Single-Use Systems (SUS) & Closed systems EUGMP- Annex-1 Questions 1. Single-use systems (SUS) are used as an alternative to: A. Terminal sterilizationB. Reusable equipmentC. Gowning systemsD. HVAC systemsAnswer: B Questions 2. SUS may consist of: A. Only filtersB. Only sensorsC. Individual components or multiple componentsD. Stainless-steel tanksAnswer: C Questions 3. SUS should be designed to … Read more
Environmental and Process Monitoring EUGMP- Annex-1 Questions 1. The purpose of an environmental monitoring programme is to ensure: A. Faster batch releaseB. That cleanrooms maintain appropriate air cleanlinessC. Operator competencyD. Media sterilityAnswer: B Questions 2. Environmental monitoring programmes must also: A. Increase product shelf lifeB. Detect excursions from environmental limitsC. Eliminate all viable particlesD. Replace … Read more
Environmental Monitoring – Total Particle Monitoring EUGMP- Annex-1 Questions 1. A total particle monitoring program should be established to: A. Reduce batch sizesB. Assess contamination risks and maintain sterile environmentsC. Replace viable monitoringD. Evaluate operator performanceAnswer: B Questions 2. Environmental monitoring limits for Grade D in operation are: A. Fixed by regulationB. Not predeterminedC. Same … Read more
Aseptic process simulation (APS)/ media fill questions EUGMP- Annex-1 Questions 1. What is another name for an Aseptic Process Simulation (APS)? A. Sterility testB. Media fillC. Endotoxin challengeD. Cleaning validationAnswer: B Questions 2. What is the purpose of periodic APS? A. To replace routine monitoringB. To verify the effectiveness of controls for aseptic processingC. To … Read more
Multiple-Choice Questions (MCQs) & answer on cleaning validation Considering Packaging Materials & Tubing and Hoses Questions 1: Which of the following is a primary consideration before using tubing or hoses in pharmaceutical manufacturing? A. Color of the tubing B. Biocompatibility and inertness with the contact material C. Cost of the tubing D. Manufacturer’s brand name Answer: … Read more
Multiple-Choice Questions (MCQs) & answer on cleaning validation Objective-Type Questionnaire 1.Question : According to the 1993 U.S. FDA cleaning validation guidance, cleaning validation is not required when the cleaning process is used:A. Between batches of different products on multipurpose equipmentB. Only between batches of the same productC. Between batches of high-potency pharmaceuticalsD. For any dedicated … Read more
Questions and Answers on Validation Master Plan (VMP) Questions 1. The VMP should be: A. Very detailed and lengthyB. Brief, concise, and clearC. A replacement for all SOPsD. Written only by external auditorsAnswer: B Questions 2. The VMP should not repeat information already documented elsewhere; instead, it should: A. Omit referencesB. Refer to existing documents … Read more
SITE MASTER FILE Site Master File that is useful to the regulatory authority in planning and conducting GMP inspections. The Site Master File is prepared by the pharmaceutical manufacturer and should contain specific information about the quality management policies and activities of the site, the production and/or quality control of pharmaceutical manufacturing operations carried out … Read more
QUALITY MANUAL QUALITY MANUAL describes one comprehensive model for an effective pharmaceutical quality system that is based on the quality concepts, includes applicable Good Manufacturing Practice (GMP) regulations and complements serves as the Validation Road map, setting the course, justifying the strategy, outlining the preliminary test and acceptance criteria, and documenting the necessary programs that … Read more
SOP ON CAPA (CORRECTIVE ACTION AND PREVENTIVE ACTION) PURPOSE: To lay down the standard operating procedure for Corrective Action and Preventative Action (CAPA) is a system of quality procedures required to eliminate the causes of an existing nonconformity and to prevent recurrence of nonconforming product, processes, and other quality problems. SCOPE: This SOP is applicable … Read more