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...