level: Level 4
Questions and Answers List
REGULATORY OPERATIONS slide 59
level questions: Level 4
| Question | Answer |
|---|---|
| Quality Risk Management as Part of Regulatory Operations | 1 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 UTILITIES | 1 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 Management | 1 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 PRODUCTION | 1 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 Studies | 1 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. |