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GUIDANCE DOCUMENT

Process Validation: General Principles and Practices Guidance for Industry January 2011

This guidance outlines the general principles and approaches that FDA considers appropriate elements of process validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients (APIs or drug substances), collectively referred to in this guidance as drugs or products. This guidance incorporates principles and approaches that all manufacturers can use to validate manufacturing processes.

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All written comments should be identified with this document's docket number: FDA-2008-D-0559 .

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Must-Have Process Validation Templates with Samples and Examples

Kavesh Malhotra

Process validation is the key to ensuring consistent and reliable product quality. Business professionals and process heads understand the significance of analyzing data gathered throughout the design and manufacturing stages. It confirms that processes we created can consistently produce products that meet predetermined standards.

Process validation has become a cornerstone of quality management across industries, such as pharmaceuticals, manufacturing, and technology. According to a recent industry survey, 86% of organizations consider process validation critical for ensuring regulatory compliance and minimizing production risks. Efficient validation processes improve product quality, reduce costs, and enhance customer satisfaction. However, the challenge lies in implementing a robust validation framework that guarantees consistent outcomes. This is where SlideTeam’s process validation templates come to your rescue.

Unlock the potential of your process validation endeavors with our expert-curated PowerPoint Slides. These presets are indispensable assets for implementing and optimizing validation processes. By downloading these dynamic bundles, you gain access to a wealth of structured, content-ready slides that can be customized to suit your requirements. Don't miss the opportunity to empower yourself and elevate your task management to professional heights. Take the first step by downloading one of these exceptional presentations today!

Each of these templates is 100% customizable and editable. The content-ready nature provides you with a structure and helps you start; the editability feature means that each can be tailored to meet specific audience requirements. 

Template 1: Pyramid with Seven Levels Of Process Validation

This layout presents a visual representation of the seven levels of process validation. Each level denotes a crucial step in the validation process, including the design plan, design implementation, and design validation. Use this preset to create a comprehensive overview of your validation journey. The pyramid structure helps in communicating the hierarchy of validation stages and their interdependencies. Revolutionize your process validation with this cutting-edge presentation template. 

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Template 2: Quarterly Process Validation Improvement Roadmap with Phases

This PPT Template offers a detailed roadmap for enhancing your process validation procedures. It breaks down the validation journey into quarterly phases, allowing you to plan and track progress. The design encompasses key tasks, milestones, and action steps required for each phase across the change control. Use this roadmap to ensure a systematic and organized approach to process validation improvements. Take your validation processes to the next level. Get this exclusive design layout today!

Template 3: Design Verification and Validation Process Requirement Gathering Methods Ppt PowerPoint Portfolio Templates

This flowchart focuses on the critical step of requirement gathering for design verification and validation. It provides a structured approach to document and analyze needs of your validation processes. Using this layout, you can systematically validate and verify your designs to ensure they meet the desired specifications. It enables you to align your validation activities with design objectives, resulting in efficient and reliable outcomes. Enhance your task management efficiency with our exclusive process validation preset. Download now for instant results!

QUALITY PROCESSES MATTER

Process validation is the cornerstone of consistent and reliable product quality. Our collection of process validation templates allows you to streamline your validation procedures, enhance product quality, and minimize production risks. These layouts serve as powerful tools for professionals and process heads, enabling them to validate, implement, and improve their processes effectively. Don't miss the opportunity to download these valuable templates and advance your validation efforts.

As we advance, download our top product design process templates and revolutionize your design processes. Click here to access these powerful tools and take your organization's product creation practices to the next level.

FAQs on Process Validation

What are the three stages of process validation.

Process validation typically consists of three stages that ensure the reliability and consistency of a manufacturing process. These stages include:

• Stage 1: Process Design. In this stage, the process is designed based on product requirements and specifications. It involves defining critical process parameters, establishing process limits, and conducting risk assessments. Design input and validation play a crucial role in this stage to ensure that the process meets the scalability of the desired output.
• Stage 2: Process Qualification. Once the process design is established, the next stage is to qualify the process. This involves implementing the process strategy on a small scale and collecting data to demonstrate its capability and reproducibility. The process is tested, monitored, and optimized to ensure it consistently produces high-quality products within the desired specifications. Validation and product development are essential components of this stage.
• Stage 3: Continued Process Verification - After the process is qualified, it enters the stage of continued process verification. In this stage, the process is continuously monitored to ensure it remains in a state of control and continues to meet the defined quality standards. Understanding and implementing appropriate controls are critical to maintaining process performance over time. Regular monitoring, data analysis, and periodic reviews are conducted to ensure ongoing process reliability and compliance.

What are the four types of validation?

