Regulatory

  1. Annex 1 FAQs: Responding To The 2022 Revision 5/11/2026

    Viewing the Annex 1 revision as a natural extension of current habits, rather than a burden, allowed for a seamless transition. Since contamination control was already standard, the update simply validated existing excellence.

  2. Navigating Regulatory Expectations For Injectable Packaging 12/4/2025

    Explore insights on extractables, focusing on how they relate to the revised EU GMP Annex 1, new and evolved expectations under USP <382>, and the use of VHP decontamination in aseptic environments.

  3. 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.

  4. Planning For Scale-Up 5/21/2026

    From rapid early-stage production to scalable commercialization, discover the packaging and continuity challenges companies face as they prepare for launch.

  5. Streamline Global Regulatory Submissions 5/21/2026

    Discover a more streamlined approach with one accountable partner supporting regulatory submissions globally.

  6. 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.

  7. The Pathway To Operational Readiness 6/24/2025

    Ready to ensure your facilities, systems, and teams are prepared for success from Day One? Discover a proven framework to accelerate operational readiness, mitigate risks, and achieve sustainable results.

  8. How Crucial Is Culture Media Selection In Environmental Monitoring? 6/20/2023

    Explore culture media regulatory requirements, the impact of manufacturing guidelines and media features and specifications on environmental monitoring, and the importance of media supplier selection.

  9. 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.

  10. 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.