cGMP: A Guide to Current Good Manufacturing Practices

If food and drug manufacturers ever need a lesson on why they must uphold the highest production standards, they can study the 2012 New England Compounding Center tragedy where poor practice at a compounding pharmacy resulted in a meningitis outbreak that cost more than 100 lives.

Any company making goods for human consumption has especially high standards to meet. In the US, manufacturers of pharmaceuticals, supplements, and certain foods, must adhere to what the FDA terms Current Good Manufacturing Practices (cGMP).

Current Good Manufacturing Practices regulations are defined by the FDA as systems that assure proper design, monitoring, and control of manufacturing processes and facilities.

For pharmaceutical production, for example, cGMP regulates manufacturing controls aimed at ensuring the identity, strength, quality, and purity of drug products. This is achieved through strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.

Through its authority under the Federal Food, Drug, and Cosmetic Act, the FDA has promulgated the Good Manufacturing Practices (GMP) regulations.

The FDA adds the “c” to the GMP acronym to emphasize to manufacturers that they need to stay “current” or up-to-date in the way they comply with the regulations.

“The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement,” the FDA says. “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.”

All consumables—from food to pharmaceuticals—need to be produced to the highest standards because the population has the right to expect not to be harmed by anything they ingest.

While Good Manufacturing Practices are vital for all types of products consumed by the public, the FDA points out that pharmaceuticals can present a challenge that is often not found with food and drink. While a shopper can observe if the loaf of bread they pick up at the store has turned moldy, it is not possible for that same consumer to detect (through smell, touch, or sight) whether a drug product is safe or if it will work.

Product testing is required under cGMP, but the FDA warns manufacturers that they cannot rely on testing alone to ensure quality. Because only a small sample of any manufactured batch of pharmaceuticals is tested, it is important the drugs are produced under conditions and practices required by the cGMP regulations to assure that quality is built into the design and manufacturing process at every step.

To ensure the safety and efficacy of the drugs they produce, pharmaceutical manufacturers need to comply with a range of cGMP requirements aimed at ensuring their facilities are in good condition, equipment is properly maintained and calibrated, employees are qualified and fully trained, and their processes are reliable and reproducible:

• Facilities and equipment: A manufacturer’s buildings and facilities must be properly maintained to ensure pharmaceuticals are produced in safe and effective conditions. Equipment used within the plant must be well-maintained and calibrated.

• Raw materials and products: Manufacturers are required to maintain a master formula for each of the pharmaceutical products they produce. The master formula must be followed, without deviation, through the entire manufacturing process.

• Staff: Staff involved in every step of the manufacturing process are required to be suitably trained for the tasks they carry out.

• Procedures and Processes: Standard operating procedures (SOPs) are required for all aspects of the manufacturing process and must be kept up to date. This means manufacturers must regularly review all procedures to ensure they are based on the latest science and technology applicable to the pharmaceutical being manufactured.

Effective software solutions have become indispensable tools for all manufacturers, and these solutions are particularly important for pharmaceutical producers needing to comply with cGMP requirements.

The Pharma 4.0 era of drug manufacturing has seen the industry embrace a range of digital solutions that have enabled significant advances in all aspects of the production process, resulting in significant improvements to overall product quality and production efficiency.

Software plays a multifaceted role in enabling pharmaceutical manufacturers to achieve cGMP compliance and enhance their overall operations:

• Data analytics: The analysis of data gathered from the various production line operations is an invaluable resource when it comes to ensuring equipment, and the plant as a whole, is operating effectively and compliantly.

• Product traceability: Electronic logbooks make product tracing more efficient and accurate, and enable manufacturers to compile more comprehensive product information.

• Interactive staff training: Interactive digital training guides workers through relevant processes more effectively than paper instructions or meetings. One of the emerging technologies in this sphere is computer vision, a solution that trains workers as they perform a given task.

• Media-rich SOPs: In the same way interactive training is more effective than paper-based instructions, digital SOPs can provide a more media-rich, interactive outline of operating procedures than an SOP outlined in the pages in a physical manual. Digital SOPs can provide staff with a clearer picture of how to do things, and what to do in case something goes wrong.

Tulip is currently being used by some of the largest pharmaceutical manufacturers to help streamline processes, improve quality, and automate data collection and compliance procedures.

Using Tulip, manufacturers are able to create a system of apps that address any number of different challenges a pharmaceutical producer might face. Some of the most common use cases we see manufacturers leverage our platform for include digital work instructions, machine monitoring, electronic batch records, and documentation around activities such as equipment use, line clearances, and changeovers.

By connecting systems and processes to a centralized, digital solution, pharmaceutical manufacturers are able to ensure data integrity and traceability in accordance with FDA 21 CFR Part 11.

If you’re interested in learning more about how Tulip can help streamline cGMP compliance in your production facilities, reach out to a member of our team today!