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cGMP revamp reaches conclusion in US

06-Oct-2004

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The US Food and Drug Administration will start using a risk-based approach for prioritising site inspections for certain pharmaceutical products, the agency has announced in a final report on its current good manufacturing practice (cGMP) initiative.

Starting in the autumn, the frequency and/or scope of manufacturing inspections will be reduced for firms the FDA determines have succeeded in implementing effective quality systems approaches, according to the report, which brings to an end the agency's Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach initiative, launched in August 2002.

"We hope that this approach will create positive incentives for other firms to implement effective quality systems at their manufacturing sites," the report said.

 

The report describes plans for the future resulting from the FDA's completed assessment of the cGMP regulations, current practices and the new tools in manufacturing science that will enable a progression to controls based on quality systems and risk management.

 

"Americans must have confidence in the quality of their medications even as we face more sophisticated technology and manufacturing processes, " Health and Human Services Secretary Tommy Thompson said in a statement on the initiative.

 

"This final report provides clear guidance for both FDA and manufacturers to implement a risk-based quality assessment system that will ensure that the drug supply in the USA is of consistently high quality," he added.

 

FDA Acting Commissioner Lester Crawford noted that the agency has already begun to implement the new scientific and risk-based approach to pharmaceutical manufacturing and product quality."

 

The FDA's initiative has focused on its current regulation of pharmaceutical quality, encompassing veterinary and human drugs, as well as select human biologicals such as vaccines. The report describes specific steps the agency is taking to achieve this system. Some of these include.

 

• the formation of a Council on Pharmaceutical Quality that will be charged with policy development and continuing change management, including the ongoing implementation of certain quality management systems within the FDA relating to pharmaceutical quality regulation;

• a first step in establishing a new risk-based pharmaceutical quality assessment system is to replace the current chemistry, manufacturing and controls review system, in the Office of New Drug Chemistry within the Centre for Drug Evaluation and Research.

• the issuance of a draft guidance on the role of quality systems in the pharmaceutical current good manufacturing practice regulations to ensure agency regulatory practices encourage similar progress in the pharmaceutical industry as well as enabling manufacturers to tailor their quality system to fit their specific manufacturing environment;

• more systematic risk-based approaches to inspectional oversight of pharmaceutical manufacturing, beginning with pilot implementation of a risk-based model for prioritising domestic manufacturing sites for many human drug cGMP inspections;

• the issuance of a final guidance on aseptic processing used in the manufacturing of sterile drugs, encouraging the adoption of modern science and technology and risk-based approaches;

• the issue of a final guidance on Process Analytical Technology - a framework for allowing the regulatory processes to more readily adopt state-of-the-art technological advances in development, production and quality (more detail on this will be published on In-Pharmatechnologist.com later this week);

• the publishing of a draft guidance on GMP for combination products (ie, those combining components from two or more of these regulatory categories: drug, device or biological product);

• continued active collaboration with the International Conference on Harmonisation of the Technical Requirements for Registration of Pharmaceuticals and the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products, leading to the implementation of an internationally agreed plan for a pharmaceutical quality system based on an integrated approach to risk management and science; and

• the FDA's decision to seek membership in the Pharmaceutical Inspection Cooperation Scheme, a cooperative agreement among national health regulatory authorities whose purpose includes leading international development, implementation and maintenance of the cGMP standards and quality systems of worldwide pharmaceutical inspectorates.

 

Meanwhile, the agency has committed to various other initiatives in the coming monthsm including the formulation of a proposed rule amending CFR Part 11 on electronic records and electronic signatures, which is expected to be published for public comment in 2005.

 

Also planned is a draft guidance on the use of computerised systems in clinical trials that will replace guidance issued in April 1999, the formulation of a technical dispute resolution process for cGMP disputes, and finalisation of guidance on preparation and use of a comparability protocol for assessing chemistry, manufacturing and control changes to chemical entities, protein drug products and biological products.

 

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