User requirements are typically divided into several categories to ensure comprehensive coverage of all aspects of product development, manufacturing, and quality control and to help guide the risk-based approach to verification.
Product User Requirements
These requirements relate directly to the product being manufactured and the processes involved in its production. They include:
- Critical Quality Attributes (CQAs) of the product
- Critical Process Parameters (CPPs)
- Required throughput and production conditions
- Specifications for raw materials and finished products
Quality Requirements
Quality requirements focus on ensuring that the product meets all necessary quality standards and regulatory compliance. This category includes:
- Good Manufacturing Practices (GMP) compliance, including around cleaning, cross-contamination, etc to ensure compliance with various regulations such as FDA guidelines, EU GMP, and ICH standards.
- Documentation and record-keeping standards
- Contamination control strategies are a key part of quality requirements, as they are essential for maintaining product quality and patient safety.
- Data integrity requirements fall under this category, as they are crucial for ensuring the quality and reliability of data.
Not everyone advocates for this breakdown but I am a huge proponent as it divides the product specific requirements for the more standard must’s of meeting the cGMPs that are not product specific. This really helps when you are a multi-product facility and it helps define what is in the PQ versus what is in the PPQ.
Safety User Requirements
Safety requirements address the safety of personnel, patients, and the environment. They encompass:
- Occupational health and safety measures
- Environmental protection protocols
- Patient safety considerations in product design
General User Requirements
General requirements cover broader aspects of the manufacturing system and facility. These may include:
- Facility design and layout
- Equipment specifications
- Utility requirements (e.g., power, water, HVAC)
- Maintenance procedures
By categorizing user requirements in this way, pharmaceutical companies can ensure a comprehensive approach to product development and manufacturing, addressing all critical aspects from product quality to regulatory compliance and safety. This will help drive appropriate verification.
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