Good Manufacturing Practice (GMP)

• Quality management
• Cleanliness and hygiene
• Buildings and facilities/premises
• Equipment
• Raw materials
• Personnel
• Processvalidation and qualification
• Complaints
• Documentation and record keeping
• Inspections and quality audits

The 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 and market medicinal products are obliged to comply with the GMP regulations. All employees of the respective company must act accordingly - regardless of whether they are management, production or quality control employees.

Good Manufacturing Practice is part of the GxP regulations, as is Good Distribution Practice.

The GMP inspectorates of the competent state authorities are responsible for monitoring GMP requirements, depending on the industry. Possible violations can result in serious operational sanctions such as sales stops, closures and even criminal prosecution.

Governments, ministries and international organizations are responsible for creating GMP guidelines in the form of laws, regulations or guidelines. The pioneer is the US Food and Drug Administration (FDA), which lists regulations in the Code of Federal Regulations Title 21 Part 22.

Which regulations govern the manufacture of medicinal products in Germany?

The manufacture of medicinal products in Germany is governed by the German Medicinal Products Act. It is implemented via the legally binding Drug and Active Ingredient Manufacturing Ordinance.

The most important objectives of Good Manufacturing Practice:

• Quality assurance: reproducible product quality as well as assured quality and thus protection of one's own company as well as consumers from defective product quality.
• Information: Traceability of all ingredients at all times.
• Patient safety: medicines that are effective and safe.
• Ability to act: no plant closures, official sanctions and distribution stops.
• Efficiency: no contamination and therefore less waste.

The GMP certificate certifies that pharmaceutical products, foodstuffs, cosmetics, chemical products, biotechnological products and medical devices have been reliably tested and can therefore be approved for sale. This certificate confirms that the production processes and operating 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 GMP requirements.

Here are some of the ways Yaveon 365 helps:

• Lot tracking and management: Yaveon 365 enables full traceability of batches throughout the supply chain. This helps companies to track the origin and whereabouts of their products, which is an essential part of GMP requirements.
• Qualityassurance and control: The system supports the management of quality control processes, including the documentation and verification of test results. This ensures that products meet the specified quality standards.
• Documentation and compliance: The solution supports GMP through electronic signatures that secure critical changes and make them accessible only to authorized persons. The audit trail logs all changes with user data, time stamp and reason for change, ensuring complete traceability for audits and inspections.
• Recipe management: The system enables precise management and control of recipes and production processes to ensure that products are manufactured consistently and to specification.