Declaration of Compliance (DoC) and Good Manufacturing Practice (GMP) for FCM

Content:

• The GMP Regulations and requirements applicable to all industry sectors and all stages of manufacture, processing and distribution of FCMs in markets such as the EU, Switzerland, US, Canada, China, Mercosur countries and Japan;
• The steps to be considered in implementing a quality assurance system and policies for FCMs;
• How to implement a hygiene policy, where applicable;
• The steps with respect to documentation, labelling, document retention and traceability of FCMs;
• How to address the key aspects of the FCM production process, including: raw material specifications, contamination prevention, management of change, storage packaging, warehousing and transportation;
• How to carry out quality control and check specifications for FCMs;
• How to outsource work under GMP for FCMs;
• How to handle a compliance complaint, a product recall and incident management for FCMs, and
• How to perform regular internal and supplier (external) audits for FCMs.