Regulatory

  1. Importance Of Architectural Layout To Prevent Contamination 8/21/2025

    In this segment from the Pharmaceutical Online Live event, “Contamination Control Strategies For Drug Manufacturers,” panelists discuss the importance of unidirectional flow for preventing contamination, as well as specific architectural requirements related to the European Union's Annex 1 regulations. Poor or aging facility design is not an acceptable excuse for noncompliance.

  2. Annex 1 FAQs: Why Is A Good Supplier Partnership Pivotal To Meet Regulatory Expectations? 5/11/2026

    Struggling to keep pace with EU GMP Annex 1? The right supplier partnership brings critical regulatory insight your team may be missing. Learn how strategic collaboration closes compliance gaps and prepares you for future regulations.

  3. Advanced CCIT Strategies For Combination Products 7/14/2026

    Gain insight into how deterministic CCIT methods support sterility assurance, product stability, and patient safety for prefilled syringes, auto-injectors, and other combination products.

  4. EU Med Device Regulations: Ensuring Compliance For Integral Combination Products

    Review the EU Medical Device Regulation (MDR) changes, specifically with respect to integral combination products, and examine the technical documentation packages supporting functionality and content.

  5. A Practical Road Map For Compliance To EU GMP Annex 1

    Learn how to interpret the Annex 1 container closure requirements, develop deterministic analytical methods for CCIT, and design packaging studies that generate robust data demonstrating good CCI.

  6. Annex 1 FAQs: How Are We Responding To Provide Confidence For Customers? 5/11/2026

    For procurement and quality teams evaluating packaging and delivery component suppliers, understanding how a partner responds to regulatory change matters as much as the quality of their products.

  7. Annex 1 FAQs: How Do You Understand Risk Regarding Contamination Control? 5/11/2026

    True Annex 1 compliance requires a facility-wide contamination-control culture. Discover how rigorous risk awareness shapes behavior at every touchpoint across a manufacturing environment.

  8. Nitrosamine Impurities Deadline: Are Your Products Compliant? 12/5/2023

    Learn how to select an experienced nitrosamine mitigation provider and how a tailored, quantified strategy can help you bring your product into compliance while maintaining control of the process.

  9. The Container Closure Integrity Requirements In The Revised EU Annex 1

    Learn about the advantages and disadvantages of CCI testing methods, how the revised EU Annex 1 may impact your strategy for ensuring CCI of sterile pharmaceutical products, and more.

  10. Human Factors Testing: Engaging End-Users In Med Device Development 3/11/2025

    Explore the significance of human factors in the development of medical devices through an illustration of how important it is to incorporate the end users in the device development process.