1. PURPOSE
1.1 To lay down a procedure for analyst qualification.
2. SCOPE
2.1 This SOP is applicable to all the analysts in Quality Control Department.
3. RESPONSIBILITY
3.1 Sr. Executive: Quality Control
3.2 Asst. Manager: Quality Control
4. ACCOUNTABILITY
4.1 In charge: Quality Control.
5. PROCEDURE
5.1 Identify the samples of known analytical values.
5.2 Assign a code number and enter the details like analytical value(s) of Sample(s), acceptable limit(s), A.R.No. and code No. in register.
5.3 Enter A.R.No. in validations A.R.No. register.
5.4 Do not disclose the initial analytical results.
5.5 If necessary store all the coded samples at 2 – 8° C in sealed container (s).
5.6 Allot the coded samples to analyst along with calculation sheet (raw data sheet) and disclose the necessary information required for analysis before start up.
5.7 The analyst shall be qualified for either one or more of following techniques.
5.7.1 HPLC
5.7.2 GC
5.7.3 Titrimetry
5.7.4 UV-VIS Spectroscopy
5.7.5 FTIR
5.7.6 Particle size by Malvern
5.7.7 Melting Range
5.7.8 Total Organic Carbon analysis
5.7.9 Optical Rotation
5.7.10 Microbial limit test
5.7.11 Gram’s staining for detection of nature of bacteria
5.8 Compare the results with the initial results.
5.9 If the results are with in the acceptance limit the analyst will be deemed as capable of performing the analysis.
5.10 If tthe acceptance level then, train the analyst and requalify.
5.11 Acceptance Criteria,
TEST ACCEPTANCE CRITERIA
5.11.1 Assay by HPLC
(on Anhydrous / dried basis) ± 0.5 % of the initial value
5.11.2 Assay by Non Aqueous Titration
(on Anhydrous/dried basis) ± 0.5 % of the initial value
5.11.3 Infra Red Spectra / U.V Spectra Shall be comparable
5.11.4 Melting Range ± 2°C
5.11.5 TOC + 15 % of the initial value
5.11.6 Residual solvents by GC + 15 % of the initial value
5.11.7 Particle size by Malvern + 15 % of the initial value
5.11.8 Optical rotation by Polarimeter + 2°
5.11.9 Microbial limit test
5.11.9.1 Pathogens Shall be comparable with
initial results.
5.11.9.2 Ae robic count + 20 % of the initial value.
5.11.11 Staining shall be comparable with
the initial results
5.12 Frequency, Once a year.
5.13 Number of tests shall be selected based on the job carried out by the particular analyst.
5.14 Attach chromatograms and strip charts with analyst qualification report (Annexure – I).
5.15 Head of the department shall write his comments and conclude the analyst qualification report.
END OF DOCUMENT
Analyst qualification, quality control, analytical value
