Explore the essential steps in process validation for the life sciences industry, from concept development to implementation. Learn how to ensure compliance and product quality.
Take a deep dive with us as we walk you step by step through that process validation journey — from ideas on paper to the implementation of validation protocols to satisfy stringent regulatory requirements.
Process Validation underpins the assurance of product quality, safety and efficacy in the life sciences industry. This strategy is all-encompassing asit involves everything from idea, to trial phase, and finally full-fledged deployment. Through this guide, we aim to assist life science professionals with comprehensive insights on process validation steps helping them focus more closely on regulatory compliance.
- Concept Development
It all starts with an idea; a new manufacturing process, a modification of an existing one or the launch of a new product. The idea is to now start defining the most important properties of these modules that will influence the quality of the product.
This is key for initiating the validation process that follows. A proper validation plan must account for key inputs and failure modes.
2. Design Qualification (DQ)
Then comes Design Qualification (DQ) after the concept. DQ verifies the design that the process or equipment i used is serving its intended purpose.
This set involves high level planning efforts, including design validation, risk mitigation and extensive design specifications. The intent is to create a design that complies with the regulations and standards of the industry.
3. Installation Qualification (IQ)
After the DQ, we start with Installation Qualification (IQ). IQ Confirms that the equipment is installed correctly to the manufacturer’s specs.
It is an important step in making sure that the processfunctions as it should. Comprehensive details of these steps are documented indicating compliance with regulatory requirements.
4. Operational Qualification (OQ)
Operational Qualification (OQ): This step involves making sure the process or equipment actually performs in the way it is supposed to under normal operating conditions.
At this stage different parameters such as temperature, pressure and speed are tested to comply with specific criteria. These tests are guided by the validation protocols developed previously, and results of each test are systematically recorded.
5: Performances Qualification (PQ)
Performance Qualification (PQ) — This is the last mile in the process validation journey. Here, PQ is intended to ensure a process that produces a product which constantly meets catered guides or quality attributes.
This process simulates the real world and provides in-depth data gathering/analysis in PQ. If PQ is done successfully, it proves that process is robust and reliable.
Step 6: Follow-Up Monitoring and Compliance
Successful PQ is not the conclusion of process validation. Monitoring and compliance need to be continuous as it is the only way to ensure that the system remains in its validated state.
Care should be taken on the regulatory front so that any changes or deviation and unexpected events that would have minimal impact on regulatory compliance.
In Summary: The Importance of Quality Through Process Validation
Implementing a process this way for novices in the life science industry is an arduous journey from concept to operationalization. The develop-test-validate-review-requalify structure of Process validation including process development from the broader principles, if possible to deep dive its nature is a framework that helps companies navigate through this maze.
Any procedure designed to guarantee that processes are dependable, fault-sensitive and abide by regulations.Contact BioBoston Consulting today,
