Beyond GMPs: The Latest Approaches to Good Manufacturing Practices - - BioPharm International


Beyond GMPs: The Latest Approaches to Good Manufacturing Practices

BioPharm International

Most standards are well written and understood, but many are not and have been subject to multiple interpretations not only by industry but also by FDA itself.

New Initiatives Until recently, more than 25 years had passed since the last major changes were made to FDA's regulatory systems. Cognizant of new challenges facing both industry and the agency, FDA has initiated several new programs.

"Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach" was announced on August 21, 2002. This new initiative is intended to commence "a systematic reappraisal of FDA's approaches to product quality regulations." FDA's current inspection program is overburdened with new obligations and an increasing number of firms requiring inspection, while the number of completed inspections has been decreasing over the past several years.2

FDA hopes to incorporate the most up-to-date concepts of risk management and use its resources effectively and efficiently to address the most significant public health risks, including:
  • encouraging the early adoption of new technological advances by the pharmaceutical industry
  • facilitating modern quality management techniques, including implementation of quality systems approaches to all aspects of pharmaceutical production and quality assurance
  • encouraging risk-based approaches that focus both industry and agency attention on critical areas
  • ensuring that regulatory review and inspection policies are based on state-of-the-art pharmaceutical science
  • enhancing the consistency and coordination of FDA's drug quality regulatory programs, in part by integrating enhanced quality systems approaches into the agency's business processes and regulatory policies concerning review and inspection activities.

As a result of the initiative, multidisciplinary working groups are developing guidance documents in various phases of completion. These documents are available on the agency's website ( including:

  • Part 11, Electronic Records, Electronic Signatures — Scope and Application
  • Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical cGMP
  • Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practices
  • Comparability Protocols — Protein Drug Products and Biological Products, Chemistry, Manufacturing, and Controls Information
  • PAT — A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance

FDA is also making important changes to its inspection program, including:

  • The Office of Regulatory Affairs (ORA) and the Center for Drug Evaluation and Research (CDER) signed a memorandum of understanding establishing a Pharmaceutical Inspectorate (PI) within ORA. This PI will be staffed with highly trained individuals within ORA who will devote most of their time to conducting human drug quality inspections and other complex or high-risk pharmaceutical operations.
  • To serve as a member of the PI, an investigator will have to obtain and maintain a Level III Drug Certification. This certification signifies that an individual has received extensive training on advanced technology in the pharmaceutical manufacturing process and how those technologies are evaluated during an inspection.
  • A board has been established to review certification packages; select candidates for membership into the PI; and develop, update, and maintain the curriculum for the Level III Drug Certification program.
  • The pre-approval inspection compliance program has been revised, giving field offices more opportunity to utilize a risk-based approach in determining the necessity of pre-approval inspections.
  • The agency is emphasizing a risk-based approach in selecting inspection sites to ensure its limited resources are appropriately utilized.

FDA is looking internally at quality systems and controls to enhance the consistency and predictability of their internal inspection program. The key message FDA wants to deliver is that "FDA is regulating product quality to serve the patient, and drug companies should view the patient as a customer, too." In the past, a lack of knowledge of what affected product quality led to FDA micromanagement of the inspection processes. FDA is adopting a more scientific and systems-based approach. If processes are well understood and controlled, FDA will be able to redefine their inspection approach.

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