Validating articles

24-Aug-2019 01:54

The FDA regulation is harmonized with ISO 8494, which treats "verification" and "validation" as separate and distinct terms.On the other hand, many software engineering journal articles and textbooks use the terms "verification" and "validation" interchangeably, or in some cases refer to software "verification, validation, and testing (VV&T)" as if it is a single concept, with no distinction among the three terms.The desired results are established in terms of specifications for outcome of the process.Qualification of systems and equipment is therefore a part of the process of validation.In 1983 the FDA published a guide to the inspection of Computerized Systems in Pharmaceutical Processing, also known as the 'bluebook'.Recently both the American FDA and the UK Medicines and Healthcare products Regulatory Agency have added sections to the regulations specifically for the use of computer systems.It must be based on a Validation Risk Assessment (VRA) to ensure that the scope of validation being authorised is appropriate for the complexity and importance of the equipment or process under validation.Within the references given in the VP the protocol authors must ensure that all aspects of the process or equipment under qualification; that may affect the efficacy, quality and or records of the product are properly qualified.

FDA, or any other food and drugs regulatory agency around the globe not only ask for a product that meets its specification but also require a process, procedures, intermediate stages of inspections, and testing adopted during manufacturing are designed such that when they are adopted they produce consistently similar, reproducible, desired results which meet the quality standard of product being manufactured and complies the Regulatory and Security Aspects.

In the UK, computer validation is covered in Annex 11 of the EU GMP regulations (EMEA 2011).

The FDA introduced 21 CFR Part 11 for rules on the use of electronic records, electronic signatures (FDA 1997).

The validation scope, boundaries and responsibilities for each process or groups of similar processes or similar equipment's must be documented and approved in a validation plan.

These documents, terms and references for the protocol authors are for use in setting the scope of their protocols.

FDA, or any other food and drugs regulatory agency around the globe not only ask for a product that meets its specification but also require a process, procedures, intermediate stages of inspections, and testing adopted during manufacturing are designed such that when they are adopted they produce consistently similar, reproducible, desired results which meet the quality standard of product being manufactured and complies the Regulatory and Security Aspects.

In the UK, computer validation is covered in Annex 11 of the EU GMP regulations (EMEA 2011).

The FDA introduced 21 CFR Part 11 for rules on the use of electronic records, electronic signatures (FDA 1997).

The validation scope, boundaries and responsibilities for each process or groups of similar processes or similar equipment's must be documented and approved in a validation plan.

These documents, terms and references for the protocol authors are for use in setting the scope of their protocols.

"Process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.