ICHAPPS

To lay down the procedure for Calibration of Melting Range/Melting Point Apparatus. This procedure is applicable for Calibration of all Melting Range/Melting Point Apparatus located in quality control lab. Operate the instrument as per the SOP for operation of melting range/point apparatus. Point Apparatus , Range Melting, temperature , reference

To lay down the procedure for Calibration of Auto Titrator. This procedure is applicable for Calibration of  Auto Titrator in quality control. Operate the instrument as per the respective SOP and calibrate the Auto Titrator  as follows. Determine the normality of 0.1 N NaOH/0.1N Perchloric acid solution by taking  ~150 mg of Potassium hydrogen phthalate. Calculate the % RSD five such determinations. Auto titrator , Perchloric acid, potassium, linearity graph

To lay down the procedure for Calibration of UV/Visible Spectrophotometer. This procedure is applicable for Calibration of  UV/Visible Spectro- photometer in Quality control lab. Operate the instrument as per the respective SOP and calibrate the UV/Visible Spectrophotometer as follows, Perform the following tests for calibration of instrument. UV Visible , Spectrophotometer, Spectro photometer , volumetric flask

To lay down the procedure for calibration of hplc. This sop is applicable for the calibration of hplc’s in qc / ipqc laboratories. Follow the respective sop for operation and carry out the following tests for the calibration of a hplc system as applicable. Flow rate accurac, gradient composition acuracy, injection volume precision, oven temperature/sample chiller temperature. calibration of HPLC , Restriction capillary, specific gravity , separately, caffeine

To provide a procedure to operate and Calibrate the UV-VIS spectrophotometer. The procedure is applicable to the UV-VIS spectrophotometer. Model Shimadzu, UV1700 UV-VIS being used for analytical purpose at the Quality Control laboratory, It is the responsibility of the Quality Control personnel involved in the UV/Visible Spectrophotometer Calibration, to follow the procedure and schedule as mentioned in this Standard Operating Procedure. Spectrophotometer , parameters, instrument, compartment, Potassium nitrate

To provide a procedure for operation and maintain the Veego make Karl Fischer Apparatus. The procedure is applicable to the Veego make Karl Fischer Apparatus used for analytical purpose in the Quality Control laboratory, It is the responsibility of the Quality Control personnel involved in the operation of  Karl Fischer apparatus to follow the procedure as mentioned in this Standard Operating Procedure. Karl Fischer , silicagel, stopcock, titration, buret reading

To provide a procedure for the Preparation, Qualification, Packing, Storage and usage of Working Standards. The procedure is applicable to all the products manufactured and analyzed. It is the responsibility of the Quality Control to follow the procedures for the preparation, Qualification, packing, storage and usage of the Working Standard . Working Standard shall be used in the analysis of a particular Product to compare its results with that of Working Standard for the identification of the Product and to identify the impurities and assaying of the Product. Preparation, Qualification, Packing, Storage , bythe HRF

To provide a procedure to operate and maintain the Shimadzu LC-2010 series, gradient HPLC system. This procedure is applicable for the HPLC used in the Quality Control department. It is the responsibility of all the personnel involved in the analysis using of the system. Check that the instrument and surroundings are clean, if not, clean with a soft cloth duster. gradient HPLC system , mobile phase, suitable solvents , purge button, purge icon

To provide a procedure to operate and Calibrate the spectrophotometer xxxxx (Perkin Elmer, Spectrum one). This procedure is applicable to the FTIR Spectrometer (Perkin Elmer) used in the Quality Control department. I t is the responsibility of the Quality Control personnel involved in the calibration of FTIR Spectrometer (Perkin Elmer) to follow the procedure and schedule as mentioned in this Standard Operating Procedure FTIR, spectrophotometer, Pellet Press , automatically, barrel https://ichapps.com/qms/view/operation-and-calibration-of-ftir-spectrophotometer

