cGMP and Regulatory Updates

1.0 DESIGN QUALIFICATION 1.1 Define the Biometric Technology Used. It’s Principle and Capturing System. E. g 1.2 Define the Extraction and Comparison Process Specify how the system will extract the captured data and convert into mathematical Code /template for comparison purpose. Specify the threshold value for the purpose of comparison. 1.3 Define Vendor Qualifications for Biometric System. - Number of Biometric System installed. - Types of the technology used. - Type of post marketing feed back received by him. 1.4 Define Final Specifications and Acceptance Criteria agreed between Vendor and User. - Technology to be used. - Capturing device to be used. - Extraction and Comparison system to be used. - Threshold value for the match. - Maximum Failure rate (False Rejection, False Acceptance) per day. 2.0 IQ FOR BIOMETRICS 2.1 Check the computer system where it will be installed. - Check the drive. - Check the space required. - Check the ancillary softwares required on Computer. - Check ...

CHECKLIST-Design Inputs for New Computer Systems A Purpose of System i) Clear statement of what the system is to do. ii) Expected benefits. iii) Relation to other system. 1.0 Controlled Function 1.1 Operating Modes a) Automatic mode. b) Manual mode. c) Maintenance mode. d) Operational interlocks. 1.2 Description of Operations. a) Sequence of operation. b) Modifiable parameters. c) Limiting conditions. 1.3 Controlled elements. a) Valves, heaters, motors…… b) I\P, relays, solenoids, motor starters …. 2.0 Computer System 2.1 Hardware. a) CPU b) Memory devices. c) Recording devices. d) Communication interfaces. e) Operator terminals 2.2 Software a) Operating System b) Communication drivers. c) Network Controllers. d) Configurable Programs. e) Application Programs 3.0 Information Input 3.1 Measured Inputs a) Number, Type, and location of each sensor. b) Type, Model Number, and software version of all transducers and signal converters. c) Model number and software version of all analog input...

1.0 PURPOSE This procedure is provide a documented procedure and this procedure is Labelling and Packing department of production in Operation and Cleaning Process. 2.0 SCOPE This procedure is applicable to procedure of Operation and Cleaning of Packing Line in packing department at Vital Healthcare. 3.0 RESPONSIBILITY It is responsible for production chemist / packing supervisor. 4.0 PROCEDURE 4.1 Pre Start Up a) When same batch of the same product is to be continued from the previous shift. b) Ensure that the packing material of the same batch is kept near the line. c) When new pack of the same batch No. or new batch No. of same product or different product is to be taken on the packing line. d) Physically check the cleanliness of the packing line as per the packing line clearance. e) Record the previous product batch details and next product batch details in the space specified. f) Get the line clearance checked by production supervisor and cleared by Quality Assurance supervisor an...

Remov Contaminated Oil 1) Run pump for a few minutes to heat up the oil. Stop pump. 2) Place a 2-3 inch wooden block under the end opposite the drain valve. 3) After completely draining the contaminated oil, pour equivalent quantity of fresh oil into the intake port. 4) Open exhaust port and operate pump for about 1 minute with the intake port alternately open and closed to circulate the fresh oil. 5) Repeat above steps as many times as necessary until you flush clean oil from the pump. 6) Fill with clean oil to the indicated level. 7) Start the pump and check for a) Operating pressure b) Leaks in the system If leak is suspected check each hose clamp and equipment’s at the joints to make sure they are tight. Please Note : Check for proper connectivity of vapour trap This will prevent release of vapours in to atmosphere.

1. It should be ensured that the drier is clean and ,fit for use (see document entitled "Cleaning of Fluid Bed Drier). 2. The cleaned bags should be examined to ensure that they are free from holes and other defects. 3. The finger sleeves of the bag should be fixed to the respective hooks on the holding ring. The bag support frame should be inserted and the filter bag unit should be clipped to the retaining strap. 4. The cleaned bowl of the drier should be examined to ensure that the inner surface is clean and that there is no damage to the wire mesh sieve at the bottom. The bowl should be labeled with the name and batch number of the product being processed. 5. The wet material (to be dilled) should be loaded into the bowl and the mass spread uniformly. The trolley carrying the bowl should then be wheeled in and positioned beneath the sealing ring in such a way that the sight glass is in the front and the bowl raising lever on the base is accessible. 6. The earthling should be cl...

