ICHAPPS

To describe a standard operating procedure for the calibration of vacuum gauges. The standard operating procedure describes in detail the method for the calibration of vacuum gauges in the plant. The responsibility of calibrating the gauges lies with the staff of rank not lower than the supervisor of maintenance department. The responsibility of preparation, review and approval of the standard operating procedure lies with the Manager (Maintenance), Head of Production and Head of QAD respectively. Vacuum Gauges , Engineering, U-Tube Manometer

To describe a standard operating procedure for the operation of refrigeration unit. The standard operating procedure describes in detail the method of the operation of refrigeration unit. The responsibility of operating the refrigeration unit lies with the staff of rank not lower than the junior utility operator. The responsibility of preparing, reviewing and approving the standard operating procedure lies with the Manager-Maintenance, Head of Production and Head of QAD respectively. Refrigeration Unit , Junior Utility Operator, Engineering

To describe a standard operating procedure for the operational qualification of different equipments. The standard operating procedure describes in detail the method of the operational qualification of different equipments. The responsibility of carrying out operational qualification of  different equipments lies with the staff of rank not lower than the maintenance engineer. The responsibility of preparing, reviewing and approving the standard operating procedure lies with the Manager - Maintenance, Head of Production and Head of QAD respectively. Different Equipments , Maintenance Engineer, Engineering

To describe the standard operating procedure for operation of diesel generator. The standard operating procedure describes in detail the method for operation of diesel generator. The responsibility of operating the diesel generator lies with the staff of rank not lower than the junior utility operator of maintenance department. The responsibility of preparing, reviewing and approving the standard operating procedure lies with the Manager-Maintenance, Head of Production and Head of QAD respectively. Diesel Generator , Engineering, Coolant temperature

To describe a standard operating procedure for prevention of accidents while carrying out the mechanical operations. The standard operating procedure describes in detail the method to be followed in prevention of accidents while carrying out the mechanical operations. The responsibility of following safety methods for the  prevention of the accidents lies with each and every person who is attending a maintenance job. The responsibility of preparing, reviewing and approving the standard operating procedure lies with the Manager - Maintenance, Head of Production and Head of QAD respectively. Prevention of Accidents , Mechanical Operations, Engineering

To describe a standard operating procedure for shifting a heavy equipment. The standard operating procedure describes in detail the method of shifting a heavy equipment. The responsibility of shifting a heavy equipment lies with the maintenance supervisor under the guidance of maintenance engineer. The responsibility of preparing, reviewing and approving the standard operating procedure lies with the Manager - Maintenance, Head of Production and Head of QAD respectively.        shifting a heavy equipment , Engineering, QAD respectively

To describe the standard operating procedure for the operation of an air compressor unit. The standard operating procedure describes in detail the method of operation of an air compressor unit. The responsibility of operating an air compressor unit lies with the staff of rank not lower than the junior utility operator. The responsibility of preparing, reviewing and approving the standard operating procedure lies with the Manager - Maintenance, Head of Production and Head of QAD respectively. Air Compressor , Operation, Air Compressor Motor, Engineering

To describe a standard operating procedure for replacement of shaft oil seal/coupling tyre of refrigeration unit. The standard operating procedure describes in detail the method for replacement of shaft oil seal/coupling tyre of refrigeration unit. The responsibility of replacement of shaft oil seal /coupling tyre of refrigeration unit lies with the staff of rank not lower than the junior utility operator. The responsibility of preparing, reviewing and approving the standard operating procedure lies with the  Manager-Maintenance, Head of Production and Head of QAD respectively. Refrigeration unit , Coupling tyre, Replacement , Shaft, Oil seal

To describe a standard operating procedure for cleaning of condenser tubes of refrigeration compressors. The standard operating procedure describes in detail the method for cleaning of condenser tubes of refrigeration compressors. The responsibility of cleaning the condenser tubes of refrigeration compressors lies with the staff of rank not lower than the junior utility operator. The responsibility of preparing, reviewing and approving the standard operating procedure lies with the Manager-Maintenance, Head of Production and Head of QAD respectively. Refrigeration unit , Addition, Changing, Unloading, Oil pressure