To provide a procedure to operate the Cyclomixer in regular usage of laboratory analysis. This procedure is applicable for the Cyclomixer to support the testing in the Quality Control department. It is the responsibility of all the personnel involved in the analysis using of the equipment. Before connecting the power supply, ensure that the main switch is at off position. Switch on the power plug and place the glass apparatus on designated place (rubber groove) and hold properly the glass apparatus to avoid spillage and breakage. Cyclomixer , Remi, pilot bulb , clockwise, spillage , power supply

To provide a procedure Operation and Calibration of Conductivity meter, Polmon CM-540. This procedure is applicable to the conductivity meter, Polmon CM-540 used in the Quality Control department. It is the responsibility of the concerned personnel involved in the operation of the conductivity meter, to follow the procedure as written in this SOP. Conductivity meter , Polmon CM , purified water, distilled water, tissue paper

To provide a procedure to operate and maintain the CE make Hygro -Thermometer. This procedure is applicable for the Thermohygro meters being used for the monitoring of environment in the Quality Control department. It is the responsibility of all the personnel involved in the analysis using of the equipment. Check whether the instrument is in 0C mode for temperature or not if not go to 0C mode by pressing the 0C/0F switch. Hygro Thermometer , Humidity, monitoring, parameters

To provide a procedure to operate and maintain the Cintex make incubator. This procedure is applicable for the BOD incubator being used for storage of standard   materials and samples in the Quality Control department. It is the responsibility of all the personnel involved in the analysis using of the equipment.  Cintex , incubator , temperature, external across, Core Procedure

To provide a procedure for the Operation of Remi make R8-C Centrifuse. This procedure is applicable for the Centrifuse being used for the analytical purposes in the Quality Control department. It is the responsibility of all the personnel involved in the analysis using of the equipment. Check that the instrument and surroundings are clean, if not, clean with a soft cloth duster. Centrifuse , rotation, accelerated , ceased

To provide a procedure for the Operation of Cintex make CIC-1 Heating mantle. This procedure is applicable for the heating mantle being used for the analytical purposes in the Quality Control department. It is the responsibility of all the personnel involved in the analysis using of the equipment. Check that the instrument and surroundings are clean, if not, clean with a soft cloth duster . Heating Mantle , Cintex CIC 1 , spillages, temperature rising , flammable liquids

To provide a procedure for the Operation of Cintex make CIC-10 Hotplate. This procedure is applicable for the Hot plate, Cintex, CIC – 10 being used for the analytical purposes in the Quality Control department.  It is the responsibility of all the personnel involved in the analysis using of the equipment . Check that the instrument and surroundings are clean, if not, clean with a soft cloth duster. Hotplate , Cintex CIC , hotplate, knob , the liquids, fume hood

To provide a procedure for the Operation of Remi make 2MLH magnetic stirrer. To provide a procedure for the Operation of Remi make 2MLH magnetic stirrer. This procedure is applicable for the hotplate being used for the analytical purposes in the Quality Control department. It is the responsibility of all the personnel involved in the analysis using the equipment . Check that the instrument and surroundings are clean, if not, clean with a soft cloth duster. Magnetic stirrer , MLH magnetic stirrer , hotplate, bumping, liquids

To provide a procedure to operate and maintain the Cintex make CIC-61 Vacuum Oven. This procedure is applicable for the Cintex make CIC-61Vacuum oven used in the Quality Control department.  It is the responsibility of all the personnel involved in the analysis using of the system. Check that the instrument and surroundings are clean, if not, clean with a soft cloth duster. Before using the Vacuum oven , check the validity of calibration Temperature controller , Microprocessor, instrument, Vacuum

To provide a procedure to operate and maintain the Vacuum pump, Arunvac, AVB 50. This procedure is applicable for the Vacuum pump Arunvac, AVB 50 used in the Quality Control department. It is the responsibility of all the personnel involved in the analysis using of the equipment. Before switching on the vacuum pump check the oil level through the view glass. Before using the vacuum pump , ensure that the equipment is calibrated or not. If it is not, it is to be used only after calibration . Vacuum pump , Arunvac AVB , calibrated

