Regulatory Initiatives

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Current Regulatory Initiatives and Groups

Drug Shortages

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

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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.

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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

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