Check the blender status. It shall be clean and ready for use. In case it is not clean, get the same cleaned and ready for use. 1.0 If the materials required for a batch are dispensed from a central dispensary, all the weighed materials should be collected as one batch per pallet (wherever possible.) The pallet should be clean and no material should be received in dirty containers or in the original containers of the suppliers. 2.0 Each raw material from the central dispensary should be weighed to verify the gross weight indicated by the dispensing depat1ment. 3.0 Any discrepancies in the weight should be suitably rectified. 4.0 The weights should be recorded on the manufacturing sheets and countersigned by the supervisor. 5.0 If the materials are dispensed from the stores, they should be weighed on appropriate scales with adequate capacity and sensitivity (see document entitled Weighing of Materials ). 6.0 It must be ensured th...

1.0 INTRODUCTION In the final stages of manufacture of bulk drugs, it is necessary to clarify the reaction mixture to remove extraneous and other suspended matter which may be present. This is done by means of filtration of the reaction mixture. This document gives the procedure for clarification of reaction mixtures by filtration through horizontal plate filters. 2.0 PRECAUTIONS a) It is advisable to use freshly boiled and cooled purified water . b) The suitability of the filter paper and filter cloth used for filtration must be ascertained before use. c) It must be ensured that flexible tubings used in the filter asembly have been cleaned. Where they have been stored away after cleaning, the open ends should have been covered with polythene sheets. If this has not been done or there is evidence of dust on the tubings, they should be cleaned and dried before use. 3.0 SETNNG OF THE FILTERATION MACHINE a) All the removable parts of the filter assembly should be cleaned with hot water an...

1.0 PURPOSE This SOP describes the procedure of using D. G. Set. 2.0 RESPONSIBILITY Responsibility of this operation is with maintenance department. 3.0 PROCEDURE a) Check battery voltage. b) Check suction air filter. c) Check lubricant oil in oil pan. d) Check diesel level in service tank. e) Check water level in Radiator. f) Check V belts. g) Check the cleaning of Radiator. h) Confirm that the capacitors of main panel are off. i) Insert the key in control panel and press the bypass (yellow) button with one finger and press Green Start button for few seconds and release .DG will get started .DO NOT PRES GREEN BUTTON ONCE DG STARTS. j) Check oil pressure. temperature. k) Check speed , it should be 1500 rpm. l) Check frequency, it should be 49.5 to 50.5 cps. m) Check voltage an...

1.0 PURPOSE This SOP describes the procedure of using Chilling Compressor 2.0 RESPONSIBILITY Responsibility of this operation is with maintenance department. 3.0 PROCEDURE a) Check voltage on panel . it should be 400 v to 440 v b) Check oil level . c) Ensure suction valve is closed and discharge valve is open. d) Check ammonia level in tank. e) Start condenser cooling pump. f) Check inlet valve of condenser cooling, inlet cooling of jacket and outlet valve of jacket cooling are open. g) Check brine level in brine tank and specific gravity of brine. h) Start brine pump. i) Start compressor and wait till comes on load . j) Open suction valve and check suction pressure. k) Check oil pressure ,it should be 1 kg/cm2 above suction pressure. l) Check suction delivery and oil pressure every two hours.

1.0 PURPOSE This SOP describes the procedure of using Boiler. 2.0 RESPONSIBILITY Responsibility of this operation is with maintenance department. 3.0 PROCEDURE a) Check water quality and water level in the service tank. b) Check feed water pump for leakage. c) Check oil pump. d) Check fuel oil level in the service tank. e) Close main steam valve and start feed water. f) Open bypass valve and ensure that water is passing through blow down line. g) Start burner, temp will start rising ,when steam goes out of blow line close bypass valve. h) Pressure starts rising and boiler will get cut off at 10 kg/ cm2 i) Give blow down and observe blow down time. j) Repeat steps ( f) to (i). k) Open main steam valve to plant. l) Check smoke color and adjust blower and oil pressure. m) Note down pressure, temperature, oil pressure every hour. n) Give blow down after every 4 hours. o) After closing the boiler do not forget to cool it for 30 min. by circulating water.

1.0 Preferred room temperature should be around 25°C. 2.0 Fix all the fingers of the dryer bag securely to the apex which must be earthed. Do not patch up the tom bag by a synthetic cloth. It is dangerous from electrostatic hazard point of view. 3.0 Check that the bowl is free of a metal piece. The frictional spark could be externally dangerous. Lift the bowl pneumatically. 4.0 Check that all the detachable parts of the dryer are properly earthed. 5.0 Start the dryer, if there exists any discontinuity electrically the interlocking would not actuate starting of the dryer. Do not make short cuts by isolating the safety device. 6.0 Run the dryer for 15 minutes with cold air only. Start heating of air by hot water / steam only. 7.0 Monitor fluidization of the batch and maintain specified temperature of air inlet and outlet. 8.0 Beware of the hazard due to sharp p...

