ICH Guidelines for Host Cell Protein and Biological Products

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a global project to discuss scientific and technical aspects of pharmaceutical product registration. Regulatory authorities of Europe, Japan and the United States are in exchange with experts from the pharmaceutical industry in order to reduce or eliminate the need to duplicate the testing of new medicines. ICH guidelines have been adopted as law in several countries, but are only used as guidance for the U.S. Food and Drug Administration (FDA), they are not statutory law in the United States.

Good clinical practices

The ICH compose Good clinical practices (GCP) to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration. Aim is to set and maintain maintaining safeguards on quality, safety, and efficacy, and regulatory obligations to protect public health.

Good clinical practice (GCP) is an international quality standard that is provided by ICH. GCP guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of institutional review boards, clinical research investigators, clinical trial sponsors, and monitors

ICH Guidelines

The ICH guidance Q6B (1999) Specifications state that test procedures and acceptance criteria for biotechnological/biological products, guides the setting of acceptance criteria and specifications in which HCPs as process (cell substrate derived) impurities are considered.

This gives a very high level limit test driven approach, although in the case of HCPs, the rapid improvement in proteomics since creation of the guideline necessitates further levels of consideration.

Q6B Guideline 

The Q6A guideline adresses chemical substances and their respective test procedures and acceptance criteria for new drug substances.

Q6A Guideline

Clinical investigation of medical devices for human subjects – GCP

A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.