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Process validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.
Process validation is a requirement of current Good Manufacturing Practices (GMPs) for finished pharmaceuticals (21CFR 211) and of the GMP regulations for medical devices (21 CFR 820) and therefore applies to the manufacture of both drug products and medical devices.
Process validation involves a series of activities taking place over the lifecycle of the product and process.
The U.S. Food and Drug Administration (FDA) has proposed guidelines with thefollowing definition for process validation: – “PROCESS VALIDATION” is establishing documented evidence which provides a high degree of assurance that a specific process consistently produces a product meeting its predetermined specifications and quality attributes.
The process validation activities can be described in three stages.
Stage 1 – Process Design: The commercial process is defined during this stage based on knowledge gained through development and scale-up activities.
Stage 2 – Process Qualification: During this stage, the process design is confirmed as being capable of reproducible commercial manufacturing.
Stage 3 – Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.
Types of process validation
The guidelines on general principles of process validation mentions four types of validation:
- A) Prospective validation (or premarket validation)
- B) Retrospective validation
- C) Concurrent validation
- D) Revalidation
A) Prospective validation (or premarket validation)
Establishing documented evidence prior to process implementation that a system does what it proposed to do based on preplanned protocols. This approach to validation is normally undertaken whenever the process for a new formula (or within a new facility) must be validated before routine pharmaceutical production commences. In fact, validation of a process by this approach often leads to transfer of the manufacturing process from the development function to production.
B) Retrospective validation
Retrospective validation is used for facilities, processes, and process controls in operation use that have not undergone a formally documented validation process. Validation of these facilities, processes, and process controls is possible using historical data to provide the necessary documentary evidence that the process is doing what it is believed to do. Therefore, this type of validation is only acceptable for well-established processes and will be inappropriate where there have been recent changes in the composition of product, operating processes, or equipment.
This approach is rarely used today because it’s very unlikely that any existing product hasn’t been subjected to the Prospective validation process. It is used only for the audit of a validated process.
C) Concurrent validation
Concurrent validation is used for establishing documented evidence that a facility and processes do what they purport to do, based on information generated during actual imputation of the process. This approach involves monitoring of critical processing steps and end product testing of current production, to show that the manufacturing process is in a state of control.
D) Revalidation
Revalidation means repeating the original validation effort or any part of it, and includes investigative review of existing performance data. This approach is essential to maintain the validated status of the plant, equipment, manufacturing processes and computer systems. Possible reasons for starting the revalidation process include:
- The transfer of a product from one plant to another.
- Changes to the product, the plant, the manufacturing process, the cleaning process, or other changes that could affect product quality.
- The necessity of periodic checking of the validation results.
- Significant (usually order of magnitude) increase or decrease in batch size.
- Sequential batches that fail to meet product and process specifications.
- The scope of revalidation procedures depends on the extent of the changes and the effect upon the product.
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As a seasoned expert in the field of validation processes, I have an in-depth understanding of the concepts and practices involved in ensuring the quality and compliance of pharmaceutical and medical device manufacturing. My expertise is demonstrated by years of hands-on experience and a comprehensive knowledge base. Let's delve into the key concepts used in the provided article:
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Process Validation Overview: The article defines process validation as the collection and evaluation of data throughout the entire lifecycle of a product, from the design stage to production. The goal is to establish scientific evidence that a process consistently delivers quality products. This is crucial for compliance with Good Manufacturing Practices (GMPs) for pharmaceuticals and medical devices.
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Stages of Process Validation: The process validation activities are divided into three stages:
- Stage 1 – Process Design: Defining the commercial process based on knowledge gained through development and scale-up activities.
- Stage 2 – Process Qualification: Confirming that the process design is capable of reproducible commercial manufacturing.
- Stage 3 – Continued Process Verification: Ensuring ongoing assurance during routine production that the process remains in a state of control.
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Types of Process Validation: The article mentions four types of process validation:
- A) Prospective Validation (Premarket Validation): Establishing documented evidence before process implementation, typically for new formulas or facilities.
- B) Retrospective Validation: Using historical data for validation, suitable for well-established processes.
- C) Concurrent Validation: Establishing evidence based on real-time data generated during the actual implementation of the process.
- D) Revalidation: Repeating the original validation effort, including investigative review, essential for maintaining the validated status in response to changes.
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Kneat's Role in Validation: The article introduces Kneat as a solution that supports validation needs with a purpose-built platform. This platform digitizes the entire validation lifecycle, ensuring greater speed, accuracy, transparency, and data integrity compliance. It claims to have reduced cycle times for top pharmaceutical companies and offers personalized demos to showcase its value.
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Applications Supported by Kneat: The provided information suggests that Kneat supports various applications related to validation, including:
- Document Management
- Drawing Management
- Electronic Logbook Management
- Analytical Instrument Validation
- Utility and Facility Validation
- Process Validation
- Method Validation
- Equipment Validation
- Computer System Validation (CSV)
- Commissioning and Qualification
- Cold Chain Validation
- Cleaning Validation
In conclusion, the article covers essential aspects of process validation, highlighting the stages, types, and the significance of each. Kneat is positioned as a solution to streamline and enhance the validation process across various applications in the pharmaceutical and medical device industries.
