Pharmaceutical Guidelines

 SOP for Vortex Mixer Standard operating procedure to mix the solution or to dissolve the various substance in to solvent. 1.0 Objective To define the operation of the instrument for better and error-free use of the same. 2.0 Scope This procedure is applicable to mix the solution or to dissolve the various substance into the solvent. 3.0 Responsibility 3.1 Doing: Technical Assistant / Executive 3.2 Checking: Executive/Manager 4.0 Accountability Head of the Department 5.0 Procedure 5.1 Switch “ON” the mains. 5.2 Switch “ON” the instrument. 5.3 Red light will glow. 5.4 Put the test tube on the rubber pad. 5.5 Set the speed with the help of the knob. 5.6 On completion turn the speed knob anticlockwise. 5.7 Switch “OFF” the instrument. 5.8 Switch “OFF” the mains. 6.0 Abbreviations Nil

 SOP for Technology Transfer Standard operating procedure for transfer the pharmaceutical product manufacturing technology from one site to another. 1.0 OBJECTIVE: To lay down the procedure that the required information, data and technology about the product, processing and analysis is transferred and available at the site so that quality and integrity are maintained. 2.0 SCOPE: This SOP shall be applicable to the new products which are transferred from R&D or all other product from one site to another site or from contract giver. 3.0 RESPONSIBILITY: R&D Head / Head QA & QC / GM-Production / Unit Head / Contract Giver. 4.0 ACCOUNTABILITY: Head- QA & QC 5.0 PROCEDURE: 5.1 Ensure the new product proposal is approved by QA. 5.2 Manufacturing license for a commercial production or test license for registration batches for the proposed product shall be obtained from local FDA. 5.3 Technology transfer documents shall be received from R&D or contract giver. 5.4 Analyti...

  SOP for Sampling and Testing Schedule of Purified Water Standard operating procedure for schedule & frequency for testing, locations for sampling and type of analysis required to be carried out for the Purified water for monitoring & assurance of its quality. 1.0 OBJECTIVE To define the schedule & frequency for testing, locations for sampling and type of analysis required to be carried out for the Purified                                                                                      water for monitoring & assurance of its quality. 2.0 SCOPE This Procedure is applicable during sampling and analysis of purified water. 3.0 RESPONSIBILITY 3.1 Doing: Tech.Assistant (Microbiologist) 3.2 Checking: Executive/Manager 4.0 ACCOUNTABILITY Head of the Departm...

 SOP for Safety in Laboratory Standard Operating Procedure of safety in quality control laboratory during analysis of pharmaceutical products and raw material. 1.0 OBJECTIVE To describe a procedure for maintaining safety in the laboratory. 2.0 SCOPE This procedure applies to the quality control laboratory in the manufacturing facility. 3.0 RESPONSIBILITY 3.1 Officer – Quality control 3.2 Executive –Quality control 4.0 ACCOUNTABILITY Manager - Quality control 5.0 PROCEDURE 5.1 Guidelines for personal laboratory safety 5.1.1 Eating, drinking or smoking in the laboratory should be strictly prohibited. 5.1.2 Use safety goggles for eye protection while handling corrosive and highly toxic materials. 5.1.3 Wear lab coats when handling corrosive, toxic, or flammable materials. 5.1.4 Wear gloves when handling corrosive and highly toxic materials. 5.1.5 Know where safety equipment (eyewash, extinguishers) is located and how to use it. 5.1.6 Do not carry corrosives by the mouth of the bottle....

 SOP for Operating Procedure of Water Bath Standard operating procedure of water bath in microbiology laboratory. 1.0 OBJECTIVE To lay down the procedure for operation of the water bath. 2.0 SCOPE This procedure is applicable to the water bath, installed at Microbiology laboratory in QC. 3.0 RESPONSIBILITY 3.1 Doing: Technical Assistant 3.2 Checking: Executive/ Manager 4.0 ACCOUNTABILITY Head of the Department 5.0 PROCEDURE 5.1 Ensure that the platform is dry. 5.2 Connect the power supply. 5.2 Ensure the water level in water bath. It should be sufficient to pour the heating element. 5.4 Switch “ON” the main power supply and instrument mains. 5.5 Temperature setting Press SET key-ALI red LED becomes “ON”-lower display will show SP- Upper display of last stored value. The last digit will show blinking –Press UPkey to increase the value-After getting desired value .Press SHIFT key to shift the digit-Now 3rd digit will show blinking-Press UP key to get desiredvalue-proceed similarly fo...

  SOP for Cleaning of Coulter Counter Standard operating procedure to clean the coulter counter. 1.0 OBJECTIVE To clearly lay down procedure for cleaning . 2.0 SCOPE This procedure is applicable to coulter counter, installed in quality control department . 3.0 RESPONSIBILITY 3.1 Doing : Technical Assistant 3.2 Checking : Executive/Manager 4.0 ACCOIUNTABILITY Head of the Department 5.0 PROCEDURE 5.1 After completion of the testing, switch ‘OFF’ the instrument. 5.2 Switch ‘OFF’ the mains. 5.3 Open the door and remove the sample holder. 5.4 Clean the sample holder with water and finally with 0.2μ filtered water and mop with tissue paper . 5.5 Clean the tube and waste jar with water and finally clean with cotton cloth . 5.6 Remove orifice and wash it with dilute nitric acid and then with water. 5.7 Clean the outer surface of instrument with cotton cloth. 5.8 For the cleaning of internal part fill the vacuum flask with 0.2μ filtered water for injection and pass it through vacuum filling...

SOP for Calibration of pH Meter Temperature Sensor Standard operating procedure for the calibration of pH meter temperature sensor using water for injection (WFI) / purified water (PW).   1.0 Objective To provide a standard operating procedure for the calibration of pH meter temperature sensor.   2.0 Scope This procedure is applicable to pH meter.     3.0  Responsibility   Doing: Technical Assistant/Executive   Checking: Executive /Manager   4.0 Accountability :  Head of the Department Procedure Frequency: Twice in Year. Calibration Procedure for pH meter temperature sensor.   Keep the sensor probe of reference calibrated digital thermometer in the beaker containing water for injection (WFI) / purified water (PW) of about temperature 35°C. Add cold WFI/PW slowly drop wise and bring the temp. between 27°C to 30°C. Compare the temp. shown by reference calibrated digital thermometer and pH meter & record it in...