S1 - Your partners in compliance - WDA Licence & GDP Certificate - understanding and training
Good Manufacturing Practice guidelines require that all pharmaceutical
products are developed and produced according to strict regulations
designed to maintain consecutive quality and safety standards. GDP aims to ensure this level of quality is maintained throughout the distribution chain.
Whether thinking of applying for a Wholesale Distributor Authorisation (WDA) or are an existing WDA holder; or a company that must operate to GDP standards, a new perspective and approach is always beneficial. Our highly experienced team can provide a full audit of your current processes, procedures and records against current guidelines, which can be extended throughout your supply chain.
Compliance can affect the frequency of your company's inspections: this is why we offer flexible solutions so that we can provide and ensure compliance and excellence.
RP-PS provide a detailed understanding of licence holder and senior management responsibilities with regards to their WDA licence and GDP activities.
With both high-level (senior management) and detailed (operator) training on all relevant UK and EC regulations and guidelines, in respect to Wholesale Distribution Authorisation and Good Distribution Practice, you will never be in doubt of your responsibilities and how to fulfil them, regardless of whether you hold a WDA & GDP certificate of just operate to GDP standards.
It does not stop at the audit
As part of our services we have developed a continued care and compliance service that focusses on the improvement cycle; using risk assessment, gap analysis, and remedial proposals for any non-compliances and/or identified areas for improvement.
Prior to any regulatory inspection we highly recommend a pre-inspection audit, this is crucial in ensuring a positive Regulatory Agency or customer inspection. In order to do this, we also advise our clients on process and procedural improvements. Pre-inspection audits are also an excellent way to engage and prepare staff for actual audits and inspections.
Our Site Inspection Readiness (SIR) package provides ongoing support through regular self-inspections, training and mentoring to ensure that your operations and staff are at a high standard or readiness for any type of inspection.
A Responsible Person (RP) is responsible for safeguarding product users
against potential hazards arising from poor distribution practices.
Hazards may arise anywhere within the supply chain e.g. purchasing suspect
products, poor storage and failing to establish bona fides of suppliers/customers.
RP-PS can provide experienced and qualified Responsible Persons to
be named on your Wholesale Distribution Authorisation. As an RP, we can set up compliant quality management systems in line with Good Distribution
Practices as evidenced by successful Regulatory inspections.
We have an extensive and coherent understanding of new regulations and
a substantial amount of experience in assisting pharmaceutical businesses
and their suppliers to adapt their practices to meet the requirements and
provide assurance against new regulations.
Contact us now to understand how we may assist your business in gaining a Wholesale Distribution Authorisation and/or GDP Certificate of Compliance to operate in the transport of pharmaceutical products.