On 21 June 2023, PIC/S quietly published version 17 of its Guide to Good Manufacturing Practice for Medicinal Products (‘PIC/S GMP Guide’), PE 009-17 effective 25 August 2023. The sole substantive change being introduced with PE 009-17 is inclusion of the revised Annex 1 (Manufacture of sterile medicinal products), which was published in September 2022, after undergoing revision which was extensive in terms…
‘Continuous Improvement’ or ‘Continual Improvement’ within a quality system can be described as a process of ongoing improvement of products, services or processes through incremental and/or breakthrough improvements. Within the Pharmaceutical Industry, it’s important that companies ask themselves how continuous improvement has been built into the Pharmaceutical Quality System (PQS). The term may appear in…
It has been a big year for industry as organisations scramble to be in full compliance with PIC/S PE009-13. With the due date on January 1st 2019, this deadline is coming sooner than many of us would like! On the 12th September, I attended the CAPSIG NSW/TGA seminar in Sydney which provided an insight into…
PE00-015 Guide to Good Manufacturing Practice for Medicinal Products has recently been adopted by the TGA in Australia. Notably, this update splits Annex 2 into Annex 2A: Advanced Therapy Medicinal Products and Annex 2B: Biological Medicines separately: Annex 2A: Manufacture of Advanced Therapy Medicinal Products for Human Use (ATMP) harmonises with the EudraLex Volume 4…
PE00-015 Guide to Good Manufacturing Practice for Medicinal Products has recently been adopted by the TGA in Australia. Notably, this update separates Annex 2 into advanced therapy medicinal products (ATMP) and biological medicines, as follows: Annex 2A: Manufacture of Advanced Therapy Medicinal Products for Human Use (ATMP) harmonises with the EudraLex Volume 4 Guidelines on…
Please complete the form on the contact us page. We will get back to you within one business day.
Phone: +61 3 9887 6412
Email: [email protected]
