AboutMichael Anisfeld Expertise Disclaimer:
SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT).
My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements
Experience
Past/Present Clients UN agencies (UNFPA, UNICEF, UNIDO)
Governments (Australia, Canada, India, United Kingdon, United States
Companies - over 200 companies in 37 countries
Question HOW i can i address failure in analytical instruments calibration failure
Answer If an analytical instrument fails its calibration (is out-of-tolerance), then you need to do the following:
FROM NOW INTO THE FUTURE:
a. recalibrate and correct the instrument;
b. shorten the time period to the next recalibration (if it was every 12 months make it every 3 or 6 months).
FROM NOW BACK INTO THE PAST:
c. calculate by what percentage the instrument was out of tolerance (for example 1.3%);
d. go back in time to when the last acceptable calibration occurred on the instrument, and then find out which product/materials have been testing, between then and now, on the instrument;
e. recalculate all test results between then and now, incorporating the 1.3% out-of-tolerance factor;
f. If any tests are now recalculated as Out-Of-Specification (OOS), you need to make a decision as to whether to recall the product, or ........?????
