‘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 …
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 …
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 …
This is the second of a two-part blog covering the changes to PIC/S version 16. Previously we discussed changes to Annex 13 – Manufacture of Investigative Medicinal Products, and today I am doing a comparison of the new Annex …
Historically, the PIC/S GMP Guide has chapters and annexes revised, aligned and corrected to close the gap between the international GMP guidelines and to further develop and harmonise GMP standards. PIC/S PE 009-16 (or version 16) of the Guide, …
“We’ve got a new project for you. We’re going to replace our cold-chain account with passive packaging.”
It’s a notion I’ve heard many times before, but I will admit to having to abandon more passive packaging projects than I’ve completed …
I’m often asked to clarify the difference between TGA Medicinal Cannabis and EU GMP Medicinal Cannabis, i.e. who is that has the highest “Gold Standard” for Medicinal Cannabis? I suspect this has come about because many are trying to …
On 1 January 2021, ANVISA, Brazil became the 54th member of PIC/S. Like all other PIC/S members, both ANVISA and Brazil’s pharmaceutical industry will realize a wide range of benefits of PIC/S membership, particularly at this time of the …
As many are aware, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) develops and provides standards and guidelines for the harmonisation of Good Manufacturing Practice(GMP) in the global pharmaceutical industry.
Those who fall under the umbrella of participating countries, often take for …
Serialisation labelling requirements (serialization) for pharmaceutical products can improve patient safety, prevent counterfeit products from entering the market, and enable more efficient recalls.
Why is serialisation on labelling so important?
Supply chains for pharmaceutical manufacturing and medical device production are becoming …
