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Pharma Industry Opportunities for Streamlined Approach to Innovations

Bryan J. Coleman
Pills banner - ISPE Pharmaceutical Engineering

As 2019 is well underway there are great opportunities ahead for the pharmaceutical industry as the FDA continues its long-anticipated efforts at streamlining cumbersome application processes which will enable manufacturers to move forward with an eye towards innovation and technical advances while continuing to hone-in on the non-negotiables of product safety and efficacy. These non-negotiables of operational challenges, including quality and data reliability, don’t garner the headlines that product innovations do but they are no less important to the total picture of the quality regulatory landscape.

The FDA has issued numerous final, revised, and draft guidance documents in recent months, indicating that the Agency is prepared to move forward with a streamlined approach that fosters the adoption of newer technology, scientific breakthroughs in treatments, and the recognition of the need to provide better healthcare and patient experience to the Nation. That being said, their expectations of the innovators are that the quality of products and the associated testing and production methods will continue to meet the same with high GMP standards.

Notably, FDA’s Center for Drug Evaluation and Research (CDER)’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality Draft Guidance released in February 2019 announces the Agency’s intent to make public a comprehensive listing of informally recognized voluntary consensus standards related to pharmaceutical quality in an effort to streamline the compilation and assessment of marketing applications for products regulated by CDER. Provided the proposed voluntary consensus standard is not be in conflict with any statute, regulation, or policy under which FDA operates, there would be the potential of streamlined compilation and a review of marketing applications because the validity of the particular standards would have already been evaluated allowing the Agency to focus on the output of the standard (e.g., the attribute evaluated by the standard test method).

As the FDA continues to harmonize and leverage their existing regulatory approaches in increasingly more creative ways, the pharma industry will find ample opportunities to flex and grow along industry trends. Still based in sound science and documented evidence, FDA expects companies to tighten controls over raw materials and quality, equally to internal design and production. Likewise, FDA has extended its expectations of equally shared responsibility for quality accountabilities between the sponsor and the contract manufacturer (CMO) to guarantee safe and effective drugs for the patient. These innovative developments across the pharma industry will generate increased pressure for more effective data capturing systems as well as methods to handle that data, coupled with concerns related to accountability, source, supply/availability, and quality.

Regulatory health authorities around the globe are taking steps now to prepare their review and inspection approaches to be meaningful and effective. The question is “Will your company be ready to meet the next audit, study design, application, or quality event with the same compliance vigor to match your innovative product design?”

Regulators are gaining more control and oversight of the pharma industry. Now, more than ever, companies must plan and prepare for not only meeting quality requirements but ensuring that their quality measures are taking into account the new supporting technologies, supply chain capabilities/arrangements, and feedback mechanisms to sustain one cohesive program. It is important to proactively prepare for these changes as their impacts will surely be significant. This includes impacts on cost of implementing changes to organizational prioritization and to internal processes around accountability/supply, source, availability, and quality. If the pharma industry and regulators continue to maintain their role of ensuring compliance and new innovative drugs will be safe and effective for patients, this will provide for better health care outcomes.

As Senior Director for Pharmaceutical and Medical Device Consulting Service for EAS, I am continually inspired by this forward-thinking industry and together we can proactively make for a brighter future in the healthcare realm. Countless patients, caregivers, and their families benefit from not only proactive solutions but from the continually sharp focus on quality and compliance with industry and safety standards.

As we look to the future and continue to work towards creating solutions for patients, let’s take a moment and return to the quality benchmarks basics that are the hallmark of our industry and present a basis from which we are led to opportunities for growth.