Synergy Monitoring Systems to meet with EU-GDP requirements
In Europe, companies acting as a wholesale distributor of medicinal product for human use have to hold a wholesale distribution authorisation (WDA). Article 80(g) of the EU Directive 2001/83/EC provides that distributors must comply with the principles of and guidelines for GDP. The current EU-GDP guidelines of 5 November 2013 ref.: 2013/C 343/01 outline the requirements for holders of a WDA on Good Distribution Practice of medicinal products for human use. In Ireland, the licensing authority for the wholesaling of medicinal products for human use is the Health Products Regulatory Authority (HPRA).
Chapter 3 of the EU Guidelines 2013/C 343/01 Good Distribution Practice of medicinal products for human use sets of the requirements for ‘Premises & Equipment’.
Section 3.2.1 outlines requirements for ‘Temperature and Environment Control’
Section 3.3 outlines requirements for ‘Equipment’
Section 3.3.1 outlines requirements for ‘Computerised Systems’
Section 3.3.2 outlines requirements for ‘Qualification and Validation’
‘Before a computerised system is brought into use, it should be demonstrated, through appropriate validation or verification studies, that the system is capable of achieving the desired results accurately, consistently and reproducibly.’
‘Wholesale distributors should identify what key equipment qualification and/or key process validation is necessary to ensure correct installation and operation. The scope and extent of such qualification and/or validation activities (such as storage, pick and pack processes) should be determined using a documented risk assessment approach.’
Further clarification on the above requirements is provided by the HPRA in their own guidance document IA-G0046-2, 10 APRIL 2014, HPRA Guide to Good Distribution Practice of Medicinal Products for Human Use.
Regarding Computerised Systems the HPRA advocate a ‘risk management approach’ in determining the extent of validation appropriate to the critical systems installed.
The HPRA also suggest further information is available on the European Commission website, in Annex 11 (Computerised Systems) of ‘The Rules Governing Medicinal Products in the European Union Volume 4 Good Manufacturing Practice Medicinal Products for Human and Veterinary Use’.
Regarding ‘Equipment Qualification and Validation’ the HPRA provide additional clarifications on the documented qualification and validation requirement for equipment. The HPRA also suggest further information is available on the European Commission website, in Annex 15 (Qualification and Validation) of ‘The Rules Governing Medicinal Products in the European Union Volume 4 Good Manufacturing Practice Medicinal Products for Human and Veterinary Use’.
Summary of the Guideline Requirements:
The guideline documents referred to above set out some clear requirements for installation of computerised systems and hardware which are performing critical QA functions within the authorised facility.
1. Computerised Systems require Validation.
2. Equipment requires Qualification and Validation.
How does the Hanwell Synergy System assist in demonstrating compliance with the GDP guidelines?
Synergy is a fully validatable software platform, compliant to FDA 21 CFR Part 11 and GAMP5. The validatable Synergy software offers the very latest in centrally controlled monitoring systems with a huge amount of flexibility featuring customised views, detailed permission control and much more.
The Synergy Software is supplied with full and extensive Software Installation Qualification (IQ) Protocols and Software Operational (OQ) Protocols. In Addition the system is supplied with full Hardware Installation and Operational Protocols to cover all elements of the hardware installation. These software and hardware protocols are executed on site by our engineers and all tests are fully signed off and approved by the client following completion.
The resultant documentation provides our clients with the documentary evidence required by the guidelines to ensure the installed systems are capable of achieving the desired results accurately, consistently and reproducibly.
The Synergy System has been designed and built to meet the strict requirements of the regulated industries. All of the Software Design and Development and the Hardware Design and Development is in house at Hanwell.
This provides our customers with the assurance that strict quality and change control systems are in place covering ALL elements of the system. As all of the development is in-house, our clients benefit from the change control procedures in place at the factory. As new hardware is added or software enhancements included the change control systems risk assess all of the potential impacts on the validated system. The change control documentation issued by Hanwell as new releases are issued makes it easier for our clients to perform their own impact assessments when and if changes to the system may be required.
• Browser based technology with SQL database
• Full Installation & Operational Protocols covering System Software and Hardware
• Access Control and Security in accordance with requirements of CFR 21CFR Part 11
• Individual versions tailored to key market sectors.
• Top level pictorial overview of site activity and alarms on start up
• Devices can be added at will with no interruption to logging
• User access management and control via simple permissions process
• Seamlessly supports multiple geographical locations
• Easy navigation to alarms, reporting tools and administration areas
• Easy access to historical data
• Supports all Hanwell current and future hardware
• Option to design additional bespoke reports
• Installation of software on central server removes need to install or update multiple PC’s
• Allows flexible grouping of sensors to customise views even across multiple sites
• Variety of alarm features available including email and SMS notifications
• Full history of recorded data available for analysis by users at all times
• Export data files to CSV formats
• Automated reporting directly to PDF format at user defined timescales
• Interactive graphical and tabular data
2. IA-G0046-2, 10 APRIL 2014,
HPRA Guide to Good Distribution Practice of Medicinal Products for Human Use.