ISPE engages with all levels of regulators in the development and presentation of our education, training, document development, and interpretation to ensure that our offerings are cutting-edge and focused on clarifying issues and solving problems of importance to industry.

Current Regulatory Initiatives and Groups

Drug Shortages

ISPE’s Drug Shortages Initiative is facilitating communication between the pharmaceutical industry and global health authorities to understand and address this complex problem.

Learn more about the Drug Shortages Initiative

Quality Metrics

ISPE is conducting the industry’s first Quality Metrics Pilot Program designed to define and operationalize standard metrics reporting to the FDA. The pilot will refine the proposed set of metrics and definitions, data submission process, and evaluation.

Learn more Quality Metrics Initiative

Blend Uniformity/Content Uniformity

An ISPE-sponsored group of regulators, industry, and academia are identifying alternative approaches to assess Blend and Content Uniformity.

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Regulatory and Compliance Committee (RCC)

The RCC’s role is to build effective partnerships with regulators and agencies globally and ensure all ISPE Members have access to the latest regulatory developments and expectations.

RCC Regional Focus Groups facilitate global activity:

Asia-Pacific Focus Group
Europe-Middle East-Africa Focus Group
Latin America Focus Group
North America Focus Group

Product Quality Lifecycle Implementation (PQLI®)

Through PQLI, ISPE assists industry and regulators in advancing manufacturing sciences across the product lifecycle in order to achieve excellence in drug development and in pharmaceutical production. Manufacturing sciences shall be defined as the integrated application of scientific knowledge, technical innovation and quality risk management to deliver product and process understanding.

PQLI Technical Committees address various key topics:

Process Validation
Process Capability
Knowledge Management

Learn more