Validation

To enhance the effectiveness and safety of pharmaceuticals after their approval for use, validation and process controls must be implemented.  Process controls include raw materials inspection, in-process controls and final product targets and are established to monitor on-line and off-line performance of the manufacturing process and then to validate it. Even upon validation, current good manufacturing practice (CGMP) requires that a well-written procedure for process controls be established to monitor its ongoing performance.

Ambitech fully understands the impact that the validation process has on a client’s project. Our experienced personnel have participated in the development of Management of Change (MOC) documents including Change Control forms, Installation Qualification (IQ), Operational Qualification (OQ), Process Qualification (PQ), protocol amendments, and Deviation Notices for a variety of food and pharmaceutical process and support systems. Ambitech’s validation processes not only include the authoring of background information, but our knowledge of equipment design and operation and maintenance issues are employed to generate meaningful protocol challenges for OQ and PQ.

Our understanding of both project and validation work processes allows us to effectively integrate the concerns of the client’s various stakeholder groups (ownership, QA, validation, engineering, etc.). The early integration of these sometimes divergent concerns is paramount to the success of any validation process. Using our expertise and facilitation skills to assist in optimizing validation protocols while minimizing the time requirements for pre-approval and post-approval signature processes is one of the many reasons why our clients have such a strong interest in retaining Ambitech.

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