- Patients take the individual dose, not the average—sometimes every day for their entire life. Patients deserve the assurance that their drug will meet every quality requirement for each dose, not just on the average. That’s the objective of cGMPs, and that should be no less the objective of one’s business.
- Manufacturing processes are fraught with opportunities for unwanted variation to creep in from incoming raw materials and components to equipment, test methods, operators, facilities, utilities, and warehouses. Manufacturing a product that is continually faithful to what market approval was based on and all quality requirements only happens when done so intentionally. One can’t test quality into products.
- Standard operating procedures declare how a company intends to control variation and ensure predictability. The operative word is “standardize.” A company has the liberty to standardize how it works to be as efficient as possible to meet regulatory requirements. Contrary to common belief, cGMPs do not prescribe exactly how to comply, but the expectation is to keep up with current industry practice. A company is responsible for applying product and technical knowledge to the practice of cGMPs.
- When following standard operating procedures, records are created that document how the work was performed and the results. The way and when information is recorded and is important. Sometimes it is so crucial to the outcome that recording information must be witnessed. Documentation is how one proves and defends one’s work.
- Records contain data that describe how well the intent was achieved. The data can be collected, translated into performance metrics, interpreted by process owners and subject-matter experts for analysis and decisions to target actions to continuously improve processes, reduce waste, increase efficiency, prevent future failure, and enhance knowledge.
- A regular review of these performance metrics by a cross-functional management team is part of the mechanism to provide oversight and governance. When taking action on unacceptable trends a company becomes an anticipating organization, rather than a reactive one. A management review of the quality management system (QMS), like any other business review, is the primary source of data-driven confidence that one is operating in a state of control and is the basis for the confidence that one is maintaining an economical control of quality, increasing operational capability, and the ability to compete while meeting cGMP compliance expectations.
- Compliance to cGMPs supports the business by ensuring continuous quality and continuous supply of products to customers and patients. Continuous quality is quality that can be trusted. Continuous quality enables business performance to be predictable.
The QA Pharm
The QA Pharm is a service of John Snyder & Company, Inc.
John Snyder & Company, Inc., provides consulting services to companies regulated by the Food and Drug Administration. We help our clients to build an effective Quality Management System to enable reliable supply of quality products to their patients. We also help our clients to develop corrective action plans to address regulatory compliance observations and communication strategies to protect against accelerated enforcement action.
Contact us at firstname.lastname@example.org.