|By Len Monheit
|Comment on this Editorial|
As expected, the long-awaited arrival of a proposal for GMP guidelines from the FDA has triggered a flurry of activity both within and outside of the industry. And in Canada, with new regulations for Natural Health Products accompanied by guidance documents anticipated in Canada Gazette II in the next few months, plans are being developed to present and interpret the regulations, and to guide industry compliance efforts.
Trade associations, awaiting the news in both countries, have an obligation to constituents to help them prepare for the changing regulatory environment, and have begun fulfilling this role with conference calls, web-casts and discussion papers. And with regulations presently only at proposal stage, one must be aware that the final rules and more importantly, the interpretation and enforcement of the rules and guidelines has still not been determined, and will likely be a process of evolution.
At SupplySide in a few weeks, a discussion session has been established where FDA representatives will be available to answer industry questions. Several consultancy groups within the industry have begun dissecting the massive GMP document to understand its implications, preparing for their own guidance role in helping clients to comply, whether these clients are the associations themselves or individual companies.
Over the past three weeks, several new participants have emerged, including conference organizers, seeking to present the guidelines and related issues on each side of the border-through seminars, conferences, training manuals, system and facility audits and other activities. While some of these groups may be extremely proficient, profoundly knowledgeable and capable of bringing even the shoddiest operation into complete compliance, this opportunism is a little disconcerting.
As the events, resources and seminars proliferate, potential attendees will have some decisions to make. While excellent information will be provided by the trade associations, extra individualized support may, in fact, be required for many companies, and so the choice of groups to provide this support will be critical.
Decisions will need to be made throughout the industry.
Which events will the company attend? How will it decide? Who will be sent? At what stages of the GMP proposal evaluation? How will you capture and interpret what the regulations mean for your company specifically rather than in the general overview likely to be presented in an open seminar format? (It’s great to send people to gather the latest intelligence, but getting an ‘appropriate’ interpretation in the context of your specific business is critical. So is making effective use of the intelligence gathered, especially, if, as is usually the case, the costs for event participation are prohibitive.)
As the organization decides where and with whom to allocate its resources, regulatory familiarity is obviously critical, but so too is industry and organizational familiarity. And the events themselves, as well as providing an interactive discussion, must be presented with practical, logical deliverables to bring back to the organization, otherwise the return is just not there.
Many activities and groups will be competing for the organization’s attention. It would be quite easy to operate without a plan. It would be far better to organize, act and comply with a strategy in mind.