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Evolution of the implementation of a quality management system in the Belgian laboratories for anatomic pathology
framework of this licensing the laboratories are obliged to elaborate a quality management system within five years. However, the requirements concerning topics like access/safety and hygiene, maintenance ...
General considerations on the biosafety of virus-derived vectors used in gene therapy and vaccination.
one of the requirements within the European regulatory framework covering the conduct of clinical trials using GMO. Risk assessment methodologies for the environmental risk assessment of genetically ...
Establishment of the Ph. Eur. BRP for varicella vaccine batch 1.
monograph for varicella vaccine (live) (0648) requires a vial of an appropriate reference material to be titred in triplicate to validate each assay and the virus concentration of the reference preparation is ...
Development and validation of a targeted LC-MS/MS quantitation method to monitor cell culture expression of tetanus neurotoxin during vaccine production
medium suffer from variability, lack of sensitivity, and/or require specific antibodies. In accordance with the consistency approach and the three Rs (3Rs), both aiming to reduce the use of animals for ...
Non-sterile pharmaceutical water: source of life and/or potential carrier for opportunistic pathogens
water quality might be required. The European pharmacopoeia provides quality standards for water for injections (WFI), purified water or water for preparation of (herbal) extracts. It stands to reason ...