GMP for the Pharmaceutical Industry

Level: Fundamental
Type: Classroom Training Course
ISPE CEUs: 1.3

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GMP for the Pharmaceutical Industry (G01)

This interactive course is designed to expand understanding of GMPs in today’s regulatory environment for the European pharmaceutical industry. The course will delve into current GMP challenges, provide up to date information about European and US regulatory structure including collaboration to enforce GMP requirements, explore current regulatory expectations during GMP inspections and share valuable insight into the compliance auditing process.

Overview

The quality of pharmaceuticals has global impact. The GMPs provide a foundational standard for ensuring this quality. Data integrity is also an integral and critical element of GMPs and the quality of pharmaceuticals. Since GMPs were introduced in the 1970s, they have continued to evolve with advances in scientific and technical knowledge around pharmaceutical manufacturing. This evolution is evidenced by the numerous GMP and quality guidelines issued (and revised), amendments and updates to existing relevant legislation, as well as the passage of new legislation. The recent ICH quality documents also play an important role in achieving GMP compliance.

Given the importance of historical perspectives to future successes, the history of the GMP regulations in the EU and the US to date will be summarized. Participants will gather current information about both regulatory structures and how the regulatory agencies collaborate to enforce GMP requirements. Through lectures and hands-on exercises (including open class discussions, case studies and activities), participants will discuss relevant pharmaceutical GMP guidelines and updates, explore current GMP challenges and approaches to resolve them, and discuss current quality issues and trends in the pharmaceutical industry with an emphasis on applying GMPs in specific day-to-day operations.

Course Modules

  • GMP Timeline – EU and US
  • EU and US: Structure, Collaboration and Communication with Industry
  • GMPs in the Pharmaceutical Laboratory
  • Data Integrity: Manufacturing Challenges
  • Role of ICH Quality Guidelines in Achieving GMP Compliance
  • Global Quality and Quality Risk Management
  • The Inspectional Data Story

Take Back to Your Job

  • An overview of U.S. and European pharmaceutical GMP origins and timeline
  • Practical knowledge of the structure of the EU and US regulatory agencies and their collaboration to enforce GMP requirements
  • Understand the significance of GMPs in the Pharmaceutical Laboratory
  • Integration of the concepts of specific ICH Quality Guidelines in achieving GMP compliance
  • Leveraging current inspectional data to achieve a better understanding of the focus of regulatory authorities
  • Recognize potential GMP problem areas before they become issues
  • Learn best practices for regulatory inspections
  • Locate up to date/current information regarding regulatory authority initiatives and activities

Who Should Attend?

  • Regulatory Affairs, Quality Assurance, Quality Control specialists
  • Manufacturing and Validation specialists
  • Technical support personnel
  • All levels of management who require current/up to date knowledge of GMP regulations and related guidelines
  • Service organizations, suppliers, and vendors who serve pharmaceutical industry clients

Community of Practice (COP)

This training course is of particular interest to existing and future members of the Regulatory and Quality Networking, and Pharma 4.0 Special Interest Group  Communities of Practice (COP).

This course is not currently scheduled, but may be offered at your company site. Please contact ISPE for more information