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GMP Consulting Services
ComplianceNet
specializes in helping small, start up pharmaceutical firms
establish efficient, cost effective quality systems that
will pass inspection and produce high quality products.
We also work with larger firms to review current systems to make
them more efficient and robust enough to stand up to current
regulatory challenges.
 | Auditing: We
perform all types GMP and GLP Audits and provide a very
detailed, specific report of recommended actions, including
full references to the pertinent regulations and guidance
documents.
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| Quality Systems:
We can create, review, implement or improve any Quality
Systems, including all those for QA, Manufacturing,
Laboratories, and support groups.
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| Process
Validation: We can set up a process validation
program that will pass inspector scrutiny, everything from
writing the SOPs and Master Plans to writing and executing the
protocols and summarizing the data into usable reports.
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| Equipment
Qualification: We can write the qualification protocols on
all major pharmaceutical equipment or review your current
program to ensure it is current and compliant.
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| Computer
Validation: We can write the SOPs, Master Plans, and
protocols required to make sure your systems are fully
validated and compliant with 21 CFR Part 11 Electronic
Records, Electronic Signatures.
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| Facility
Monitoring: We can review your current Facility
Monitoring program to ensure it is robust enough to pass
inspection. We can help you analyze locations that show
frequent excursions for how to correct the situation. We
can also analyze data, create trend reports, and write
validation protocols.
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| Utility
Monitoring: We can review your current Monitoring
programs for water, steam, and plant supplied gases to ensure
they are robust enough to pass inspection. We can help
you analyze use points that have had frequent excursions for
how to correct the situation. We can also analyze data,
create trend reports, and write validation protocols.
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| Management:
We can assist with management strategies, especially for small
companies that want to set up the most cost effective and
efficient compliance team possible with limited resources.
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| Training: We can
bring training programs to your site and we offer several
courses a year at various international sites.
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Contact
Us for More Information |
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FDA
on
Systems Based Inspections |
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Q: Will the investigator tell me whether
they are doing full or abbreviated coverage and/or what
systems they plan to cover when they start?
A: There is no requirement for the
investigator to notify the firm whether the inspection
is full or abbreviated OR what systems will be covered.
Robert C. Coleman, FDA
Presentation at PDA
October 2002
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