Search results with tag "Active substances"
Guideline on stability testing for applications for ...
www.ema.europa.euexisting active substances and related finished products and the respective ICH/VICH Guidelines for new active substances and drug products. It is intended to be applied in the European Union. The guideline seeks to illustrate the stability data required for variations to active substances and/or finished products.
Assessment report - European Medicines Agency
www.ema.europa.euactive substance are well controlled by the process. Potential and actual impurities were well discussed with regards to their origin and fate and characterised. The characterisation of the active substance and its impurities are in accordance with the EU guideline on chemistry of new active substances.
DRAFT OECD GUIDANCE DOCUMENT
www.oecd.org5 No. 46, Detailed Review Paper on Amphibian Metamorphosis Assay for the Detection of Thyroid Active Substances (2004) No. 47, Detailed Review Paper on Fish Screening Assays for the Detection of Endocrine Active Substances (2004) No. 48, New Chemical Assessment Comparisons and Implications for Work sharing (2004)
GUIDELINE ON SPECIFICATONS: TEST PROCEDURES AND …
www.ema.europa.eucompounds suitable as active markers or analytical markers. Includes chromatographic fingerprinting. 2.1.3. Impurities Impurities can be classified as follows: - impurities arising from starting materials (active substances, excipients) and containers; - process related impurities arising from the manufacturing process.
Annex 2 Stability testing of active pharmaceutical ...
www.ich.org90 of API placed on stability studies should be representative of the quality of the material to be made on a production scale. For existing active substances that are known to be stable, data from at least
Reflection paper on the Requirements for Selection …
www.ema.europa.euReflection paper on the Requirements for Selection and Justification of Starting Materials for the Manufacture of Chemical Active Substances EMA/CHMP/CVMP/QWP/826771 ...
Guideline on Active Substance Master File Procedure
www.ema.europa.euthe active substance and its use in the medicinal product needs to be justified in this MAA or MAV. Although the ASMF procedure is developed to keep intellectu al property of the ASM confidential, it is also permissible to use the procedure when there is no confidentiality issue between the Applicant/MA . 1.
Guideline on Active Substance Master File Procedure
www.ema.europa.euThe main objective of the Active Substance Master File (ASMF ) procedure, formerly known as the European Drug Master File (EDMF) procedure, is to allow valuable confidential intellectual property or
Additional guidance on documents relating to an …
www.ema.europa.euAdditional guidance on documents relating to an active substance master file EMA/CHMP/CVMP/QWP/549010/2012 Page 2/10 . When should each …
active substance, excipient and primary container …
www.ema.europa.euuse (e.g. difficulties to differentiate between starting material, active substance and finished product in some cases, scarcity of starting materials/active substance/finished product (autologous products and matched-donor scenario), small volumes of production). The level of documentation that is expected to
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