Good manufacturing practice (GMP) is a set of guidelines that manufacturers must follow to ensure that their products are safe, compliant, and high-quality. The FDA lays down these guidelines to provide a thorough and unadulterated process of product manufacture. GMP focuses on processes and procedures to reduce the risk of introducing contaminants or non-approved substances into a final product.
While pharmaceutical manufacturers can follow general manufacturing principles to produce safe and effective drugs, there are additional requirements with a special focus on safety and production standards for pharmaceutical products. In this article, we will address the importance and the key requirements of GMP in pharmaceutical industries.
Why is GMP Important?
GMP is an essential regulatory practice in the pharmaceutical industry that regulates quality standards. This practice ensures products (drugs) meet the optimal quality standards and are safe for consumers’ consumption. GMP makes sure that the drug contains the necessary active ingredients, serves its purpose for use, and has no severe, life-threatening side effects. To effectively produce this result, the drug would have gone through numerous trial and error experiments, and the FDA would have deemed it suitable for consumption and in compliance with GMP.
Not only does GMP reduce risks, but benefits the industry in several ways. For example, the FDA may not approve a product due to lack of compliance with GMP.
How Do Good Manufacturing Practices Help to Ensure Safety?
One of the ways by which good manufacturing practices (GMP) ensure safety is their control over the circumstances surrounding drug production and manufacture. GMP controls the state of the facilities, equipment, raw materials, and methods implemented during drug manufacture.
GMP ensures that pharmaceutical facilities are geared towards safe and quality drug production. One requirement in particular, is that around electronic signature, 21 CFR Part 11. Such requirements ensure that electronic records follow the rules to appropriately document a materials journey from raw substance to finished packaged product.
Controlling all the factors surrounding drug production and manufacture ensures safety for the pharmaceutical personnel and the final consumers of the product.
What are the Key Requirements for GMP?
The GMP regulations are put in place to be thoroughly followed to prevent any risks associated with drug manufacture. There are, however, some key requirements of GMP that pharmaceutical companies are obligated to meet to attain maximum quality standards. These requirements include:
Validation:
Validation is the process of keeping a documented record of all the methods that take place during the production process. This record includes testing and experiments, date, duration, the quantity of raw materials used, trial and error practices, and every other detail of the production process. Every pharmaceutical company must keep this record for every production and update it as the process pans out.
Complaints examination:
Pharmaceutical companies are expected to address complaints made about a product. The product should be thoroughly reviewed and resolved, and appropriate corrections must be made to eliminate any mistakes in the complaints.
Quality risk management:
Pharmaceutical industries should implement a risk management protocol that alerts them when a risk factor is detected in a production process and can assess and update risks and errors. This requirement puts out the previous “Quality by inspection” protocol, where mistakes can only be discovered through inspection. It, instead, puts in place the “Quality by standard” protocol, where industries implement risk control as part of their processes.
Proper maintenance of facilities and equipment:
The facilities and equipment used during manufacture should be in their best and of good use. Therefore, it is essential to provide proper maintenance and keep them for easy access and usage.
Develop a team of competent personnel:
Pharmaceutical manufacturing companies should develop a team of highly trained and competent personnel that would take part in any production and manufacturing process. This would speed up the company’s operation and ensure there are no mistakes from the scientists’ end.
Key Takeaways
•Good Manufacturing Practices (GMP) is a set of guidelines put in place for manufacturing companies by the FDA to ensure maximum safety and reduce the risk of health hazards for both the manufacturers and the consumers.
•These guidelines must be thoroughly followed for the product to be approved by the FDA and deemed GMP-compliant.
•Certain requirements are expected of pharmaceutical companies to adhere to to be able to observe GMP properly.
OpsTrakker is an innovative digital solution for all pharmaceutical companies that simplifies pharmaceutical manufacturing processes with their digital solutions. OpsTrakker electronic logbooks, forms, and workflows enable electronic logs and records in compliance with GMP regulations. Workflows are configured with electronic signatures and a robust audit trail to ensure that all activities related to production are documented and secured.
We understand the importance of GMP to all pharmaceutical organizations, and as such, we can seamlessly integrate it into our solutions for your use. Get in touch to learn more today!