Strengthen your GMP in the company by understanding the 12 basic guidelines and maximizing today's technologies.
The system of Good Manufacturing Practice (GMP) ensures that manufactured products such as food, cosmetics and pharmaceutical products are consistently produced and controlled according to defined quality standards. Every aspect of the manufacturing process is examined and covered by GMP to protect against product risks such as cross-contamination, adulteration and incorrect labelling. The implementation of GMP can help to reduce loss and waste, and protect both the company and the consumer from negative food safety incidents.
The quality of manufactured products is strictly regulated, as it could pose negative health risks to consumers and even to the environment. Good examples of how a manufactured product that does not comply with GMP guidelines can have fatal consequences for consumers are: poor hygiene and inadequate temperature controls, cross-contamination and adulteration.
The GMP rules are followed by many manufacturers all over the world. The respective national governments are responsible for regulating the production, verification and validation of manufactured products and for ensuring that they are effective and suitable for market distribution.
In the USA, for example, GMP is enforced by the US FDA through the Current Good Manufacturing Practices (CGMP), which cover a wider range of industries such as cosmetics, food, medical devices and prescription drugs. In Europe, relevant guidelines for the pharmaceutical sector are controlled by the European Commission, through the Pharmaceutical Inspection Co-Operation Scheme (PIC/S).
The relevant authorities carry out factory inspections to determine whether a manufacturing company complies with the GMP guidelines. If serious violations are found during the inspection, all products are recalled, which is problematic for the manufacturers both in terms of profit and business operations.
The 12 GMP guidelines contain several basic ideas that help manufacturers to implement an effective manufacturing process and to integrate quality within the company and the associated processes. As a rule, the GMP guidelines are flexible, although countries with their legislation follow their local guidelines and principles. But almost all regulations are derived from the basic GMP concept and the associated GMP guidelines:
The principle of quality management (QM) is to ensure that the products manufactured are suitable for their intended use, meet the requirements and do not endanger consumers due to inadequate safety, quality or action mechanisms. Therefore, quality assurance, GMP standards, quality control and quality risk management should be fully and correctly implemented to achieve this quality objective.
The essential requirements according to the WHO (World Health Organization) Good Manufacturing Practices for Pharmaceuticals are as follows:
The sanitary and hygienic area is of crucial importance in every aspect of the manufacturing process. It includes everything that can cause contamination, such as premises, personnel, equipment, containers and production materials. All possible sources of contamination should be identified and eliminated with a detailed sanitation and hygiene programme.
In principle, the premises should be located in an environment suitable for the operation. There should be no risks for contamination of materials and products. Besides, the premises should be easy to clean and maintain so that operating problems hardly ever occur.
As with the premises, equipment should be designed, located and maintained so that it functions as intended. They should also be cleaned and stored by procedures. In the event of a defect or malfunction, they should be removed or marked as defective.
All materials used for production should be properly stored according to the conditions specified by the manufacturer as appropriate. An appropriate warehouse management system should be implemented to ensure that all incoming materials are correct and of high quality.
A successful implementation of GMP standards depends heavily on the people who implement them. For this reason, it is important that all employees are qualified and trained for this task. They should be aware of the GMP guidelines. Continuous training, hygiene instructions and other instructions important for their needs should be provided. The responsible managers should be aware of the job descriptions for each employee to avoid misunderstandings and reduce the risk of problems such as overlapping responsibilities.
The qualification is intended to ensure that systems, premises and equipment are suitable for the intended purpose. Validation checks whether processes and procedures can repeatedly deliver high-quality products. Critical phases in the manufacturing process should be reviewed to ensure that product quality is consistent and maintained at a high level. According to the WHO, qualification and validation should provide GMP documentation that confirms the following points:
The handling of complaints is also part of GMP, so all manufacturing companies should have a well-thought-out GMP complaints system. An ideal complaint management system should have a suitable resolution process for all eventualities.
Good GMP documentation and record-keeping is an essential part of the quality assurance system and is required by the GMP guidelines. Accurate logging helps managers and supervisors to keep an overview of the history of the manufacturing process and the corrective actions taken. All general requirements for GMP documentation are listed below:
Inspections should be carried out regularly to monitor whether the GMP guidelines are implemented and adhered to. Areas that require more work are documented, and corrective measures are provided for continuous improvement. Quality audits are carried out to evaluate the quality systems implemented by the manufacturing company.
GMP audit checklists support companies in complying with the GMP guidelines laid down by the supervisory authorities. By conducting visual inspections on site and carrying out production evaluations, non-compliant processes are identified. Measures are then taken immediately to exploit improvement potential.
GMP-compliant regulations are developed to increase and ensure the safety of finished products, especially pharmaceutical products. The aim is to provide consumers with the highest possible quality. Compliance with GMP not only has a positive effect on the reputation of manufacturing companies but also reduces batch recalls and negative evaluations by consumers. Below you will find 5 measures that you can follow to maintain GMP conformity:
Conduct routine visual site inspections and check the overall safety of the production place using this GMP Site Walkthrough Checklist. See template
Used this template to review efficient processes and staff training on proper hygiene procedures. See template