Quality Assurance

Environmental Monitoring – Total Particle Monitoring EUGMP- Annex-1

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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

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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) & Answers on cleaning validation Considering Packaging Materials & Tubing and Hoses

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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

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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)

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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

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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

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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)

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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

SOP OF PRODUCT RECALL

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SOP OF PRODUCT RECALL PURPOSE: This procedure covers transmission of information by means of a Rapid Alert between the different parties related to the recall of medicinal products, which have quality defects, including counterfeit or tampered products, when urgent action is required to protect public health. The procedure may be used also for transmission of … Read more

SOP on Cleaning, Maintenance and Calibration of Stability Chamber

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SOP on Cleaning, Maintenance and Calibration of Stability Chamber Objective: To lay down a procedure for cleaning, maintenance and calibration of stability chamber. Scope: This SOP is applicable for the cleaning, maintenance and calibration of stability chamber. Responsibility: QC Chemist or above AND Electrician or above Accountability: Head – Quality Control & Head – Engineering Procedure: Cleaning: Chamber shall be cleaned … Read more