Current good manufacturing practices (CGMPs) outlined in federal code form the basis of U.S. Food and Drug Association’s (FDA) regulations. They also serve as a framework for international standards such as ISO 9000 and the International Council for Harmonization (ICH) Q9 guidelines. The intent of these regulations and guidelines is to protect consumers and to help quality organizations function in optimal ways. Despite best intentions, many organizations continue to fail to meet these standards or follow these guidelines.
Some of the most common GMP audit findings that appear on FDA citation lists year after year relate to:
These findings suggest real life challenges that quality organizations are struggling to meet. Unfortunately, they also bring real consequences, such as a warning letter, a Form 483, suspended production, and delayed release dates. These all add up to increasing costs and potential failure.
One recent FDA warning letter to a pharmaceutical manufacturer summarizes significant violations of CGMP for finished pharmaceuticals and points to the vulnerabilities of a poor or simply outdated quality management system:
Today’s Quality System Inspection Technique (QSIT)2 outlined by the FDA provides a predictable approach for any external FDA audits you are expecting. It also serves as a framework for any internal GMP audits you complete. It takes into consideration the six systems that make up a quality program. The six systems include:
The importance of repeatedly examining your quality system cannot be overemphasized; and the value of compliance audit software cannot be overstated. The benefits of being able to perform and effectively respond to regular audits include:
Last year nearly 800 drug products were recalled because many facilities struggle with CGMP issues.3 A robust QMS lies at the heart of adhering to CGMPs. A company’s processes and products can only be as good as the QMS used to manage and produce them. Many of the common findings point to written procedures as the basis for process and quality controls. Inadequate, incomplete, or missing documents reveal a system that is out of control.
Unfortunately, despite best intentions, it is not always easy to remedy GMP audit findings when you are relying on outdated practices, including manual and paper-based systems that are error-prone. Because these systems remain unconnected, quality data is inaccessible and siloed. This makes it difficult to execute informed and timely decisions, address quality events, and remain compliant.
Advanced and intelligent quality systems consistently yield safer and higher quality products (the objective of following CGMPs) because they allow quality professionals to manage quality data and processes with greater ease.4
The benefits of using an advanced digital solution include:
A compliant system facilitates adherence to CGMPs. However, regulators are beginning to look beyond GMP audit findings and encouraging quality organizations to embrace mature quality practices that can prevent the disruptions that have impacted the pharmaceutical industry dramatically over the past several years.5 Embracing an ongoing culture of quality is becoming imperative as regulators and consumers alike continue to rely on pharmaceutical companies to self-regulate and fulfill a vital role in the health care ecosystem.
The crowning benefits of adopting digital solutions exceed compliance. Pharma Manufacturing reports that, “One thing is almost certain: Regulators or industry will not be able to solve these problems by working separately. The global dimensions of pharmaceutical manufacturing and scientific innovation dictate a highly collaborative, data-driven and science-based path forward.”6 It is becoming increasingly evident that improved efficiency can only be unlocked using enterprise quality system software.
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