VALIDATION ANS QUALIFICATION OF

MEDICAL DEVICE

 Prepared By: Quality & Regulatory Affairs Specialist

 Mohammad Khush Noor
 B. Tech – Mechanical Engg.
 mdkhushnoor786@gmail.com
 VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE

‘VALIDATION’ The assurance that a product, service, or

system meets the needs of the user or customer.

Validation: Are we building the right product?

 VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE

MEDICAL DEVICE VALIDATION:

In the context of medical device development, validation refers to the process of
demonstrating that a device is able to consistently meet its intended use,
performance, and safety requirements. The purpose of validation is to ensure that the
device will function as intended and be safe for use by patients.

Validation typically involves a series of tests and evaluations that are performed
during different stages of device development, such as design, development, and
manufacturing. These tests may include functional testing, reliability testing, and
performance testing, among others.

In order to validate a medical device, it is important to establish clear and

measurable criteria for success, and to document all test results and observations in
a structured and organized manner. The validation process should be well-
documented and well-controlled, and should adhere to applicable regulatory
requirements and industry standards.
 VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE
Medical device validation typically involves the following steps:
 Planning: Developing a validation plan that outlines the scope of the validation effort,
the acceptance criteria, and the validation activities that will be performed.
 Design and development: Ensuring that the device design and development process
meets all applicable regulatory standards and requirements.
 Verification: Conducting testing and analysis to ensure that the device meets all
design and performance specifications.
 Validation testing: Conducting testing to demonstrate that the device meets all
requirements and is safe and effective for its intended use.
 Documentation: Creating and maintaining documentation that demonstrates
compliance with regulatory requirements.

Ultimately, successful validation of a medical device provides assurance that the device
is safe, effective, and reliable for use in clinical settings, and can help to establish trust
and confidence among patients, healthcare providers, and regulatory authorities.
 VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE

 In general, validation refers to the process of ensuring that something is accurate, reliable,
and meets the required specifications or standards. In different contexts, validation can have
different meanings, such as:

1.Data validation: The process of checking data to ensure that it is accurate, complete, and consistent.
2.Software validation: The process of checking software to ensure that it meets the specified
requirements and performs its intended functions correctly.
3.Process validation: The process of verifying that a manufacturing or production process is capable of
producing consistent and high-quality products that meet the required specifications.
4.Validation of qualifications or credentials: The process of verifying that a person's educational or
professional qualifications or credentials are genuine and meet the required standards.
5.Equipment qualification: It is a series of inspections, tests, and assessments to ensure that a given
piece of equipment is compliant and ensures reliable performance.

Overall, validation is an important process in various fields and industries to ensure quality and
reliability.
 VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE

 Importance of Validation:
Validation is particularly important for medical devices as they directly impact patient health
and outcomes. Poorly validated medical devices can have serious consequences for patients,
such as inaccurate diagnoses, ineffective treatments, or adverse events. For example, if a
diagnostic device is not properly validated, it may provide false or misleading results, leading
to incorrect diagnoses and inappropriate treatments. If a therapeutic device is not validated, it
may not deliver the intended treatment dose or may cause harm to the patient.

Furthermore, poorly validated medical devices can result in regulatory non-compliance and
may lead to product recalls, legal liabilities, and damage to the reputation of the manufacturer.
The regulatory bodies such as the US Food and Drug Administration (FDA) and the European
Medicines Agency (EMA) have strict guidelines on the validation of medical devices to ensure
their safety, efficacy, and quality.
 VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE

 Regulatory Requirements
The regulatory requirements for medical device validation vary depending on the country or region in
which the device will be marketed. In the United States, medical devices are regulated by the Food
and Drug Administration (FDA), while in Europe, they are regulated by the European Medicines
Agency (EMA), and India, medical devices are regulated by the Central Drugs Standard Control
Organization (CDSCO). In general, medical device validation involves demonstrating that the device
is safe and effective for its intended use, and that it meets certain quality standards.

The validation process typically involves the following steps:

1.Design and development: The device manufacturer must design and develop the device according
to certain quality standards and regulatory requirements.
2.Preclinical testing: The device must undergo preclinical testing to demonstrate safety and efficacy in
animals or in vitro models.
3.Clinical trials: The device must then undergo clinical trials to demonstrate safety and efficacy in
humans. The FDA may require different levels of clinical evidence depending on the risk of the device.
VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE

VALIDATION MASTER PLAN (VMP)

A validation master plan (VMP) is a document that outlines the
approach and activities to be undertaken to ensure that a medical
device meets its intended use and is safe and effective for its
intended purpose. The VMP is an essential part of the validation
process and serves as a guide for the entire validation effort.
 VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE

 VALIDATION MASTER PLAN (VMP)

The following are some of the key elements that could be included in a validation master
plan for a medical device:

 Introduction: A brief overview of the medical device, its intended use, and the purpose of the
validation master plan.

