Pharmacovigilance audits are an essential component of any pharmaceutical company’s Quality Management System. If carried out correctly, auditing provides an unbiased opinion of operational performance of the Pharmacovigilance system, measuring the system against its own procedures and against the regulatory guidelines, and ensuring that the system itself remains compliant with the regulations.
What Is a CAPA And Why Is It Required?
Where the GvP (for the EU) and specific legislation in other territories refers to “the quality processes”, they are referring to Standard Operating Procedures (SOPs).
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