Pharmaceutical companies offered advice on how to describe manufacturing processes
This advice on the manufacture of the finished dosage form has been released for public consultation, until 9 January 2016
New draft guidance on how pharmaceutical firms should describe their manufacturing processes when making market approval applications has been released by the European Medicines Agency (EMA). This advice on the ‘manufacture of the finished dosage form’ has been released for public consultation, which will continue until 9 January 2016.
EMA says required manufacturing descriptions should include information about critical steps and intermediates, linking pharmaceutical development, proposed control strategies and process validation. It also addresses increases in outsourcing within the industry and new manufacturing practices, including increasingly complex manufacturing chains, prolonged storage and transportation.
As regards the industry’s increasing complexity, for instance when making biotechnological products and continuous manufacturing processes, the draft says information on how accidental deviations from approved manufacturing process will be managed 'can be helpful to assure that the intended quality of the product is retained'.
The draft covers batch formula issues. For instance, when a bulk product is assembled into different presentations or packs, the production batch size should be defined by the original bulk before any division. When the length of the subsequent processes and assembly is considered critical (e.g. filling for aseptically manufactured products), the division pattern should be indicated, the draft adds.
The guidance applies to biological medicinal products, but not advanced therapy medicinal products (ATMPs).