 Scope: A description of the scope of the validation effort, including the devices, systems, and
processes to be validated.

 Validation approach: A description of the overall approach to be used for the validation effort,
including the validation strategy, the testing methods to be used, and the acceptance criteria.

 Responsibilities: A description of the roles and responsibilities of the various stakeholders

involved in the validation effort, including the validation team, the device manufacturer, and
any third-party vendors.
 VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE

VALIDATION MASTER PLAN (VMP)

The following are some of the key elements that could be included in a validation
master plan for a medical device:

 Documentation: A description of the documentation that will be required for the

validation effort, including protocols, test plans, reports, and other supporting
documentation.

 Risk management: A description of the risk management approach to be used for

the validation effort, including the identification, assessment, and mitigation of risks
associated with the medical device.

 Change control: A description of the change control procedures to be used for the
medical device, including the management of any changes to the device or its
associated processes.
 VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE

 VALIDATION MASTER PLAN (VMP)

The following are some of the key elements that could be included in a validation
master plan for a medical device:

 Training: A description of the training requirements for the various stakeholders involved in
the validation effort, including the validation team, the device manufacturer, and any third-
party vendors.

 Validation schedule: A timeline for the validation effort, including key milestones and
deadlines.

 Conclusion: A summary of the validation master plan and any key considerations or
recommendations for the validation effort.

Overall, a validation master plan is a critical component of the medical device

validation process, helping to ensure that the device is safe and effective for its
intended purpose.
 VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE

PROCESS VALIDATION
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
 VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE
 PROCESS VALIDATION
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.
 VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE

PROCESS VALIDATION
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.
 VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE

 PROCESS VALIDATION
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.
 VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE

MACHINE QUALIFICATION VALIDATION

Machine qualification validation is a crucial process that ensures that a machine is fit for its intended
purpose and can produce reliable results. It involves testing and verifying the performance and
accuracy of the machine according to predetermined specifications.

Why is equipment qualification required?

First of all, qualification is required by regulatory authorities. CDSCO, FDA, EMA, MHRA,
and WHO require that GMP (Good Manufacturing Practice) equipment used for manufacturing of
medical device need to be qualified before released for their intended use. During the qualification
process, a piece of equipment will be tested to prove that it meets the requirements of what a user
has expected (user specification) and what the equipment is designed for (design/functional
specification).
 VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE

 Machine qualification validation

The three major stages of an equipment protocol qualification are:

•Installation Qualification (IQ)

•Operational Qualification (OQ)

•Performance Qualification (PQ).

In the Specification group, the critical attributes for the equipment are User Requirement
Specification (URS), Functional Requirement Specification (FRS), and Design Specification (DS).
Moreover, the qualification process needs to be documented. The auditor will visit the drug
manufacturing site on a routine basis and documentation is certainly one of the main focuses of
the audit. Those documents are the best way to prove that the equipment qualification was
properly performed.
 VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE

Machine qualification validation

 Installation Qualification (IQ):
This step ensures that the machine is installed correctly and meets all the
manufacturer's specifications. The installation process involves verifying the
machine's electrical and mechanical connections, checking for leaks, and confirming
that all components are present and functioning correctly.

 Operational Qualification (OQ):

This step ensures that the machine operates correctly and meets the user's
requirements. The OQ process involves testing the machine's performance by filling
and sealing a predetermined number of pouches with the liquid product. The
performance tests are designed to verify that the machine can operate at the required
speed and accuracy.
 VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE

 Machine qualification validation

 Performance Qualification (PQ):
This step ensures that the machine consistently produces the desired results over an
extended period. The PQ process involves testing the machine's performance by
filling and sealing a predetermined number of pouches with the liquid product under
different conditions, such as varying product viscosity, temperature, and filling volume.
The performance tests are designed to verify that the machine can consistently
operate at the required speed and accuracy and meet the user's product
specifications.
 VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE
 Machine qualification validation
Validation Results:

The machine qualification validation was completed successfully. The installation qualification (IQ)
process verified that the machine was installed correctly and met all the manufacturer's
specifications. The operational qualification (OQ) process verified that the machine operated
correctly and met the user's requirements for speed and accuracy.
The performance qualification (PQ) process verified that the machine consistently produced the
desired results over an extended period. The machine was tested under different conditions, and the
results were within the required specifications.

