COVID SUPPLY CHAINS: FACT NOT FICTION—CHAPTER 2, PART 2
The truth, the whole truth, and nothing but the truth
Picking up from yesterday
Yesterday, we finished off with the electronic Common Technical Document (eCTD).
The eCTD has been in use for over 20 years, and before that it was pallet loads of paper files, that were scrutinised in tiny detail be the regulatory authority concerned.
All that would take around 12 - 18 months. [Note that’s a bit longer than the 2 weeks to do the fraudulent Rolling Reviews which ignored the Chemistry, Manufacturing and Controls element—the piece that ensures the supply chain is safe].
COVID SUPPLY CHAINS: FACT NOT FICTION—CHAPTER 2, PART 2
It is crucially important to recognise that drug safety is determined by the nonclinical Module’s 3 and 4 in combination. That is because safety tests must be carried out on the material that will be administered to patients.
It has never been acceptable to regulatory authorities for a clinical trial sponsor or product license holder to merely test a trial batch(es) for safety and infer all future production will be safe.
The way that is assured is by these companies adhering to good practices (GxP), covered in the next section.
Module 4 is titled ‘Safety’.