Audits can be tailored to a company’s specific need, they can focus on a particular area in the style of a self inspection or can be used to help identify the issues in an area of suspected weakness to facilitate effective corrective and preventative actions.
Global audits may be performed.. The company has considerable experience of overseas regulatory inspections particularly in the USA and India.
Consultation prior to or following a regulatory inspection is offered. Assistance in preparing a site for regulatory inspection can be provided; this includes an assessment of systems and facilities and also the key role the ‘back room’ can have in inspection success.
Pharmassure can provide assistance with post inspection remediation strategy to ensure a prompt return to compliance.
Pharmassure are happy to consider specific company requirements in relation to the support of pharmaceutical manufacture and importation to the EU.
Darren Jones is the Director of Pharmassure International Limited. Darren performs all audits and site visits personally.
Additionally he has provided QA support to an API facility which included lab scale production for parenteral products, traditional manual plant and modern computer controlled facilities. He also provided QA support to tablet processing and packaging operations. Darren’s last role in industry prior to joining the MHRA was working in production outsourcing, selecting and managing contract manufacturing sites primarily engaged in sterile manufacture.
Upon leaving the MHRA in 2012 Darren established Pharmassure International; his time is split between NSF-DBA where he is an Associate and Pharmassure projects.
Pharmassure International holds Public Liability and Professional Indemnity Insurance; evidence of which can be supplied as part of the project documentation package.
A daily rate is charged for time expended. Alternatively a quote can be provided for specific projects. VAT at the prevailing rate is chargeable.
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