Regulatory Compliance for Pharmaceuticals > FAQ

• The Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Veterinary Medicine (CVM) all play central roles in ensuring that safe and effective drugs are available to the American public. CVM regulates the manufacture and distribution of drugs that will be given to animals.
• The Office of Regulatory Affairs (ORA) is the compliance and enforcement center of the FDA. Its aim is to protect consumers by maximizing compliance of FDA-regulated products and minimizing risk associated with those products.
• An Office of Combination Products regulates products comprised of two or more regulated components (e.g., drug/device, biologic/device, drug/biologic, or drug/device/biologic products). Drugs are chemically synthesized, while biologics are derived from living sources such as humans, animals, plants, and microorganisms.

The risk-based approach to cGMP aims to allocate FDA resources effectively to regulatory review, compliance, and inspections. For example, the frequency and/or scope of inspections will be reduced for firms that FDA determines have acquired sufficient process understanding and have succeeded in implementing effective quality systems.

In addition, FDA expects that applying a risk-based approach to the product quality review process will facilitate continuous improvement in pharmaceutical manufacturing.
 

This FDA imperative is best outlined in the report Pharmaceutical Quality for the 21st Century: A Risk-Based Approach. In the past few years, FDA has made significant progress in implementing the concepts of QbD into its premarket processes. QbD means that quality should be built into a product with a thorough understanding of the product and process by which it is developed and manufactured, along with a knowledge of the risks involved in its manufacture and how best to mitigate those risks.

While QbD will provide better design predictions, it is widely recognized that industrial scale-up and commercial manufacturing experience provide new and very important knowledge about the process and the raw materials used. FDA is aware that knowledge is not static and builds throughout the manufacturing life cycle. FDA’s release of the process validation guidance in January 2011 notes the need for companies to continue benefiting from knowledge gained and continually improve throughout the process life cycle. They must adapt to correct root causes of manufacturing problems quickly. This vigilant and nimble approach to be essential to best protect the consumer (patient).

Process analytical technology (PAT) has been defined by the FDA as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of Critical Process Parameters (CPP), which affect Critical Quality Attributes (CQA).

PATs are systems that enhance process understanding, reduce variability, and assist in identifying and controlling critical points in a process. They include:

• Appropriate measurement devices that can be placed in-line
• Statistical and information technology tools
• A quality systems approach for data analysis to control processes and ensure production of in-process materials and final products of desired, consistent quality

Compliance with FDA regulations goes a long way toward preparing your organization to meet ICH guidelines and ISO standards, but they are not interchangeable. Without adequate CGMP compliance, for example, drug products are considered adulterated.

FDA CGMP guidance documents, on the other hand, are not requirements. They represent current thinking on acceptable practices. Likewise, ICH guidelines and ISO standards are not requirements, but guidelines developed by expert working groups made up of industry and governmental representatives from member countries around the world.

While there is an overall trend toward harmonizing standards and regulations governing pharmaceutical products, voluntary guidelines have a customer focus that is outside the regulatory mandate to protect the public health.

Oriel STAT A MATRIX has programs and consulting capabilities to help guide newcomers through the often overwhelming maze of regulatory compliance and international standards certification requirements. Our highly experienced consultants—most of whom have been through this process in the corporate world and many of whom are former FDA investigators—understand your needs as well as your concerns.

Oriel STAT A MATRIX also works with major pharmaceutical companies to sharpen or refresh employee skills and capabilities, providing experts in specific subject areas as needed, as well as to educate and inform their new employees. Likewise, Oriel STAT A MATRIX works with start-up companies to jump-start their programs and cost-effectively address new initiatives.