Regulatory Compliance

Good Manufacturing Practices (GMP/cGMP) aim to ensure the effective design, operation and control of manufacturing processes and facilities. At BPE, we embed the principles of GMP throughout the services that we deliver to our Clients. We have considerable experience and expertise in reviewing both existing and planned processes/facilities against GMP and completing Validation against the appropriate Regulatory requirements.

We can work with you to embed GMP and complete Validation against all of the following:-

  • Manufacturing Processes
  • Equipment
  • Facilities
  • Standard Operating Procedures (SOP’s)

Our approach is to work towards Quality on a holistic basis through Design, Implementation and Operation.

CE Marking of Process Equipment

The CE Marking of Process Equipment is the responsibility of the manufacturer. However, the specialist equipment used in the process industries often requires the use of complex packages with associated complex CE Marking requirements. Unfortunately there are often conflicting requirements between the relevant regulations and directives which need to be resolved. Keith Plumb, our CE Marking Consultant has extensive experience of working with manufacturers and users to resolve these issues.

One particularly problematic area is the Machinery Directive which often requires the manufacturer to issue a Declaration of Incorporation which prohibits the user from putting the equipment into service until it has been incorporated. Our team have the skills to carry out the required risk assessments and conformity assessments to ensure that the equipment is incorporated and safe to use.

Our risk assessment skills and complete understanding of the ATEX requirements within the process industries also allows us to assist with CE marking of complex ATEX assemblies. We have a well defined approach with a fully developed road map and document templates.

For more details please call us on (0)1962 717070 or click here