The Never-Ending Story
At one time, death and taxes were meant to be the only two certainties. For Quality Assurance Managers, ever-changing guidelines for pharmaceutical ingredients might be justifiably added as a third. It seems that no sooner is the ink dry on the latest in-house Quality Manual, regulators have introduced a new set of requirements needing to be included.
Whilst crystal balls are in short supply, that doesn’t mean organisations should be totally surprised by future compliance initiatives. Pro-active Quality Departments are likely to have already spotted a number of the key concerns that occupy regulators. At Surfachem, we have our own ideas as to the direction of travel and have identified some possible core topics.
Mandatory full‑chain ingredient traceability
A registration of all manufacturers, suppliers and distributors of all ingredients contained in licensed medicines. Not just the API and the excipient “as is” but a drill-down into API starting materials as well as all components of branded excipients and all aligned to a digitally auditable supply chain from raw material to finished dose. The technology is there and yes, it will probably be an implementation nightmare, but it’s a likely scenario for an industry that prioritizes full transparency.
Tighter controls on distribution intermediaries
It’s fair to say that regulators hate opacity… so consider the ingredient coming from thousands of miles away and the multiple logistics and commercial hands it can pass through. Many times it’s certainly not one pair; so how many? Two, four, more? Do you know? And if not, then how do you know the conditions under which it is handled. Organisations might expect a rippling out of Good Distribution Practice inspections across the broad logistics function and with an enhanced emphasis on risk management, auditable documentation and control of supply chains.
Improved responses to product shortages
The on-going shortages of many generic medicines has become a worrying feature of the industry. Manufacturers may point to the economics of cost of goods versus return on investment, but for national health care providers, a different set of principles underpin their responsibilities. In response, regulators could require at least two qualified suppliers for every critical active ingredient, geographically diverse sourcing, and validated alternative synthesis routes. This might also extend to certain excipients where over-reliance on a brand with specific analytics (but not much more) can hit production hard when there is no approved alternative. While such measures would impact primarily Marketing Authorisation Holders, distributors might be required to factor in shortage mitigation approaches not only in supplier approvals but increased stock holding.
Move to ingredient‑level carbon disclosure
Would it be such a surprise if regulators wanted to see carbon footprint data on a per kilo/ton of API/excipient basis and reporting extended to smaller and medium-sized organisations, distribution as well as manufacturing. If not the devil, then the footprint is in the detail and formal inspections by competent authorities may be on the cards with greater interrogation of what is currently contained in self-declarations and returns. In addition, all those in the supply chain may be required to demonstrate year-on-year improvements to their carbon footprint particularly when considering where sourcing of many ingredients takes place.
A regulators’ holy grail is perhaps to be able to see the whole life story of every ingredient — where it came from, how it behaves, who touched it, and what risks it carries — and they want that story to be digital, traceable and auditable. Are we there yet? No, but that’s a likely direction of travel and one which will require all Quality Departments to consider carefully what they will need to do meet the expectations of regulators.
