Quality

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.  Our vision is to enable customer success with high quality and innovative drug delivery solutions that improve patient well-being.  One critical component of Quality is related to contamination control.  The evolving requirements around Global Manufacturing Practices require a strong commitment, strategy and plan to address the risk of contamination in parenteral combination products.  Specifically, with the EU GMP Annex 1: 2022 revision published in August 2022 and effective on August 25 2023, the implementation of a Contamination Control Strategy (CCS) by medicinal product manufacturers has become mandatory. The revision provides general Good Manufacturing Practice guidelines for pharmaceutical companies to ensure that microbial, particulate and endotoxins and pyrogen contaminations are prevented in the final combination product for patient safety.

Understanding the EU GMP Annex 1: 2022 revision

The revision focuses on three key aspects:

• The development of a holistic Contamination Control Strategy, ensuring a planned set of controls and monitoring for particulate, microorganism, endotoxin and pyrogen are in place derived from product and process understanding.
• The application of Quality Risk Management (QRM) principles in the definition of the CCS strategy
• The implementation of an effective Quality System which supports the development and manufacture of sterile combination products throughout their lifecycle.

One of the key challenges for pharmaceutical and biotechnology companies is to assess the overall capabilities of their critical suppliers to support their CCS by adhering to the highest contamination control standards. 

BDM-PS’s approach to EU GMP Annex 1: 2022 Revision

As a primary packaging supplier for pharmaceutical and biotechnology companies, BDM-PS designs and manufactures products to meet the stringent standards of product quality to ensure patient safety. 

Reflecting industry aims to improve patient safety, the fast-evolving regulatory landscape includes more stringent requirements for the pharma industry. The recently updated EU GMP Annex 1 emphasizes the need for these requirements to be met throughout the whole pharma supply chain. BDM-PS recognizes the significant role of primary packaging in contributing to overall drug quality and safety when meeting the highest quality and safety standards.

BD is taking a proactive approach to reassess our global Quality expectations and integrate the new requirements into our standard operating procedure. This proactive approach demonstrates BD’s continued commitment to support our customers in their efforts to meet the requirements of EU GMP Annex 1: 2022.

BDM-PS has implemented a holistic Contamination Control Strategy. Our CCS builds on a risk-based approach to contamination management and processes that cover all aspects of risk of contamination throughout the product lifecycle. The approach encompasses end-to-end supply chain activities, starting from product design to managing risk associated with materials and services supplied by BD, to manufacturing process controls, environmental controls throughout the supply chain, all the way to the delivery of product to our customers.

As the EU GMP Annex 1 revision was being prepared, the BDM-PS WW Sterilization Assurance organization proactively monitored expectations and improved and deployed updated Global procedures.  There updates were incorporated into a multi-year roadmap which laid out the improvements and update of our global processes and requirements to be implemented across our sites. Each of our sites continues to perform in-depth assessment of their manufacturing controls, ensuring that the holistic Contamination Control Strategy is implemented.

Our Contamination Control Strategy is formalized in a Global Standard Operating Procedure (SOP) that defines the scope of the strategy, the set of procedures defining the global requirements for each element of contamination control and how the strategy is implemented. This SOP also outlines roles and responsibilities of global functions and sites, as well as the requirements for monitoring and implementing continuous improvement of the strategy.

Where we are on the Journey

BD has made significant progress around our CCS initiative with actions starting before the latest EU GMP Annex 1 revision was released.  Main achievements include:

• Risk assessment on gowning processes and deployment of harmonized Manufacturing personnel gowning/de-gowning, qualification and reprocess management requirements
• Definition of Global cleanroom Cleaning and Disinfection minimum requirements
• Definition of a Global strategy for Identification of microorganisms 
• Definition of Global minimum requirements for Environmental Monitoring of viable and non-viable particulates and physical parameters in cleanroom and associated environment
• Creation of environmental monitoring harmonized tools for data collection and trend analysis
• Re-definition of the type of manufacturing activities per cleanroom classification and rules to be applied in manufacturing to prevent and control contamination

Along with the documented Gap Assessment and resulting action plan completed upon release of the EU GMP Annex 1 revision, site technical assessments for contamination control have been completed.

Next steps

Our focus at BDM-PS continues to be on our site implementation plan and on driving a harmonized approach that applies Risk Management Principles and tools, where sites: 

• Evaluate local processes against global expectations and implement procedures and processes as required
• Conduct risk assessments of the manufacturing processes to identify risk and appropriate controls related to these changes
• Continue to implement the global requirements into the site processes 

We are committed to the continued successful execution of our CCS and, more importantly, to the success of our customers.  We are happy to share more details around our strategy and plan with our partners.  If you would like to discuss, please contact your BD account manager or complete the form below to be contacted.