Revision of the PIC/S Guidelines for ATMPs and Biological Medicinal Products

Especially in the field of biological agents and medicinal products and in ATMPs, developments are progressing rapidly. The development of vaccines in the context of the Corona pandemic has clearly shown this. This necessarily also has an impact on the relevant guidelines.

The PIC/S also takes this development into account and has started a revision of two parts of its GMP Guidelines (Annex 2A and Annex 2B), which deal with the manufacture of advanced therapy medicinal products (ATMPs) and biological drug substances and products for human use. The PIC/S itself says: "Although one of the objectives of this present revision was to prepare a document that would stand for several years the field is rapidly changing; it is recognised that amendments may be necessary to accommodate technological change, to clarify uncertainty or to specifically recognise important alternatives".

Annex 2A in particular should not only take into account the special circumstances of ATMPs, such as the frequently long phases of clinical testing, but also the changes in the internationally relevant guidelines, e.g. European Commission guideline on GMP for ATMPs.

For this reason, the PIC/S has now started a commentary period for the drafts until 20 December.

However, this also covers more far-reaching questions of patient safety or the much-discussed question of the release of "Out-of-Specification (OOS)" batches under certain conditions. Also an issue is when certain manufacturing activities need to be extended to hospitals as part of a decentralised or point-of-care manufacturing.

More generally, PIC/S would like to discuss with those commenting how harmonised international GMP standards can help facilitate the manufacture of these products, particularly given the increasing volume of manufacturing that takes place across borders and in non-traditional manufacturing environments.

Please find the GMP Annex related to ATMPs on the PIC/S website

Source: RAPS Article


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