Strengthen good manufacturing practices in your organization by understanding GMP guidelines and maximizing today’s technologies.
Published April 16th, 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.
Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGMP) are, in most cases, interchangeable. GMP is 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.
The 5 P’s of GMP
All employees are expected to strictly adhere to manufacturing processes and regulations. A current GMP training must be undertaken by all employees to fully understand their roles and responsibilities. Assessing their performance helps boost their productivity, efficiency, and competency.
All products must undergo constant testing, comparison, and quality assurance before distributing to consumers. Manufacturers should ensure that primary materials including raw products and other components have clear specifications at every phase of production. The standard method must be observed for packing, testing, and allocating sample products.
Processes should be properly documented, clear, consistent, and distributed to all employees. Regular evaluation should be conducted to ensure all employees are complying with the current processes and are meeting the required standards of the organization.
A procedure is a set of guidelines for undertaking a critical process or part of a process to achieve a consistent result. It must be laid out to all employees and followed consistently. Any deviation from the standard procedure should be reported immediately and investigated.
Premises should promote cleanliness at all times to avoid cross-contamination, accidents, or even fatalities. All equipment should be placed or stored properly and calibrated regularly to ensure they are fit for the purpose of producing consistent results to prevent the risk of equipment failure.
GMP regulations are mandated by manufacturers’ respective national government 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:
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.
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 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 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 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 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 misbranding. A GMP audit helps improve the overall performance of different systems including the following:
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 opportunity to transform 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. With iAuditor you can:
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
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.
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