Expiry dating of investigational medicinal products
Calibration standards are used to construct calibration curves from which the concentrations of analytes in QCs and in unknown study samples are determined.(Source: Guidance for Industry Bioanalytical Method Validation 2001- CDER)Cell bank system: A cell bank system is a system whereby successive batches of a product are manufactured by culture in cells derived from the same master cell bank (fully characterised for identity and absence of contamination).
(FDA 21 CFR 210.3)The accuracy of an analytical procedure expresses the closeness of agreement between the value which is accepted either as a conventional true value or an accepted reference value and the value found. Accuracy can often be expressed as percent recovery by the assay of known, added amounts of analyte.An undesirable medical condition can be symptoms (e.g. tachycardia, enlarged liver) or the abnormal results of an investigation (e.g. In clinical studies an AE can include an undesirable medical condition occurring at any time, including run-in or wash-out periods, even if no study treatment has been administered.An adverse event can also be failure of expected pharmacological action.These samplers are used to determine the viable (microbiological) content of the air in the processing room.Some accepted samplers are Slit-To-Agar (STA) samplers, Centrifugal Samplers (CS), and Sieve Microbial Atrium (SMA) samplers.A raw material, intermediate, or an API that is used in the production of an API, which is incorporated as a significant structural fragment into the structure of the API.
An API starting material can be an article of commerce, a materials purchased from one or more suppliers under contract of commercial agreements, or produced in-house.
The analytical procedure refers to the way of performing the analysis.
It should describe in detail the steps necessary to perform each analytical test.
Accuracy is a measure of the exactness of the analytical method.
Any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals.
They can be found in almost every imaginable environment on the planet.