GMP‑compliant pharmaceutical manufacturing

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GMP‑compliant pharmaceutical manufacturing

Pharmaceutics

Reliable pharmaceutical manufacturing

A guarantee of outstanding supply security

Background

Germany produces a wide range of medicines used to treat conditions such as cancer, rheumatoid arthritis, stroke, diabetes, hepatitis C, HIV and influenza, as well as vaccines against diphtheria.
This ensures short, efficient supply routes from manufacturing to patients, while pharmaceutical products bearing the “Made in Germany” hallmark are in strong demand worldwide.
To maintain this level of manufacturing excellence, product quality and supply security, MEGLA supports the pharmaceutical industry with essential, production‑accompanying IT systems.

GMP – Good Manufacturing Practice

A fundamental principle of the pharmaceutical industry

Good Manufacturing Practice (GMP) refers to the standards that ensure the consistent and controlled manufacture of medicinal products. GMP requirements are laid down in national and international regulatory frameworks.

To obtain a manufacturing licence, pharmaceutical facilities worldwide must comply with GMP regulations.

Research

Drug manufacturing

Graphic representation of a pharmaceutical production line for medicine manufacturing

Manufacturers of equipment through to the packaging materials industry

For manufacturing purposes, pharmaceutical companies must comply with GMP requirements (Good Manufacturing Practice).*

_{* Cf.: German Ordinance on the Manufacture of Medicinal Products and Active Substances (AMWHV).}

Patient

GMP‑compliant manufacturing with AVEVA PI

We specialise in the implementation and operation of validated systems.
For several customers in the pharmaceutical industry, we have successfully implemented AVEVA PI as a validated system.

AVEVA PI as a validated system (triple‑redundant)

Graphic representation of the continuous validation process between development, quality control and production - MEGLA AVEVA PI

Document management for controlled documents (version‑controlled)
Documentation of approvals, releases and regular updates
Deviation management
Documentation of corrective actions (CAPA)
Tamper‑proof recording of actions, in particular system changes
Quality Management System (QMS)
Design Qualification (DQ)
Functional or Operational Qualification (OQ)
Installation Qualification (IQ)
Performance Qualification (PQ)

Solution partner: AVEVA

Learn more about your benefits with the AVEVA PI System.

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