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 (design certificate, or DQ); b) Premises, supporting engineering networks and equipment were built installed in accordance with their design specifications (installation qualification or IQ); c) The premises, support facilities and equipment functioned in accordance with their design sp
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 as far as possible from strong magnetic or electric fields. 6.4 Avoid strong vibration or sunlight. 6.5 Protect the device from dust and corrosive gases 6
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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PARACETAMOL (ACETAMINOPHEN) TOXICITY , SPECIFIC INGESTION & TREATMENT :
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01-SOP FOR IN PROCESS CHECKS DURING MANUFACTURING AND PACKING (PHARMACEUTICAL)
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TIPS TO MANAGE MENTAL HEALTH
QUALITY MANAGEMENT IN THE DRUG INDUSTRY
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THEOPHYLLINE TOXICITY, SPECIFIC INGESTION & TREATMENT :
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HPLC WORKING PRINCIPLE
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Active pharmaceutical ingredient (API)
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QUALITY ASSURANCE
QUALITY ASSURANCE Principle : A broad concept called "Q uality Assurance" encompasses all elements that can have an individual or overall impact on a product's quality. The sum of all the measures made to guarantee that pharmaceutical products are of the quality needed for their intended purpose. Quality assurance consequently takes into account GMP as well as other elements, such as product development and design, that fall outside the purview of following guide. The system of quality assurance appropriate to the manufacture of pharma [1] ceutical products should ensure that: · - Taking into consideration GMP's requirements as well as those of other related codes, such as good laboratory practice (GLP) and good clinical practice (GCP). · - Written specifications for production and control operations and the adoption of GMP standards. · - Job descriptions for managers clearly define managerial responsibilities. ·
HPLC CALIBRATION SOP
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