Case Study.

Annex 1 of the EU GMP guidelines.

An international pharmaceutical company for sterile products had to meet the new requirements of the Annex 1 EU GMP guidelines.

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The Challenge.

The pharmaceutical company was confronted with the strict Annex 1 guidelines, which required far-reaching adjustments to its existing processes and systems. In particular, the requirements for more comprehensive contamination controls, the redesign of facilities and extended risk management posed major challenges. The following points had to be addressed:

  • Stricter contamination controls: There have been calls to develop comprehensive contamination control strategies (CCS) covering all aspects of production.
  • Adaptations to the systems: Higher requirements for bio-decontamination and cleanroom management, often combined with the integration of modern technologies such as RABS and isolators, required modifications.
  • Increased risk management: The company needed to ensure that facilities, equipment and processes are linked together in an integrated risk management system.
  • Documentation and continuous monitoring: It was necessary to seamlessly monitor production processes and use data for decision-making.

The Benefits.

  • Carrying out a gap analysis to identify weaknesses in the existing processes.
  • Implementation of new, digital monitoring systems for the continuous control of production and environmental conditions.
  • Comprehensive optimization of production processes to adapt to the new Annex 1 requirements.
  • Tailor-made training programs for personnel in the area of aseptic production and regulatory requirements.

The Outcome.

30% reduction in the risk of contamination

through new monitoring systems and optimized processes.

Compliance achieved before the regulatory deadline,

thanks to targeted adjustments and process optimizations.

More efficient production processes

and improved compliance with Annex 1 guidelines through training and modern technologies.

The Result.

The pharmaceutical company was able to successfully implement Annex 1 compliance through targeted measures, thereby significantly increasing production safety.

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