Medical

ISO 9187-1 PDF

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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Injection vials made of glass tubing. Quality assurance aspects of packaging. Quality control – pharmaceutical control laboratories. Information on reference materials for pharmacopoeial analysis. Plastics collapsible containers for human blood and blood components. Internal audit and periodic review. Annex is – Quality systems requirements for national good manufacturing practice inspectorates.

Tuberculosis programme – fixed-dose combinations.

BS EN ISO 9187-1:1999

Quality control – specifications and tests. Quality control – reference materials. Plungers and discs for pen-injectors for medical use.

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Information on general publications. Annex 9 – Guidelines on packaging for pharmaceutical products. Annex 11 – Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource generic products.

Reusable all-glass or metal-and-glass syringes for medical use. Annex 10 iao Model certificate of analysis. Appendix 2 – Labels 1. Calibration, validation and verification of equipment, instruments and other devices. Infusion equipment for medical use. Appendix 4 – International standards on packaging. International Infrared Reference Spectra. Sample collection and testing. Closures for injection vials. Injection vials made of moulded glass. Aseptic processing and sterilization by filtration.

Containers and accessories for pharmaceutical preparations.

ISO – Injection equipment for medical use — Part 1: Ampoules for injectables

Annex 6 – Good manufacturing practices for sterile pharmaceutical products. Annex 5 – Basic elements of good manufacturing practices in pharmaceutical production. Design, performance requirements and tests. Screw-neck bottles for syrups. Good manufacturing practices for sterile pharmaceutical products.

Packaging materials and closures. Quality systems – model for quality assurance in final inspection and test. Glass transfusion bottles, closures and caps. Repacking, relabelling and dispensing. Quality systems – model for quality assurance in production, installation and servicing. Injection equipment for medical use. Package inserts for patients patient information leaflets. General aspects of packaging. Annex 4 – Considerations for requesting analysis of drug samples 1.

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Dissolution test requirements for individual monographs. Measures to combat counterfeit drugs. Aluminium caps for injection vials. Finishing of sterile products.

Freeze-drying closures for infusion bottles. Materials and setting-up of equipment, instruments and other devices. Quality assurance – inspection. Evaluation of test results.

Annex 7 – Guidelines on pre-approval inspections. International Nonproprietary Names for pharmaceutical substances.

Requirements and test methods. Drug quality assurance terminology. Caps made of aluminium-plastics combinations for injection vials.