Method development documentation [Bioanalytics]

posted by Ken Peh – Malaysia, 2013-12-17 04:30 (4571 d 19:12 ago) – Posting: # 12065
Views: 4,670

Dear Friends,

Would appreciate your input and comments.

For bioanalytical method development, we are told to show where we get the method from and how we start until we get the method before method validation. How much documentation is sufficient ? Do we need to record all the steps, procedures and print out all the chromatograms as proof ?

Thank you.

Best regards,
Ken

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,571 registered users;
124 visitors (0 registered, 124 guests [including 25 identified bots]).
Forum time: 00:42 CEST (Europe/Vienna)

Competence, like truth, beauty and contact lenses,
is in the eye of the beholder.    Laurence J. Peter

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5