Protect products with the highest possible quality!
Production according to applicable GMP (Good Manufacturing Practice) guidelines is fundamental for MODI in all business areas and thus part of the corporate culture. With the continuous improvement of our processes with regard to the “EU Guide to Good Manufacturing Practice”, these processes are continuously transferred to our quality management system.
Our products are manufactured with the help of systematic controls, electronic documentation, defined work processes and trained and motivated employees according to the rules of the GMP and can therefore guarantee the optimal quality.
Quality assurance plays a central role in the environment of the pharmaceutical, food and cosmetics industry, since deviations in quality (for example in the production and distribution of pharmaceuticals) could have a direct impact on the health of consumers and consumers. A GMP-compliant quality management system is therefore crucial for ensuring product quality.
A GMP-compliant quality management system must meet the following requirements:
- Document management for standard documents and records: Standard documents (work instructions, forms, plans) must be version-controlled and follow a predefined process (approval, release, regular updates and revision). Recordings (electronic or in paper form) must be complete, correct, traceable / assignable, timely and legible and appropriately archived (protection against loss, damage, manipulation, ensuring legibility over the entire prescribed archiving period). Computer systems must have an audit trail that records all actions in a tamper-proof manner.
- Deviation management: Processes, procedures and methods must be described in specification documents. Deviations from this must be documented and assessed in a documented, formal process by those responsible for quality assurance. Resulting corrections or corrective and preventive measures must be documented and tracked.
- Change management: In the event of changes to processes, procedures or the condition of the equipment, these must be justified, planned and approved by quality assurance and documented before implementation.
Qualification of equipment (systems and equipment as well as, if applicable, buildings and premises): In a planned and documented process, it must be shown that the equipment is suitable for the intended purpose and works reliably under the local conditions (during commissioning and later at regular intervals ). For this purpose, four phases are run through, each of which requires a separate plan and report: Design qualification (DQ), installation qualification (IQ), functional or operational qualification (OQ) and performance qualification (PQ).
Validation of processes and methods: In a planned and documented process, it must be shown that the processes (e.g. manufacturing processes) and methods (e.g. analytical methods in quality control) meet the requirements of the product and thus deliver reliably reproducible results.
Employee training: Employees must be adequately trained and documented before starting their work.
Risk management and internal audits: Establishing and operating a functioning risk management system as well as carrying out regular internal audits (in addition to the external audits) are decisive for a GMP-compliant quality management system.