The pharmaceutical industry involves various steps and procedures in drug manufacturing—from formulation to packing finished products. Different equipment is employed to help carry out these processes. Incorporating complex, advanced equipment has allowed the industry to develop novel and innovative drugs/products, ensuring quality and safety.
Equipment validation is critical in the pharmaceutical industry – as equipment is integral and essential to these systems or processes. Even the slightest error or malfunction may pose a costly risk and delay for the product owner and manufacturer.
What is Equipment Validation?
Equipment validation is the terminology that describes a set of independent procedures used to document whether a piece of equipment, system, or process consistently produces results within predefined specifications and requirements of its intended purposes. These requirements are determined by user needs and various regulatory and safety requirements. It involves a series of activities (e.g., testing, qualification, and documentation) to verify and document the equipment’s performance, functionality, and reliability.
Equipment validation is not a singular-step activity, instead it is a combination of steps. The significant phases of equipment validation are:
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
Why is validation important?
Equipment validation methodology is based on the principle that machinery is designed, constructed, maintained, and adapted to perform the operations intended to be carried out. Equipment validation is a fundamental component of good practices (GxP) and guarantees reliable product quality, resulting in fewer recalls and higher customer satisfaction.
When is Validation Necessary?
- Regulatory Compliance: Pharmaceutical manufacturers must regularly validate their equipment by regulatory bodies—the frequency varies based on equipment criticality and the product.
- New Equipment Installation: Before being introduced to the manufacturing process, a new piece of equipment must undergo verification before being released for use in actual drug production.
- Equipment Modifications: Any significant modifications to the equipment, software, or operating procedures require revalidation to verify that the changes do not compromise the quality and safety of the manufactured drugs.
- After Maintenance or Repairs: Following maintenance or repairs, the performance of revalidation is crucial. This ensures that any adjustments made during maintenance do not impact product quality.
- Change in Manufacturing Process or Product: Equipment validation becomes necessary if there are changes in the manufacturing process or drug formulation (e.g., changes in raw materials, manufacturing steps, or product specifications).
The Process of Equipment Validation
Procurement typically starts with producing required documentation and user requirement specification (URS). The URS combines system requirements to support system design, verification, operations, and maintenance. This is based on product knowledge, process knowledge, regulatory requirements, and organization/site quality requirements. Then, developing a validation plan (VP) begins that outlines the scope, objectives, and approach. The VP should identify critical equipment parameters, acceptance criteria, and validation protocols.
Installation Qualification (IQ) is the first step in equipment validation, focusing on verifying that the equipment is installed correctly and meets specifications (e.g., documented proof that the equipment meets the design intention). The main objectives are:
- Checking instruction manuals, schematic diagrams, and spare parts lists is readily available.
- Confirm that the equipment is connected correctly to utilities (e.g., electricity, water, gas) and support systems.
- Check that all necessary accessories and equipment components are present.
- Guarantee that the equipment meets the defined physical and environmental requirements.
Operational Qualification (OQ) is an inspection of equipment functionality (e.g., documented proof that the equipment performs as specified). This phase focuses on verifying and confirming that the equipment can operate within critical equipment parameters and perform those functions accurately and consistently. The main objectives are:
- Validate that the equipment operates within parameters and acceptance criteria.
- Verify the accuracy and precision of the equipment’s measurements and processes Document that the equipment complies with regulatory requirements and industry standards.
Performance Qualification (PQ) ensures that the equipment functions reliably and consistently, producing desired results and its intended purpose (e.g., documented proof that the equipment will dependably perform daily tasks regularly).
Tips for Effective Validation
- Detailed Validation Plan Development – A thorough validation plan outlines the validation approach, methodologies, risk assessment, and timelines. Thus, this effectively provides a roadmap for successful execution.
- Proper Record-keeping and Documentation—Accurate and comprehensive documentation is fundamental to equipment validation. All validation activities, including test procedures, results, deviations, and corrective actions, should be recorded. Documentation should be detailed, organized, and easily accessible.
- Implement Change Control Procedures—Once validation is completed, implement robust change control procedures and management. A thorough assessment should be conducted before any changes or modifications to validated equipment, processes, or systems are implemented.
Equipment validation is a critical process in the pharmaceutical industry. Incorporating machinery in the various procedures and steps has helped increase process efficiencies, quality, and safety. By collaborating with an experienced validation partner; companies can streamline processes and expedite validation timelines while ensuring regulatory compliance. Therefore, companies must leverage the knowledge and resources of a trusted partner.
