ISO (E). PDF disclaimer. This PDF file may contain embedded typefaces. In accordance with Adobe’s licensing policy, this file may. DIN ISO norm. • Reduced glass particles, airlines, inclusions and scratches for improved camera inspection. • Outstanding chemical resistance, neutrality. ISO. Fourth edition. Injection equipment for medical use —. Part 1: Ampoules for injectables. Matériel d’injection à usage médical —.
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BS EN ISO 9187-1:1999
Quality control – reference materials. Quality systems – model for quality assurance in production, installation and servicing. Appendix 1 – Storage areas 1.
Caps made of aluminium-plastics combinations for infusion bottles and injection vials – requirements and test methods.
BS EN ISO – Injection equipment for medical use. Ampoules for injectables
Annex 6 – Good manufacturing is for sterile pharmaceutical products. A list is given below of the standards on packaging issued by the International Organization for Standardization ISOas of 10 Octoberstarting with the four main standards, after which they are listed in numerical order.
Package inserts for patients patient information leaflets. Materials and setting-up of equipment, instruments and other devices. Glass containers for pharmaceutical use and rubber closures for containers of pharmaceuticals. Model certificate of analysis for use in trade and procurement. Quality management and quality systems elements. Requirements for dosage form containers. Guidelines for quality improvement.
Monographs for The international pharmacopoeia.
Needles – requirements and test methods. Equipment for drug control laboratories. Appendix 3 – Self-inspection and quality audits 1. Appendix 1 – Model analytical test report for active pharmaceutical ingredients, excipients and pharmaceutical products.
Plastics collapsible containers for human 9178-1 and blood components. Screening tests for antimalarials and antituberculosis drugs.
Starting materials for pharmaceutical products: Preparation for the inspection. Finished cartridges – requirements and test methods. Repacking, relabelling and dispensing. Injection caps made of aluminium-plastics combinations without overlapping plastics part.
Injection vials made of moulded 918-1. Equipment, instruments and other devices. Dissolution test requirements for individual monographs. Requirements in The international pharmacopoeia. Packaging materials and closures.
Annex 11 – Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource generic products.
Oso products for equivalence assessment of interchangeable multisource generic products. Quality assurance – inspection. International Infrared Reference Spectra. Pen-injectors for medical use. Annex 7 – Guidelines on pre-approval inspections.
Glass barrels for injectables. Freeze-drying closures for infusion bottles.
Finishing of sterile products. Aseptic processing and uso by filtration. Appendix 2 – Equipment for a first-stage and medium-size pharmaceutical control laboratory. Caps made of aluminium-plastics combinations for injection vials.
Quality systems for national GMP inspectorates. Hazard analysis and critical control point system.