To describe a standard operating procedure for cleaning of condenser tubes of refrigeration compressors. The standard operating procedure describes in detail the method for cleaning of condenser tubes of refrigeration compressors. The responsibility of cleaning the condenser tubes of refrigeration compressors lies with the staff of rank not lower than the junior utility operator. The responsibility of preparing, reviewing and approving the standard operating procedure lies with the Manager - Maintenance, Head of Production and Head of QAD respectively. Refrigeration , Preparing, Electrically, Conde nsor , Outlet nipples

To describe standard operating procedure for installation of storage tanks. The standard operating procedure describes in detail the method of installation of storage tanks. The responsibility of installation of storage tanks lies with the staff of rank not lower than the maintenance engineer of maintenance department. The responsibility of preparing, reviewing and approving the standard operating procedure lies with the Manager-Maintenance, Head of Production and Head of QAD respectively. Storage Tanks , Fabricate, Spirit Level, Pedestals

To describe standard operating procedure for installation of distilled water plant. The standard operating procedure describes in detail the method of installation of distilled water plant. The responsibility of installation of distilled water plant lies with the staff of rank not lower than the maintenance engineer of maintenance department Water Plant , Installation, Distilled, Maintenance

To describe standard operating procedure for calibration of storage tanks. The standard operating procedure describes in detail the method of calibrating the storage tanks. The responsibility of calibrating the storage tanks lies with the staff of rank not lower than the maintenance engineer of maintenance department. The responsibility of preparing, reviewing and approving the standard operating procedure lies with the Manager-Maintenance, Head of Production and Head of QAD respectively. Storage , Calibration, Tanks, Supervisor

To describe a standard operating procedure for carrying out equipment major / minor breakdown maintenance. The standard operating procedure describes in detail the method for carrying out equipment major/minor breakdown maintenance. The responsibility of carrying out equipment major / minor breakdown or routine maintenance lies with the staff of rank not lower than supervisor of  maintenance .   Maintenance , Major, Minor, Breakdown , Carrying, Procedure

To lay down the procedure for Sampling of Raw materials. This procedure is applicable for all the Raw materials (Non-sterile). Upon receipt of “Material Receipt Report (MRR)” from warehouse, IPQA chemist shall check the details on the MRR and supplier COA. IPQA chemist shall enter the details in the Raw Material Inward register as per the MRR (Refer Format No.: xxxxx Solid & Liquid (in carboys & drums) Raw materials . Shall prepare the sampled labels the number of labels shall be as per the table below. Raw Materials , Quality Control, Sampling , bottle

To lay down the procedure for Testing and Release of Raw materials, Intermediates and Active Pharmaceutical Ingredients (API).  This procedure is applicable for all Raw materials, Intermediates and API. Upon receipt of sample from QC distribution, executive – QC shall assign the analysis work to analyst at various sections. Analyst shall take the concerned sample from respective tray. Testing , Release , Raw Materials, Intermediates, Pharmaceutical , Ingredients

To lay down the procedure for Sampling and approval of packing material. Upon receipt of Material Received Receipt (MRR) from stores, IPQA chemist shall enter the particulars of the packing material inward register as per Annexure –I. Before sampling, IPQA chemist shall verify the packing material details according to MRR. For every individual consignment AR. number shall be allotted. One samples shall be drawn for each consignment. Packing Material , Approval, Sampling, chemist, designee

To lay down a procedure for Operation of HPLC (Shimadzu with LC 10AT and SPD-M10 AVP).  This SOP is applicable for HPLC (Shimadzu with LC 10AT and SPD-M10 AVP) in quality control department. Connect the instrument to 230 volts A/C power supply. Switch on the instrument pumps A and B. Connect the required column for sample analysis and equilibrated for ten minutes with water/methanol or acetonitrile. LC Solution , acetonitrile, maximum, minimum, acetonitrile, equilibrated

To lay down a procedure for Operation of HPLC (Shimadzu with millennium software). This SOP is applicable for Operation of HPLC (Shimadzu with millennium software) in Quality control department. Connect the instrument to 230 volts A/C power supply. Switch on the instrument and pumps. Connect the required column as per standard test procedure for the sample analysis and column shall be equilibrated by using either water: methanol (50:50) or water: Acetonitrile or ratio. Millennium, Performance, Liquid, Chromatograph,   Shimadzu

