process validation ppt presentation download

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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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Process validation PowerPoint Presentation Templates and Google Slides

Save your time and attract your audience with our fully editable ppt templates and slides..

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Items 1 to 10 of 78 total

• Medical Device Validation
• Quality Assurance / Quality Management
• Product and Process Validation
• TQM Tools and Techniques
• Risk Management Process

Process Validation Training PPT...

Product & process validation, information and training presentation. | sample pages..

Process Validation

Validation needs to be Risk based.

Cleaning validation sampling and test methods

Execution of the Validation Master Plan

Validation of Combination products.

Operation Qualification (OQ)

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Process Validation

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Lay your hands on our aesthetically pleasing Process Validation PowerPoint template to explain the guidelines and activities that ensure that a process consistently delivers products/services with the desired/required quality, specifications, and standards.

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Validation Part 3: Process validation

Jan 02, 2020

320 likes | 447 Views

Supplementary Training Modules on Good Manufacturing Practices. Validation Part 3: Process validation. Validation. Objectives To review: Validation, risk analysis, and critical steps of processing Points to consider in process validation of: solid dose mixing tablet compression

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• tablet compression
• compression force
• particle size distribution
• determining critical control point

Presentation Transcript

Supplementary Training Modules on Good Manufacturing Practices Validation Part 3: Process validation

Validation Objectives To review: • Validation, risk analysis, and critical steps of processing • Points to consider in process validation of: • solid dose mixing • tablet compression • sterilization • Finalization of validation

Validation Introduction

Validation Reliable, repeatable, under control • At least first 3 consecutive batches - repeatable • Must investigatefailures • The rationale should be documented if experimental method is changed • document deviations, decisions and reasoning • Does not improve processes • Should not validate bad processes

Validation Design user or process requirements Install installation qualification Operate operational qualification Validate performance qualification and process validation Review periodically (+ change control) DQ, IQ, OQ and PQ

Validation Critical factors or parameters • Need to be determined • Need to be monitored during validation • May affect the quality of the product

Validation Setting Limits • Marketing authorization limits • stability specifications • Release specification • Validation limits Marketing authorisation limitsbased on stability specifications Batch release limits Validation limits

Validation Determining critical control pointexample of a tablet granulation process • Particle size distribution of the active(s) • Blending time for the powder • Granulating time and speed, • Amount of granulating fluid-binder concentration • Drying time - final moisture content, granule particle size distribution • Granule active content and homogeneity, blending time of external phase

Validation Determining critical control points

Validation Solid dose mixing (1) • Homogeneity in blending – the key to quality! • Sampling strategy • Sample site, label, container • Storage • Transport • Sample thief

Validation Solid dose mixing (2) • In situ analysis • Methods of analysis • Statistical analysis • inter-batch • intra-batch • within-sample-site

Validation Tablet compression variables • Fill volume • Pre-compression force, compression force • Turntable speed • Dwell time • Granule size and feed • Ejection force, lubrication

Validation Tablet compressionparameters • Mass • Hardness • Moisture • Friability • Disintegration • Dissolution • Thickness Tablet coating variables • Spray rate • Inlet andoutlet air temp • Coating weight

Validation • Lethality of cycle • D value • Z value • F value • Fovalue min 8 Moist heat sterilization “Z”

Validation Sterilization validation (1) • Sterility test • Physical measurements • Chemical and biological indicators • Loading patterns

Validation Sterilization validation (2) • Cooling fluid or gas • Automated process • Leak tests • Control instrumentation • Steam quality • Heat distribution

Validation Dry heat sterilization • Parameters • Air circulation, positive air pressure, HEPA filter • Advantages • microorganisms destroyed • depyrogenation possible • Disadvantages • poor heat transfer • higher temperatures for long periods

Validation Process variation Controllable causes of variation may include: • Temperature, humidity • Variations in electrical supply • Vibration • Environmental contaminants • Light • Human factors • Variability of materials • Wear and tear of equipment

Validation Change control • Must be a review procedure for validated processes • From time to time changes may be necessary • Documented change control procedure needed • “Like for like" changes do not require re-validation

Validation Mixing validation liquid and solid dose change control and scale up • Mixer type and size • Batch size • Pilot study scale up • Limit on the proportion of the scale up

Validation Finalization of validation process • Final report required • Summarize and reference protocols and results • Conclusion required: “Is the process valid” • Final report should be reviewed and approved by • the validation team • “authorized person”

Validation Group Session • You are given a tablet manufacturing flow chart to study • List the critical steps that are required to be validated • List the critical equipment required to be qualified • Identify the variables and construct a table as directed

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