Process Validation

Drug product quality and safety are result of effective process validation.  

Each phase of the manufacturing process needs to be designed and controlled to ensure that the finished product meets all quality attributes. Every choice could have impacts and thus need to be thoroughly documented and interpreted to gain knowledge on the manufacturing process and identify any source of variation.

Validation should cover multiple aspects of the drug product manufacturing, starting from the correct choice of manufacturing components would need to undergo a specific validation of their use with the drug product, especially in case components are made of polymeric materials. The same concept applies to primary packaging, where Extractables and Leachables have huge impacts on drug safety.

Critical operations such as cleaning and disinfection requires to be accurately planned starting from a risk—based approach to the actual validation plan and protocols.

Documentation of validation is the only way to demonstrate that the manufacturing process of a pharmaceutical product is under control. FDA, EMA and national authorities consider the validation of every critical operation a must.

Due to the complexity and multiple variable in a typical exercise, a solid scientific and regulatory expertise and initial phase of planning and designing are fundamental for the success of the validation and to demonstrate that a process is capable of consistently delivering quality product.

Our experts support you in the development and the execution in several fields such as:

• Extractable and Leachables strategy for in-process materials and primary packaging, including risk assessment according to USP (<1663>, <1664>,>,<1665>,<665>, BPOG)
• Cleaning validation plan and protocols, risk assessment
• Disinfectant qualifications plan
• Process Validation plans