"The standard is of vital importance to the pharmaceutical industry and its suppliers of pharmaceutical primary packaging materials. For the first time, the principles of Good Manufacturing Practice are specified as part of an ISO standard," explained Dr. Jürgen Thürk, Convenor of the working group that developed the new standard.
Good Manufacturing Practices (GMP) relate to quality control and quality assurance enabling companies in the pharmaceutical sector to minimize or eliminate instances of contamination, mix-ups, and errors. This in turn, protects the customer from purchasing a product which is ineffective or even dangerous. Up until now, however, there was no applicable guideline or rule for primary packaging materials, which contain, seal or are used for dose application and have direct contact with the medicinal product.
The publication of ISO 15378:2006, Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001:2000, represents an international consensus on good practice and establishes a benchmark that can be applied for quality improvement, training, auditing and certification.
Developed with the participation of pharmaceutical sector experts, ISO 15378:2006 incorporates in a single document the quality management requirements of ISO 9001:2000 together with the Principles of Good Manufacturing Practice (GMP) for the design, manufacturing and supply of primary packaging materials for medicinal products.
In addition, the new standard gives guidance on risk management and validation and – in line with current developments worldwide – contains guidance annexes on both these aspects.
ISO 15378:2006 was developed by ISO technical committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use. The standard costs 154 Swiss francs and is available from ISO national member institutes (see the complete list with contact details) and from ISO Central Secretariat.
- ISO 15378:2006 [Withdrawn]Primary packaging materials for medicinal productsParticular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)