medicines-medical devices-regulatory affairs
This post concerns the introduction of temporary new arrangements by the TGA, for GMP inspections of: When were the temporary new arrangements for GMP inspections introduced and what are they called? The temporary new arrangements for GMP inspections were introduced…
Updates to the EU Compilation of Union Procedures on Inspections and Exchange of Information, were adopted in September 2021 with a period of 9 months (following publication) before coming into force i.e. June 2022. The changes are relevant for holders of GMP…
The TGA, Australia has provided an update on its GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic. The update concerns certain temporary measures introduced in 2020 for overseas manufacturers. The following items are addressed: On-going…
The European Medicines Agency has recently published a 29 page Reflection Paper on Good Manufacturing Practice (GMP) and Marketing Authorisation holders (MAHs). Whilst it is recognised that many MAH companies are not directly engaged in the manufacture of medicinal products…
The TGA, Australia has issued guidance on GMP compliance requirements and framework for managing GMP compliance signals. The 17 page guidance document outlines: the Good Manufacturing Practice (GMP) compliance requirements according to the Manufacturing Principles for manufacturing biologicals and medicines…
About PIC/S The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is 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…
The EMA has published a Q&A on the principles of GMP for the manufacturing of startingmaterials of biological origin used to transfer genetic material for the manufacturing ofAdvance Therapy Medicinal Products (ATMPs). Is a GMP certificate required for manufacturing and…