this page updated
06 jan 2002
© SBConsult Aps 2001

- Consulting for the pharmaceutical and related industry -

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With an increased focus on health costs from governments it is more vital than ever for the industry to stay competitive and wherever possible reduce costs , speed up development time, and assure that no regulatory delays occurs before the product can get on the market. Considerable ressources are offered by the pharmaceutial and related industries to keep on top of constantly increasing requirements in order to maintain compliance with current GMP.

SBConsult/Søren Bogø offers assistance to pharmaceutical, medical device, and related
manufacurers in the following areas based on twentyfive years of experience with cGMP systems:

Verify/upgrade your compliance to current EEC, US-FDA, Canadian GMP-regulations. Get a review of applicable regulations or guidelines that may apply to your particular situation or system to assure that all expected requirements can be met as well as advice on ways best to achieve compliance, whether your concern is sampling procedures, organizing of stability studies, validation program for utilities, cleaning or manufacturing procedures, or your documentation for training, annual product review or other GMP-related activities.

Quality Management
Review/upgrade of your system for Change Control, Deviation handling, Investigation Reporting, Corrective Actions Materials Handling, Training, Maintenance and Calibration, and other central systems.
Training sessions can be developped for particular personnel groups on specific issues tailored to your needs.
Get assistance to organize a no nonsense system for Planning of DQ, IQ/OQ/PQ, Protocol-design, and Reporting of validation activities in a single comprehensive system tailored to applicable requirements and your specific situation, which can be easily understood by the personnel performing the validation tasks and reporting them and explained to regulatory authorities to demonstrate an organized approach.
Documentation Systems
SOPs, development, editing, review, issuance of written procedures.
Records and Logs, general and specific, (Manufacturing, Maintenance, Calibration, Training etc. ).
Manuals, implementation of entire QA-systems.
- all implemented in a way to assure that written procedures and records will be accurate, complete and compliant, and well suited to adequately demonstrate your compliance in the case of scrutiny by regulatory authorities as part of regulatory submissions or during inspections.
Internal audits/"Selfinspection".
Inspektion of suppliers and vendors.
Inspection of contractors (production, QC or other).

mailto:info@sbconsult.net or see Contact