In Ireland, Wholesalers of Medicinal Products for Human Use are obliged to comply with the Medicinal Products Control of Wholesale Distribution Regulations 2007 to 2013 and Directive 2001/83/EC as amended. Persons engaged in wholesale distribution of medicinal products for human use, require a wholesale distribution authorisation (WDA) issued by the HPRA (Health Products Regulatory Authority) and must comply with the relevant Regulations, Directives and guidelines.
The EU have issued GDP guidelines EU2013/C 343/01 outlining the requirements for WDA holders. Section 3.3.1 of the guideline outlines the requirements for Computer System Validation while Section 3.3.2 outlines the requirements for qualification of Key Equipment & Processes.
In Ireland the HPRA have additionally issued further guidance on these requirements in IA-G0046-2 ‘Guide to Good Distribution Practice of Medicinal Products for Human Use’. Section 5.9 of this guide provides further clarification from the HPRA on Computer System Validation and Equipment Qualification.
Hanwell’s Synergy Software & Hardware Monitoring Systems address our clients’ full requirements in demonstrating compliance with the requirements of the GDP Guidelines. The ‘Synergy Validated Software Suite’ is supplied with full software IQ/OQ Protocols in addition to full Hardware IQ/OQ Protocols which are executed on site to provide our clients with the documentation required to demonstrate that their critical monitoring systems are achieving the desired results accurately, consistently and reproducibly.
Contact us below to request further information and benefit from our extensive experience in installing and qualifying our monitoring systems in the regulated manufacturing and distribution market.
Synergy
The validatable Synergy Software provides users with immediate alarm notification, 24/7 monitoring and data acquisition for historical analysis.
Temperature
The Hanwell RL4000T Series of temperature radio transmitters ranges from -200°C up to +110°C and in between (depending on application).
Temperature/RH
The Hanwell RL4000RHT series of radio transmitters and data loggers are our most premium and accurate temperature and relative humidity wireless transmitters.
Alarms SMS Module
The SMS Module is an optional add-on to the Synergy Radio System to provide out of condition and/or systems alarms generated from the wireless monitoring system via SMS text message.