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6704223018 Date of fabrication/manufacture. Any lot or batch of a drug that does not comply with specifications is quarantined pending final disposition and is not made available for sale. 5.5 For equipment used for significant processing or testing operations, usage logs are maintained. The number of samples taken should be determined statistically and specified in a sampling plan. Filling and sealing are followed as quickly as possible by labelling. (2) No lot or batch of packaging material shall be used in the packaging of a drug unless the lot or batch of packaging material complies with the specifications for that packaging material. Records of SOPs for all computer and automated systems are retained where appropriate. 17.
All relevant GMP documents (such as associated records of actions taken or conclusions reached) and SOPs are approved, signed, and dated by the quality control department. Equipment is operated in a manner that prevents contamination. 2.4 Evidence establishing the period of time during which the drug in the container in which it is sold will meet the specifications for that drug. 22. (3) Notwithstanding subsection(1), water may, prior to the completion of its tests under that subsection, be used in the fabrication of a drug. In many cases (e.g., metered-dose aerosols), packaging quality is critical to the overall performance and effectiveness of the drug product. 3. ARTE France. Sterilizing filters have a rated pore size of 0.2 m or less. C.02.026 The samples referred to in section C.02.025 shall be in an amount that is sufficient to determine whether the drug or raw material complies with the specifications for that drug or raw material.