The expert product, process and testing problem solvers for the regulated industries...

 

Our Mission

We perform independent investigations and corrections of failures of products, processes, or testing for the pharmaceutical, dietary supplement, medical device, food, and cosmetic industries by applying our proven 10 step method described below.

Call on us when you have need assistance with blends, formulations, preservatives, dosage forms, contaminations, water systems, adverse events, recalls or potential recalls, safety issues, out-of-specification test results, regulatory letters, adverse government inspection reports, standard operating procedures (SOP's), and any other product, process or testing issue.

Company Profile

We have over 22 years experience in the regulated industries, and have developed a 10 step process that consists of the following:

1) Interview: Interview all personnel involved in a respectful manner.
2) Investigate: Thoroughly investigate all processes, equipment and testing procedures.
3) Research: Perform any necessary research regarding the problem.
4) Hypothesize: Formulate failure theories and corrections.
5) Test: Design and supervise new procedures and testing.
6) Review: Review all data and information.
7) Correct: Design and implement corrective actions.
8) Revise SOP's: Draft and implement revised Standard Operating Procedures.
9) Report: Report all information and results to management.
10) Follow Up: Mark calendar to follow up to ensure compliance.

 

Contact Information

Telephone
310-355-6046
FAX
310-454-9592
Postal address
15515 Sunset Blvd., Suite 115, Pacific Palisades, CA 90272-3530
E-mail
fixitnow@gmpinvestigations.com
 

 

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Last modified: December 13, 2002