What is ISO 20069-Changes to drug delivery systems about?
ISO 20069 discusses drug delivery systems. ISO 20069 is an international standard on guidance regarding changes to drug delivery systems.
ISO 20069 provides guidance for the assessment and evaluation of planned changes to drug delivery systems that are integral with, packaged with, or cross-labeled for use with a specified medicinal product.
ISO 20069 applies to the drug delivery system’s lifecycle from registration clinical studies to end-of-life. ISO 20069 applies to the assessment of changes within the following drug delivery systems:
- Needle-based injection systems for medical use
- Aerosol drug delivery devices
- Needle-free injectors for medical use
Note 1: The applicability of ISO 20069 to non-integrated software is relevant to the extent that those software changes can impact the drug delivery system and/or impact how users interact with it.
Note 2: Depending on the nature of the change, there can be additional assessments and resulting activities, which can be outside the scope of ISO 20069.
Note 3: ISO 20069 does not provide guidance for defining the objective of the change, nor the various potential opportunities/options for fulfilling this objective.
Who is ISO 20069-Changes to drug delivery systems for?
ISO 20069 on assessment and evaluation of changes to drug delivery systems is useful for:
- Suppliers of medicine and drugs
- Manufacturers of drugs and medicine
- Quality check centres for drug delivery systems
- Regulatory authorities
Why should you use ISO 20069-Changes to drug delivery systems?
Drug delivery systems are engineered technologies for the targeted delivery of therapeutic agents.
ISO 20069 guides organizations wishing to implement a systematic approach to assess and evaluate changes to needle-based injection systems, needle-free injectors, and aerosol delivery devices for medical use throughout their lifecycles.
ISO 20069 guidelines assist you with general requirements on process framework, quality and risk management, relationships within the organization and with suppliers or external organizations, and a process that concludes 3 phases. Phase 1 provides guidance on change, identifies change types, assesses the impact of change, phase 2 on plan and execute activities, and phase 3 on the final evaluation.
Thus, enhancing the drug delivery systems to ensure the safe delivery of medical devices.
