Search results with tag "Biological medicinal"
Guideline on similar biological medicinal products ...
www.ema.europa.euThe Guideline on similar biological medicinal products containing biotechnology -derived proteins as active substance: quality issues lays down the quality requirements for a biological medicinal product claiming to be similar to another one already marketed.
Guideline on similar biological medicinal products
www.ema.europa.euany biological medicinal product which is the subject of a suspected adverse reaction report, with due regard to its brand name and batch number . 3.2. Choice of Reference Product The reference medicinal product must be a medicinal product authorised in the EEA, on the basis of a
ICH Q5C Stability testing of Biotechnological / Biological ...
admin.ich.orgauthorisation applications for biological medicinal products. 16 ICH Q5C - Stability testing of Biotechnological / Biological products Medicinal products covered by ICH Q5C ICH Q5C applies to well characterised proteins and polypeptides isolated …
PE009, the PIC/S guide to GMP for medicinal products
www.tga.gov.auBiological medicinal substances and products for human use (Annex 2) _____ 46. Starting material and API supplier management _____ 46. Therapeutic Goods Administration PE009, the PIC/S guide to GMP for medicinal products: TGA interpretation and expectations for demonstrating compliance V2.1 September 2020 ...
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ec.europa.euThis medicinal product is subject to additional monitoring. This will allow quick identification of ... In order to improve the traceability of biological medicinal products, the name and the batch number . ... baseline, was similar to that seen in the general population. Reporting of suspected adverse reactions .
Guideline on the requirements for quality documentation ...
www.ema.europa.euAssuring the quality of biological medicinal products is challenging, as they often consist of a number of product variants and process related impurities whose safety and efficacy profiles are difficult to predict. However, unlike chemical entitie s, …
Recommendations for the evaluation of animal cell cultures ...
www.who.intHistorically, the major concerns regarding the safety of biological medicinal products manufactured in animal cells have been related to the possible presence of microbial contaminants and, in some cases, to the properties and components of the cells themselves such as DNA and proteins.
Recommendations for the evaluation of animal cell …
www.who.intENGLISH ONLY FINAL Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell
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