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Compliance
The purpose of regulatory compliance is to provide a controlled link between documentation submitted to regulatory authorities in support of marketing authorisations and documentation that is utilised by the company's Operations/Production and QA departments. A regulatory compliance system is a formal, documented system which will ensure that the product is always manufactured and released in line with the Good Manufacturing Practises (GMP), technical agreements and currently licensed particulars.
As part of the regulatory compliance system a number of Standard Operating Procedures (SOPs) should be introduced which will set up and manage the documented system. Whilst Quality Assurance (QA) is the department with responsibility for controlling the SOPs, Regulatory Affairs also has certain responsibilities with respect to SOPs. These include, but are not limited to, demonstrating compliance to GCP guidelines , pharmacovigilance and documentation control (in particular change control procedures).
- Ivowen Limited can provide expert advice on the set-up of a Compliance System in your company. Moreover, we can support your new team with the Change Control Procedures that need to be implemented as part of a Compliance System.
- Change Control Procedures allow your company to measure the cost of a change vs. the potential savings to decide if you really need that change. It is also quality assurance driven, and any change which is GMP related must be approved through the change control procedure before being implemented.
- It is also the responsibility of a regulatory compliance department to make certain that the regulatory compliance system in place measures the companies adherence to the current marketing authorisations. This can be achieved by introducing a schedule of regulatory compliance audits to monitor the system.
- Ivowen Limited can prepare the necessary SOPs to manage a compliance system including the introduction of compliance audits to monitor the system
- Ivowen Limited can prepare or review job descriptions for personnel currently involved in documentation control
- Ivowen Limited can provide the necessary support to the compliance team by carrying out external system audits on a regular basis.
- Ivowen Limited can provide updates on all regulatory changes and developments in the EU that may impact on your company in relation to compliance
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