European Medicines Agency
stability testing, etc. Specifications are chosen to confirm the quality of the drug substance and drug product rather ... • microbiological testing for drug substances and solid dosage forms which have been shown during development not to support microbial viability or growth
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www.health.pa.govJan 04, 1984 · between different drugs, drug components, in-process materials, packaging materials or labeling, and to minimize the possibility of contamination. (ii) The receipt, storage and withholding from use of components pending sampling, identification, and testing prior to release by the materials approval unit for manufacturing and packaging.