Quality by Design (QbD) is a structured approach to process development that emphasizes science and risk management principles. Applying QbD allows companies to develop manufacturing …
Materials Management
Of all the subsystems of a Pharmaceutical Quality System, the Materials Management subsystem may require the most cross-functional collaboration and teamwork. For example, the Materials …
Item Specifications
A specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria …
FAT / SAT Support
Investing in equipment should never have to be a risk. Testing equipment and reviewing documentation for traceability purposes does a great deal towards lowering the …
Process Validation
Current Good Manufacturing Practices (CGMPs) enforced by the FDA require that all manufacturing processes be validated. Validation ensures that controlling the inputs (i.e. parameters) within …
Quality Management System Development
A Quality Management System (QMS) is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordinate …
Quality Risk Management
Quality Risk management (QRM) is a systematic process for the assessment, control, communication, and review of risks to quality of the drug product across the …
Aseptic Manufacturing
Safety First. That’s the mantra echoed across almost every industry in the world. This is especially true in the life sciences industry. But this safety …
Detailed Product and Process Description (DPPD)
In Big Pharma and the life sciences industry, product development is a massive effort that spans several different functions and documents. This process is not …