Hal Baseman

The objective of our industry is to manufacture and distribute high quality, healthcare products and therapies that benefit the public. One of the basic challenges to meeting this objective involves producing drug, biologic, and medical-device products that not only are safe, effective, and compliant with global regulatory requirements but also readily available for use by the patient. Achieving this objective means that these products must remain available and affordable, as well as a reasonable business proposition for manufacturers. To that end, today’s drug manufacturing industry must address issues related to drug shortages, quality metrics, drug-product costs, innovative therapies, counterfeit products, and supply chain integrity. 

Industry associations, in particular the Parenteral Drug Association (PDA), have a strong role in helping the industry meet challenges. For nearly 70 years, PDA has been the leader in providing thoughts on the current needs, best practices, topics, and positions that are important to the manufacturing of quality drug products. PDA does this by providing venues for exchange of information and connecting people, science, and regulation through the publishing of oft-cited technical reports and papers, international conferences and meetings, and hands-on Training and Research Institute education courses.

Through these and other efforts, much knowledge has been gained throughout the years. This knowledge results in better process understanding, helping us design processes, establish control systems, and make informed decisions. This understanding is especially relevant in recent years, where the industry has seen changes, faced issues, and noted an evolution of product manufacturing technologies and methods. As we consider the state of our industry, the following guiding and linked principles emerge:

The use of science- and risk-based approaches to make decisions related to the evaluation, design, qualification, operation, and monitoring of sterile product manufacturing processes is beneficial, if not essential, for the development and implementation of process control strategies.

The use of technology should be considered and encouraged to reduce risks to product quality identified in manufacturing processes and operations. The best use of new technology will come from a partnership of manufacturers, regulators, and suppliers.

Traditional testing and monitoring methods may not always be the most effective way to mitigate risks from newer technologies and product manufacturing processes. Where this is true, critical thinking and innovative methods must be considered. 

New products, therapies, and packaging configuration will continue to present challenges to existing and traditional methods for development, manufacture, validation, and testing of sterile products.   

Where scientific expectations are similar and agreed upon, requirements and guidance should be consistent in technical language and definition, thus reducing the risk of misunderstanding of global regulatory expectations. 

The industry is beginning to recognize that the most effective way to address drug product manufacturing issues is to focus directly on improving the manufacturing process. Efforts on quality systems, risk-based decision-making, process development, validation, contamination control, and supply chain integrity are essential elements of information and knowledge exchange. Using all tools at our disposal to better understand and control the variables inherent in our manufacturing process will provide opportunity to improve those processes. PDA will continue to support the industry as a leader in efforts to provide that knowledge and understanding, as it has done for the past 68 years. 


Hal Baseman is chief operating officer for ValSource and chairman, Parenteral Drug Association Board of Directors. hbaseman@valsource.com.

Articles

Industry associations play a strong role in helping the pharmaceutical industry meet challenges.