Glossary of terms used on this site
All
| Term | Definition |
|---|---|
| (c)GMP |
Good Manufacturing Practice is that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorisation or product specification. |
| Active Pharmaceutical Ingredient (API) - |
Any substance or mixture of substances intended to be used in the manufacture of adrug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body. |
| Adjuvant |
A chemical or biological substance that enhances the immune response against an antigen. |
| Advanced therapy medicinal product |
Advanced therapy medicinal product’ means any of the following medicinal products for human use: a gene therapy medicinal product, a somatic cell therapy medicinal product, a tissue engineered product. |
| Antibody |
Proteins produced by the B-lymphocytes that bind to specific antigens. Antibodies may be divided into 2 main types based on key differences in their method of manufacture: Monoclonal antibodies (MAb) – homogenous antibody population obtained from a single clone of lymphocytes or by recombinant technology and which bind to a single epitope. Polyclonal antibodies – derived from a range of lymphocyte clones, produced in human and animals in response to the epitopes on most ‘non-self’ molecules. |
| Batch (or Lot) |
A specific quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits. In the case of continuous production, a batch may correspond to a defined fraction of the production. The batch size can be defined either by a fixed quantity or by the amount produced in a fixed time interval Batch Release. |
| Batch Release |
The batch release is the Q.P. certification within the EC/EEA which ensures hat the batch has been manufactured and checked in accordance with the requirements of its marketing authorisation, the principles and guidelines of EC Good Manufacturing Practice or the good manufacturing practice of a third country recognised as equivalent under a mutual recognition agreement and any other relevant legal requirement before it is placed on the market. |
| Best Practice |
Best Practice systems, procedures and processes that would be considered to meet an optimal level of compliance are often called Best Practice to highlight that these do not only comply with the GMP rules but also are optimal in regard to a robust or lean system or process. |
| Biological substance |
For biological medicinal products, starting materials shall mean any substance of biological origin such as micro-organisms, organs and tissues of either plant or animal origin, cells or fluids (including blood or plasma) of human or animal origin, and biotechnological cell constructs (cell substrates, whether they are recombinant or not, including primary cells). A biological medicinal product is a product, the active substance of which is a biological substance. A biological substance is a substance that is produced by or extracted from a biological source and that needs for its characterisation and the determination of its quality a combination of physico-chemical-biological testing, together with the production process and its control. The following shall be considered as biological medicinal products: immunological medicinal products and medicinal products derived from human blood and human plasma as defined, advanced therapy medicinal products Any other substances used for manufacturing or extracting the active substance(s) but from which this active substance is not directly derived, such as reagents, culture media, foetal calf serum, additives, and buffers involved in chromatography, etc.are known as raw materials. |
| Bioreactor |
A contained system into which biological agents are introduced along with other materials so as to effect their multiplication or their production of other substances by reaction with the other materials. Bioreactor may be fitted with devices for regulation, control, connection, material addition and material withdrawal |