1.0 AIM To lay down a standard operating procedure for pressure quartz filter. 2.0 SCOPE Maintenance Department 3.0 AREA OF OPERATION Maintenance Department. 4.0 RESPONSIBILITY Operator/Maintenance Supervisor concerned. 5.0 ACCOUNTABILITY Maintenance Incharge. 6.0 NORMAL OPERATION Put ON Green push button of raw material pump. Open valves 1 & 2, get filtered water from the plant. 7.0 AIR SCOURING a) Open valves V6 and V5 to loosen the accumulated dirt from the filter media. This operation is carried out for 1.5 to 3.0 minutes at the rate 2 m_3_/hr. at 0.35 kg/cm_2” pressure. 8.0 BACK WASHING OPERATION 8.1 Close valves 1 & 2 and open valves 3 & 4 to remove accumulated dirt and clean filter bed till clear water comes out in the drain. It will take about 5 minutes. 8.2 Back wash the filter after every week in running of the plant. 9.0 REVIEW DATE After 2 years or when procedure is changed.

1.0 AIM To lay down a standard operating and cleaning procedure for Multicolumn distillation still. 2.0 SCOPE Maintenance Department 3.0 AREA OF OPERATION Multiple column and surrounding area. 4.0 RESPONSIBILITY Operator/Maintenance Supervisor concerned. 5.0 ACCOUNTABILITY Maintenance Head. 6.0 PRE-START UP 6.1 Check the cleanliness of still. 6.2 Check dry saturated steam supply after PRV it should be 4.8 to 6 Kg/Cm_2_. 6.3 Check the conductivity of D.M. Water and it's supply. 6.4 Compressed air supply should be 6 Kg/Cm_2_. 6.5 Check the cooling water supply; and it's pressure should be 1 to 1.8 Kg/Cm_2_. 6.6 Check the emergency stop button is in released position. 7.0 START UP 7.1 Keep the main switch ON position. 7.2 Keep the control on rotary switch in ON position. 7.3 Set high and low steam temperature limits on Temp. Indicator Controller 7.4 Set high and low distilled water temperature limits on Temp. Indicator Controller. 7.5 Set conductivity limit...

1.0 AIM To lay down a standard operating procedure for L.V. Panel. 2.0 SCOPE Maintenance Department 3.0 AREA OF OPERATION Maintenance department. 4.0 RESPONSIBILITY Operator/Maintenance Supervisor concerned. 5.0 ACCOUNTABILITY Maintenance Incharge. 6.0 CHANGE OVER OPERATION M.S.E.B. & D.G. SET. 6.1 If M.S.E.B. supply fails, the Air Circuit Breaker on L. V. Panel gets trip automatically and OFF indication comes. Then turn the interlock key anti clockwise and remove from A.C.B. key slot. 6.2 Start D. G. Set, raise voltage to read to 415 volts on voltmeter (placed on change over side) on the L. V. Panel Board, Push the interlock key in the key slot of change over switch. (Marked as D. G. Set) and turn it clockwise. Make the change over switch ON. 6.3 When M.S.E.B. supply comes the Voltmeter on Air Circuit Breaker (A.C.B.) side indicates the voltage. Check the voltage indicated to 415 volts. Switch OFF change over switch and turn interlock key anti clockwise and remove from key slot. 6...

1.0 AIM To lay down a standard operating procedure for Boiler. 2.0 SCOPE Maintenance Department 3.0 AREA OF OPERATION Boiler House. 4.0 RESPONSIBILITY Operator/Maintenance Supervisor concerned. 5.0 ACCOUNTABILITY Maintenance Incharge. 6.0 STARTING PROCEDURE: (BOILER) 6.1 Open the valves on water supply line and fuel supply line. 6.2 Put the electric main switch 'ON'. 6.3 Close the main steam valve and open the auxiliary steam valve. 6.4 Put the FILL switch 'ON' to fill up the coil and check the water is coming out from the auxiliary drain pipe. 6.5 Press FUEL CIRCULATION switch for about half a minute. 6.6 Put the FIRE switch ON. Check the BURNER ON Green lamp comes ON. If Heater gives a larm check the boiler trouble shooting problem, rectify it and then start the boiler again. 6.7 Observe the steam is coming out from the auxiliary valve drain pipe. Then stop the auxiliary valve and open main steam valve. 6.8 Check the following operating conditions of boiler during the...

