Cgmp In Pharmaceutical Industry

[Donahue Granados]

The FDA's definition of cGMP is accurate. The information included in a final guidance document, which typically ranges from 10-30 pages long, is comprehensive but that doesn't mean it's clear. Reading cGMP guidelines provided by the regulatory agency can leave you with a lot of questions.

If you're wondering why "current" good manufacturing practices and why "quality by design" matters, you're not alone. In this post, we'll cover the official definition for these essential guidelines in terms you can understand with insights from pharma industry experts. Read on for some extra color and context on the definition of what cGMP is, why it's important, and how to achieve compliance in your organization.

Current good manufacturing practices are defined by the FDA as systems to assure proper design, monitoring, and control over manufacturing processes and facilities in pharma and other FDA-regulated industries. These systems are designed to help organizations assure drug products are the correct identity, strength, purity, and quality.

If current good manufacturing practice is followed, organizations can avoid many of the most common causes of quality failure which threaten patient safety, such as drug contamination, deviations, or mix-ups. The FDA is very clear that current good manufacturing practices are designed for flexibility to provide a universal framework for the entire pharmaceutical industry. Also, the guidelines aren't a checklist; they're a set of "minimum requirements" for total quality management.

The latest cGMP was published in 2016, the Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. This 58-page document provided some excellent updates to prior cGMP for the industry, but it also sparked more questions than it answered in the eyes of many pharmaceutical organizations. The FDA followed up with a Q&A in 2018 to clarify some of the most common questions about the latest guidance. Some of these questions are addressed here, with insights from pharma industry subject matter experts.

The FDA publishes systems for current good manufacturing practices to emphasize the need for flexibility in total quality management. Organizations can't afford to adopt a rigid, guidelines-focused approach to total quality management (TQM), or they'll struggle to adapt when the next set of cGMP is released, or any other issue occurs which requires organizational change.

It's not possible to write a universal prescription for quality in the pharmaceutical industry, especially when the industry is in an active state of change. The standards which work for a mature enterprise with an extensive portfolio of market-approved drugs aren't the right standards for a small, pharma startup with a globally distributed workforce.

Organizations need to understand current good manufacturing practices and how they align with other systems - and the other 'x's of GxP - for total quality management to discover an approach which eliminates risk and scales effectively.

Organizations need to implement a comprehensive system for quality management or eQMS software which integrates data with operations to build quality into design and manufacturing. The QMS system should facilitate continuous risk assessment and allow leaders to update controls in real-time instead of relying on inspection, testing, or complaints to identify issues. Quality by design can save costs, facilitate organizational agility, and improve outcomes.

The FDA approaches drug safety as a benefit-risk equation by continuously working on compiling and understanding data on drug efficacy and risks. These insights are collected from sources such as clinical trial data, clinical patient data, billing information, and emerging academic research.

If the risks to the target population begin to outweigh benefits, the FDA may take actions, including recommending the pharma manufacturer adopt a formal strategy for Risk Management and Mitigation (REMs).

Tragedies such as the compounding error in New England highlight the real purpose of the FDA's current good manufacturing practices. The system isn't designed to provide a rigid framework for pharma companies. Perceiving current good manufacturing practice as a set of hoops to jump through is a mistake. Failure to comply can have real and devastating consequences.

Every organization should understand how the cGMP apply to their operations and how the FDA will assess this compliance. Instead of focusing on merely meeting the requirements, organizations should focus on adopting management systems which comply with FDA requirements and enhance patient safety.

Testing raw materials at your quality control laboratory when you receive them is no longer enough, especially if you're dealing with critical materials. Today, pharma companies need to audit their suppliers and establish effective working relationships actively. The subject of third-party risk is currently subject to a great deal of attention and discussion in the pharma industry, and it's critically important.

If bad materials are hitting your dock, your organization lacks robust systems. It's too late to implement controls upstream. As a pharma manufacturer, "strong systems" means developing a working understanding of your supplier's controls and quality management system. It also requires a great partnership and trust.

Current good manufacturing practices are not a management system. Instead, they're a set of principles compiled by the FDA which act as a minimum standard for operations in the pharmaceutical industry. Following current good manufacturing practice to the letter of the law can help your organization comply with FDA requirements, but it's not the most effective approach to operations.

The FDA's guidance acknowledges the role and limitations of cGMP and encourages organizations to adopt healthy and flexible systems for total quality management to exceed these requirements. By understanding the definition and purpose of current good manufacturing practice, you can make the shift from focusing your energy and resources on compliance to become a quality-driven organization.

Meg has amassed over a decade of experience as a QA/RA and compliance professional, with a range of cross-functional skills and knowledge spanning from non-profits to medical device start-ups.

Meg is Senior Quality Specialist at Qualio, a member of the Qualio+ expert team, and a certified auditor for both ISO 9001 and ISO 13485.

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Pharmaceutical Quality affects every American. The Food and Drug Administration (FDA) regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (CGMP) regulations for human pharmaceuticals. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. Most people, however, are not aware of CGMP, or how FDA assures that drug manufacturing processes meet these basic objectives. Recently, FDA has announced a number of regulatory actions taken against drug manufacturers based on the lack of CGMP. This paper discusses some facts that may be helpful in understanding how CGMP establishes the foundation for drug product quality.

CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. CGMP provides for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.

The CGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement. Accordingly, the "C" in CGMP stands for "current," requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. Systems and equipment that may have been "top-of-the-line" to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today's standards.

It is important to note that CGMP regulations for drugs contain the minimum requirements. Many pharmaceutical manufacturers are already implementing comprehensive, modern quality systems and risk management approaches that exceed these minimum standards.

A consumer usually cannot detect (through smell, touch, or sight) that a drug product is safe or if it will work. While CGMP requires testing, testing alone is not adequate to ensure quality. In most instances testing is done on a small sample of a batch (for example, a drug manufacturer may test 100 tablets from a batch that contains 2 million tablets), so that most of the batch can be used for patients rather than destroyed by testing. Therefore, it is important that drugs are manufactured under conditions and practices required by the CGMP regulations to assure that quality is built into the design and manufacturing process at every step. Facilities that are in good condition, equipment that is properly maintained and calibrated, employees who are qualified and fully trained, and processes that are reliable and reproducible, are a few examples of how CGMP requirements help to assure the safety and efficacy of drug products.

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