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Quality

Historically much of the pharmaceutical industry's focus has been on inspection-oriented Quality Assurance. However the drive by regulatory agencies towards a systems based approach and the introduction of quality risk management has required companies to take a more holistic view of product and process quality. There is a whole range of risk management methods and tools, which have been developed and used in other sectors and are now being used in the pharmaceutical industry. Effective use of many of these tools requires detailed product and process knowledge gathered throughout the product lifecycle.
Key enablers to adopting and maintaining a systems approach to quality are knowledge management and risk management. These are the skills and experiences we can bring to your organisation in the areas of :
  • SOP Preparation
  • Stability Protocols
  • Cause and Effect Analysis
  • Corrective Actions/Preventative Actions (CAPA)
  • Risk Assessment Tools
  • Change Management
  • Quality Key Performance Indicators

Compliance

There are two aspects to compliance which are Procedural compliance to SOP's and the GMP's and Product Compliance to marketing authorisations.
  • Auditing
  • Audit Remediation
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