ISO 8362-4 PDF

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies. (ISO member bodies). The work. INTERNATIONAL. STANDARD. ISO. Second edition. Injection containers and accessories —. Part 4: Injection vials made of moulded glass. Find the most up-to-date version of ISO at Engineering

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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. Quality systems – model for quality assurance in design, development, production, installation and ido. International Standard ISO Quality systems – model for quality 83362-4 in production, installation and servicing.

Quality systems – model for quality assurance in final inspection and test.

Quality management and quality systems elements. Guidelines for processed materials. Guidelines for quality improvement. Reusable all-glass or metal-and-glass syringes for medical use. Design, performance requirements and tests. Transfusion equipment for uso use. Glass transfusion bottles, closures and caps.

Plastics collapsible containers for human blood and blood components. Injection containers for injectables and accessories.

Injection vials made of glass tubing.

Closures ieo injection vials. Aluminium caps for injection vials. Injection vials made of moulded glass. Freeze-drying closures for injection vials. Caps made of aluminium-plastics combinations for injection vials.

Injection caps made of aluminium-plastics combinations without overlapping plastics part. Infusion equipment for medical use. Infusion sets for single use, gravity feed.

BS EN ISO – Injection containers and accessories. Injection vials made of moulded glass

Freeze-drying closures for infusion bottles. Caps made of aluminium-plastics combinations for infusion bottles. Sterile single-use syringes, with io without needle, for insulin.

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Elastomeric parts for aqueous parenteral preparations. Aluminium caps for transfusion, infusion and injection bottles – general requirements and test methods. Injection equipment for medical use. Caps made of aluminium-plastics combinations for infusion bottles and injection vials – requirements and test methods.

BS EN ISO 8362-4:2004

Glass cylinders for dental local anaesthetic cartridges. Plungers and discs for dental local anaesthetic cartridges. Aluminium caps for dental local anaesthetic cartridges.

Glass barrels for injectables. Containers and accessories for pharmaceutical preparations. Screw-neck bottles for syrups. Screw-neck bottles vials for solid and liquid dosage forms.

Screw-neck vials made of glass tubing 836-24 liquid dosage forms. Pen-injectors for medical use. Requirements and test methods. Needles – requirements and test methods.

Finished cartridges – requirements and test methods. Glass cylinders for pen-injectors for medical use. Plungers and discs for pen-injectors for medical use. Disposable hanging devices for transfusion and infusion bottles – 3862-4 and test methods. Appendix 4 – International standards on packaging 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.

Quality control – specifications and tests. The international pharmacopoeia – 50 years on. Isso for The international pharmacopoeia. Dissolution test requirements for individual monographs. Basic tests for pharmaceutical substances and dosage forms. Quality control – reference materials. International Chemical Reference Substances. International Infrared Reference Spectra. Information on reference materials for pharmacopoeial analysis. Quality control – pharmaceutical control laboratories.

Good practices for national pharmaceutical control laboratories. Equipment for drug control laboratories. Requests for analysis of drug samples. Quality assurance – good manufacturing practices. Good manufacturing practices in pharmaceutical production. Good manufacturing practices for sterile pharmaceutical products.

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Guidelines for good storage practices. Hazard analysis and critical control point system. Quality assurance – inspection. Quality systems for national GMP inspectorates. Quality assurance – packaging. General aspects of packaging. Glass containers for pharmaceutical use and rubber closures for containers of pharmaceuticals.

Quality assurance – general topics. Starting materials for pharmaceutical products: 8362–4 certificate of analysis for use in trade and procurement. Screening tests for antimalarials and antituberculosis drugs. Tuberculosis programme – fixed-dose combinations. Comparator products for equivalence assessment of interchangeable multisource generic products. Measures to combat counterfeit drugs. Information on general publications.

Nomenclature and computerized systems.

BS EN ISO 8362-4:2011

International Nonproprietary Names for pharmaceutical substances. Drug quality assurance terminology. Harmonization of regulatory requirements. Annex 3 – Good practices for national pharmaceutical control laboratories.

Equipment, instruments and other devices.

Materials and setting-up of equipment, instruments and other devices. Calibration, validation and verification of equipment, instruments and other devices. Evaluation of test results. Appendix 1 – Model analytical test report for active pharmaceutical ingredients, excipients and pharmaceutical ieo.

Appendix 2 – Equipment for a first-stage and medium-size pharmaceutical control laboratory. Annex 4 – Considerations for requesting analysis of drug samples 1.

ISO injectable vials – SGD-Pharma

Annex 5 – Basic elements of ixo manufacturing practices in pharmaceutical production. Annex 6 – Good manufacturing practices for sterile pharmaceutical products. Manufacture of sterile preparations.

Aseptic processing and sterilization by filtration. Finishing of sterile products. Annex 7 – Guidelines on pre-approval inspections. Preparation for the inspection. Carrying out the inspection. Sample collection and testing. Annex 8 – Quality systems requirements for national good manufacturing practice inspectorates.