Follow
1.0 OBJECTIVE : To describe the procedures and guideline for preparation of Reagents, Solutions and Indicators and their maintenance in Quality control department.
2.0 SCOPE : This procedure is applicable for preparation of required reagents, solutions (such as mobile phase, diluents etc) and indicators and their storage which are used for analytical purpose.
3.0 RESPONSIBILITY
3.1 QC Analyst / Officer shall be responsible to perform the activity as per procedure.
3.2 Overall responsibility for training, implementation and follow-up with the QC Manager or his/her nominee.
4.0 ACCOUNTABILITY
4.1 Head of Quality.
5.0 PRECAUTIONS
5.1 All chemicals should procure only from approved manufacturers.
5.2 Hazardous chemicals/Reagents/Indicators should be handled as per procedure (SOP No.: QC/017).
5.3 Always use hand gloves, goggles and mask during preparation of mobile phase, diluents, reagents, indicators and solutions.
5.4 Never pipette chemicals with mouth, always use a pipette-filler.
5.5 Never use the expired materials for preparation of reagents, indicators and solutions.
6.0 PROCEDURE
6.1 Preparation
6.1.1 Use clean and dry glassware (clear / amber, as per requirement) for preparation and storage of mobile phase, diluents, reagents and indicators.
6.1.2 Prepare mobile phase, diluents, reagents or indicators as specified in respective method.
6.1.4 Label the bottles for reagents/solutions (as per Annexure-I), indicators (as per Annexure-II) and mobile phase/diluents (as per Annexure-V).
6.1.5 After preparation, make necessary entry in reagent preparation (Annexure -III) and indicator preparation register (Annexure -IV).
6.1.6 Enter the batch number/Lot number of the mother reagent from which the reagent solution or the indicator solution is prepared for traceability back to original chemical used.
6.1.7 The validity of the prepared reagents/ indicators prepared in Quality control lab which are used for chemical tests of different samples are three months from the date of preparation.
6.1.8 Validity of solvents and solvent mixtures used in chromatographic systems or for washing/cleaning purposes are as per the Annexure-VI. Validity time is considered from the date of preparation/dispensing from the original container (s).All chemicals/solvents must be within valid expiry date.
6.1.9 Always use freshly prepared buffer, mobile phase and diluents (for HPLC analysis), however can be used up to 48 hours after preparation depending on continuity of analysis, but the system suitability requirement has to be checked every after 24 hours.
6.1.10 Reagents/ Solutions/ Indicators required for microbiological testing is prepared and stored in the microbiology section.
6.2 Storage and use
6.2.1 Use only appropriate Quality and Quantity of solvents for preparation of mobile phase, diluents, reagent and indicators as specified in respective STP.
6.2.3 Store mobile phase, diluents, reagents and indicators in amber colour glass bottles when specified in respective method.
6.2.4 Ensure that there is no precipitation, color change and haziness. Discard the solution if precipitate, color change or haziness is observed.
6.2.5 Do not dip pipette into the reagent bottle, take out approximately required quantity of reagent into beaker/ test tube.
6.2.6 Do not transfer left over quantity of the reagent/indicator to the original reagent bottle.
6.2.7 Use droppers for Indicator.
6.2.8 Close the bottle properly and keep at designated place after each use.
6.3 Destruction of Reagents, Solutions and Indicators after due date
6.3.1 The unutilized reagents/ solutions/ indicators are destroyed by following procedure. The Reagents/Solutions/Indicators are divided into two categories: One as water based and another as solvent based.
6.3.2 The water based reagents/solutions/indicators are destroyed by putting the contents in wash basin and flushing with plenty of water.
6.3.3 Solvents used for the preparation of mobile phase/ reagents/ solutions/ indicators are destroyed by diluting the contents in water and then pouring through wash basin followed by flushing of wash basin with plenty of water. But when the Indicators/Reagents are prepared in solvents which are immiscible with water, put contents into the container labeled as “Waste Disposal (For organic solvents)” and washing the glass bottles / container initially with respective solvent.