Operation of Refrigerator LG Electronics Turbo To provide a procedure for the Operation of LG electronics make Turbo refrigerator. This procedure is applicable for the refrigerator being used for the storage of sample purpose in the Quality Control department. It is the responsibility of all the personnel involved in the analysis using of the equipment. Switch on the refrigerator continuously. Close the door of the refrigerator after using the refrigerator immediately Label the materials to be stored with name, date of preparation and other necessary Refrigerator, LG electronics , Turbo , moistened, detergent, evaporation tray

To provide a procedure for the Operation of LG electronics make Turbo refrigerator. This procedure is applicable for the refrigerator being used for the storage of sample purpose in the Quality Control department. It is the responsibility of all the personnel involved in the analysis using of the equipment. Switch on the refrigerator continuously. Close the door of the refrigerator after using the refrigerator immediately. LG electronics , Turbo, refrigerator , disinfectant, moistened, evaporation

To have a written procedure for Electronic data storage and reading. To store and read the Instrumental analytical data in the form of electronic data storage. It is the responsibility of Executive Quality Control to follow this SOP. Copy the required data from the source computer to the destination CD writer CD to be written. If the data copying is not possible directly, follow the procedure as per the instrument software. Write the copied data from hard disk to CD. Data Storage , Retrieving , copying, procedure, Precautions

To provide a procedure to operate the Cyclomixer in regular usage of laboratory analysis. This procedure is applicable for the Cyclomixer to support the testing in the Quality Control department. It is the responsibility of all the personnel involved in the analysis using of the equipment. Cyclomixer, remi , pilot bulb, clockwise, spillage, power supply

To have a procedure to follow the injection sequence for HPLC and GC analysis. This SOP is applicable to the HPLC and GC analysis in Quality Control Department. It is the responsibility of  Quality Control personnel to follow this SOP. Ensure that the chromatographic conditions are as per the Method / SOP pertaining to the particular product. Inject the mobile phase or diluent in which the sample is to be dissolved as blank run. injection, sequence, chromatography

To provide a procedure to operate and maintain the CE make Hygro -Thermometer. This procedure is applicable for the CE make Hygro Thermometers being used for the monitoring of environment  in the Quality Control department.  It is the responsibility of all the personnel involved in the analysis using of the equipment. Hygro Thermometer , Humidity, monitoring , parameters

To have a procedure for the electronic data file numbering system.  To allot numbers for electronic data files generated during analysis in quality control department.  It is the responsibility of Quality Control personnel to follow this SOP. The chromatograms shall be acquired and stored with the combination of system identification number and data file number as below.   Electronic , annexure, chromatograms, combination

To provide a procedure to operate and maintain the Cintex make CIC-71 Cooling incubator.  This procedure is applicable for the Cintex make CIC-71 Cooling  incubator being used for storage of standard materials and samples  in the Quality Control department. It is the responsibility of all the personnel involved in the analysis using of the equipment. cooling incubator , cintex , temperature controller, external agency

To provide a procedure for sending and receiving the samples to outside laboratory for analytical testing. This SOP is applicable to  Quality Control Department. It is the responsibility of  Quality Control personnel to follow this SOP while sending and receiving the samples to outside laboratory for analytical testing. Quality Control Department has to follow the procedure for sending the samples, which are not possible to analyse in the department, to outside laboratory. analytical testing , Nil, chemicals, instruments , particulars

To provide a procedure to operate and maintain the Cintex make CIC-2 Water Bath. This procedure is applicable for the Cintex make CIC-2 Water bath being used for the analytical purposes in the Quality Control epartment. It is the responsibility of all the personnel involved in the analysis using of the equipment. Check that the instrument and surroundings are clean, if not, clean with a soft cloth duster . WATER BATH CINTEX , calibrate, electronic

