Licensing & Compliance
Expert support and guidance past the technical and regulatory barriers from initial conception to a fully compliant production facility.
Our consultants understand the significance of the many different factors and the interactions between the Facility, the People and the Process that constitute the Production Environment and their impact upon ultimate Regulatory Compliance. We can support you through every stage of attaining your complaint facility to ultimate Inspection Readiness.
Manufacturing of medicinal products requires adherence to Good Manufacturing Practice, a facility built in line with the MHRA’s Orange Guide and many other stringent regulatory requirements.
aQmen Consultancy LLP have the expert skills, experience and proven solutions to ensure you get the facility you really need.
We can provide;
- Structured Documentation Packages and support through completion
- Comprehensive Knowledge and Understanding of Regulatory and GMP requirements
- Extensive experience of Cleanroom facilities and processes, with expertise to facilitate peer reviews and carry out necessary witness testing
- Training and guidance through a highly specialist area of construction We will remove the pain of learning
- We can provide the experience for dealing with main contractors /PFI and a working knowledge of the contractual process
- We will ensure that you get the facility that reflects your operational needs at the best market price
- We will save you money in getting unlicensed facilities to full ‘Inspection Readiness’
- We will give you ‘Peace of Mind’ knowing the facility will pass any regulatory inspection whilst offering Environmental, Operator and Product protection
User Requirements Specification (URS)
Validation Master Plan (VMP)
Functional Design Specification (FDS)
Design Qualification (DQ)
Installation Qualification / Operational Qualification (IQ / OQ)
Performance Qualification Protocols
Standard Operating Procedures (SOP)
Site Master File
Clear, systematic and structured documentation is a regulatory requirement traceable through all stages of a facilities development –
- The facility design, construction and validation.
- Process and procedure development, equipment commissioning and training.
- Operating and controlling the facility and product produced.
aQmen Consultancy can support your documentation through every stage with;
- Templated and Modular documentation system.
- Content review and management of quality documentation, controlled document flow and inspectorate visibility.
- Comprehensive expert review of documentation and processes including;
- Change Control
- Standard Operating Procedures
- Cleaning Procedures
- Contamination Control
- Training Matrices
- Support to rectify documentation and create new documents
- Providing comprehensive knowledge of Cleanroom facilities, processes and HVAC systems together with expertise to facilitate peer reviews and any necessary witness testing.