Gowning and D-gowning Procedure for workers, staff and visitors in production Department 1.0 OBJECTIVE 1.1 To lay down a procedure to be followed for Entry & Exit of Executives, Staff, and Visitors in production area (gowning and degowning procedure). 2.0 SCOPE 2.1 This standard operating procedure is applicable for the entry in capsule … Read more
operation of double door autoclave 1 OBJECTIVE Double door autoclave is used for sterile zing media, glasswares, equipments, garments, etc. required to be used in microbiology lab. 2 SCOPE This procedure is applicable for operation of double door autoclave which is installed in microbiology lab at ABC pharma . 3 RESPONSIBILITY Microbiologist. 4 … Read more
sop for environment monitoring program OBJECTIVE Lay down the procedure for environment monitoring program. 2.0 SCOPE This procedure is applicable for Drain, Compressed air Nitrogen air, microbiological environmental monitoring of area (Dry powder injection Block I and II /Microbiology laboratory/ Oral solid dose area) and personnel at M/s abc company 3.0 RESPONSIBILITY • Officer … Read more
Preparation Filtration Usage and Destruction of Disinfectant Solution 1.0. OBJECTIVE : 1.1 To lay down a procedure for Preparation , Filtration ,Usage and destruction of Disinfectant Solution. 2.0 SCOPE : 2.1 This procedure is applicable for Preparation , Filtration ,Usage and destruction of Disinfectant Solution in Injection (Parenteral) at ……. 3.0 RESPONSIBILITY : 3.1 … Read more
Media received and preparation Management 1.0 OBJECTIVE Lay down the procedure for Media received and preparation Management 2.0 SCOPE This procedure is applicable for Lab media management at …… 3.0 RESPONSIBILITY • Department microbiologist, officer and executive shall be responsible to follow the procedure of preparation and usage of sterile media as per … Read more
qualification for the personnel entering in to aseptic area 1.0 OBJECTIVE: To lay down a Procedure to define the Standard Operating Procedure for “Qualification for the personnel entering in to Aseptic Area”. 2.0 SCOPE: 2.1 This SOP is applicable for Qualification for the personnel entering into Aseptic Area by Training, Gowning and Microbiological … Read more
sop for calibration and validation of micro autoclave 1.0 OBJECTIVE 1.1 To describe a procedure for calibration and validation of laboratory autoclave. 2.0 SCOPE 2.1 This procedure is applicable for calibration and validation of laboratory autoclave in Microbiology Laboratory 3.0 RESPONSIBILITY 3.1 Officer Microbiologist 3.2 Executive Microbiologist 4.0 ACCOUNTABILITY 4.1 Head – QC … Read more
sop for Sterility failure investigation 1 OBJECTIVE Investigation on sterility failure is required to find out the root cause, and to take the appropriate actions for future analysis. 2 SCOPE This procedure is applicable to find the cause and take preventive action in case of sterility failure detected at abc company 3 RESPONSIBILITY Microbiologist. … Read more
cleaning and operation of discard autoclave 1.0 OBJECTIVE 1.1 To describe a procedure for the operation and cleaning of Discard autoclave in microbiology laboratory. 2.0 SCOPE 2.1 This procedure is applicable for the operation of discard autoclave which is used for discarding used media from various testing in Microbiology Laboratory 3.0 RESPONSIBILITY … Read more
sop for operation of fogger machine 1. OBJECTIVE 1.1 This describes a Procedure for operation of Fogger Machine. 2. SCOPE 2.1 This Procedure is applicable for operation of fogger machine used for fumigation in Production area and Microbiology Laboratory 3. RESPONSIBILITY 3.1 Officer Microbiologist 3.2 Executive Microbiologist 4. ACCOUNTABILITY 4.1 Head –QC 5. … Read more