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
Sampling and testing of Sterile surgical Gloves Objective: To lay down the procedure for Sampling and testing of sterile surgical gloves. Scope: This SOP is applicable for sampling and testing of sterile surgical gloves. Responsibility: Personnel (Microbiology-QC) shall be responsible for sampling and testing of sterile surgical gloves. Executive/ Officer shall be responsible for ensuring the compliance … Read more