1.0 AIM To lay down a standard operating procedure for Air Compressor. 2.0 SCOPE Maintenance Department 3.0 AREA OF OPERATION Maintenance area. 4.0 RESPONSIBILITY Operator/Maintenance Supervisor concerned. 5.0 ACCOUNTABILITY Maintenance Incharge. 6.0 STARTING PROCEDURE: (AIR COMPRESSOR) 6.1 Remove moisture Air receiver by opening the drain valve. 6.2 Observe crank case oil is 3/4 to 1/2 level of sight glass if not make crak case oil level with fresh oil. 6.3 Turn on full supply of cooling water by opening gate valve on cooling water line. 6.4 Put main switch ON press the green bush button of pressure control switch, then push the start push button & press the pressure control push button till the motor goes from start to Delta connection. 6.5 Operate the Air Compressor in following operating conditions- a) Oil pressure should be in between - 15 to 40 PSI b) Loading and unloading pressure should be in between6.2 kg/cm”2_. 6.6 Note down the operating conditions in dialy log-book. 7.0...

1.0 AIM To lay down a standard operating procedure for A/C Compressor. 2.0 SCOPE Maintenance Department 3.0 AREA OF OPERATION Air conditioning room. 4.0 RESPONSIBILITY Operator/Maintenance Supervisor concerned. 5.0 ACCOUNTABILITY Maintenance Incharge. 6.0 STARTING PROCEDURE: (A/R COMPRESSOR) 6.1 Put ON main switch in the control panel. Main switch should kept on for one hour before starting the A/C compressor for heating the crank case oil. 6.2 Confirm compressor crank case oil level is 1/2 to 3/4 of the sight glass. 6.3 Make the minimum basin level of the cooling tower sump by opening the Gate Valve on the water supply line. 6.4 Start all AHU in various departments. 6.5 Open gate valves on cooling water and chilled water line. 6.6 Start cooling water pump, cooling tower and chilled water pump by Green push button in the control panel. 6.7 Put ON all the toggle switches in the control panel. 6.8 Press P.D.S. repeatedly to equalize the system. Start A/C compressor by pushing start Green...

1.0 Procedures a) Before Starting the Engine ,ensure the generator is set up for the correct voltage, Check owners operation manuals and wiring diagrams for the correct hook ups prior to starting the generators. b) Ensure the generator output breaker is in the OPEN position. c) Never start or stop a generator with the output breaker in the CLOSED position. d) Check all liquid levels of the diesel engine: water, oil, fuel. Add any fluid if required. e) Ensure the generator , radiator, and control cabinet louvers are open for proper air flow across the engine and generator . f) While performing the generator checks, wear work gloves and safety shoes. When checking the battery, or adding water to it wear acid resistant gloves and safety goggles. Check Generator Voltage and Phase Rotation g) Start the generator and check the generator voltage(all pha...

Principle: Filterable products are separated in a perforated basket. The liquid/solid slurry is introduced into the rotating body of the centrifuge via a feed pipe. The centrifugal force pushes the slurry to the side, forcing the liquid through the perforations in the basket while the solids are retained within by means of a fine screen or cloth. The remaining solids (cake) can then be washed and spun at higher Cs to achieve a relatively dry cake. The resultant cake is then discharged through the bottom of the basket by means of a single motion plow mechanism. Install a clean filter bag Securing the lid Connect the three process lines on the cover, Start the centrifuge. Adjust the machine speed via the speed controller. When the tachometer indicates that the machine is at feed speed, the process slurry is introduced into the rotating bowl. Solid particulate accumulates in a uniform ring on the bowl’s inside diameter while ...

1.0 OBJECTIVE: To lay down an approved procedure for the Preparation, Distribution, Review, Retrival and Archival of Standard Operating Procedure 2.0 SCOPE: This procedure is applicable to the preparation, distribution, review, retrival and archival of Standard Operating Procedure used in Quality Assurance, Quality Control, Production and Stores Departments. 3.0 RESPONSIBILITY: Manager-Quality Assurance 4.0 ACCOUNTABILITY: General Manager 5.0 DEFININTIONS: 5.1 Standard Operating Procedure: Standard Operating Procedure is a logical sequence of events in instructional form for performing the activities. 5.2 Master Copy: The first copy of Standard Operating Procedures that bears original signatures are stamped ‘MASTER COPY’ in red ink, at the top left corner. 5.3 Controlled Copy: A photocopy of the Master Copy along shall be stamped as ‘CONTROLLED COPY’ in Green ink with Sign and Date at the bottom left corner that shall be used with in the organization and is distributed to a limited num...