Strengthen good manufacturing practices in your organization by understanding GMP guidelines and maximizing today’s technologies.
Published 31 Aug 2023
Good Manufacturing Practices or GMP is a system that consists of processes, procedures and documentation that ensures manufacturing products, such as food, cosmetics, and pharmaceutical goods, are consistently produced and controlled according to set quality standards. Implementing GMP can help cut down on losses and waste, avoid recall, seizure, fines and jail time. Overall, it protects both company and consumer from negative food safety events.
GMPs examine and cover every aspect of the manufacturing process to guard against any risks that can be catastrophic for products, such as cross-contamination, adulteration, and mislabeling. Some areas that can influence the safety and quality of products that GMP guideline and regulation address are the following :
Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGMP) are, in most cases, interchangeable. GMP meaning the basic regulation promulgated by the US Food and Drug Administration (FDA) under the authority of the Federal Food, Drug, and Cosmetic Act to ensure that manufacturers are taking proactive steps to guarantee their products are safe and effective. cGMP, on the other hand, was implemented by the FDA to ensure continuous improvement in the approach of manufacturers to product quality. It implies a constant commitment to the highest available quality standards through the use of up-to-date systems and technologies.
It is paramount to the manufacturing industry to regulate GMP in the workplace to ensure consistent quality and safety of products. Focusing on the following 5 P’s of GMP helps comply with strict standards throughout the entire production process.
Further information can be found at this PDF Guide to GMP: Good Manufacturing Practices.
GMP regulations are mandated by manufacturers’ respective national governments to regulate the production, verification, and validation of manufactured products and ensure that they are effective and safe for market distribution.
For example, in the United States, GMP is enforced by the US FDA through Current Good Manufacturing Practices (CGMP) which cover a broader range of industries such as cosmetics, food, medical devices, and prescription drugs. The FDA conducts facility inspections to assess if a manufacturing company complies with CGMP regulations. If any serious violations are found during the inspection, FDA recalls all products, which is problematic for manufacturers in terms of both profit and business operations.
The quality of manufactured products is highly regulated as it can pose negative health risks to consumers and even the environment. Poor hygiene, temperature-control, cross-contamination, and adulteration in any step of the manufacturing process are some examples of how a manufactured product that doesn’t follow GMP regulations can bring fatal consequences to consumers. See GMP regulation and preamble sources by country here.
GMP standards are developed to enhance the safety of manufactured products, especially pharmaceutical goods, and to ensure consumers get the highest quality possible. Adherence to GMP standards not only positively impacts the reputation of manufacturing companies but also reduces batch recalls and negative reports from consumers. Below are 4 measures you can follow to uphold GMP standards:
Create Your Own GMP Audit ChecklistEliminate manual tasks and streamline your operations.Get started for free
Eliminate manual tasks and streamline your operations.
GMP guidelines are a set of principles that help manufacturers implement an effective manufacturing process and ensure that quality is built into the organization and the processes involved. GMP guidelines are customarily flexible, with countries having their own legislation to comply with local GMP guidelines and principles. But almost all regulations are derived from the basic concept and guidelines which are:
The principle of quality management is to ensure that manufactured products are fit for their intended use, comply with requirements and does not place consumers at risk due to inadequate safety, quality, or efficacy measures. To achieve this quality objective, quality assurance, good manufacturing practices, quality control, and quality risk management should be comprehensively and correctly implemented.
The system of quality assurance aims to ensure that manufactured products are designed and developed in a way that meets the requirements for Good Manufacturing Practice.
Good Manufacturing Practice for Products
As a part of quality assurance, good manufacturing practice is concerned with production and quality control. It aims to mitigate the risks that are inherent in the production process. Its basic requirements according to WHO’s Good Manufacturing Practices for Pharmaceuticals state the following:
Quality control is a part of Good Manufacturing Practice that focuses on sampling, specification, and testing. It checks the organization, documentation, and release procedures to ensure that products go through the required tests before being released for sale or supply.
Quality risk management
Quality risk management is a systematic process of assessing risks that can affect the quality of the product. According to its principles, quality risk management should ensure that:
Sanitation and hygiene are vital in every aspect of the manufacturing process. It covers anything that can cause contamination such as personnel, the premises, equipment, containers, and production materials. All potential sources of contamination should be identified and eliminated with a comprehensive sanitation and hygiene program.
As a principle, the premises should be situated in an environment that is suitable for its operations and one that is free from risks of contamination of materials and products. The premises should also be designed to minimize errors in operations and should be easy to clean and maintain.
Same with the premises, equipment should be designed, located, and maintained to function according to its intended use. Additionally, it should be cleaned and stored according to procedures. In the event of a defect or malfunction, it should be removed or labeled as defective.
All materials used for production should be stored properly according to the appropriate conditions which are set by the manufacturers. There should be a proper stock management system implemented to ensure that all incoming materials are correct and of high quality.
