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Interim Quality Management &
Locum Services
Qualified Person (QP) services for batch release of both commercial products
according to Directive 2001/83/EC and investigational medicinal products (IMP)
according to Directive 2001/20/EC. This is offered on an interim or contract
basis depending on the client’s QP requirements e.g. as a backup QP to cover
your own QP’s absence or as interim Head of Quality during recruitment.
Responsible Person (RP) services for businesses holding Wholesale Dealers
Licences (WDL) to comply with the prevailing requirements of Good Distribution
Practice (GDP)
Auditing
We can set up and carry out Good Manufacturing Practice (GMP) audits of client
subcontractors e.g. with contract manufacturers or packers, analytical
laboratories including Active Pharmaceutical Ingredient (API) suppliers. Wide
experience has been obtained in auditing companies across Europe and the
Asia/Pacific region.
Regulatory Inspections & Regulatory Affairs
Assisting companies in the preparation for GMP inspections by the Health
Authorities with specific experience of the UK’s MHRA and Ireland’s IMB. Support
would be given e.g. with a Gap Analysis and assistance as required with
procedures, protocols and reports.
Review of Module 3 (Quality section) for Marketing Authorisation Applications to
the national or European agencies.
Quality System Development
Support can be provided to companies in developing quality policies, standard
operating procedures and associated records to achieve GxP compliance.
GxP Training
Training in e.g. GMP and GDP can be developed to meet the customer’s specific
requirements and presented in-house at client’s premises which minimises costs
in sending staff on external courses. |
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