09:00 - 12:00 GMT
FCM Declaration of Compliance (DoC) and Good Manufacturing Practice (GMP)
This module will look at good manufacturing practice (GMP) regulations and the corresponding requirements that directly impact FCMs. EU GMP Regulation (EC) No 2023/2006 on FCMs, the US 21 CFR § 174.5 requirements and the Chinese GMP Standard GB 31603-2015 on FCMs will be discussed. GMP regulations / requirements for FCMs in Switzerland, Canada, Mercosur and Japan will also be detailed.
A number of key guidance documents, prepared by specific trade industry associations in the EU, will be presented and discussed in detail. Additionally, critical aspects of GMP requirements will be highlighted during the training, especially when considering where a stakeholder is in the supply chain (for example, whether they are a manufacturer of an intermediate or a final FCM).
During this module, you will learn about:
Ioan ParaschivRegulatory Affairs Manager FCM and REACH, Knoell, Netherlands
- 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.