Validation is an integral part of the pharmaceutical industry involving two key phases that work in tandem to ensure the highest quality and compliance standards. These phases, commissioning and qualification, are carefully executed to guarantee that pharmaceutical products meet stringent regulatory requirements and customer expectations. The commissioning phase takes precedence as the initial step in the validation process. It consists of two vital components: Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT). After successfully completing the commissioning phase, ownership of the equipment is transferred to the customer, signifying the completion of this crucial stage.
In the next phase, Installation & Operational Qualification (IQ/OQ), the customer takes center stage in carrying out the testing and qualification procedures governed by strict adherence to industry-standard quality guidelines and pharmaceutical regulations, including the Good Manufacturing Practices (GMP). These phases are not mere procedural hurdles but rather indispensable safeguards, assuring the highest levels of quality and regulatory compliance throughout the entire pharmaceutical production process.