and results in the setting up of a Drafting Group, which develops new or amends existing GMP guidance documents.
Other avenues for training and exchange supported by the organization include the PIC/S Joint Visits Programme which teams up inspectors from three different countries to observe GMP inspections in each country, as well as “Expert Circle” groups to enable inspectors to discuss and exchange information on specific technical areas of GMP, develop draft guidance documents, and to provide for training opportunities in their field of expertise. Expert Circles on Human Blood, Tissues, Cells and Advanced Therapy Medicinal Products (ATMPs), Computerised Systems, Active Pharmaceutical Ingredients (APls), Good Distribution Practices (GDP) and Quality Risk Management (QRM) are currently active and meet regularly.
Sentry BioPharma Services offers temperature sensitive biological product management to pharmaceutical companies, hospitals and organizations with need for validated GMP storage, labeling, kitting and temperature-sensitive drug distribution services. For more information about how Sentry’s GMP services can help protect the integrity and delivery of your biological products to patients, contact Sentry via email or by phone at 1-866-757-7400.