To provide a written procedure for Re-testing of Raw Materials and Intermediates. This SOP is applicable to all the Raw Materials and Intermediates. It is the Responsibility of Quality Control Dept., stores/ware house, production and Quality Assurance to follow the procedure given in this SOP. For any new product intermediates/Raw materials, data pertaining to shelf life/re-test date has to be provided during the technology transfer. Intermediates , Raw Materials , ware house, data pertaining , stability data

To provide a written procedure for Re-testing of Raw Materials and Intermediates. This SOP is applicable to all the Raw Materials and Intermediates. It is the Responsibility of Quality Control Dept., stores/ware house, production and Quality Assurance to follow the procedure given in this SOP. For any new product intermediates/Raw materials, data pertaining to shelf life/re-test date has to be provided during the technology transfer. Centrifuge, soft cloth duster , ceased, test tubes

To provide a procedure to operate and maintain the Eutech make Cyberscan 1100 pH meter. The procedure is applicable for calibrating the Eutech make Cyberscan 1100 pH meter used at the Quality Control department. It is the responsibility of the Quality Control personnel involved in the pH meters calibration activity to follow the procedure and schedule as mentioned in this Standard Operating Procedure. Cyberscan, electrode , equilibrium,  pH meters , Linearity, chloride aqueous

To provide a procedure for operation of Kipp’s Apparatus. This procedure is applicable for the Kipp’s apparatus used in the Quality Control  department  It is the responsibility of the Quality Control personnel involved in the generation of Hydrogen sulfide gas using Kipp’s apparatus to follow the procedure as mentioned in this Standard Operating Procedure Kipps Apparatus , Hydrogen sulfide, surroundings, leakage of gas

To provide a procedure to operate and maintain the Electro pharma make EMS-8 Sieve shaker The procedure is applicable for calibrating the Electro pharma make EMS-8 Sieve shaker used at the Quality Control  It is the responsibility of the Quality Control personnel involved in the operation of  Sieve shaker to follow the procedure as mentioned in this Standard Operating Procedure. Electropharma, clean with a soft, tightening screws

The procedure is applicable for calibrating the Campbell make C-TDA-2 tapped density tester used at the Quality Control department. It is the responsibility of the Quality Control personnel involved in the operation of tapped density tester to follow the procedure and schedule as mentioned in this Standard Operating Procedure. Check that the instrument is clean and free from dust, if not, clean with a soft cloth duster. Density , Tester, cylinder Holder clean , Anvil

Indent & receive the columns from Purchase department and verify whether correct columns are received against to Specify the column make, brand name, dimensions and particle size. Check the column for physical damage which may have occurred during shipping.  Retain safely the column performance certificate sent by the manufacturer. Ensure that the column ends are securely closed. HPLC columns , purchase, installation, performance evaluation, suitability

Before using the Hot air oven, check whether it is calibrated or not. If not, calibrate it. Switch on the instrument by the “MAINS” switch on the control panel of the instrument. The control panel consists of Microprocessor based Temperature controller, Three heat control switch (Rotatory switch) to control heating rate control, ON/OFF switch for FAN. Glassware drying , Cintex make, soft cloth duster , Microprocessor

Reverse laminar air flow unit works with the principle of reverse laminar flow, which is helpful to control the material exposure. Before starting the work on reverse laminar flow, switch on blow and observe pressure obtaining from magnahelic gauge. The pressure when the instrument is in operating condition should be between 5 to 15 PSIG. For any composite sample preparation of raw materials, intermediates and finished product, should be Operate under the air flow only. laminar flow unit , material exposure, methanol , magnahelic gauge

Before using ensure the validity of calibration. Switch on the power. Switch on the normal light and open the front door pulling towards the front side to keep the TLC plates Place the TLC plate in UV chamber horizontally on the base of the chamber. Switch on the particular nm wavelength light i.e. 254 nm or 365 nm light at which the TLC is to be viewed. Do not expose to UV light while handling the UV cabinet, use always normal light only while performing the operations. Altech , UV cabinet , ethanol, sodium salicylate

