If you are a newly or pre-existing WDA (H) holder, deploying the services of our External Audit Team can be extremely beneficent. Their full audit will evaluate your current processes, administering protocols and documents with respect to the Guidelines on Good Distribution Practice (GDP) for Medicinal Products for Human Use (2013/C 343/01).
By doing this, any non-conformities which could impact the quality of products or result in a negative outcome during a MHRA audit and subsequent GDP Compliance Certificate issuance are identified. The number and severity of non-conformities seen during the inspection determine the content of your certificate and future inspection intervals.
If any discrepancies are found during our assessments, we will assist you in determining the underlying cause and creating a plan for rectifying them. We can then help you to put it into practice.
Our Consultants are all registered with MHRA and boast certification as ISO Lead Auditors, having taken part in countless compliance inspections/audits.
Our pre-inspection audits have proven successful in helping clients to minimize the amount and gravity of non-conformities, resulting in desirable inspection results.
Our assessment of processes and procedures across the organisation enable us to provide clients with advice on how they can enhance them. We are also able to review resources needed to meet specific objectives, as well as preparing staff for impending external audits.
GDP Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01) stipulate the requirement of the Responsible Person (RP) as well as their duties and obligations expected of them by undertaking this role. The RP must have a high level of knowledge, demonstrate competence and deploy the right skills so that patients and healthcare professionals have the confidence and trust to use medicines.
Pharmacy Consulting Limited has been offering services to new UK Wholesale Distributors of Medicines since 2006.
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