ISO 15378:2017 was developed by the Pharmaceutical Quality Group (PQG) for manufacturers of packaging material for medicinal product and now orally inhaled medicine, with reference to Good Manufacturing Practice (GMP).
It incorporates the requirements of ISO 9001 with additional GMP requirements specific to packaging materials. In this global era, quality norms for healthcare industry have become very stringent. To ensure risk free business, most of the healthcare product manufacturers demand some sort of assurance from their suppliers of Packaging material either through supplier audit or third-party certification. ISO 15378:2017 – GMP Certification covers entire manufacturing process and is designed specifically for industries manufacturing Healthcare Packaging Material.
Its primary objective is to facilitate risk management and implementation of a controlled system to eliminate these risks to ensure production of safe products to correct requirements.
The 2017 revision has added focus on electronic origination and controls and the interface with production throughout all process steps, as well as ensuring the importance of controls in terms of traceability and verification of materials throughout the process chain.
It is an interactive standard that can be applied to Global, Primary, Secondary and Complex manufacturers, each with specific requirements.
- Features and Benefits
- Applicability
- Consulting Methodology
- ISO 15378:2017 is a standard relevant to all parts of the pharmaceutical industry supply chain, allowing shared knowledge, practices and implementation to manage risks and safeguard the wellbeing of people and business
- Whether a contractual need or simply looking to reduce overall risk to your organisation and products, there are a number of key benefits to implementing a certificated ISO 15378:2017 system.
ISO 15378:2017 applies to any company in the pharmaceutical packaging industry. Since the packaging for the pharmaceutical industry has detailed specifications on permissible materials and techniques used, this standard applies best and is recognized by global pharmaceutical industry.
Technocrat Consultants guides companies to make changes in their operations to acquire this standard. We offer simple yet effective solutions for companies to meet their goals of sustainable growth.