GMP Validation Limited is a Technology and Validation Consultancy practice set up to specialise in the support of clients, developing and manufacturing pharmaceutical products.
The GMP Group can assist clients to ensure that the introduction of processes and process equipment is undertaken efficiently and effectively and in such a manner that it can be fully validated in accordance with regulatory requirements.
The GMP Group have experience in the presentation of documents to the relevant regulatory authorities and can ensure that documents not only contain the relevant information but also have been prepared against a standard operating procedure, which will include signing off. The following validation activities can be undertaken:
- Validation master planning
- Design qualification and GMP reviews
- Installation qualification
- Operational qualification
- Performance qualification
- Process validation
- Protocol and procedures writing
- Thermal mapping and sterilisation process development
- Prospective, retrospective and routine validation studies
- Environmental testing
- Computer, control system and software validation
- Training for validation
- Construction auditing
- Factory and site acceptance test witnessing
All operations are controlled and directed by The GMP Group’s management team, located in their Havant office, Hampshire England.
The GMP Group employs qualified and experienced personnel to develop projects and regularly transfers experienced individuals throughout Europe, Middle East and Asia to supplement their client’s requirements.
The GMP Group believe that the GMP requirements of a pharmaceutical or biotech facility and the subsequent validation of the process, equipment, facility and procedures adopted to meet these requirements are part of a total quality concept, which cannot be considered in separate parts. The total quality requirements are a fundamental part of the design and specification of the facility.
�Significant effort has been made within The GMP Group to develop a consistent and structured approach to procurement and validation.�
The GMP Group staff uses this approach to procurement and validation, the project is then adapted to reflect local national or regional regulatory requirements. For example in Europe validation strategies will reflect EU directives as well as national interpretations of GMP requirements.
Wherever possible local standards, conventions for numeric values and units of measurement will be used.
Our offices maintain close links with our US colleagues and are fully capable of supporting clients intending to export to the USA and who therefore must also satisfy FDA requirements.