Cleaning procedure for Softened Water Storage Tanks To implement the cleaning procedure for Softened Water Storage Tanks. This SOP covers the cleaning procedure for Softened Water Storage Tanks. Procedure: Ensure that there is no production activity in the concerned area. Turn off the tank which should be cleaned and put a sign “UNDER PREVENTIVE MAINTENANCE” … Read more
To implement and procedure of the replacement procedure for the Purified Water Pump. This SOP covers the replacement procedure for the Purified Water Pump. PROCEDURE Ensure that there is no production activity in the concerned area. Turn on the Reverse Osmosis system and put a sign “UNDER PREVENTIVE MAINTENANCE”. Drain water from the purified water … Read more
The procedure of storing uniforms for microbiological analysis To lay down the Procedure of storing uniforms for microbiological analysis This SOP is applicable to provide the long and qualitative operation of UV -cabinets,s and the sterility of used materials. PROCEDURE: General cleaning After another replacement germicidal lamp: Power off the UV cabinet. Thoroughly clean the … Read more
Operation and calibration procedures of viscometer Operation and calibration procedures of viscometer. PROCEDURE Plugin the instrument Start the instrument by pressing the ON/OFF button on the back panel The following is displayed: REMOVE SPINDLE PRESS ANY KEY REMOVE SPINDLE PRESS ANY KEY Remove the spindle and press any key. The following is displayed: REPLACE SPINDLE … Read more
Waste treatment procedure for medicinal products which must be utilized/destructed OBJECTIVE To provide waste treatment procedure for medicines which must be utilized/destructed. SCOPE This SOP is applicable to waste treatment compliance of medicines which must be utilized/ destructed. RESPONSIBILITY Quality Control Analyst shall be responsible for following the procedure mentioned in this SOP. ACCOUNTABILITY QC … Read more
Physical and chemical quality control test of purified water OBJECTIVE To provide the procedure of purified water quality control. SCOPE This procedure is applicable to the quality control of purified water in the sampling point. RESPONSIBILITY Quality Control Analyst shall be responsible to follow the procedure mentioned in this SOP. ACCOUNTABILITY Quality Control and Head … Read more
Refresher training of QC physical-and-chemical laboratory staff OBJECTIVE To provide QC physical-and-chemical laboratory staff with the information about the necessity of refresher training for more effective work. SCOPE This SOP is applicable to QC physical-and-chemical laboratory staff. RESPONSIBILITY Quality Control Analyst shall be responsible for following the procedure mentioned in this SOP. ACCOUNTABILITY QC Head … Read more
Hot plate operation procedure Stuart SD 300 OBJECTIVE To provide the hotplate Stuart SD 300 operation procedure. SCOPE This SOP is applicable to the hotplate Stuart SD 300 operation procedure. RESPONSIBILITY Quality Control Analyst shall be responsible for following the procedure mentioned in this SOP. ACCOUNTABILITY QC Head and QA Head shall be accountable for … Read more
To lay down the procedure of work organization in the microbiological laboratory. It is applicable to the work organization in the microbiological laboratory. PROCEDURE General items The main task of the microbiological laboratory is to control the microbiological purity production environment and products during all manufacturing levels. The microbiological laboratory does analysis of raw material, … Read more
Maintenance of microbiological control and quality: In stability Container-Closure Integrity The ability of the container-closure system to maintain the integrity of its microbial barrier hence, the sterility of a drug product throughout its shelf life, should be demonstrated. Sterility testing at the initial time point is not considered sufficient to demonstrate the microbial integrity of … Read more