Consulting in pharmaceutical compliance

The demands made on quality assurance systems in the life science industry are constantly increasing. Recent incidents in the pharmaceutical, cosmetics and food industry have resulted in ever higher requirements from the authorities. Efficiency and effectiveness need to be further improved with the increasingly complex work processes and supply chains. Often companies lack the experience and human resources to meet all of these demands.

With the experience gained from many successfully completed compliance projects, Chemgineering assists you in maintaining an overview over regulatory and business requirements and carrying out production that is efficient and compliant in the long term.

Risk assessment and risk management

Risk assessment and risk management are the tools we use for solution-oriented GMP compliance consulting. This is how we focus on the really quality-relevant aspects and examine all the areas systematically. With the experience of our specialists, there is no jumble of paper and frustrated workforce at the end of the compliance project, but GMP-compliant systems and processes that will withstand audits from the very onset.

Quality Management Systems: Develop, introduce, improve.

Chemgineering assists you in implementing a compliant quality management system tailored to your business, according to the specific requirements of the various bodies and authorities:

  • ISO (22000, 13485, 17025, 22716)
  • European Guidelines (2009/94 / EC, Eudralex Volume 4, 1223/2009)
  • FDA (21 CFR Parts, 111, 210 & 211, 225 & 226, 820)
  • AMG (Germany)
  • HMG (Switzerland)
  • AMG (Austria)
  • Standards (ASTM)

As part of your team, we work with you to develop a system tailored to your business and as well as your needs, guiding you throughout the entire lifecycle. </p><p>From development through introduction to reviewing in everyday work.

Inspections and audits: Prepare, manage, succeed

Have the authorities been in contact with you? Does an important customer want to conduct an audit to review the agreed measures? Do you have many suppliers but too few resources to carry out the required audits? &nbsp;Our experienced auditors and professional organization support you in the preparation and organization of inspections and audits. With the help of mock audits, your systems and processes are put through their paces, and a report is created with improvement measures. Following the actual audit by the authorities, we assist you in evaluating action plans and responses to the authorities.

Validations: Concept, planning, implementation

The validation of procedures, methods and processes is a tried-and-tested standard. Think. The conception, planning and implementation of validations require more than just knowledge of the respective regulations and rules. What is easy to read is often difficult to implement in practice where the experience is lacking. Using the know-how from many successfully completed validation projects, we assist you in validating processes and analytical methods. The validation concepts developed by us have already been reviewed many times by various authorities and have been rated as "compliant". We always orient ourselves to your needs and the requirements of products or processes. And in this way you get a sustainable concept that is easy to implement. We accompany you through the entire validation process from the original development to on-site implementation. Training of your employees also goes without saying.

Our services in the field of Consulting in pharmaceutical compliance

  • Lifecycle management for processes and plants
  • Concept development
  • Quality management: Optimization and implementation
  • Risk management
  • Quality oversight & KPIs
  • Training on all quality-related subjects
  • ICH Q3D implementation
  • Technology and method transfer
  • QC system optimization
  • Analytical method validation
  • Supplier qualification and third-party audits worldwide
  • Preparatory and follow-up work relating to inspections
  • Mock audits & GAP analyses
  • Reliable track-and-trace concepts
  • Person-in-plant and interim management

Other topics

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