Process Validation

Process validation is a three-stage approach starting with process qualification, moving to process performance qualification (traditional process validation) and finishing with continued process verification. All three elements constitute a full process validation lifecycle.

Even before the three elements of process validation comes planning.  A comprehensive and fully-justified Validation Master Plan can avert misunderstandings and provide rationale and strategy behind for the risk-based approach applied to process validation for validation your products.

While validation for the manufacturing methods is important to process validation, validation of processes supporting the manufacturing methods is also important.  Such validations include validation of sterilization and sanitization processes, validation of processes used across multiple products, such as lyophilization and mixing, and validation of cleaning processes to prevent product contamination and cross-contamination between products.

Compliance Team’s process validation experts can evaluate your process, identify a validation strategy, create a validation master plan, and help your organization to fulfill all tasks identified in the validation master plan to ensure your processes meet validation requirements.  Our experts can also consult on continued process verification to ensure that each process’s validated state is sustainable.  Our experts can also integrate process validation strategy with the overall compliance strategy to ensure that process validation is a value-add to your organization.   In other words, we help you to simplify the complex.

Compliance Team is ready to formulate a complete, compliance process validation for your regulated product offerings.