Issue link: https://www.e-digitaleditions.com/i/1295512
Tablets & Capsules October 2020 31 onsite after installation by inspecting the specific prod- ucts the production line will be processing and/or pack- aging. Ideally, this is done at the time the system is origi- nally installed in the production line. It is critical for manufacturers to remember, however, that the original onsite validation relates only to the spe- cific products tested at the time. As new or additional products are developed and introduced onto the pro- duction line, or as the packaging type or size (including labeling) changes, the system will need to be re-validated for each change. Verification Verification is the process of periodically confirm- ing that the inspection equipment being used on the production line is still operating as effectively as when it was first validated. Verification uses standard, estab- lished tests performed at regular intervals to provide evidence-based confirmation that the system continues to function as specified. Formal performance verification is typically done annually to support audit requirements, but it may be conducted more frequently, as regulators require. Verification should continue throughout the pro- ductive life of the system. Both validation of installed systems and periodic ver- ification of operating systems can be conducted either internally by the end user or externally by the equipment supplier. Validation and verification services are often included as part of equipment purchase contracts. This relieves onsite staff of the responsibility for conducting tests they may not be familiar with. The preventive controls most often used to identify blister packaging errors and mark the packages for rejec- tion are in-line X-ray and machine-vision inspection sys- tems. These systems quickly and efficiently detect miss- ing or damaged products and defective packaging and remove them from the production line. The software that operates these systems also col- lects data on their performance, recording successful and unsuccessful inspections. This data provides a valuable record in the event of a regulatory agency inspection or lawsuit. But to maintain their full effectiveness, the inspection systems must be validated, verified, and mon- itored on an ongoing basis to ensure that they are per- forming as intended. The terms validation, verification, and monitoring are often used interchangeably, creating confusion within organizations and across industries when they are inter- preted and used in different ways. In fact, each term iden- tifies a distinct process with a clear purpose that occurs at a specific point in the equipment lifecycle. It is important to understand the differences to ensure that each process is performed in compliance with regulatory requirements, particularly where the equipment is designated as a critical control point (CCP) in a larger production line system. Validation When applied to an inspection system that is part of a tablet or capsule manufacturing or filling line, validation is an objective, data-based confirmation that the inspec- tion system does what it was designed, manufactured, and installed to do. The International Featured Standards (IFS) organization defines validation as "confirmation through the provision of objective evidence, that the requirements for the specific intended use or application have been fulfilled." An important part of the validation procedure is the production of detailed data that demon- strates to line managers and regulators that the system is operating as designed. The inspection system manufacturer will validate its performance before delivery, testing it with generic prod- ucts and packaging similar to what the end user will be producing. But that is only the beginning of the valida- tion process. That same system needs to be validated Photo 1: This X-ray image from a blister package inspection system reveals missing and damaged tablets. The terms validation, verification, and monitoring are often used interchangeably, creating confusion within organizations and across industries when they are interpreted and used in different ways.