BPI Contributor

September 25, 2023

20 Min View
Managing Complex Considerations With Pharmaceutical Facility Design

Date: Sep 25, 2023

Duration: 20 Min

This webcast features: Patrick Nieuwenhuizen, Director, Principal Consultant, Quality Management & Compliance & Gerardo Gomez, PhD, Director, Service Line Lead, QMC, PharmaLex.

Pharmaceutical manufacturing facilities, regardless of where they are, must meet GMP principles and procedures. There are, however, many other important and often poorly understood considerations with facility design. Beyond quality and compliance and country-specific expectations, facility design has a huge impact on decisions that both the sponsor and the contract manufacturing organization (CMO) must make.

The issues faced and questions to consider will vary depending on the circumstance. If a sponsor is seeking a CMO they need to bear in mind that they will not be able to influence the design of the facility, so they must consider how they can overcome issues if the CMO’s facility design is not an exact match for their product. On the other hand, if a CMO is building a facility, the questions relate more to what they need to do to ensure the design is most suitable for a wide variety of clients.

This webinar will explore the impact of facility design on both the sponsor and CMO.

Key Takeaways:

  • Designing a facility that will be most suitable for a wide variety of clients, while ensuring those clients won’t face non-compliance issues during an audit. Suitability would include concepts such as having enough space for people, allowing space for waste materials, being able to get equipment in and out properly, and having the right technology.

  • Designing a facility for a single product type, particularly advanced therapeutic medicinal products (ATMPs). What are the key considerations in that scenario? Is there potential to introduce additional product types in the future? How can CMOs optimize the design so it ensures a long lifespan for the facility?

  • Including all key stakeholders in the design such as microbiologists to ensure contamination issues are considered, the core designers, and the architects and engineers. How do you bring all these key groups to an agreement to ensure the facility meets the needs of the end client?

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