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13 September 2013

Auditing Services

GMP: Good Manufacturing Practices

ASTM: American Society for Testing and Materials

ISO: International Organization for Standardization

 

Good manufacturing practices (GMP/ISO/ASTM) require that companies ensure the supply of active ingredients, excipients, packaging materials and services capable of affecting the product quality, from qualified suppliers. Also regulatory authorities increasingly require to closely monitor suppliers of components/ingredients.

Recent scandals, such as heparine or dried milk, caused by suppliers whose quality systems were ineffective or even non-existent, have determined the need to step up monitoring, forcing companies to implement gigantic – and therefore highly expensive, audit plans.

The whole works are complicated by the present geographical relocation of the supply chain, in connection with an increase in the supply of components/ingredients from Asian suppliers.

 

Our consulting services

  • Implementation of a new process for suppliers qualification based on risk assessment, capable of classifying suppliers ascribing them a score which identifies the connected risk. Depending on this classification iteration of audits and analytical activities may be reduced for low-risk suppliers, allowing companies to performsincerely that the produced excipient is of pharmaceutical grade these tasks in full compliance with regulations even when limited budgets are available
  • Planning and performing of routine audits and “for cause” audits to suppliers of raw materials, packaging materials and services for pharmaceutical products, based on current GMP/ISI/ASTM laws and guidelines
  • Drafting of audit reports and of remedial and precautionary actions for the supplier (follow-up)

We perform for you audits conducted by a group of expert auditors to components, packaging materials and services suppliers.

 

Use cases

  • When it is necessary to inspect a upplier of raw materials, packaging materials and product services, both for routine checks and “for cause”
  • To perform all expected inspections of the audit plan having available a team of qualified inspectors
  • Whenever the company wants to renovate its suppliers qualification process, accepted by regulatory authorities, to cut connected costs
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