When performing testing of this regard, obviously the observation is recorded by the analyst and this is the raw data, but is there any regulations on these observations being witnessed by a second person.
E.g if the specification was “white solid”, and the analyst has wrote “white solid” without a witness we are A) “trusting” the result which isn’t very GMP
B) It is possible that one persons “white” is another persons “off white”
Different companies , I have seen different procedures, but interested if there is any standard guideline, or required to witness at all.
The analyst performing testing and analysis of samples of any raw materials, intermediate products, or finished products is “Certified” by assessing his/her competency to perform those tests for which he/she is certified.
Therefore, the tests performed and the observations made by him need not be witnessed by a second person. However, there should be an oversight by the supervisor / second person of the analysis/tests being performed by the analyst. (A supervisor’s physical presence is required in the laboratory). The calculations should be checked by the supervisor for accuracy, also the raw data should be checked for accuracy, completeness, and compliance.
Please see the regulatory requirement as per 21CFR part 211 (USFDA-CGMP) under subpart J -Records and reports (section 211.194 Laboratory records) as follows:
(a) Laboratory records shall include complete data derived from all tests necessary to assure compliance with established specifications and standards, including examinations and assays, as follows:
(7) The initials or signature of the person who performs each test and the date(s) the tests were performed.
(8) The initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards.
This topic was automatically closed 10 days after the last reply. New replies are no longer allowed.