Good Distribution Practice And Audit Services

1. Good Distribution Practice And Audit Services

2. Keeping product safety and quality throughout distribution is of the utmost importance in every industry, however in pharmaceutical distribution it can be a matter of life or death. Good Distribution Practice (GDP) compliance certification shows that you are complaint with good distribution practices and attention to product quality and patient safety whilst storing and transporting medicines for human or animal use. Compliance certificates issued by the Competent Authorities carry weight, certificates provided by third parties are NOT recognised. What is GDP? GDP is the part of quality assurance that regulates the movement of medicines, products and devices from manufacturer to wholesaler and then to distributor (pharmacy/clinic/hospital). GDP requires a suitable and representatively tailored quality system for your distribution and warehouse centre. Globally accepted GDP regulations stipulate that distributors of products should align their operations along with the standards. The scheme makes sure that continuous management systems are in place within the whole supply chain. From the delivery of raw materials (active pharmaceutical ingredients/API) to the manufacturing plants to the shipment of finished medicinal products to distribution points, to final delivery to pharmacies, hospitals and healthcare professionals. Quality assurance of pharmaceuticals should span the whole cycle to be considered effective. Warehousing and transport are a vital part of this and why GDP is necessary. The regulations apply to pharmaceutical firms and their logistics partners, accountable for shipment and storage. This can be split into storage and transport. Companies that offer storage services are obliged to have a GDP license issued by the UK Competent Authority, the MHRA (Medicines and Healthcare products Regulatory Agency). Transporters who are licensed for holding (storage) of medicines may hold product for clients under a suitable technical agreement and after a qualification audit, to ensure the site is suitable and that operations will ensure product quality. Sites that act as a transit point do not need a GDP wholesale distribution authorisation, as long as the ambient goods do not stay for longer than 36 hours. In addition cold chain products are not to be stored within a transit points refrigerators under any circumstances. Strangely enough a transport company with temperature-controlled transport for shipment does not need a WDA and could be parked in your site yard for days with your product, if you confirm the vehicle has been mapped, maintained and meets EU GDP expectations. A specific valuation of a supplying companies compliance against the specific GDP requirements of a given territory is the most efficient way to institute that your quality management systems are aligned

3. GDP Audit Services GDP compliance audits are carried out against the GDP guidelines (standard)for whichever territory you are working within. The UK currently works to EU GDP 2013/C 343/01, and the expectations of the MHRA. With lots of guidelines and regulations to take into consideration, you may be overwhelmed when trying to perform such an audit. Paradigm Shift Consulting professional team can handle an audit from beginning to end, covering all relevant parts of the standard, and will tailor the audit specific to your needs. Our team can be a flexible resource and an extension of your own team. We can provide a lead auditor, agenda and focus and make the audit a training session for your staff. After the audit, and report, we can assist with advice on whether the site is suitable for engagement as a service provider. If we carry out an audit for your site, we can potentially advise on remedial actions, training, updating of procedures etc. Call Paradigm Shift Consulting for Your GDP Audit Needs! Paradigm Shift Consulting takes pride in our GDP Audit services that aim to help our clients guarantee they meet all the needed quality standards. We assess and check internal controls in your Quality System; determine risks and recommend areas of improvement.