To lay down the procedure for operation of HPLC (Shimadzu) -equipment identification number: LAB3  Connect the instrument to 230 volts A/C power supply. Switch on the instrument and pumps. Connect the required column as per standard test procedure for the sample analysis and column shall be equilibrated by using either water: methanol (50:50) or water: Acetonitrile or ratio. shimadzu HPLC , Quality Control , equilibrated, numerical, browse project, threshold

To lay down the procedure for Gas chromatograph (Aster) -Equipment identification number: LAB. Connect the instrument to 230volts A/C power supply. Switch on the instrument. Open the door of the oven and connect the required column. Set the carrier gas pressure as per the requirement by rotating the carrier knob on. Ensure that no leak is observed near the column ends by spraying soap solution. No air bubbles should be observed near the column ends when IPA solution is sprayed. Close the oven door properly. datalab GC , chromatograph, Isopropyl alcohol , activate

To lay down the procedure for maintenance of desiccators. This SOP is applicable for maintenance of desiccators in Quality control department. Charge sufficient quantity of silica gel/calcium chloride in the desiccator. Place porcelain plate in the desiccator. Place the material container with appropriate label on the porcelain plate of the desiccator. Keep the desiccator in a designated place. HPLC Columns , Washing, acetonitrile , hexane, isopropyl, ethanol

To lay down the procedure for maintenance of desiccators. This SOP is applicable for maintenance of desiccators in Quality control department. Charge sufficient quantity of silica gel/calcium chloride in the desiccator. Place porcelain plate in the desiccator . Place the material container with appropriate label on the porcelain plate of the desiccator. Keep the desiccator in a designated place. Desiccators , Maintenance, Quality control, chloride, designated

To lay down the procedure for condition and regeneration of GC columns. This SOP is applicable for condition and regeneration of GC columns in Quality control department. All columns shall be conditioned before and after analysis. Column conditioned shall be minimum one hour. Column condition temperature parameters mentioned as below. HPLC Columns , propyl alcohol, hydro furan, methylene

To lay down a procedure for handling and storage of HPLC and GC columns. This procedure is applicable for handling of HPLC and GC columns used in Quality Control Department. All columns shall be washed after completion of analysis. Each column shall be given column-identification number. The identified column number shall contain two parts as described below. Handling, Storage , GC Columns, suitability , laboratory, exceeds

To lay down a procedure for operation of conductivity meter. This procedure is applicable for quality control department.  Take 100 mL sample in a dry and cleaned beaker. Dip the electrode in beaker. Press the PRG/CAL key Enter the pass word by using the ?key press OK Display goes to PRG/Calib Select the PRG/Option By using ?key and press the OK display options menu. Press OK key display goes to measure conductivity or TDS. Conductivity Meter , quality control, cleaned beaker , electrode, tabilized input

To lay down the procedure for Operation, and Calibration of conductivity / TDS Analyzer   Equipment identification No: xxxxx This Sop covers the operation and Calibration of procedure of conductivity / TDS analyzer. Connect the power cord to the 220 V AC supply socket (Properly grounded). Fix the ATC probe and Cell to the clip provided on the stand. conductivity, Calibration , Operation, temperature

To lay down the procedure for operation and calibration of UV cabinet. This SOP is applicable for operation and calibration of UV cabinet in Quality Control Department. Ensure that the power supply to the instrument is switched OFF before cleaning. Clean the apparatus with a clean dry cloth every day. Once in a week remove adhered dust by wet mopping using detergent solution . Afterwards wipe the surface with a clean dry cloth to remove traces of detergent . UV Cabinet , Afterwards wipe, observation, compartment

To lay down the procedure for operation of sieve shaker (Retsch). This SOP is applicable for sieve shaker in Quality Control Department. Connect the instrument to 230 volts A/C power supply. Turn the main switch on, located at left-front side of the instrument. A led light glows on the interval OFF and two bars of light glows on the time mode. Set the required vibration height by using rotating knob. The Vibration height displays on the front of the sieve plate. Sieve Shaker , Vibration, instrument, completion, sieve

