CGMP  SOPs available for purchase, singly or grouped, for U.S. FDA-regulated industries:
o  Medical device companies
o  Pharmaceuticals
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

This site  The Web 

J. E. Lincoln and Associates LLC, PO Box 2786, St. George  UT  84771-2786 | Phone: 435.840.0252 | 

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  Pharmaceuticals;
  o  Medical gases;
  o  Dietary supplements / nutraceuticals;
  o  ISO 14001, Environmental Management System; 
  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  510(k) templates;
  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

Medical Instruments


                                                                                              Site last updated 02/16/2013.