Win-Win Situation

API site audit reports

Win-win Situation For All The Parties

PHARMALANE UK aims to gather all the resources and provide a win-win solution for all the stakeholders by saving time, efforts and higher traveling and auditing cost for clients (Pharmaceutical companies/ MA holders); it is also preventing suppliers from the burden of hosting a huge number of customer audits and wasting the time, resources and disturbing the planned production. It is also equally beneficial to regulatory authorities as they can find the detailed audit reports for the audits performed by well qualified and certified quality auditors which also gives them the confidence on the supplier qualification process of the company during their inspections.

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    Audit Report Package

    Our Audit Report Package is very thorough and includes all of the following which is sufficient enough to qualify the supplier:

    • Full Audit Report.
    • Auditor’s CV.
    • Auditor’s non-conflict of interest declaration.
    • CAPA plan with evidence, as applicable.
    • Audit closure signed by Lead Auditor, with CAPA review confirmation.
    • Attachments including lists, certificates, licenses, layout etc.
    • Additional documents such as SMF, SOP index, Site presentation etc. as available.