Quality is the foundation of customer and patient trust

BD Neopak™ Laboratory

EU GMP Annex 1: 2022 Revision

Quality is the foundation of customer and patient trust; it is at the core of what we do to provide safe, effective products and services. All BD associates are committed to a culture of quality inspired by the customers and patients we serve.

In BD Medical-Pharmaceutical Systems (BDM-PS), we have standardized quality management systems and organizational tools across our global network to ensure consistent quality and reporting and facilitate customer audits and site validations.

Our teams have:

  • expertise in regional and local healthcare needs
  • knowledge of regional and local manufacturing requirements
  • mastery of key technical steps to prevent recall risk
  • established a global and harmonized manufacturing process that meets stringent standards and delivers products that meet state-of-art requirements.


We stay up to date on manufacturing requirements and have been aware of the EU GMP Annex 1 update since it was communicated in 2017.  BDM-PS actively contributed to this revision by providing comments during the first consultation in December of that year and the second consultation in December 2019. The EU GMP Annex 1: 2022 revision was published in August 2022 and became effective on August 25, 2023. 

The EU GMP Annex 1: 2022 revision provides general Good Manufacturing Practices guidelines for Pharmaceutical Companies to ensure that microbial, particulate and endotoxin/pyrogen contamination is prevented in the final product for patient safety.

As the primary packaging supplier for pharmaceutical companies, BDM-PS products shall be safe and effective and shall not compromise the clinical condition or safety of patients.  As part of our continuous improvement, we apply a risk-based approach to improve our practices and to support the success of pharmaceutical companies with integrating the requirements of EU GMP Annex 1: 2022 revision. This approach includes strategies based on following key elements, as described in the EU GMP Annex 1:

  • implementation of a contamination control strategy with a holistic approach
  • application of quality risk management principles in decision making
  • the use of new technologies.


 At BD, our quality policy is to consistently provide superior products and services in pursuit of our purpose of advancing the world of health™.   This will be achieved through customer-focused continuous improvement and maintaining an effective quality system which complies with regulatory requirements.

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