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13 September 2013

Mock Inspections

GMP (Good Manufacturing Practices) regulations request from pharmaceutical, nutraceutical, cosmetic products and their complements manufacturers to implement an efficient self inspection plan as a fundamental part of the company Quality Management System.

In addition to being an obligation sanctioned by the GMPs, self inspections are useful to identify and correct non-compliances which might compromise the result of inspections by Regulatory Authorities.

Even more effective, in this context, are the so-called mock inspections, carried out by an organization which is external to the company and which, precisely, mock real inspections from Regulatory Authorities ein fullh.

 

Our Consulting Services

  • Planning and performing of self inspections of all GMP critical areas in the company
  • Running of mock audits in preparation for inspections by national and international Regulatory Authorities, including drafting of inspection reports featuring observations and advice with the purpose of leading the company to such a quality level that any authority would consider satisfactory.
  • Follow-ups (series of planned checks) by remedial and precautionary actions
  • Analysis of the Company Quality System and assessment of its compliance to European and extra-European GMP standards
  • Mock inspections
  • Assistance and support to bridge the gaps
  • Employee training to deal with the inspectors’ questions
  • Behaviour rules during Regulatory Authorities inspections
  • Support to companies to enable them to answer effectively to inspection reports from national and international Regulatory Authorities

Our consulting are ideal for the optimization of the formulation and of the productive process of the drug in compliance with GMP regulations and to move scientific knowledge to industrial production

 

Use cases

  • When the company is not able to fulfil the self-inspection plan with its own strengths
  • When it is necessary to prepare the company for inspections by Regulatory Authorities
  • To facilitate a successful result of inspections by Regulatory Authorities avoiding, for example, 483 reports with negative observations or, even worse, warning letters from FDA
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