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13 September 2013

Quality System (QS)

Companies manufacturing drugs, nutraceutics, cosmetics and their components must have a Quality System compliant with GMP regulations (Good Manufacturing Practice).

A strong Quality System allows the company to work according to clearly set standards and to obtain products compliant with the expected quality requirements, avoiding problems and complaints.

Consulting provides auditing, drafting and updating of the company Quality System (QS). In the absence of a QS, the consulting service provides support aimed at its implementation, monitoring and maintenance.

 

Our consulting services

  • Planning, drafting and implementation of all Quality System procedures, in compliance with GMP specific regulations
  • Updating and monitoring of the Quality System
  • Personnel training concerning Quality System
  • Drafting of any kind of document based on the costumer’s needs and specifications
  • Definition and managing of predisposed calibration/adjustment/maintenance procedures of devices in use in the manufacturing plants (cold-storage plants, laminar flow hoods, furnaces, etc.) in compliance with current national, European and international reference regulations
  • Assessment of regulatory compliance of the company Quality System documents

Our consulting can help the company to make up a Quality System able to meet the most demanding customers’ needs and also those of Regulatory Authorities.

 

Use cases

  • When it is necessary to implement a Quality System or to update it in order to maintain its compliance with current GMP regulations
  • To allow companies to release resources presently allocated for document drafting, in order to focus them on different activities
  • To avoid problems or complaints due to products which do not meet the expected quality requirements
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