Pharma D&S




Process & Quality Services - Internal Audit e Supplier Audit (Drug products e API)

  • Internal Audit e Supplier Audit (Drug products e API)

According to GMPs, internal audits are a mandatory instrument by which pharmaceutical companies periodically verify their level of regulation compliance.

Outsourcing can support a wide plethora of activities which usually requires the use of expert resources not always available within the company, such as:
internal audit to a third party which allows an unbiased inspection of the GMP quality of the company, ensures the availability of highly professional resources in times of work overload and creates an exchange of knowledge essential to the formation of junior profiles “on the job”;
GMP audits to API suppliers, which are mandatory by the pharmaceutical companies (European Medicine Agency);
preparation of the Qualified Person's declaration concerning GMP compliance of the active substance used as starting material and verification of the supply chain;
internal audit to API suppliers even in foreign countries (India, Cina, Eastern Europe, etc) by using senior inspectors.


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