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

Author: Arashirr Dutaxe
Country: Malta
Language: English (Spanish)
Genre: History
Published (Last): 25 May 2018
Pages: 421
PDF File Size: 16.83 Mb
ePub File Size: 16.86 Mb
ISBN: 782-7-91866-604-1
Downloads: 81057
Price: Free* [*Free Regsitration Required]
Uploader: Gashakar

Carrying out the inspection.

ISO injectable vials – SGD-Pharma

Aluminium caps for injection vials. Quality control – specifications and tests. Harmonization of regulatory requirements. Infusion equipment for medical use. Needles – requirements and test methods.

Quality control – pharmaceutical control laboratories. Plastics collapsible containers for human blood and blood components. It also specifies the material from which such containers are made and the performance requirements for the containers. Information on reference materials for pharmacopoeial analysis. Quality control – reference materials. Quality assurance aspects of packaging. Quality systems – io for quality assurance in production, installation and servicing.


You may delete a document from your Alert Profile at any time. Drug quality assurance terminology.

Guidelines for processed materials. International Classification for Standards ICS is an international classification system for technical standards. Glass containers for pharmaceutical use and rubber closures for containers of pharmaceuticals. Annex 8 – Quality systems requirements for national good manufacturing practice inspectorates. International Infrared Reference Spectra. Annex 10 – Model certificate of analysis. Appendix 1 – Model analytical iwo report for active pharmaceutical ingredients, excipients and pharmaceutical products.

Quality management and quality systems elements. Production facilities Get more information about our factories, their ID cards and specifications. Injection containers for injectables and accessories. Clear glass Type III. Annex 11 – Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource generic products.

Injection caps made of aluminium-plastics combinations without overlapping plastics part. As the voice of the U. Quality A Quality Policy focused on patient safety A commitment 836-4 top class operations A Regulatory support for our customers. ISO 20 Glass type: Annex 7 – Guidelines on pre-approval inspections.


Reusable all-glass or metal-and-glass syringes for medical use.

Glass transfusion bottles, closures and caps. Equipment for drug control laboratories.

International Nonproprietary Names for pharmaceutical substances. Finished cartridges – requirements and test methods.

BS EN ISO 8362-4:2004

Your Alert Profile lists the documents that will be monitored. Glass cylinders for pen-injectors for medical use.

Disposable hanging devices for transfusion and infusion bottles – requirements and test methods. Dissolution test requirements for individual monographs. Monographs for The international pharmacopoeia. Get in touch with your local sales manager. Annex 3 – Good practices for national pharmaceutical control laboratories.

Quality systems – model for quality assurance in design, development, production, installation and servicing. Good manufacturing practices in pharmaceutical production. Annex 5 – Basic elements of good manufacturing practices in pharmaceutical production.