Conclusion:
The machine qualification validation process for the new packaging machine was successful. The
machine was installed correctly and met all the manufacturer's specifications. The machine was able
to operate at the required speed and accuracy and consistently produced the desired results over an
extended period. The machine qualification validation process ensured that the machine was fit for
its intended purpose and could produce reliable results.
 VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE

CLEANING VALIDATION
Cleaning validation is an essential part of medical device
manufacturing process to ensure the safety and efficacy of the
device. It is a documented evidence that proves the cleaning
process of the device is effective and removes all residues,
contaminants, and other impurities. The purpose of this report is to
outline the cleaning validation process of a medical device and the
various tests and methods used to validate the cleaning process.
 VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE

CLEANING VALIDATION
Cleaning Validation Process:

The cleaning validation process involves several steps, including identification of

critical cleaning areas, selection of appropriate cleaning agents, development of
cleaning procedures, and execution of cleaning validation tests.

Identification of Critical Cleaning Areas:

The first step in the cleaning validation process is to identify the critical cleaning
areas of the medical device. These areas are those that come into contact with
the patient's body or fluids and are at risk of contamination. The critical cleaning
areas can be identified by conducting a risk assessment that considers the
device's design, materials, and manufacturing process.
 VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE

 CLEANING VALIDATION
Selection of Appropriate Cleaning Agents:

Once the critical cleaning areas are identified, the next step is to select appropriate cleaning
agents. The cleaning agents should be effective in removing all residues and contaminants
without damaging the device's materials or affecting its performance. The selection of cleaning
agents should be based on their compatibility with the device's materials and their ability to
remove specific types of residues.

Development of Cleaning Procedures:

After the selection of appropriate cleaning agents, the cleaning procedures are developed.
The cleaning procedures should be detailed, clear, and easy to follow. They should include
instructions for the preparation of the cleaning solution, the application of the cleaning agent,
the rinsing process, and the drying process. The cleaning procedures should be validated to
ensure that they are effective in removing all residues and contaminants.
 VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE
 CLEANING VALIDATION
Execution of Cleaning Validation Tests:

The final step in the cleaning validation process is to execute the cleaning validation tests.
The cleaning validation tests should be designed to demonstrate that the cleaning process is
effective in removing all residues and contaminants. The tests should be performed using
worst-case scenarios to ensure that the cleaning process is effective under all possible
conditions.

Cleaning Validation Tests and Methods:

The cleaning validation tests and methods used depend on the nature of the device, the
cleaning agents, and the manufacturing process. Some of the commonly used tests and
methods are:
 Visual Inspection: A visual inspection is performed to check for any visible residues or
contaminants.
 Swab Testing: Swab testing involves the collection of swab samples from the critical
cleaning areas and testing them for the presence of residues or contaminants.
 VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE
 CLEANING VALIDATION
 Rinse Water Testing: Rinse water testing involves the collection of rinse water samples from
the critical cleaning areas and testing them for the presence of residues or contaminants.
 Total Organic Carbon (TOC) Testing: TOC testing involves the measurement of the amount
of organic carbon present in the cleaning solution or rinse water.
 High-Performance Liquid Chromatography (HPLC) Testing: HPLC testing involves the
separation and identification of specific residues or contaminants using a high-performance
liquid chromatography system.

Conclusion:
In conclusion, cleaning validation is a crucial part of the medical device manufacturing process
to ensure the safety and efficacy of the device. The cleaning validation process involves
several steps, including identification of critical cleaning areas, selection of appropriate
cleaning agents, development of cleaning procedures, and execution of cleaning validation
tests. The tests and methods used to validate the cleaning process depend on the nature of
the device, the cleaning agents, and the manufacturing process. Proper cleaning validation
ensures that the device is free from residues and contaminants and safe for use by patients.
.
VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE

STERILIZATION VALIDATION
Sterilization validation is a critical aspect of the development and
manufacturing process of medical devices. It ensures that the device is
free from harmful microorganisms, thereby reducing the risk of infection
and ensuring patient safety. This report outlines the steps involved in
the sterilization validation process of a medical device.
 VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE
 STERILIZATION VALIDATION

Sterilization Method:

The first step in the sterilization validation process is to determine the appropriate
sterilization method for the medical device. The method selected should be
effective in killing microorganisms without damaging the device. Common
sterilization methods include gamma radiation, ethylene oxide (EO) gas, and steam
sterilization.

