5.3.1 Analyst shall check whether the sample taken for analysis is in accordance with the ‘Request for Analysis’ by comparing the A.R.No. indicated on both.
5.3.2 Analyst shall take relevant Specification / Standard Test Procedure by referring to the details (product name with strength, intended market/code number) given in the ‘Request for Analysis’.
5.3.3 Analyst shall review the Record of Analysis and Result Sheet for correctness against the current Specification and Standard Test Procedure.
5.3.4 For the analysis of in-process samples of exhibit batches, pre-validation batches and validation batches, the sampling protocol / validation protocol shall be referred for the relevant Specification / STP number and acceptance criteria, wherever applicable.
5.3.5 If the sample is stored in polyethylene bags (self sealed / heat sealed), then the Analyst shall place the original bag, after opening in another self sealing poly ethylene bag, and thus preserve the sample throughout the analysis.
5.3.6 If the sample needs special care such as moisture prevention, light resistance, nitrogen atmosphere, then the same shall be maintained throughout the usage of the sample during the analysis.
5.3.7 Handle the microbiological samples carefully to avoid any microbial contamination using sterile poly bags.
5.3.8 Analyst shall organize to get the microbiological tests done wherever required by microbiology laboratory as per procedures defined for microbiological testing.
5.3.9 Analyst shall organize required resources (Glassware, Chemicals, Columns, Instrument etc.) in such a way that the analysis can be carried out in an efficient and sequential manner.
5.3.10 Analyst shall organize the work place in such a way that samples glassware, documents, chemicals are kept in a segregated and safe manner.
5.3.11 Analyst shall display a status board indicating relevant details on the work bench.
5.3.12 Analyst shall start the analytical work by checking description and recording the results in the authorized worksheets. If the description is found different from that of the specification analyst shall intimate the Group Leader/Supervisor.
5.3.13 Analyst shall refer to the current version of relevant General Testing Procedure (GTP) as mentioned in the individual STP / Specification for performing the analysis.
5.3.14 Analyst shall follow appropriate safety procedures throughout the analysis.
5.3.15 All weighing shall be carried out using calibrated analytical balances within the range for which it can be used.
5.3.16 The glassware shall be kept close to the analytical balance so that weighed material can be transferred quickly without loss and with least exposure.
5.3.17 Samples shall be transferred into pre-labeled glassware by ensuring correctness of label before transferring.
5.3.18 While performing blend uniformity test, analyst shall weigh and transfer the whole quantity of individual sample representing the unit dose.
5.3.19 The print out of weight taken shall have details entered and attached to the relevant portion of Record of Analysis.
5.3.20 Analyst shall record details of weights, dilutions and all analytical details in the Record of Analysis, concurrently as the activity is carried out.
5.3.21 Analyst shall check the validity of chemicals, reagents, indicators before using them for analysis. All invalid chemicals, reagents, indicators shall be discarded after crossing the labels.
5.3.22 All reference standards, in house reference standards, working standards, primary standards and impurity standards shall be handled as instruction provided on the label.
5.3.23 Official Pharmacopoeia reference standards shall not be used for routine analysis unless otherwise specified or authorized by laboratory head.
5.3.24 Analyst shall check standards before use for details such as item name, pharmacopoeia reference, validity and direction for use.
5.3.25 Analyst shall use the potency value of standards for all calculations as indicated on the label.
5.3.26 Analyst shall consider the potency as 100% while using official pharmacopoeia reference standards when no potency is mentioned on the label.
5.3.27 Analyst shall place all chemicals, standards and others accessories back to their original storage area as soon as use is completed.
5.3.28 Analyst shall check instrument conditions like cleanliness and calibration status before starting analysis on any instrument.
5.3.29 Analyst shall enter relevant details of analysis in the instrument log book at the beginning of analysis and complete the details of usage and other relevant steps after the analysis is completed (wherever applicable).
5.3.30 Analyst shall enter relevant details of the usage log books
5.3.31 Analyst shall bring to the attention of Group Leader/Supervisor any abnormal observations or incidents during analysis.
5.3.32 Analyst shall raise a laboratory incident in consultation with Group Leader/Supervisor.
5.3.33 Analyst shall collect and identify all analytical print outs from Instruments/Equipments in such a way that they are traceable to particular sample.
5.3.34 Wherever validated excel calculation sheets are provided, analyst shall use the same with all controls as specified in the laboratory SOP.
5.3.35 Analyst shall calculate results as soon as analysis is completed and indicate the result of the test (Complies/Does not comply or for information only) in the Record of Analysis and Result Sheet.
5.3.36 Analyst shall bring to the notice of Group Leader/Supervisor any test failure as within 24 hours of occurrence and follow the instruction from group leader/laboratory head.
5.3.37 Analyst shall record all additional testing if any, for OOS / OOT investigation, in authorized Record of Analysis.
5.3.38 To the extent possible, analyst shall retain all original analytical sample and standard preparations in the specified manner so as to facilitate investigation.
5.3.39 Analyst shall record and retain all results obtained during OOS investigation along with raw data duly identified for submissions for disposition of OOS investigation.
5.3.40 Analyst shall verify results obtained for critical tests such as Impurities, Assay and Residual Solvents whether the result is Out Of Trend (OOT).
5.3.41 Analyst and Group leader shall follow steps given in the current versions of SOP for investigation and closure of OOT.
5.3.42 If few portions of a test detail is not applicable for the sample then analyst shall indicate “NA” against each of those entries in the Record of Analysis
5.3.43 If whole test is not applicable for the sample then analyst shaii indicate “NA” against the title of the test in Record of Analysis.
5.3.44 If the whole page of Record of Analysis is not applicable for the sample then analyst shall draw a line diagonally across the page and indicate “NA” even if it is the continuation page of a test which is already indicated as “NA”.
5.3.45 If multiple batches are analysed together, analytical details shall be entered in the Record of Analysis of the first A.R. Number and a reference of this A.R. Number shall be given in subsequent Record of Analysis.
5.3.46 Analyst shall compile the report as soon as all tests are completed and shall arrange the Record of Analysis and Raw Data in the same sequence as in the Specification / Result Sheet.
5.3.47 Analyst shall securely fasten the report along with all the raw data and report of Microbiological tests (wherever applicable). The ‘Request for Analysis’ shall be attached at the first sheet of the complete set of the report.