Good manufacturing practice (GMP) for FCM
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 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 the position of a stakeholder in the supply chain (for example whether they be 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
- which of the GMP Regulations and requirements are applicable to all industry sectors and all stages of manufacture, processing and distribution of FCMs in markets such as the EU, Switzerland, the US, Canada, China, Mercosur countries and Japan
- what steps need to be considered for implementing a quality assurance system and quality policies for FCMs
- how to implement a hygiene policy, where applicable
- what the steps are 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 for specifications for FCMs
- how to outsource work under GMP, for FCM
- how to handle a compliance complaint, a product recall and an incident management, for FCMs and
- how to perform regular internal and supplier (external) audits for FCMs.