Certification of Analyst, Purpose :
Certification of Analyst, The purpose of this SOP is to determine the capability of the newly recruited analyst to perform analysis accurately within the specified parameters and to demonstrate the analyst’s ability to perform in quality control laboratory at XX Pharmaceuticals Ltd.
Certification of Analyst, Scope :
This SOP applies to assure that the analysts are familiar with all test parameters, analytical procedures, instruments operation and documentation in quality control laboratory of XX Pharmaceuticals Ltd.
Definitions/Abbreviation:
Standard Operating Procedure (SOP): Standard Operating Procedure.
Responsibilities:
The roles and responsibility is as follows:
Officer/Executive/ Sr. Executive, Quality Control
[][]To follow the instructions of this procedure correctly.
[][]To maintain the records properly as per SOP.
Manager, Quality Control
[][]Responsible for the certification of analyst and verification of results and comparison with acceptance criteria.
[][]To ensure that this procedure is kept up to date.
[][]To confirm that the SOP is technically sound and reflects the required working practices.
[][]To arrange training on the SOP to all concerned personnel and to ensure implementation of the SOP after training.
Head of Quality Assurance
[][]Approval of SOP
[][]To ensure the overall implementation of the SOP.
Procedure:
General Precaution(s):
[][]Training should be conducted until the analyst is competent enough to carry out the analysis independently.
[][]Make sure that new employee know about the laboratory safety procedure.
[][]Adequate knowledge on handling of spillages and management of chemicals & reagents in the laboratory.
[][]Hands on waste management in the laboratory.
[][]Understanding the operation, cleaning and calibration procedure of instruments used in the laboratory.
Operation:
[][]Recently approved two specific samples of raw material or finished product or packaging material shall be given to the analyst to perform test for analyst certification.
[][]The samples are to be coded as (A) or (B).
[][]These samples packed in a manner which can prevent exposure to moisture, light and heat.
[][]In-Charge, QC should ensure that the analyst is performing the specified tests following respective method of analysis and specification.
[][]The analytical findings shall be recorded in the respective worksheet and the summary of results shall be entered in the prescribed format (Annexure-I).
[][]In-Charge, QC shall review the results in comparison with the known values for the test carried out and forward to Head of QA for approval.
[][]The analyst shall be considered qualified if the results obtained by him/her within the specification limit and within acceptable limit for certification of analyst.
[][]The details like calculations, chromatograms and spectrums along with comments of Head of QA shall be filed in training file of analyst.
[][]No repeat of the test will be allowed to the analyst.
[][]The result are provided by analyst will be crosscheck to the previous result and check the similarity.
[][]Head of QA will decide for the selection of analyst for routine analysis after review of analysis report. If the analyst is failed to qualify the test analyst will undergo further training.
[][]The certification of analyst shall be applicable to him/her only for carrying out these activities for which he/she is certified.
[][]Re-certification of the analyst shall be carried out once in every three years.
[][]The acceptance criteria for the analytical results shall depend upon the nature of tests carried out and the range provided in the specifications.
[][]Following acceptance criteria may be used for evaluation comparing with approved analyst.
[][]Assay by Spectrophotometer +/- 1% of previous value
[][]Assay by HPLC +/-0.5% of previous value
[][]IR spectra should match with standard and previous spectra
[][]Water content by KF +/-1% of previous value
Annexure:
Annexure-I: Analyst Certification Report.