BS ISO 20069:2019 - Guidance for Assessment and Evaluation of Changes to Drug Delivery Systems

In the ever-evolving world of pharmaceuticals, ensuring the safety and efficacy of drug delivery systems is paramount. The BS ISO 20069:2019 standard provides comprehensive guidance for the assessment and evaluation of changes to drug delivery systems, making it an indispensable resource for professionals in the field.

Overview

This standard, officially titled Guidance for Assessment and Evaluation of Changes to Drug Delivery Systems, is a critical document for anyone involved in the development, manufacturing, or regulation of drug delivery systems. Released on August 7, 2019, it offers a structured approach to evaluating changes, ensuring that any modifications do not compromise the system's performance or patient safety.

Key Features

• Standard Number: BS ISO 20069:2019
• Pages: 46
• Release Date: 2019-08-07
• ISBN: 978 0 580 96194 6
• Status: Standard

Why This Standard is Essential

Drug delivery systems are a crucial component of modern healthcare, responsible for the safe and effective administration of medications. As technology advances and new materials and methods are developed, changes to these systems are inevitable. The BS ISO 20069:2019 standard provides a framework for assessing these changes, ensuring that they meet rigorous safety and performance criteria.

By adhering to this standard, organizations can:

• Ensure compliance with international regulations and guidelines.
• Maintain the integrity and reliability of drug delivery systems.
• Minimize risks associated with changes to existing systems.
• Enhance patient safety and treatment outcomes.

Comprehensive Guidance

The BS ISO 20069:2019 standard covers a wide range of topics related to drug delivery systems, including:

• Identification and classification of changes.
• Risk assessment and management strategies.
• Testing and validation procedures.
• Documentation and reporting requirements.
• Regulatory considerations and compliance.

Who Should Use This Standard?

This standard is designed for a broad audience, including:

• Pharmaceutical manufacturers and developers.
• Regulatory affairs professionals.
• Quality assurance and control specialists.
• Research and development teams.
• Healthcare providers and institutions.

Enhancing Drug Delivery Systems

With 46 pages of detailed guidance, the BS ISO 20069:2019 standard is a comprehensive resource that supports the continuous improvement of drug delivery systems. By following the recommendations outlined in this standard, organizations can ensure that their systems remain at the forefront of safety and innovation.

Conclusion

The BS ISO 20069:2019 standard is an essential tool for anyone involved in the lifecycle of drug delivery systems. Its guidance helps to navigate the complexities of change management, ensuring that modifications are thoroughly evaluated and implemented safely. By integrating this standard into your processes, you can enhance the quality and reliability of your drug delivery systems, ultimately benefiting patients and healthcare providers alike.

Invest in the future of healthcare with the BS ISO 20069:2019 standard, and ensure that your drug delivery systems are equipped to meet the challenges of tomorrow.

BS ISO 20069:2019

This standard BS ISO 20069:2019 Guidance for assessment and evaluation of changes to drug delivery systems is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics
• 11.040.01 Medical equipment in general

1

This document provides guidance for assessment and evaluation of planned changes to drug delivery systems that are integral with, packaged with, or cross-labelled for use with a specified medicinal product. This document is applicable to the drug delivery system’s lifecycle from registration clinical studies to end-of-life. This document is applicable 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

These are covered by the ISO 11608 series, ISO 20072 and ISO 21649, respectively.

This document might also be useful for assessing and evaluate changes to other drug delivery devices or systems.

Examples of changes that are within the scope of this document include but are not limited to the following:

1. a)

   the same route of administration (e.g. change resulting in including a marketed prefilled syringe to an autoinjector);

2. b)

   changes to the drug delivery system design (e.g. change in configuration or layout of electrical and mechanical components);

3. c)

   changes to the medicinal product that affect the drug delivery system; including the primary container closure (e.g. viscosity, particle size);

4. d)

   changes in production or handling of the drug delivery system (e.g. process scale, manual to automated assembly, glue bond to sonic weld, mould cavitation, sterilization, storage, transportation, work instructions or methods);

5. e)

   changes in component materials or source of supply;

6. f)

   changes in software, including changes related to cybersecurity, encryption and connectivity;

7. g)

   changes in the user interface, including packaging;

8. h)

   changes to labelling and/or instructions for use.

Revisions or additions of software are within the scope of this document. The software can either be integrated into the physical drug delivery system, separate, or both.

The applicability of this document 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.

Depending on the nature of the change, there can be additional assessments and resulting activities, which can be outside the scope of this document.

This document does not provide guidance for defining the objective of the change, nor the various potential opportunities/options for fulfilling this objective.