SOP on Container Closure Integrity Testing (CCIT) for Dry Powder for Injection 1.0 Objective 1.1 To lay down the procedure for performing Container Closure Integrity Testing (CCIT) for Dry Powder for Injection using Chemical (Dye Ingress) Method and Microbial Challenge Study. 2.0 Scope 2.1 This SOP is applicable to Container Closure Integrity Testing of Dry … Read more
SOP FOR ANALYST QUALIFICATION FOR MICROBIOLOGICAL ANALYSIS 1.0 OBJECTIVE To establish a standardized procedure for qualification and requalification of analysts performing microbiological analysis to ensure competency, accuracy, and compliance with regulatory requirements. 2.0 SCOPE This SOP applies to all microbiologists working in the Microbiology Department involved in microbiological testing activities. 3.0 RESPONSIBILITY 3.1 Trainee Officer … Read more
SOP for PROCEDURE FOR MICROBIAL LIMIT TEST 1.0 OBJECTIVE To establish a standardized procedure for determining microbial load, including specified pathogenic microorganisms, in raw materials and finished products using the Microbial Limit Test (MLT). 2.0 SCOPE This procedure applies to the analysis of microbial contamination and specified pathogens in raw materials and finished pharmaceutical products … Read more
Questions & Answers Disinfection in Pharma EUGMP- Annex-1 Questions 1. According to section 4.33, what is required before disinfection can be effective? A. Temperature controlB. Prior cleaning to remove surface contaminationC. Use of a sporicidal agentD. Personnel training Answer: B Questions 2. Cleanrooms should be cleaned and disinfected: A. Only during shutdown periodsB. Once a monthC. … Read more
Environmental and personnel monitoring – viable particle EUGMP- Annex-1 Questions 1. Microbial monitoring in aseptic operations should be: A. RareB. Performed only weeklyC. FrequentD. OptionalAnswer: C Questions 2. A combination of methods for microbial monitoring may include: A. Chemical analysisB. Settle plates, air sampling, glove, gown, surface samplingC. Weight measurementsD. Only visual inspectionAnswer: B Questions … Read more
ENVIRONMENTAL MONITORING BY SETTLE PLATE METHOD OBJECTIVE: To lay down a procedure Environmental monitoring by settle plate method. SCOPE: This SOP is applicable for Environmental monitoring by settle plate method of this organization. RESPONSIBILITY: Quality control – Executives Quality control – Officer (microbiologist) ACCOUNTABILITY: Quality control – Head PRECAUTIONS : Glass wares employed for sampling should be … Read more
ENVIRONMENTAL MONITORING BY AIR SAMPLING METHOD OBJECTIVE: To lay down a procedure Environmental monitoring by Air sampling method. SCOPE: This SOP is applicable for Environmental monitoring by Air sampling method of this organization. RESPONSIBILITY: Quality control – Executives Quality control – Officer (microbiologist) ACCOUNTABILITY: Quality control – Head ABBREVIATIONS: SCDA: Soya bean Casein digest agar PRECAUTIONS: Before … Read more
Personal monitoring by contact plate method in sterility testing area. OBJECTIVE: To lay down a standard operating procedure for personal monitoring by contact plate method in sterility testing area. SCOPE: This SOP is applicable for personal monitoring by contact plate method in sterility testing area. RESPONSIBILITY: Quality control – Executives Quality control – Officer (microbiologist) ACCOUNTABILITY: … Read more
SOP on container closure integrity for Dry powder for injection Objective : To lay down the procedure for container closure integrity for Dry powder for injection. Scope: This SOP is applicable for container closure integrity for Dry powder for injection. Responsibility: Officer or above of Microbiology Laboratory. Head – Microbiology section. Accountability: Head – Quality Control. Procedure: Chemical … Read more
SOP on container closure integrity for Dry powder for injection Objective : To lay down the procedure for container closure integrity for Dry powder for injection. Scope: This SOP is applicable for container closure integrity for Dry powder for injection. Responsibility: Officer or above of Microbiology Laboratory. Head – Microbiology section. Accountability: Head – Quality Control. Procedure: Chemical … Read more