Strengthen your Good Manufacturing Process (GMP) in your company by understanding the 7 basic GMP principles. Learn why companies chose to get certified and make it all the easier by maximizing the technologies of today..
Lumiform enables you to conduct digital inspections via app easier than ever before.
Get a kickstart with one of our +12000 ready-made and free checklists
Good Manufacturing Practice (GMP) is the testing of manufacturing products such as food, cosmetics, and pharmaceutical products with the help of defined quality standards. GMP supports the avoidance of cross-contamination, adulteration, and mislabelling, which can reduce loss and waste and, thus, provide consumers with optimum protection.
Obviously, the standards depend on which industry they’re referring to. A GMP covers every aspect of production and pays close attention to all possible risks and hazards. As a result, manufacturers will have peace of mind knowing they eliminated all potential failures before their products hit the shelf.
Use a manufacturing process audit checklist to give your consumers the best money can buy!
The quality of manufactured products is strictly regulated, as it may pose negative health risks to consumers or the environment. Win manufactured products that do not comply with GMP guidelines can have fatal consequences for consumers, such as poor hygiene and inadequate temperature controls, cross-contamination, and adulteration.
GMP is a globally recognized system for process evaluation. A company that wants to ensure good manufacturing practice must first implement a basic system for effective evaluation and documentation. Only accurate and complete documentation can guarantee the safety of the manufactured products.
The GMP guidelines for obtaining GMP certification contain a number of basic ideas that help manufacturers implement an effective manufacturing process as well as integrate quality within the company and the associated processes. These GMP guidelines may vary depending on local and national legislation. Meanwhile, almost all regulations are based on this basic GMP concept:
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 or quality defects. These measures are taken care of by the company's quality manager.
The quality assurance system is designed to ensure that manufactured products are designed and developed to comply with GMP requirements.
As part of quality assurance, good manufacturing practice deals with production and quality control. It aims at minimizing the risks inherent in the production process.
The good manufacturing practices for pharmaceuticals of the WHO (World Health Organization) refer to the following aspects:
Quality control is part of the good manufacturing practice. It is used to carry out samples, specifications, and tests. This involves reviewing the facility, its GMP documentation, and release procedures to ensure that the products pass the required tests before they are sold.
Quality risk management serves the systematic identification and assessment of risks that could impair product quality. The relevant aspects for quality risk management are:
Qualification is intended to ensure that systems, premises, and equipment are suitable for their intended use. Validation checks whether processes and procedures can repeatedly deliver high-quality products. If there are critical phases in the manufacturing process, these should be checked and documented to ensure consistent quality.
The handling of complaints is based on a predefined GMP complaints system. An ideal complaint management system should have a suitable resolution process for all eventualities.
Accurate logging and documentation helps managers and supervisors to keep track manufacturing process’s history and that corrective actions are taken.
GMP-compliant regulations optimize the safety of finished products, especially in the pharmaceutical industry. This enables the highest possible quality for consumers. The following 4 tips will help you to maintain GMP conformity:
A GMP certification is achieved and maintained by following the seven GMP principles as well as continuous and consistent documentation. The use of software tools helps to rationalize and simplify the documentation of GMP records. Supervisors and employees are supported in the daily implementation of routine GMP controls.
Lumiform is an inspection and software app that can help your company with GMP planning and documentation.