Four primary types of validation are used across industries. These are: 

• Prospective Validation This type of validation is performed before the actual production process begins. It involves evaluating and documenting the capability of a process to produce products that consistently meet predetermined specifications. Prospective validation ensures that the process is designed correctly and capable of producing reliable results.
• Concurrent Validation This is conducted during routine production process. It involves ongoing monitoring and verification of critical process parameters, product quality attributes, and controls. This type of validation provides real-time assurance that the process produces products that meet required standards. 
• Retrospective Validation This is performed on processes that have been in production for some time without formal validation. It involves analyzing historical data, performance records, and product quality data to assess the process's consistency and compliance with predetermined specifications. Retrospective validation helps identify any gaps in the process and implement corrective measures.
• Revalidation This is carried out periodically or whenever significant changes occur in the process, equipment, or material. It ensures that the process remains valid and continues to produce products of consistent quality. Revalidation involves reassessing the process design, conducting performance testing, and verifying the process controls to ensure ongoing compliance.

These types of validation, along with proper design input, validation, product development, implementation, and process understanding contribute to the overall effectiveness and reliability of the manufacturing process.

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CRediT (Contributor Roles Taxonomy) was introduced with the intention of recognizing individual author contributions, reducing authorship disputes and facilitating collaboration. The idea came about following a 2012 collaborative workshop led by Harvard University and the Wellcome Trust, with input from researchers, the International Committee of Medical Journal Editors (ICMJE) and publishers, including Elsevier, represented by Cell Press.

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Zhang San:  Conceptualization, Methodology, Software  Priya Singh. : Data curation, Writing- Original draft preparation.  Wang Wu : Visualization, Investigation.  Jan Jansen :  Supervision. : Ajay Kumar : Software, Validation.:  Sun Qi:  Writing- Reviewing and Editing,

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Process Validation for Medical Devices Overview of FDA Requirements

Jan 28, 2022

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The word validation is not new to todayu2019s world but its requirement differs from field to field. In pharmaceutical industry and later in medical device field it almost become mandatory and based on risk assessment and class of the device its importance was seen as important both by regulators as well as manufacturers.<br>Read more@ https://iziel.com/process-validation-for-medical-devices/

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Process Validation for Medical Devices: Overview of FDA Requirements The word validation is not new to today’s world but its requirement differs from field to field. In pharmaceutical industry and later in medical device field it almost become mandatory and based on risk assessment and class of the device its importance was seen as important both by regulators as well as manufacturers. In USA also the word MDR is popular in medical device. This is regarding medical device reporting guidance where in lot of guidelines with lot of reference of legislation is given. This makes every manufacturer whether doing business in USA or abroad but device is manufactured in USA. Similarly, the manufacturer is outside USA but sells product in USA are all governed by MDR. MDR is about medical device reporting. Why validation is important in MDR part? The Process Validation definition states that “(a) Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures. The validation activities and results, including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated, shall be documented”

This definition is quite simple but it generates various possibilities of verification by subsequent inspection and test. Sterility test is destructive test so whole batch cannot be evaluated while partial testing cannot guarantee each piece to be sterile that is why sterilisation process requires validation. Lot of guidance documents about how to do is available. The same situation does not exist for all products many are more complex so whatever best verification and testing and limited validation we might have done it brings issues open as adverse event and some are serious which may result into death. How do we manage such situation? Risk assessment must be to the depth by team and all possibilities must be checked. Right from the design stage validation concept must be included. Even clinical evaluation also needs thorough thinking which can also result from limitations of validation because it ask for some evidence in broader manner to prove as validated what we define as acceptance criteria. In case of devices which partly interact with body tissues or go inside the body generates lot of questions on biocompatibility and toxicity. (Starts from simple irritation to sensitisation and may end in genotoxicity to carcinogenicity). If some devices are made from established and proved safe material then it is not necessary to conduct all clinical or biological testing but it needs more control and check on those material its source and incoming inspection which becomes the design part validation. Indirectly it becomes IQ (installation qualification of process). FDA recommends ISO 10993-1 devised for biological evaluation of medical devices. It provides general framework for biological testing and some time specific tests can help evaluate. Considering such as acceptance criteria for your validation process makes your process stronger with better control and first-time right approach and will reduce adverse events. Even with all guidance and standards available issues and complexities in certain products do not vanish and that time individual product guideline if available may be refereed. You may then require special process validation consultant which can guide you with latest guidance available and latest requirement.As you have seen above that with advancement of scientific knowledge new techniques are developed or existing are modified. Such changes may require review at manufacturing level and may warrant re-validation of the process. This also requires that your procedure to carryout process validation is also kept updated and all new development within or outside must be incorporated if it is related to your product. This also requires that validation be to be performed by qualified person. With advent of new things coming into picture the qualified person must not only be aware but also to be trained for that advancement if needed. Documentation at each stage is especially important in process validation and proper justification documentation if certain exemptions are taken. Documents involves all data including raw data, detailed work instructions, who did them and when with date and time (both start and completion) review comment by other qualified and independent person usually QA. Revalidation may be required if there are any process changes happen or any product related or process related deviation occur. IZiel’s Onshore-Offshore Model works with 1 Onsite Member supported by a team of 3-4 engineers from our Technical Center in India. Typically, the data is collected, evaluated and evidence is developed from the process design stage throughout production. Our Model enables the company to complete the project faster and in a cost-effective manner.

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