Difference between Process Validation and Product Validation : Pharmaceutical Guidelines

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Difference between Process Validation and Product Validation

Process validation and product validation both are important parts of good manufacturing practices and used to assure the product quality. But of of these are different concepts with different objectives.
Pharmaceutical products need to follow a set of standards as a means of assurance of quality. Such a standard is validation, whether process or product validation, it is well known that the validation is made as an essential building block of good manufacturing practices (GMP) process or a guideline for good management systems (GMS).

In this regard, pharmaceutical validation is an element of a quality assurance program that ensures the best quality of a process or a product. Needless to say, that process validation is different from product validation.
Related: Importance of Validation in Pharmaceuticals

Process Validation

product validation vs process validation
Process validation is a process of production in its goals, which, in the end, follows a process that produces products that are fit for their intended use. Pharmaceutical process validation is a stepping stone which ensures that the final product of the process meets the quality assurance principles of quality, efficacy, and safety in its usage.

In essence, the process validation in pharma ensures control in the manufacturing process, as the possibility of the finished product is consistent meets the quality and design specifications intended for the product.

The control process is a large part of validation, in which the end result must meet its specifications and be consistent in achieving desired results. Thus, the capability of the system and equipment is a major part of the manufacturing process validation.

Product Validation

Product validation process on the other hand, much like a process validation is documented evidence that ascertains the quality of the manufactured product. With a set of guidelines to follow to ensure product validation, it does come with its set of advantages including lowering the number of waste batches in products and reducing the cost of production of the product due to rigorously tested results that assure quality is maintained and thus the product will work to serve its intended purpose. It ensures the manufactured product meets all the needs and the requirements the pharmaceutical product was intended to serve.
Related: How to Write a Validation Protocol?

Difference between Process Validation and Product Validation

The major difference in process and product validation is their methodologies. Process validation is aimed at ensuring different inputs will guarantee a similar end product while product validation aims to ensure the end product works effectively to its intended purpose; meeting user needs and requirements.
Related: How Effectively Execute a Validation Protocol?

Product validation does depend on process validation to achieve quality in its outcome. Pharmaceutical process validation comprises the entire process of; process design, process qualification, and continued process verification.

Process validation is part of a guideline that makes up good manufacturing practices (GMP) which ensures uniformity in the production of pharmaceutical products from one place to those from another place. While product validation is part of a guideline which makes up good management systems (GMS). GMS ensures that products designed to serve a specific purpose do work as their intended specification to perform efficiently as well as effectively.

Process validation is documentation that involves rigorous testing of the process being employed for the manufacture of pharmaceutical products while product validation is a rigorous testing process which involves testing of the end product itself to assure quality.
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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