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