To lay down the procedure for operation of polarimeter. This SOP is applicable for polarimeter in Quality control department. Connect the instrument to 230 volts A/C power supply. Ensure the lid is closed. Switch on the instrument. Instrument initializing is displayed in the screen. After initialization of instrument select the lamp. Select and Press Na/Hal or Hg button, automatically lamp will be on. Wait for 10 minutes (Lamp warming). Polarimeter , Normal aperture, concentration , integration, instrument

To lay down the procedure for operation of HPLC (Waters alliance with PDA) configuration. This SOP is applicable for operation of HPLC (Waters alliance with PDA) in Quality control department. Connect the instrument to 230 volts A/C power supply. Switch on the instrument. Connect the required column as per standard test procedure for the sample analysis and column shall be equilibrated by using water: methanol (50:50)/water: acetonitrile. alliance, HPLC Waters , equilibrated, instrument method, acquisition

To lay down the procedure for operation of HPLC (Agilent) configuration. This SOP is applicable for operation of HPLC (Agilent) in Quality control department. Connect the instrument to 230 volts A/C power supply. Switch on the instrument by pressing switch to turn on the variable wavelength detector, autosampler, pump and vacuum degasser one by one. wavelength detector , auto sampler, pump, vacuum, Millennium icon , logbook, O peration Of HPLC (Agilent)

To lay down the procedure for operation of visible melting range apparatus. This SOP is applicable in melting range apparatus Quality control department. Connect the instrument 230 volts A/C power supply and switch on the instrument and TV monitor. The LCD monitor will automatically on by one display as follows. Now after press ‘ENTER’ key instrument gives Beep and returns to Program screen. Melting Range , Apparatus, Quality Control , spatula

To lay down the procedure for operation of HPLC (Waters 600E connected with 2487 detector/Waters 1525 with 2487 detector) configuration. This SOP is applicable for operation of HPLC ( Waters 600E with 2487 detector/Waters 1525 with 2487 detector ) in Quality control department. Connect the instrument to 230 volts A/C power supply. Switch on the 600 E pump/1525 pump. Liquid Chromatograph , Waters, power supply, Millennium icon , filters

To lay down the procedure for operation of metrohm – 701 KF titrino. This procedure is applicable in Quality Control department. Switch on the instrument at the rear side of KF titrino. “KFT” shall display. Fill the reservoir with AR grade methanol. Fill the reagent bottle located on the exchange unit with KF reagent. Switch on the 701 KF Titrino, Metrohm ,  cond, mode, start, enter,  701 KF Titrino

To lay down the procedure for operation of JASCO–P–1030 POLARIMETER. This procedure is applicable for Quality Control Department (Block-D). Switch on the main instrument, which is placed left corner of the rear side. switch on the computer. Double click on JASCO – P – 1030 Icon on the desktop. A Spectra Manager window will appear on the screen. Double click on standard menu.  A initialization dialogue box will appear on the screen. Initialization takes about 5 minutes. Polarimeter , Jasco P, cell chamber , instrument, Rotation

To lay down the procedure for operation and calibration malvern mastersizer – 2000. This SOP is applicable in quality control department. Switch on the accessories. Switch on the instrument, which is placed on the end of the panel. Switch on the computer and start the software by double click on the Mastersizer Malvern 2000 Icon on the desktop. Enter the username and click O.K. Mastersizer , Malvern, Calibration, stirring, electrical background

To lay down the procedure for operation of Bandelin Sonorex - Sonicator. This procedure is applicable in Quality Control department. Check whether the side knob is closed. This knob is opened for draining the water from the instrument and kept closed while filling the water in the instrument and when the instrument is in use. Open the top lid and check the level of water. The optimum level is at least 2/3 height of the vessel. Sonicator , Sonorex , Bandelin, cleaners, chlorinated, humid cloth

To lay down the procedure for operation of Merck Digital Burette. This procedure is applicable for Quality Control department. Fix the Burette to the Bottle containing required titrant as per STP. Switch on the Burette by pressing the upper on/off part of the on/off – Clear button. The display is 00.00.  If some other reading is displayed, then press the lower clear part of the on/off – clear button. Merck, Digital Burette , Clear button, fill button, burette, digital display

