PRODUCTION & OPERATIONAL EXCELLENCE IN PHARMACEUTICAL INDUSTRY

Balancing the Pressure to Innovate and Optimize Costs

Companies in the pharmaceutical industry are under great pressure to continuously adapt their core and support processes, such as IT and logistics, to new business models, product lines and demand cycles. The assurance of a comprehensive operational excellence under constantly changing conditions requires a highly flexibke and efficient production as well as perfectly-aligned, lean processes. At the same time, today’s production environments need a high level of openness and adaptivity in order to get the most out of the complete digitalization and networking opportunities which Industry 4.0 technologies have to offer.

msg industry advisors helps companies turn their production into a value-added and growth driver. We employ cross-industry and branch-specific best practices, methods and tools to ensure an effective harmonization, optimization and standardization of the production processes. In doing so we follow traditional approaches, such as LEAN or Six Sigma, while also taking advantage of the potential available through the latest IT systems, using them as a central lever for increasing operational excellence.

Our service portfolio specifically includes:

  • Optimizing production controlling
  • Harmonizing production processes
  • Digitalizing and networking production
  • Implementing electronic production records
  • Process automation and computer-aided manufacturing
  • Lab automation and computer-aided quality management

A Look at Regulatory Requirements

The delegated legal instrument was published on 10/2/2015 and is based on EU directive 2011/62/EU. The regulations in that instrument have far-reaching consequences on the entire pharmaceutical provision chain, from manufacturer to pharmacy. A transition period of three years has been granted, after which it will no longer be possible to introduce prescription drugs without certain safety features and the ability to trace them. msg industry advisors assists companies in implementing these legal requirements, as we know that with the right approach, these changes also hold opportunities and the potential to optimize the logistical flow chain. The following areas are affected:

  • Serialization:Randomized serial numbers in the form of 2D matrix bar codes that can be used to identify each and every pharmaceutical package will be a mandatory safety feature in Europe.
  • Tamper Evidence:The addition of a mechanism to the outer packaging of a drug allowing the user to determine whether the package has been manipulated will be a mandatory safety feature in Europe.
  • Track & Trace:In addition to these standard safety features, many countries will also require companies to be able to track and trace every single package along the entire delivery chain.

Your Contact

Christoph Piller

Christoph Piller

Project References (Excerpt)

We have proven competence in the field of operational excellence, as shown by numerous successful projects.

Harmonization of Production Controlling

Harmonization of Production Controlling

  • Creation of a concept for uniform, company-wide production controlling
  • Definition of set-up, manufacturing and malfunction times, as well as utilization
  • Harmonization of error codes across all areas of the company

Global Harmonization of Pharmaceutical Manufacturing processes

Global Harmonization of Pharmaceutical Manufacturing processes

  • Operationalization of the processes using manufacturing execution systems (MES)

Lab Automation: Computer-Aided Quality

Lab Automation: Computer-Aided Quality

  • Assurance of data and process quality in quality control and quality assurance through company-wide harmonization
  • Implementation of distributed system resources

Electronic Production Documentation

Electronic Production Documentation

  • Transfer of basic processes to electronic manufacturing documentation in order to improve quality assurance processes and reduce review and throughput times