Testing
Article 35
1. Tests shall be performed to ensure that each batch of the finished product meets the relevant specifications and is in accordance with the terms of the marketing authorisation. Tests shall be performed at appropriate stages of production to control those conditions that are important for the quality of the product. Testing methods shall be validated. 2. The following records shall be kept in connection with the tests performed: (a) name of the material or product and, where applicable, dosage form; (b) batch number and, where appropriate, the manufacturer or supplier; (c) references to the relevant specifications and testing procedures; (d) test results, including observations and calculations, and reference to any certificates of analysis; (e) dates of testing; (f) identification of the persons who performed the testing; (g) identification of the persons who verified the testing and the calculations, where appropriate; (h) a clear statement of approval or rejection (or other status decision) and the dated signature of the responsible person; (i) reference to the equipment used. 3. Reference standards shall be suitable for their intended use. Their qualification or certification status shall be documented. Whenever compendial reference standards from an officially recognised source exist, these shall preferably be used as primary reference standards, unless duly justified. The use of secondary standards shall be documented and their traceability to primary standards shall be demonstrated. Compendial materials shall be used for the purpose described in the appropriate monograph unless otherwise authorised by the relevant competent authority. 4. Materials used for quality control tests, such as reagents, culture media, glassware, and reference standards shall be of appropriate quality and used according to the instructions of the manufacturer unless scientifically justified. The expiry date of reagents and culture media shall be indicated on the label, together with specific storage conditions. Where necessary, identity verification or testing shall be considered upon receipt or before use. 5. Where appropriate, animals used for testing components, materials or products shall be quarantined before use. They shall be maintained and controlled in a manner that assures their suitability for the intended use. In addition, they shall be identified and adequate records kept showing the history of their use. 6. Used microbiological media and strains shall be decontaminated in accordance with a standard procedure and disposed of in a manner to prevent cross-contamination.