Récipients et accessoires pour produits injectables —. Partie 5: Bouchons à lyophilisation pour flacons d’injection. STANDARD. ISO. ISO. Second edition. Injection containers and accessories —. Part 5: Freeze drying closures for injection vials. Récipients et accessoires. Injection containers and accessories – Part 5: Freeze drying closures for injection vials (ISO ).
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NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be strongly affected by the nature and performance of the primary packaging. Plastics collapsible containers for human blood and blood components. General aspects of packaging. Appendix 4 – International standards on packaging. Requests for analysis of drug samples. The dimensional requirements are not applicable to barrier-coated closures. Internal audit and periodic review. Equipment for drug control laboratories.
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Annex 8 – Quality systems requirements for national good manufacturing practice inspectorates. Annex 4 – Considerations for requesting analysis of drug samples 1.
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Infusion sets for single use, 83662-5 feed. Injection equipment for medical use. Harmonization of regulatory requirements.
Aseptic processing and sterilization by filtration. Nomenclature and computerized systems. Disposable hanging devices for transfusion and infusion bottles – requirements and test methods.
Annex 11 – Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource generic products. Quality control – reference materials. Caps made of aluminium-plastics combinations for injection vials.
Finishing of sterile products.
Reusable all-glass or metal-and-glass syringes for medical use. Good manufacturing practices for sterile pharmaceutical products. Annex 3 – Good practices 83662-5 national pharmaceutical control laboratories. Preparation for the inspection. Aluminium caps for dental local anaesthetic cartridges.
ISO – Standards Australia
Requirements in The international pharmacopoeia. Elastomeric parts for aqueous parenteral preparations. Needles – requirements and test methods. Finished cartridges – requirements and test methods. Repacking, relabelling and dispensing. Get 832-5 Know Us. Follow these links to find other Standards similar to the one you are viewing.
Aluminium caps for transfusion, infusion and injection bottles – general requirements and isi methods. Good practices for national pharmaceutical control laboratories. Equipment, instruments and other devices. Screw-neck bottles vials for solid and liquid dosage forms. Annex 5 – Basic elements of good manufacturing practices in pharmaceutical production. Requirements for dosage form containers.
Quality control – specifications and tests. Glass transfusion bottles, closures and caps.