Yaveon explains what Good Distribution Practice (GDP) is, which requirements it sets, who is affected, and how certification works.
Good Manufacturing Practice (GMP) brings together all measures that ensure consistently high quality standards in the production and storage of products. This applies not only to medicinal products, but also to food, cosmetics, chemical products, medical devices, and biotechnological goods.
A manufacturing license is only granted to companies that comply with all GMP regulations.
Good Manufacturing Practice regulations are binding for the pharmaceutical, food, and cosmetics industries and are specified in corresponding industry-specific laws. All companies that manufacture, test, store, or distribute medicinal products are required to comply with GMP regulations. All employees within such companies must act accordingly – regardless of whether they work in management, production, or quality control.
Good Manufacturing Practice is part of the GxP regulations, just like Good Distribution Practice.
Compliance with GMP requirements is monitored by the GMP inspectorates of the responsible government authorities, depending on the industry. Potential violations can lead to severe operational sanctions such as distribution bans, shutdowns, and even criminal consequences.
GMP guidelines in the form of laws, regulations, or guidance documents are created by governments, ministries, and international organizations. A pioneer in this area is the U.S. Food and Drug Administration (FDA), which defines regulations in the Code of Federal Regulations Title 21 Part 22.
The key objectives of Good Manufacturing Practice:
The GMP certificate confirms that pharmaceutical products, food, cosmetics, chemical products, biotechnological goods, and medical devices have been reliably tested and can therefore be approved for sale. This certificate verifies that production processes and facilities comply with the strict quality standards and regulatory requirements of Good Manufacturing Practice.
Yaveon 365 is an ERP solution that helps companies in regulated industries meet the requirements of GMP.
Here are some of the ways Yaveon 365 supports this:
Lot tracking and batch management: Yaveon 365 enables complete traceability of batches across the entire supply chain. This helps companies track the origin and destination of their products – a key requirement of GMP.
Quality assurance and control: The system supports the management of quality control processes, including the documentation and review of test results. This ensures that products meet the defined quality standards.
Documentation and compliance: The solution supports GMP compliance with electronic signatures that secure critical changes and restrict access to authorized personnel only. The audit trail logs all changes with user data, timestamp, and reason for change, ensuring complete traceability for audits and inspections.
Recipe management: The system enables precise management and control of formulas and production processes, ensuring that products are manufactured consistently and in line with specifications.
Good Distribution Practice (GDP) – Beitrag öffnen
Yaveon explains what Good Distribution Practice (GDP) is, which requirements it sets, who is affected, and how certification works.
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