CGMP SOPs available for purchase, singly or grouped, for U.S. FDA-regulated industries:
o Medical device companies
o Dietary supplements
o Medical gases
o Environmental (ISO 14001)
o Quality Manuals
To review SOP titles or to order, click the
link below ...
Click here to see or order SOPs
J. E. Lincoln and Associates LLC, PO Box
2786, St. George UT 84771-2786 | Phone: 435.840.0252 | email@example.com
Our Current Good Manufacturing Practices (CGMP) / Quality System
Regulation Standard Operating Procedures (SOPs) provide basic templates that can be used 'as-is' or customized
by your personnel to meet your company's specialized needs. Our staff is also available to provide custom consulting
for unique requirements -- contact us for a quote.
SOPs are available for:
o Medical device
design and manufacturing;
o Medical gases;
Dietary supplements / nutraceuticals;
o ISO 14001, Environmental
o Quality Manuals (GMP, ISO 13485, ISO 9001);
o Validation templates
-- DQ, IQ, OQ, PQ, software;
o Risk Management File templates (ISO 14971:2007);
o Others available on request.
Most of our SOPs have undergone U.S. FDA review or
audit, often in response to a company's GMP remediation effort. They include the U.S. FDA's requirements
under 21 CFR 820, 111, 210, 211, ISO 13485, ISO 9001, and ISO 14971.
Click here to see or order SOPs.
Ask the Expert!
For generalized, no-charge email regulatory advice, send your questions, comments or ideas to us at the
link below. For issues that are of particular interest to the the regulated community, we may publish (with your permission)
your questions along with our answers on this web site or in our newsletter.
Click here to "Ask the Expert!"
In-house training, or live interactive web-based training, or periodic public workshops are
available for your managment, staff, operations, engineering, R&D, scientific, and/or QA / RA personnel. On any
SOP or related CGMP / QS Regulation / ISO 13485, 9001, 14971 subject, or CGMP training / refresher courses.
Click here for CGMP consulting information