Guidance

(Current) Good Manufacturing Practice (cGMP) is that part of quality assurance, which ensures that products are consistently produced and controlled within the quality standards appropriate for their intended use. Regulatory agencies such as the United States Food and Drug Administration (FDA) and international organizations such as the International Conference on Harmonization (ICH) have developed guidance documents for implementation of GMP praxis. In Europe, the European Medicines Agency (EMA) is the responsible agency for these activities.

 

International Conference on Harmonisation (ICH) www.ich.org

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) brings together the regulatory authorities of Europe, Japan and the United States as well experts from the pharmaceutical industry to discuss scientific and technical aspects of product registration.
The purpose is to make recommendations on ways to achieve better harmonisation in the interpretation and application of technical guidelines and requirements for product registration. The objective of such harmonisation is a more economical use of human, animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines whilst maintaining safeguards on quality, safety and efficacy, and regulatory obligations to protect public health. For VelaLabs´ analytical service business, the 'Q' guidelines are of highest relevance because they deal with topics like analytical validation (Q2), stability (Q1) or impurities (Q3).

 

Center for Biologics Evaluation and Research (CBER)

CBER is the center within the FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective, and available to those who need them. CBER is responsible for assuring the safety, purity, potency, and effectiveness of biological and related products.

For VelaLabs´ analytical service business the 'Points to consider' paper and the 'Guidance paper' are of most relevance because they deal with topics like “Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use” (PDF) and “Guidance for Industry Bioanalytical Method Validation” (PDF).

European Pharmacopeia (Pharm. EU)

The texts of the European Pharmacopoeia (Pharm. EU) concern the qualitative and quantitative composition of medicines, the tests to be carried out on medicines, raw materials used in the production of medicines and intermediates of synthesis. The texts also cover biologicals, blood and plasma derivatives, vaccines and radiopharmaceutical preparations. They are legally binding.

For VelaLabs´ analytical service business, the compendial methods are of great importance:  Compendial methods are validated by the organization that has developed and published the method. Pharm. EU requires users of such methods to demonstrate - during a verification exercise - the user's competence to successfully run the method.