ISPE’s regulatory initiatives and programs bring visibility and solutions to significant regulatory and quality challenges faced by the industry, facilitate the flow of information between ISPE members and global health authorities to find solutions, and promote interaction between regulatory bodies in the interests of harmonization.
ISPE members are the backbone of ISPE’s regulatory operations. They progress the work of standing committees, limited duration working groups, and high-profile initiatives. Composed of ISPE volunteers and supported by ISPE staff and advisors, these groups ensure ISPE members have access to the latest regulatory developments and expectations.
The RSC establishes ISPE’s global regulatory priorities and strategy in alignment with the direction of the ISPE Strategic Plan. These members guide ISPE’s interactions with regulators and health authorities to ensure the singularity of regulatory and compliance positions. They also act as an advisory council on regulatory issues and respond to emerging regulatory opportunities.
The RQHC anticipates regulatory, quality, and compliance developments and the potential for ISPE’s involvement or response (e.g., commentary, publication, educational presentation) to benefit the ISPE membership. The RQHC coordinates ISPE’s organizational responses to new or draft regulations and guidance and it ensures the responses are of high quality and representative of the ISPE membership.
The management body of RQHC, referred to as “RQHC Global,” provides direction and oversight to the RQH Regional Focus Groups. The regional groups provide ISPE with intelligence and identify opportunities for ISPE to provide input, guidance, and scientific and technical support on evolving regulatory issues and concerns for the specific region. The current Regional Focus Groups are Asia-Pacific, Europe/Middle East/Africa, and North America/South America.
ISPE’s APQ program is an industry-led quality management maturity assessment and benchmarking program that provides a practical set of tools and systematic approaches for organizations to advance the effectiveness of their pharmaceutical quality system. The program aligns with international initiatives that promote quality excellence and with the FDA’s focus on quality management maturity and rating the maturity of manufacturing facilities.
For more than a decade, ISPE has been instrumental in facilitating communication between the different sectors of the pharmaceutical industry and global health authorities related to drug shortages. The Drug Shortages Team provides guidance, tools, and education to assist companies and support regulatory collaboration in preventing and mitigating drug shortages and works toward harmonizing expectations. The team’s publications and tools have been cited in the FDA’s Drug Shortages: Root Causes and Potential Solutions Report and the EMA/HMA Good Practices for Industry for the Prevention of Human Medicinal Product Shortages.
ISPE’s PQLI® initiative was created to provide guidance on the practical implementation of the concepts described in ICH guidelines, focusing on ICH Q8, Q9, Q10, Q11, and Q12 to help ensure product quality throughout a product life cycle, leading to continuous product improvement. The original project produced the ISPE PQLI® Guide Series. Today, PQLI Technical Teams are developing solutions in emerging regulatory and scientific topics related to chemistry, manufacturing, and controls (CMC) and GMP approaches to ensuring product quality. The current PQLI Teams are Accelerated Development & Manufacturing, Analytical Methods (ICHQ2/Q14), Continuous Manufacturing (ICH Q13), ICH Q12 Implementation, Patient Centric Specifications, Stability (ICH Q1, Q5C), and Transportable/Point of Care Manufacturing.
A team of ISPE subject matter experts produced the Increasing Domestic Resiliency in the Supply of Essential Active Pharmaceutical Ingredients report in response to a request from a US federal agency. The report lays out technical, regulatory, and workforce changes that stakeholders in any country or region could consider to reduce the risks of API shortages to meet demands for essential medicines at any time, but particularly in pandemics and other emergencies.
ISPE also worked with McKinsey & Company to provide technical and CMC information on two workstreams to inform the European Commission Di-rectorate-General, Health Emergency Preparedness and Response Authority (DG HERA).
In 2011, the US Food and Drug Administration (FDA) introduced the revised “Guidance for Industry: Process Validation: General Principles and Practices.” The document incorporated principles from...
Pharmaceutical and biotechnology companies employ platform analytical procedures in the development stages of their synthetic and biological drug products and are beginning to leverage them for commercial products. This shift is supported by the acceptance of platform procedures in the recently adopted ICH Q2(R2) and ICH Q14. Six case studies are shared in this article to highlight how...
We are excited about the 2024 ISPE Annual Meeting & Expo in Orlando, Florida! A special thank you to the sponsors and planning committee for the Hackathon. We appreciate your commitment to ensuring that recent graduates and college students will benefit from this challenging and...
