TIPS TO MANAGE MENTAL HEALTH
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Qualification and Validation
Qualification and Validation 1- In accordance with GMP, each pharmaceutical company should identify what qualification and validation work is required to demonstrate that it is critical aspects of their particular operation are controlled. 2- Key elements of the company's qualification and validation program should be clearly defined and documented in the master validation plan. 3- Qualification and validation should create and provide documentation proof that: a) Premises, support services, equipment and processes were available designed in accordance with GMP requirements (desig...
SOP FOR DISSOLUTION APPARATUS
Dissolution Apparatus 1.0 PURPOSE: 1.1 It is intended to provide a procedure for the operation of a dissolution Apparatus. 2.0 SCOPE: 2.1 Applies to the chemical section of the quality control department 3.0 LIABILITY : 3.1 Q.C. The analyst is responsible for performing the exact operation. 3.2 Q.C. Manager to ensure accurate operation. 4.0 ABBREVIATIONS : 4.1 Quality Control Q.C 4.2 RPM: revolutions per minute 5.0 INSTRUMENT : 5.1 Dissolution Apparatus 6.0 SAFETY PRECAUTIONS: 6.1 Before turning on the heater switch, make sure that the tank is filled with purified water without a container up to the device mark. 6.2 Do not overtighten the paddle/basket and also do not hold the paddle/basket while it is in operation. 6.3 Place the device a...
SOP FOR HPLC
KNAUER HPLC 1. PURPOSE 1.1. It is intended to provide a procedure for the operation of the HPLC. 2. SCOPE 2.1. It applies to the Azura HPLC present in the quality control department. 3. LIABILITY 3.1. It is the responsibility of the QC Analyst to follow this SOP as written. 3.2. It is the responsibility of the Quality Control Manager to review and update this SOP as necessary and to ensure that this is done 4. ABBREVIATION 4.1. SOP: Standard Operating Procedure 4.2. QC: Quality control 4.3. HPLC: High-Performance Liquid Chromatography 5. SAFETY PRECAUTIONS 5.1. Check all switches. 5.2. Ensure that the operating temperature (25 - 30 C) and humidity (50 - 5%) conditions are observed. 5.3. The UPS is working properly and in good order. 5.4. Make sure all connections are through the UPS and all connecting wires are unbroken. 5.5. Make sure the mobile phase container is connected before turning the switch "ON". 5.6. The knob on the sample injection port should be in the fill po...
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01-SOP FOR IN PROCESS CHECKS DURING MANUFACTURING AND PACKING (PHARMACEUTICAL)
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TIPS TO MANAGE MENTAL HEALTH
03- IN-PROCESS CHECKS OF TABLETS AT COMPRESSION STAGE (PHARMACEUTICAL)
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QUALITY MANAGEMENT IN THE DRUG INDUSTRY
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HPLC CALIBRATION SOP
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HPLC WORKING PRINCIPLE
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QUALITY ASSURANCE
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