Strengthen good manufacturing practices in your organization by understanding GMP guidelines and maximizing today’s technologies.
Published January 25th, 2021
Good Manufacturing Practices (GMP) is a system that ensures manufacturing products, such as food, cosmetics, and pharmaceutical goods, are consistently produced and controlled according to set quality standards. 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. Implementing GMP can help cut down on losses and waste, and protects both the company and consumer from negative food safety events.
GMP regulations are mandated by manufacturers’ respective national government to regulate 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.
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 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 its intended use, complies 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.
Sanitation and hygiene is 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 defect or malfunction, it should be removed or labeled as defective.
All materials used for production should be stored properly according to its 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 its 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 recordkeeping is an essential part of the quality assurance system and is 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 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 5 measures you can follow to uphold GMP standards:
GMP compliance is crucial Having 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 opportunity to transform a reactive company culture, into a proactive, predictive workforce equipped for continuous improvement. Utilize digital tools such as iAuditor by SafetyCulture, a mobile inspection app, and sensors to move your GMP beyond compliance. Learn more about iAuditor.
See how a trusted food delivery business in Australia, Marley Spoon, immediately takes action based on real-time data using iAuditor temperature sensors:
iAuditor 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.
iAuditor 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!
General GMP Compliance Checklist
FDA GMP Cosmetics Audit Checklist
GMP Food Manufacturing Audit
GMP Site Walkthrough Checklist
SafetyCulture staff writer
Carlo Sheen Escano is a contributing writer for SafetyCulture based in Makati City, Philippines. Sheen has experience in digital marketing and has been writing for SafetyCulture since 2018. His articles mainly discuss risks in the workplace and well-known safety and quality processes used to mitigate them. Furthermore, Sheen is passionate about providing insights to global customers on how technology can help them to do the best work of their lives.
Getting started is easy, simply fill in your email and raise the game with iAuditor
Something went wrong with your submission.
Trying to log in? Click here to log in
Contact us if you require any assistance with this form.
© SafetyCulture 2021