PDA recently completed a thorough review of the revision of EU GMP Annex 1, Manufacture of Sterile Medicinal Products, which was released for public comment on Dec. 20, 2017. The Annex 1 revision represents an important restatement of the EU regulatory position on sterile product manufacturing, both for aseptic processing and terminal sterilization. As the PDA commenting team prepared their comments, it became apparent that challenging questions remain for regulators and our industry. These questions are not limited to those posed by the Annex 1 revision; they are symptomatic of an industry struggling to meet the challenges of modernization and globalization. In short, challenges every technology-driven industry faces.

These questions include the following. What is the industry’s understanding around true risk- and science-based decision-making when it comes to aseptic processing? How can a balance be achieved between increased monitoring and reliance on robust sterility assurance design, such as when additional tests may increase risk to product quality? What are the limits of traditional testing methods? And what does the industry need in order to facilitate adoption of new technologies to manufacture and control product?

If these questions make you feel uncomfortable, they should. Because much of the way we think about them may be changing. And as they say, facing and addressing change should be a bit uncomfortable.

To help the industry and our members answer these questions, PDA is hosting a timely Sterile Medicinal Products Manufacturing Conference in Bethesda, Md., May 14–15. The conference planning committee, comprised of experts from industry and regulatory agencies, designed this event to bring together the sterile products community to discuss contemporary approaches for sterile product manufacturing through case studies and personal experiences. A special focus of the conference will be a review of the proposed Annex 1 revision and recommendations from the commenting team. The conference will also cover the following sterile product manufacturing and control essentials, among others:

• Updates on relevant PDA technical reports, USP chapters and global regulatory trends
• Sterilization and terminal sterilization challenges
• Environmental, personnel and product contamination control strategies
• Isolators and barrier systems
• Filter and container integrity testing
• Quality systems and quality risk management

Change is becoming ever more necessary, influenced by the expansion of global manufacturing, the availability of knowledge, the discovery of promising therapies and the availability of new technologies.

We as an industry must ask these difficult questions and explore new ways to address them to ensure the improvements that will be required in the 21st century. We recognize that it is time for the industry to face the challenges with the objective of implementing certain and effective process improvement.

If you are responsible for decision-making, design, validation, control, operation, maintenance or management of sterile medicinal product manufacturing, or if you influence those who are, understanding the discussions, regulatory expectations, challenges and ways to meet these challenges today is essential. For more information about the conference, click here.

In addition to this conference, PDA Europe will also host three one-day meetings in Spain, Ireland and Germany to cover the impact of Annex 1. The first meeting will be held May 17 in Dublin. To register, visit the meeting website.