The vernier calipers consists of display and switches. Switch on the vernier calipers with on/off switch. We can correct the initial reding to ‘Zero’ with Zero switch. The display showed in inches or millimeters. The display can be toggled between these two ‘in/mm’ switch. Place the vernier calipers on the objective image measured. Adjust the pointers of the vernier calipers on the object exactly so that the place to be measured in between the pointers. Vernier calipers , Adjustment, external agency

Swith on the instrument with button. Liquid crystal display (LCD) segment check will be displayed as follows. After the LCD segment has been displayed, a ‘0’ (Zero) should appear on the display indicating that the instrument is ready for use. Connect the over flow and drain tubing to the appropriate fittings as indicated in Figure and route them to safe waste containers. The liquid source is connected to the inlet which accepts 1/16-inche tubing. LIQUID FLOW METER , approximately, eliminated, purely wetted

Check that the equipment is clean, if not, clean with a soft cloth duster. Check and ensure that the air outlet is opened. Connect the three-pin plug to the 230V AC socket. Load the equipment and ensure that the outlet door is opened. Switch ON the mains. Red light will glow at OFF position. Set ‘CONTINUOUS RUN’ by moving the ‘FUNCTION’ knob at on position. The green light will glow at run position. Dehumidifier , green light, Red light, soft cloth duster

This document deals with the procedure for handling deviations during analysis so as to avoid occurrence of Out-of-specification result. Obvious errors may be as under but not restricted to, Breakage of glassware during or after sample preparation Wrong weighing (Spillages during transfers) Wrong dilutions (Exceeding make up volumes, wrong pipetting etc) Breakage of pellets during IR analysis (using KBr ) etc deviations , arising, arising, pipetting , breakdown

The purpose of ALTERATION test is to check the Program files. On selecting the Alteration Test, press the Execute Button appearing in the Dialogue box for “Checking the Program Files”. The program will examine the files. If the program files are not modified or corrupted, the display will be shown as <>. HPLC, GC software integrity , Chemstation, EMPOWER

This Standard Operating Procedure is applicable to the GE812 platform Balance used in the Cytotoxic Quality Control It is the responsibility of the Quality Control personnel to calibrate the GE812  platform Balance being used as per the procedure and schedule given in this Standard  Operating Procedure. Platform Balance , powder spillage  Cytotoxic Quality Control

To provide a procedure to operate and maintain the Laboratory Temperature /Relative humidity monitoring  System (Temp/RH Data monitor I.R.A ) furnace. The procedure is applicable to I.R.A make Temp/RH Data monitor being used for monitoring of Temperature and Relative Humidity in the Quality Control laboratory Laboratory Temperature, Relative humidity, monitoring System , external agency

ndent & receive the columns from Purchase department and verify whether correct    columns are received against to specify the column make, brand name, dimensions and particle size. Check the column for physical damage, which may have occurred during shipping. Retain safely the column performance certificate sent by the manufacturer. GC columns , installation, storage, performance evaluation

Switch on the instrument using the RED switch which is on the front of the instrument. Set the desired time for sonication from 0.00 minutes to 9.59 minutes by using the upward arrow keys on the micro timer panel. Start/Stop the sonication by pressing the RED colour round toggle key. Ultrasonic Bath , micro timer panel, sonication, soft cloth

Switch on the instrument using the RED switch which is on the front of the instrument. Set the desired time for sonication from 0.00 minutes to 9.59 minutes by using the upward arrow keys on the micro timer panel. Start/Stop the sonication by pressing the RED colour round toggle key. Ultrasonic Bath , micro timer panel, sonication, soft cloth

Switch ‘ON’ the instrument, from the switch located on the power entry module. Wait till the reading is stable then press “Zero” key from keypad Select the wavelength by pressing “λ” key from keypad and press “Zero” key. Wash the Temp Troll sample tube with the solvent, which is used in the sample preparation and place in the sample compartment after filling with the same solvent by syringe , as far right as possible in the trough. Polarimeter , Autopol V, soft cloth, stabilizing temperature , Transmission surface