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level: Level 4

Questions and Answers List

REGULATORY OPERATIONS slide 59

level questions: Level 4

QuestionAnswer
Quality Risk Management as Part of Regulatory Operations1 INSPECTION AND ASSESSMENT ACTIVITIES
To design a quality product and its manufacturing process to consistently deliver the intended performance of the product (see ICH Q8); To enhance knowledge of product performance over a wide range of material attributes processing options and process parameters; To assess the critical attributes of raw materials, solvents, Active Pharmaceutical Ingredient (API) starting materials, APIs, excipients, or packaging materials; To establish appropriate specifications, identify critical process parameters and establish manufacturing controls To decrease variability of quality attributes: To assess the need for additional studies Make use of the “design space” concept.QUALITY RISK MANAGEMENT AS PART OF DEVELOPMENT
QUALITY RISK MANAGEMENT FOR FACILITIES, EQUIPMENT, AND UTILITIES1 Design of facility / equipment - Determine appropriate zones 2 HYGIENE ASPECTS IN FACILITIES - To protect the product from environmental hazards, including chemical, microbiological, and physical hazards 3 Qualification of facility/equipment/utilities 4 Cleaning of equipment and environmental control 5 Computer systems and computer controlled equipment -To select the design of computer hardware and software
Quality Risk Management as Part of Materials Management1 Assessment and evaluation of suppliers and contract manufacturers - To provide a comprehensive evaluation of suppliers and contract manufacturers 2 STARTING MATERIAL 3 USE OF MATERIALS 4 Storage, logistics and distribution conditions
QUALITY RISK MANAGEMENT AS PART OF PRODUCTION1 VALIDATION - To identify the scope and extent of verification, qualification and validation activities 2 In-process sampling & testing - To evaluate the frequency and extent of in-process control testing 3 Production planning - To determine appropriate production planning
Quality Risk Management as Part of Laboratory Control and Stability Studies1 Design of packages 2 Selection of container closure system - To determine the critical parameters of the container closure system. 3 Label controls - To design label control procedures based on the potential for mix-ups involving different product labels, including different versions of the same label.