25 Apr Warehousing and Good Distribution Practices
McArdle Skeath hold a Wholesaler Distribution Authorisation Licence issued by the Health Products Regulatory Authority (HPRA) and have been audited and issued with a certificate of Good Distribution Practices GDP.
As a primary distributor we have a quality management system, we also have technical agreements in place with the marketing authorisation holder (MAH). These technical agreements describe GDP roles and responsibilities of both parties including receipt of goods, transportation, documentation amongst others. The technical agreement serves as a basis for defining the division of GPD activities and responsibilities between both parties.
Management play a fundamental role in ensuring GPD compliance. This is achieved through operational support and by providing adequate resources and training.
We currently have a QA department which consists of 2 RP’s (Responsible Person), 1 per site Inniskeen and Hollystown, deputy RP’s and a QA Manager. They are responsible for the entire quality portfolio within the business. This includes auditing, accreditations, compliance with all regulatory bodies, temperature mapping and validation.
Our warehouse is specifically designed to meet the needs of high-volume GDP clients in the pharmaceutical and nutritional sectors. We offer Pharmaceutical Temperature Monitored and Controlled Storage Solutions with assurances of sensitivity and integrity. The quality of high value pharmaceutical life science goods is vital, which is why we offer cold chain distribution, storage and controlled supply chain management programs. Our modern temperature-controlled warehousing facilities provide storage at +2°C to +8°C and +15°C to +25°C storage for storing pharmaceutical products, allowing specific temperature requirements. We operate under strict GxP guidelines encompassing full temperature reporting from product receipt through to storage and delivery to the end customer.
Cold chain is a critical element in the Pharmaceutical and Biotechnology supply chain as some sensitive products require specific temperature control while in storage and ultimately, transit. We ensure precise planning so that the integrity of life science products is always protected.
Our transport and warehouse departments work very closely together and are in constant communication with respect to coordinating and positioning equipment, picking and loading in conjunction with a scheduling requirement of our clients. Our warehouse staff and drivers are fully GDP trained for interacting through the medicinal supply chain and are highly trained in chilled refrigeration transport. McArdle Skeath is a dedicated, fully monitored and temperature-controlled service provider for the Cold Chain industry. We fully ensure our cold chain distribution provides patient safety, product integrity, regulatory compliance, process optimisation, and cost optimisation.
We understand the needs of clients when they depend on us to collect and deliver to their production facilities. The combination of a single point of contact for a coordinated warehouse and transport service provider gives our clients the reassurance of a failsafe solution.
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