Quality by desing
The laboratory performed pharmaceutical development projects of different dosage forms following the principles of quality by design (QbD) based on ICH Q8, Q9 and Q8R2. For each formulation critical quality attributes CQA's are identified and an initial risk assessment of critical materials CMA's attributes and critical process parameters CPP's on CQA's is performed. Adequate risk management is performed and is used to design spaces using design of experiments (DoE) statistical base. Control strategies for each type of development are planned.