Current Good Manufacturing Practice (cGMP) Compliance Made Easy

cGMP stands for Current Good Manufacturing Practice, which encompasses the U.S. Food and Drug Administration’s regulations for ensuring the consistent quality and safety of products manufactured by the industries it regulates: food, drugs, biologics and medical devices.

As stated by the FDA, “cGMP provides for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.” Under cGMP, manufacturers in these industries must adequately control operations by establishing strong quality management systems, obtaining quality raw materials, detecting and investigating product quality deviations and maintaining reliable testing laboratories.

The main objective of cGMP is to protect the health and safety of consumers. Through steadfast enforcement of cGMP regulations, consumers are able to have confidence in the quality, safety and efficacy of the drugs, food and medical equipment available to them.

cGMP is important to manufacturers who must successfully comply with its regulations in order to market their products in the United States. The FDA monitors compliance by conducting regular inspections of facilities, examining physical conditions as well as required documentation.

Without continued adherence to cGMP, manufacturers run the risk of being forced to issue product recalls, pay fines or worse.

cGMP and GMP are built along the same basic good manufacturing principles, but they differ in scope.

GMP is a broad set of quality guidelines applicable to many industries. It forms the basis of regulations in many different countries. Although specific requirements vary depending on industry and location, common requirements include:

• Instructions and procedures that are clear and well-documented
• Educated and trained workers who understand their roles
• Facilities and staff cleanliness and hygiene
• Adequate control of materials at each stage of production

In contrast, cGMP is a group of mandatory regulations tailored to the industries supervised by the U.S. FDA, including pharmaceuticals, dietary supplements, medical devices, food and beverages. The “c” in cGMP differentiates the FDA’s regulations and reflects the FDA’s efforts to encourage use of the most current quality controls.

cGMP is often solely attributed to pharmaceutical manufacturing, perhaps because the industry was the original focus of the regulations. Pharma remains a large part of cGMP regulatory activity. The primary standard outlining steps for meeting minimum cGMP is FDA 21 CFR Part 211. Being able to meet its standards is required for FDA approval with the goal of assuring that “the drug products have the identity, strength, quality, and purity they purport.”

FDA 21 CFR Part 210 is used in conjunction with Part 211. Where Part 211 focuses on process control for finished pharmaceuticals, Part 210 puts forth minimum standards for manufacturing, facilities and controls.

Meeting these FDA standards is a complex endeavor, but the major elements involve:

• Qualifications and skills of personnel
• Equipment and facilities maintenance
• Control of components, product containers and closures
• Production and process controls
• Packaging and labeling controls
• Warehousing and distribution
• Laboratory controls
• Records and reports

QT9 QMS automates and streamlines multiple quality processes in one integrated solution for the pharmaceutical industry. QT9 QMS provides more than 25 modules in its standard offering that automate and centralize key quality processes, such as:

• Document control
• Risk management
• Employee training
• Measurement and testing
• Inspections
• Corrective and Preventive Actions (CAPAs)
• Supplier management
• Customer feedback
• Electronic batch records
• Inventory control
• Management review
• Regulatory compliance

QT9 QMS is a highly rated, affordable and easy to use quality management system that excels at all of the processes that go into providing high-quality goods and services that are FDA and ISO compliant.