| Placing your trust in suppliers can be a daunting prospect to many pharma companies; John Taylor of the Medicines and Healthcare Regulatory Authority explains the reassuring regulations that are in place
The objective of supplier qualification is to demonstrate an appropriate level of confidence to the purchasing organisation and user that suppliers are able to provide materials, components, equipment and services of a consistent and acceptable quality and in compliance with regulatory requirements and expectations. Coupled with this is the need for suppliers to be able to provide a cost-effective service and their ability to meet delivery deadlines, consistent with maintaining the purchaser’s obligations to his customers and stakeholders.
When we consider suppliers to the industry our first thoughts are of suppliers of the materials and components that are used in the production of medicines, but there are many more suppliers to consider. The industry relies heavily on service providers for the distribution of their products, specialist service providers for software development, recruitment agencies for permanent and temporary staff and, of course, contract manufacturers and laboratories to provide primary or support facilities. The industry’s medicines regulators need to be assured that purchased materials meet appropriate quality standards and that the services employed are compatible with the maintenance of the high standards expected by regulators and the public alike.
THE REGULATORY BACKGROUND
It is not the intention of this article to discuss medicines legislation at length, but in selecting some relevant issues it should be pointed out that there are rules and guidelines concerning the quality of starting materials and primary printed packaging components used in the manufacture of medicines. Guidance is likewise available on verification of the source of computer software and on the use of contract manufacturers and contract quality control laboratories. European Directives 2001/83/EC and 2003/94/EC implemented into national legislation, complemented by the EU guidance on good manufacturing practice (GMP) provide informative background reading. In particular, Article 46f of Directive 2001/83/EC covers requirements relating to the use of active substances in the manufacture of medicines, specifically that they have been manufactured in accordance with GMP. Particular paragraphs and annexes of the EU guide to GMP deal with the procurement of starting materials and components, and the services provided by contractors. Some of these will be referred to later in this article. |
