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2. Process validation - Wikipedia

   en.wikipedia.org/wiki/Process_Validation

   Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation. [ 1 ]

3. Process performance qualification protocol - Wikipedia

   en.wikipedia.org/wiki/Process_Performance...

   Process performance qualification protocol is a component of process validation: process qualification. This step is vital in maintaining ongoing production quality by recording and having available for review essential conditions, controls, testing, and expected manufacturing outcome of a production process.

4. Process qualification - Wikipedia

   en.wikipedia.org/wiki/Process_Qualification

   Process qualification should cover the following aspects of manufacturing: Facility; Utilities; Equipment; Personnel; End-to-end manufacturing; Control protocols and monitoring software. Process qualification is the second stage of process validation. A vital component of process qualification is process performance qualification protocol. PPQ ...

5. Verification and validation - Wikipedia

   en.wikipedia.org/wiki/Verification_and_validation

   Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.

6. Validation master plan - Wikipedia

   en.wikipedia.org/wiki/Validation_master_plan

   A VMP is the foundation for the validation program and should include process validation, facility and utility qualification and validation, equipment qualification, cleaning and computer validation. It is a key document in the GMP ( Good manufacturing practice ) regulated pharmaceutical industry as it drives a structured approach to validation ...

7. Continued process verification - Wikipedia

   en.wikipedia.org/wiki/Continued_process_verification

   Continued process verification (CPV) is the collection and analysis of end-to-end production components and processes data to ensure product outputs are within predetermined quality limits. In 2011 the Food and Drug Administration published a report [ 1 ] outlining best practices regarding business process validation in the pharmaceutical ...

8. Validation (drug manufacture) - Wikipedia

   en.wikipedia.org/wiki/Validation_(drug_manufacture)

   Process validation involves a series of activities taking place over the lifecycle of the product and process.". [4] A properly designed system will provide a high degree of assurance that every step, process, and change has been properly evaluated before its implementation. Testing a sample of a final product is not considered sufficient ...

9. Data validation and reconciliation - Wikipedia

   en.wikipedia.org/wiki/Data_validation_and...

   Industrial process data validation and reconciliation, or more briefly, process data reconciliation (PDR), is a technology that uses process information and mathematical methods in order to automatically ensure data validation and reconciliation by correcting measurements in industrial processes.