Ulverston GMP Consulting Ltd
GMP Compliance & Quality Systems Assessment
Training and Auditing for the Pharma Industry
Qualified Person Services
GMP Compliance & Quality Systems Assessment
Training and Auditing for the Pharma Industry
Qualified Person Services
Qualified Person Services
TARGET MARKET:
“Virtual” pharmaceutical companies
Manufacturers of Medicinal Products (non-
Manufacturers of OTC Medicinal Products and CHC Products
Companies importing medicinal products into EU
Importers of medicinal products and smaller manufacturers of IMPs require the services of a Qualified Person but may be unable to justify the cost of employing a full time, permanent QP, especially at current salary rates within the industry. A part-time contract QP is often the cost-effective answer.
IMPs
If an development of IMP is being progressed by discreet campaigns, separated by weeks or months, a contact QP who has a consulting role within the wider industry is often the ideal solution. Time is charged only while working on IMP release, but not during periods of inactivity or “fallow” periods between IMPs.
Contract QP for IMPs
- Ideal solution for certification / release of discreet campaigns
- Time charged only for working on QP release
- No charge for periods of IMP inactivity
- No charge for periods between different IMPs
Importers
Importers of medicinal products may only require QP services for a few days each month. Again, a contract QP may be the ideal solution, since time is charged only when certification of shipments is required.
Contract QP for Importers
- I deal solution for certification / release of discreet shipments
- Time charged only for working on QP release
- No charge for periods between certification of shipments
Additional Benefits of Consultant QP
The contract may be for variable periods each month, quarter or year. As part of the contract, your Quality System can be assessed, gaps identified and improvements recommended.
Dr. David Inglis
David is director of Ulverston GMP Consulting Ltd and specialises in GMP/Quality Assurance for the manufacturing sectors of the pharmaceutical and consumer healthcare industry. He is a Qualified Person under EU Regulations, formerly for bulk sterile antibiotics and now for bulk product intermediates in clinical trials and for medicinal products imported into the EU.
Due to qualifying under the transitional arrangements, David is unlikely to be able to work as QP outside the UK and Ireland.
IMPs
If an development of IMP is being progressed by discreet campaigns, separated by weeks or months, a contact QP who has a consulting role within the wider industry is often the ideal solution. Time is charged only while working on IMP release, but not during periods of inactivity or “fallow” periods between IMPs.
Contract QP for IMPs
-
Importers
Importers of medicinal products may only require QP services for a few days each month. Again, a contract QP may be the ideal solution, since time is charged only when certification of shipments is required.
Contract QP for Importers
-
-
Additional Benefits of Consultant QP
The contract may be for variable periods each month, quarter or year. As part of the contract, your Quality System can be assessed, gaps identified and improvements recommended.
Dr. David Inglis
David is director of Ulverston GMP Consulting Ltd and specialises in GMP/Quality Assurance for the manufacturing sectors of the pharmaceutical and consumer healthcare industry. He is a Qualified Person under EU Regulations, formerly for bulk sterile antibiotics and now for bulk product intermediates in clinical trials and for medicinal products imported into the EU.
Due to qualifying under the transitional arrangements, David is unlikely to be able to work as QP outside the UK and Ireland.