The introduction of GMP standards for excipients has been on the cards for some time now, but the plans have drawn mixed responses from the industry, ever wary of the cost implications of increased regulatory control.
The Directorate-General Enterprise and Industry at the European Commission has now officially launched two online questionnaires, aimed at excipient manufacturers and excipient users, to ascertain the impact of the draft GMP guidelines for excipient manufacture that were drawn up last December.
Ton van Lierop of the European Commission explained why it was felt that GMP standards for pharmaceutical excipients are required:
"Currently, no harmonised GMP principles for excipients have been published for the EC, leading to a non-harmonised approach which could be an issue from a public safety perspective," he told In-PharmaTechnologist.com.
"In addition, there is uncertainty at the level of manufacturers/importers of medicinal products and excipient manufacturers on which standards should be required."
However, uncertainty has been voiced regarding the potential impact of such regulations on the pharma industry. Already suffering from the heated cost competition generated from Asia, which has proved itself a more than worthy adversary in offering cheap outsourcing options to manufacturers, increasing regulatory burden (and consequently costs) could make it even harder for Western companies to compete.
On top of this is the fact that within excipient manufacture, only a small fraction of the product tends to be destined for pharmaceutical applications, with other more significant targets being the food and chemicals industries.
As such, there would seem little incentive for manufacturers to implement a whole barrage of dedicated standards and procedures for such a small segment of their business, which runs the risk of some companies deciding to drop their excipient production for pharmaceutical applications altogether.
More optimistic parties, however, see the proposed regulations as a more positive move, not just in terms of ensuring patient safety but as a tool for improving the competitiveness of companies, not only in Europe but on a worldwide scale.
However, the whole aim of the online questionnaires launched by the EC is to give industry a chance to have its say, and to smooth out any potential stumbling blocks and difficulties in subsequent drafts of the legislation.
"The main objective of the online consultation is to prepare for the legal framework foreseen," said van Lierop.
"In particular, the questionnaires are meant to allow for data collection for an impact assessment in preparation for legislation for excipients, in particular for those excipients falling under potential 'high risk' categories."
According to the draft version of the legislation compiled last December, the regulations would apply to a variety of excipients, though the final list has yet to be decided. Excipient categories currently under discussion include those products prepared from materials derived from TSE-relevant animal species (excluding lactose), excipients derived from human/animal material with potential for viral contamination risk, excipients sold as sterile and used without further sterilisation, among others.
The questionnaires, one designed for excipient manufacturers and the other for excipient users and distributors, give respondents the opportunity to comment on various policy options, from full-blown legislative control, to industry guidelines or a more self-regulatory approach. Those taking the time to fill out the questionnaire can provide details of estimated costs and impact of the proposed GMP moves, and have the opportunity to highlight specific points or issues to the EC.
For some companies, whatever the EC eventually decides to implement could merely represent a formalisation of measures the company has already decided to take independently.
For example, last year specialty chemicals firm Cognis became the first excipient producer to obtain GMP compliance following an audit by the German Association for Certification of Quality Management Systems (DQS). The firm's Dusseldorf site was certified GMP-compliant according to guidelines set out by the International Pharmaceutical Excipients Council (IPEC).
"Cognis intends to participate in the online consultations relating to the new GMP guidelines," global product line manager Jochen Seifert told In-PharmaTechnologist.com.
"As the pharmaceutical industry continues to develop, Cognis believes it is important for certain excipients - especially those used in parenteral applications such as glycerine - to be produced under strict GMP guidelines in order to assure high quality and patient safety."
Companies can forearm themselves now so as to ease the transition to legislative regulation by ensuring their excipient manufacture is up to scratch; last year IPEC published a good manufacturing practices guide for pharmaceutical excipients in collaboration with the Pharmaceutical Quality Group, which aims to help manufacturers meet internationally accepted good manufacturing practice principles.
"Qualified parties from medicinal product manufacturers/importers should be aware of their responsibility to only use excipients which are of the appropriate and pre-defined quality outlined in specifications," van Lierop said.
"In this respect, they should make sure that they only use excipients which have been manufactured in compliance with quality standards appropriate for the use in their pharmaceuticals."
Only last month IPEC held its annual meeting to discuss issues affecting the excipient industry. Among the many topics covered were the intentions to introduce GMP standards for excipient production in Europe, with the Council encouraging manufacturers to take part in the EC's online consultation.
"IPEC Europe, together with other involved European Trade Associations (AESGP, CEFIC/APIC, EFPIA, EGA, Eyecare Industry, FECC) have worked closely with the Commission through all stages of the process associated with this Directive, and have been pleased with the collaboration and open approach," Kevin McGlue, chair of the IPEC Europe GMP Committee and director of global quality assurance at speciality chemicals firm Colorcon, told In-PharmaTechnologist.com.
"This public consultation stage is an extremely important step in collecting information that will influence the final development of this Directive, therefore IPEC Europe urges all manufacturers and users of excipients that are on the draft list to ensure that they respond."
With the excipient industry forecast to hit $1.39bn (€1.04bn) by 2008, parties involved in the industry can take this opportunity to influence legislation that will directly affect their manufacturing practices.
The questionnaires will be available online until 30 July 2007, and can be accessed directly through the Directorate-General Enterprise and Industry's web page here , along with an instruction note for respondents.
