A qualification and follow-up audit of your raw materials suppliers?
A qualification and follow-up audit of your outsourcers?
To prepare for a new certification?
To incorporate new quality specifications into your existing QMS?
A qualification or follow-up audit of suppliers, manufacturers and outsourcers involves time and resources.
RNI Consulting can help you in doing follow-up audits of your suppliers and in testing how well your CAPA plans are being carried out.
The world of manufacturers and outsourcers is seeing a major positive development: Brands are looking for CDMOs that can combine R&D with a factory able to meet the requirements of the various countries where they sell.
CMOs are therefore transforming themselves to be able to cope with a wide range of development and production requirements. The main consequence of this transformation lies in the quality standards and good manufacturing practices to apply. No longer can a CMO settle for a single set of quality standards if it is to meet the wishes and international needs of these clients.
For example, a cosmetic product containing sun screen will be classified as an OTC product in the USA, and the manufacturer will be able to apply OTC GMPs.
A medical device in Europe may be classified as a food supplement or medication in another country, requiring its quality management system to be adapted to food or drug requirements.
A pharmaceutical manufacturing plant will have to apply food-grade quality standards and an HACCP analysis to be able to produce food supplements in Europe.
With the support of its network of auditors, our staff will be able to coordinate and perform audits for you with reference to the standards that are crucial for your business and meeting your objectives.