The success of GMP compliance heavily relies on the people implementing it. For this reason, it is vital that all personnel are qualified and trained to do the job. They should be aware of the principles of GMP and receive continued training, hygiene instructions, and other tools relevant to their needs. Respective managers should be clear on job descriptions for each worker to avoid misunderstandings and reduce the risk of issues like overlapping responsibilities.
Qualify systems, premises, and equipment if they are fit/ready for their intended use and validate if processes and procedures can repeatedly produce high-quality products. Critical steps in the manufacturing process should be verified to ensure that product quality is consistent and maintained at a high level. According to the WHO (World Health Organization), qualification and validation should establish and provide documentation stating that:
Handling complaints is also part of GMP, therefore all manufacturing companies should have a well-designed GMP complaint system. Ideal complaint handling should have a ready solution to provide for all contingencies.
Good documentation and record keeping are an essential part of the quality assurance system and are required in compliance with GMP requirements. Accurate recordkeeping can help managers and supervisors keep track of the historical record of manufacturing procedures and corrective measures implemented. Below are general requirements for documentation:
Inspections should be regularly performed to monitor if GMP is implemented and complied with. Document what areas need more work and provide corrective measures for continuous improvement. Quality audits are done to assess the quality systems implemented by the manufacturing company. GMP audit checklists can help companies comply with GMP guidelines set by regulatory authorities. By performing site visual walkthroughs and conducting manufacturing evaluations, you can identify non-compliant processes and take immediate action to address areas for improvement.
GMP guidelines and regulations address different issues that can influence the safety and quality of a product. Meeting GMP or cGMP standards helps the organization comply with legislative orders, increase the quality of their products, improve customer satisfaction, increase sales, and earn a profitable return of investment.
Conducting GMP audits play a big part in assessing the compliance of the organization to manufacturing protocols and guidelines. Performing regular checks can minimize the risk of adulteration and misbrand. A GMP audit helps improve the overall performance of different systems including the following:
Good Manufacturing Processes, or GMP, make sure that products are controlled in quantity and produced in such a way that meets quality standards. GMP involves many factors such as hygiene, environmental conditions, and more. Through this process, any flaws or anomalies can already be identified earlier on which wouldn’t be detected when the final product is tested or already out in the market. By making sure that your products go through GMP, you’ll have high-quality end products that are safe for use or consumption which, in turn, will give better customer satisfaction and yield higher revenue.
We’ve curated a list of GMP training courses that will guide your employees in following GMP standards so they can be proactive in minimizing risks in all aspects of manufacturing products such as food, cosmetics, and pharmaceutical goods. These courses cover topics such as good manufacturing practices, quality control, risk management, and many more.
GMP compliance is crucial in the manufacturing industry. Providing quality-assured products can secure the health and safety of the public. Robust processes and easy-to-use systems that enforce and monitor standards can strengthen GMP compliance in your organization. With technological advances in the industry, food manufacturers have more opportunities to transform reactive company culture, into a proactive, predictive workforce equipped for continuous improvement. Utilize digital tools such as SafetyCulture (formerly iAuditor), a mobile inspection app and GMP software, and sensors to move your GMP beyond compliance. With SafetyCulture you can:
See how a trusted food delivery business in Australia, Marley Spoon, immediately takes action based on real-time data using SafetyCulture temperature sensors:
SafetyCulture gives you the flexibility to power any inspection you require—onsite, underground, and across the globe. Inspect construction sites, restaurant food safety inspections, conduct temperature checks, pre-flight checks, toolbox talks, and more. It is the mobile forms inspection solution for all industries.
Some of the GMP requirements to be able to produce quality and safe products include policies such as:
The main difference between GMP and ISO (International Organization for Standardization) is the industry and their area of focus. GMP focuses on ensuring the safety and efficacy of products in regulated industries such as pharmaceuticals, medical devices, and food. ISO, on the other hand, involves establishing and maintaining a QMS that meets customer and regulatory requirements across a range of industries.
The 5Ps of GMP are the key elements to consider when implementing effective guidelines for your business. These 5Ps compose of the following:
Yes, the FDA regulates GMP in the United States. The FDA enforces GMP requirements by inspecting manufacturing facilities to ensure that they adhere to the set guidelines and are compliant with safety practices.
SafetyCulture is the world’s #1 cloud-based inspection app used to convert paper forms to digital checklists. Sign up now and download these 100% free and customizable GMP checklists!
Jona Tarlengco is a content writer and researcher for SafetyCulture since 2018. She usually writes about safety and quality topics, contributing to the creation of well-researched articles. Her 5-year experience in one of the world’s leading business news organisations helps enrich the quality of the information in her work.
What are the Goals of Ergonomics Training? Ergonomics is defined as the study of how humans at work ...
Benefits Big or small, businesses across industries are exposed to a myriad of risks. If unmitigated...
Why It’s Important to Maintain TCS Food Safety An estimated 1.3 billion tons of edible food is ...