Description

This design of the experiment protocol template is an NFT (Non-Fungible Token) downloadable document ready to use in a planned and systematic manner to handle your needs of process optimization using the Taguchi Method.  Design of experiment (DOE) is an essential tool, very useful, and highly recommended as a prerequisite before starting any process validation as per 21 CFR Part 211 and 21 CFR Part 820. 

In addition, this design of experiment protocol is intended to facilitate the collection of the documented evidence necessary to establish the best and optimum operational parameters & conditions for your processes, test methods, operators, gauges/measuring instruments, and design specifications suitable to provide the target and the expected outcome(s) consistently and repeatably.

This 42-page document is the first collectible digital asset of a design of experiment protocol template (Limited Edition) available in MS Word and Adobe .pdf format from the NFT marketplace.   It contains copyright information only authorized to be used within your company.

To download a free sample of the design of experiment protocol template, click here.  

This protocol template is an NFT digital asset intended to set forth the instructions to create and implement a design of experiment (DOE) program applicable for any type of equipment, product, material, or part number prior to entering into a process validation as part of your GMP manufacturing operations.  It describes the methodology (steps-by-steps) for the execution of the design of experiment (DOE) activities according to the FDA process validation guidelines.

Purpose of the Design of Experiment Protocol Template

This DOE design of the experiment protocol template brings the guideline to make sure that your equipment and products are suitable to work together at the expected optimum parameters and conditions, according to its intended use and applicable standard operating procedures.

This document will identify the instructions step-by-step to verify that the equipment has been challenged at its optimum conditions as per design specifications and manufacturing requirements for the products, components, and materials applicable to your company.

Design of Experiment Protocol Template Description

This design of experiments protocol can be customized and adjusted for your company’s needs and may help you to reach consistency in your manufacturing operations before starting a process validation.

Consistency is achieved when performance is close to the target with less variation.

4 Optimization Approaches in the Design of Experiments

To improve quality and consistency, four (4) optimization approaches can be used:

1. Find the factors-level combination that reduces performance variability. Identify the significant factors and their relative influences on the variability of results.
2. Adjust the factors-levels that bring performance closer to the target.
3. Determine the trend influence of factors and interactions under the study.
4. Establish the optimum conditions for the product or process, along with an estimate of the contribution of each individual factor.

10 Steps to Implement a Design of Experiment Using the Taguchi Method for Process Optimization.

The following 10 steps summarize the instructions necessary to implement a complete design of experiments using the Taguchi Methods for process optimization before moving forward with a process validation:

Step 1. Determine the number of factors.

Step 2. Determine the number of levels.

Step 3. Select the most suitable Orthogonal Array.

Step 4. Determine the number of experiments

Step 5. Find the corresponding orthogonal array table

Step 6. Determine the CQA performance characteristics to measure the process output

Step 7. Add the Critical Process Parameters and CQA performance characteristics

Step 8. Conduct the experiments, running the experiments

Step 9. Perform the statistical analysis and calculations

Computation of Average Performance

Projection of the Optimum Performance

Step 10 Predict the optimal output performance level

5 Steps to Predict an Expect Response using Design of Experiment

A prediction of the expected response under the optimum conditions can be obtained following the next 5 steps:

1. Brainstorm the quality characteristics and design parameters important to the product/process under study.
2. Design the experiment to prescribe individual test recipes.
3. Conduct the experiments.
4. Analyze the results to determine the optimum conditions.
5. Run a confirmation test(s) using the optimum conditions.

Important Note:

Once you build your own design of the experiment program using this protocol template, you can resell the same NFT if you want in the NFT marketplace to make profits of your investment.

In addition, it allows you the mechanism to handle the design of experiment documentation related to your process parameters, part numbers, raw materials, and other product received from your suppliers that need to be addressed and optimized in the most simple way.

 

SPECIAL BONUS

This protocol template describes how to perform the most relevant design of experiment’s activities applicable to your manufacturing processes in a practical way using twelve (12) template tables, as applicable to each case in your pharmaceutical and medical devices company:

• • • • Template Table 1. Process Description
      • Template Table 2. Equipment / Process Compatibility and Equivalency Description
      • Template Table 3. Process Requirements – Prerequisites
      • Template Table 4. Design Specification, User Requirements, Drawing Specifications
      • Template Table 5. Standard Operating Procedures, Test Methods, Measuring Instructions &Forms
      • Template Table 6. Vendors And Suppliers’ Description
      • Template Table 7. Product Characteristics
      • Template Table 8. Critical Quality Attributes (CQA) – Testing and Sampling Description
      • Template Table 9. Suitability Assessment – Measuring Instruments for Critical Quality Attributes
      • Template Table 10. Operators, Technicians, Inspector,s and Other Personnel Involved
      • Template Table 11. Rationale For Not Measures All Quality Attributes
      • Template Table 12. Assessment And Identification of the Most Dominant Factors to the Process

 

Don’t lose this extraordinary investment opportunity to get a utility NFT protocol template written by the experienced author: Ramon Cayuela, CIQA Director.

Buy now.

Avoid Mistakes Implementing a Design of Experiment Program.

Step 1. Review the applicable design specification tolerances, current SOP standard operating procedure(s), and bills of materials concerned to each manufacturing process, product, and its components with their attributes and characteristics necessary from each supplier and client.

Step 2. Compare your design of the experiment protocol against your current practice and actual use of your production processes, machine parameters, and their configurations considering any update(s) or change control(s) made changes to specifications included in your design requirements and standard operating procedures.

Step 3. Also, consider the applicable FDA validation requirements versus your process validation studies performed previously in your company.

Step 4. Evaluate the process parameters, specifications, and results obtained in any previous process validation (PV) study.  Moreover, verify how you established your process validation acceptance criteria, risks, and how fast you need to perform and close each process validation (PV) package including any pending item or future improvement.

Step 5. Finally, implement a robust and efficient design of the experiment program to be used prior to initiating your process validation studies, to prevent surprises, gaps or discrepancies that could arise during the process validation execution.

For more information, visit www.ciqa.net/shop to download other Validation Protocol Templates in .pdf format or fully editable in MS Word format, ready to fill, and use according to your cGMP needs at affordable prices.

ADDITIONAL VALIDATION PROTOCOL TEMPLATES ARE AVAILABLE IN MSWORD, SOLD SEPARATELY.
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QMS Software Applications

The design of experiment records and its documentation can be handled electronically using the CIQA QMS software application.  For more information about the CIQA Quality Management System (QMS) Software Applications, click here.

In addition, you can get full access free trial to the CIQA software application for 30 days, to manage and store all your design of experiment records and other information related to your QMS Quality Management Systems.

About The Author:

Ramon Cayuela Melendez, CIQA Director

Bachelor’s and Master’s Degrees in Chemical Engineering from the University of Mayaguez, Puerto Rico.

30+ years of experience in Quality System Regulations serving more than 1,000 clients in over 100 multinational companies related to pharmaceutical, biotechnology, food & medical devices.

Manager & Senior Scientist with proficient skills and experience in Pharmaceutical Validations, Quality Assurance, Regulatory Compliance, Research & Development (R&D), GMP/ISO Audits, CAPA, Automation & Software Development.

Author of over 250 Quality Management Procedures and Validation Protocols Templates NFTs.

United States & European Citizens.  Speak English & Spanish.

 

 

CIQA is a validation, quality, and regulatory compliance company with over 30 years of experience bringing consulting services to the pharmaceutical, medical device, and biotechnology industries.