To lay down the procedure for operation of THERMOLAB – Hot water bath. This procedure is applicable in Quality Control department. Remove the lid of the water bath provided at the top. Fill water in the bath to a level such that the vessel base is sitting properly over the bottom base of the water bath. Switch on the mains switch of the instrument. Switch on the Stirrer switch also. This ensures uniform temperature throughout the water bath. Hot Water , Thermolab, bottom, downward, temperature

To lay down the procedure for operation of THERMOLAB – Muffle Furnace. This procedure is applicable for Quality Control department. Open the square door of the Muffle furnace. Take the sample to be dried in a suitable container and keep it inside the furnace and close the door. For setting the required temperature, in the temperature indicator, press the PV/SV (process/set) key. Muffle Furnace , Thermolab, PV OR SV key, upward, attained

To lay down the procedure for operation of THERMOLAB – Oven. This procedure is applicable in Quality Control department. Switch on the Mains switch. For setting the required temperature, in the temperature indicator, press the upward key to increase the temperature and press the downward key to decrease the temperature. The temperature changes are highlighted in green color reading that is meant for set value (SV). Thermolab Oven , upward key, process value, highlighted, stabilizes , temperature

To lay down the procedure for operation of Metrohm 794 Basic Titrino. This procedure is applicable for Quality Control department. Switch on the Instrument and the PC. Double Click on the Tinet 2.5 Icon. Metrohm Tinet window appears on the screen. Click Methods on Metrohm Tinet window. Go to File / New. A window appears with two Icons. First Icon is start Icon. Second Icon is Edit Icon with three dots on it. Select Titration / DET or MET (Mode of titration) / U or pH (Measured quantity) and Click. Titrino , Titrino, Print immediately, Store Method, electrode, prompted

To lay down the procedure for operation of western - cooler. This procedure is applicable in Quality Control department. Turn on the mains switch. Open the door by pulling it towards us. Rotate the knob provided at top compartment in clock-wise or anti-clock-wise and set the temperature as required. Close the door by holding the handle and pushing it away from us. Do not turn off the mains switch and always keep it under on condition. Western Cooler , clock wise, pushing, knob , pulling

To lay down the procedure for operation of AG285 - METTLER TOLEDO Analytical balance. This procedure is applicable Quality Control department. Ensure that the working area and Balance is clean. Clean the weighing pan with small brush. Check all the doors of the balance are closed. Adjust the spirit level of the balance to center by rotating the Leveling knobs provided at the bottom backside. Switch on the balance by pressing On/Off button. Analytical Balance , Mettler Toledo , weighing, stabilizes , green button

To lay down the procedure for maintenance of registers in quality control department. This procedure is applicable for Quality Control Department. All the registers used in the quality control department shall be numbered. One register shall be maintained for the inwarding of registers, which is called register of registers. Registers shall be issued by Executive and above. All the registers received shall be entered into the register of register with the following details. Maintenance , Registers , inward, mentioned , equential number

To lay down the procedure for maintenance of equipment logbook. This procedure is applicable for Quality Control Department. An equipment log is to be maintained each and every instrument used in the Quality Control department as per Format No. xxxxx. Whenever the particular equipment used for the analysis, details of the sample analysed should be entered information like description of the sample, Batch number / A.R.No., test, time and signature of the user . Equipment , logbook , instrument, activity

This SOP covers the cleaning and sanitization of stability chamber and is applicable to all stability chambers at Unit- I. Stability chambers are cleaned and sanitized once in 3 Months or whenever Spillage occurs which ever is earlier as per the following procedure. Switch OFF the stability chamber. Remove the power cord and close the purified water valve. Empty the water bath . Clean the water bath with a cloth. Sanitization , stability chamber , inner walls, water bath

To lay down the procedure for operation of AG285 - METTLER TOLEDO Analytical balance. Ensure that the working area and Balance is clean. Clean the weighing pan with small brush. Check all the doors of the balance are closed. Adjust the spirit level of the balance to center by rotating the Leveling knobs provided at the bottom backside. Switch on the balance by pressing On/Off button. Analytical Balance , Mettler Toledo , weighing, stabilizes, green button

To lay down the procedure for maintenance of registers in quality control department. All the registers used in the quality control department shall be numbered. One register shall be maintained for the inwarding of registers, which is called register of registers. Registers shall be issued by Executive and above. All the registers received shall be entered into the register of register with the following details. Maintenance, Registers , inward, mentioned, equential number