Detection and assay of substances by serologic (immunologic) methods; in most applications substance in question serves as antigen, both in antibody production and in measurement of antibody by the test substance.
In the experimental (non-clinical) research arena, the phrase good laboratory practice or GLP specifically refers to a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical (including pharmaceuticals) non-clinical ...
This Annex provides guidance on the certification by a Qualified Person (QP) and on batch release within the European Economic Area (EEA) of medicinal products for human or veterinary use holding a marketing authorisation or made for export.. Relying on GMP assessments by third parties e.g. audits In some cases the QP will rely on the correct functioning of the quality management system of sites involved in the manufacture of the product and this may be derived from audits conducted by third parties.