In-PharmaTechnologist Excipient GMP Series
Cognis becomes first excipient producer to obtain GMP compliance
practice (GMP) certification for its production of pharmaceutical
excipients in Germany, the first chemical company in the world to
do so but certainly not the last.
After an audit carried out by the German Association for Certification of Quality Management Systems (DQS), the company's Dusseldorf site was certified GMP-compliant based on the guidelines issued by the International Pharmaceutical Excipients Council (IPEC).
Cognis requested the audit in response to an EU directive which will soon see certain excipients produced under GMP standards, albeit not the same GMP as for active pharmaceutical ingredients (APIs).
In its consultations with the industry, the European Commission is currently focusing on the following categories of excipients: those derived from human and animal materials with a potential viral contamination risk, especially blood products, those of animal origin subject to transmissible spongiform encephalopathy (TSE) risks, those claiming to be sterile and are used with no further sterilisation, those which are pyrogen/endotoxin controlled, propylene glycol and glycerin.
In addition, excipients used for parenteral administration already have to made under API GMP while more and more pharma companies require tests for excipients described by pharmacopeial monographs (USP-NF, European Pharmacopoeia, and Japanese Pharmacopoeia).
As an excipient provider of nine of the top ten pharma companies, Cognis decided to address these issues and incorporate the GMP criteria into its own quality management system.
"We already had ISO 9001 and ISO 14001 certification so it was relatively easy to adopt IPEC's guidelines," Guido Baumoeller, technical marketing manager of Cognis Pharmaceuticals & Healthcare, told In-PharmaTechnologist.com.
"The trend in the excipient market is towards GMP and if other chemical firms want to remain in the pharma business they will also have to move towards this direction."
Indeed, since pharmaceutical excipient manufacture is usually less than 10 per cent, and often less than 5 per cent, of the total production of a particular material, it remains to be seen how many specialty chemical companies stay with pharma as the law tightens.
IPEC's guidelines include transparency in manufacturing processes, adherence to strict guidelines in the area of hygiene and comprehensive documentation of production processes.
Cognis says that in order to achieve GMP compliance it had to implement even stricter standards in training and hygiene, pest control, cleaning of production equipment, documentation of individual process steps, traceability of intermediate products and raw materials, and supplier auditing.
The certificate covers the company's PharmaLine product range which includes hydrogenated castor oil, sodium lauril sulphate and steric acids for tablets and waxes and emollients for emulsion forms.
