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.