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:
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cGMP
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.
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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. |
Validation/Qualification
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.
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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. |
Audits
Internal
audits/"Selfinspection".
Inspektion of suppliers and vendors.
Inspection of contractors (production, QC or
other).
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