Validation Protocol:

Once the sterilization method is selected, a validation protocol is developed. This

protocol outlines the steps that will be taken to validate the sterilization process.
 VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE
 STERILIZATION VALIDATION

The protocol should include the following:

 Identification of the microorganisms of concern: The microorganisms that are most

likely to contaminate the medical device are identified. This information is used to
determine the appropriate challenge microorganisms for the sterilization process.
 Inoculation of the device: The device is inoculated with the challenge
microorganisms, and the number of microorganisms present is determined.
 Sterilization process: The device is subjected to the sterilization process according to
the selected sterilization method.
 Bioburden testing: After sterilization, the device is tested to determine the number of
residual microorganisms present. This testing is referred to as bioburden testing.
 Sterility testing: The device is tested to determine if it is sterile. This testing is typically
done using a validated sterility test method.
 Validation report: A report is generated that outlines the results of the validation study,
including the validation protocol, the results of the bioburden and sterility testing, and
any deviations or corrective actions taken during the process.
 VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE

 STERILIZATION VALIDATION

Conclusion:

Sterilization validation is an essential aspect of the development and

manufacturing process of medical devices. It ensures that the device is free from
harmful microorganisms, reducing the risk of infection and ensuring patient safety.
The validation process should follow a well-defined protocol that includes
identification of the microorganisms of concern, inoculation of the device,
sterilization process, bioburden testing, sterility testing, and generation of a
validation report. The validation report should be reviewed and approved by the
appropriate regulatory bodies before the medical device can be marketed
VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE

VALIDATION PROTOCOL
A validation protocol is a formal document that outlines the
steps, procedures, and criteria to be followed during the
validation process. It typically includes details about the
equipment, methods, and acceptance criteria for validation.
Here are the key elements
 VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE
 VALIDATION PROTOCOL

The validation protocol included the following:

 Objective:
Clearly state the purpose of the validation study, such as to verify that the equipment or
process meets its intended use and performance requirements.

 Scope:
Define the scope of the validation study, including the equipment, process, and product or
service being validated. Specify the functional and performance requirements to be validated.

 Roles and Responsibilities:

Clearly identify the individuals and their roles and responsibilities in the validation study. This
includes the validation team, the project manager, and other stakeholders.

 Equipment and Materials:

Identify the equipment and materials to be used during the validation study. Include
information on the manufacturer, model number, and specifications.
 VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE
 VALIDATION PROTOCOL

The validation protocol included the following:

 Methods:
Describe the methods to be used to validate the equipment or process. This should include test
protocols, procedures, and acceptance criteria.

 Data Analysis:
Explain the methods to be used to analyze the data collected during the validation study. This
should include statistical methods and software tools used for data analysis.

 Acceptance Criteria:
Clearly define the acceptance criteria for the validation study. This includes performance
specifications, quality standards, and regulatory requirements.

 Documentation and Reporting:

Specify the documentation and reporting requirements for the validation study. This includes the
format and content of the final validation report, as well as any interim progress reports.
 VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE
 VALIDATION PROTOCOL

The validation protocol included the following:

 Risk Management:
Describe the risk management plan for the validation study, including the identification and
assessment of potential risks and the methods for controlling and mitigating those risks.

 Timeline:
Define the timeline for the validation study, including the start and end dates for each phase of
the study.

 Sign-off and Approval:

Include a section for sign-off and approval of the validation protocol by all stakeholders
involved in the study.

A well-written validation protocol ensures that the validation process is executed in a

consistent and systematic manner, and that the results are reliable and accurate.
VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE

VALIDATION REPORT
A validation report is a document that summarizes the
findings of a validation study or experiment. The purpose of
the report is to provide evidence that a particular process,
system, or product meets the pre-defined specifications and
requirements.
 VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE
 VALIDATION REPORT

Here is a possible outline for a validation report:

 Introduction:
1. Purpose and scope of the validation study
2. Background information on the process, system, or product being validated
3. Brief summary of the validation methodology

 Validation methodology:
1. Description of the validation protocol, including acceptance criteria and test methods
2. Identification of the validation team members and their roles
3. Description of the validation materials and equipment used

 Results:
1. Summary of the results of the validation study
2. Presentation of the data collected during the validation process
3. Discussion of any deviations from the pre-defined acceptance criteria and how they
were addressed
VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE

 VALIDATION REPORT

Here is a possible outline for a validation report:

 Conclusion:
1. Overall assessment of the validity of the process, system, or product
2. Explanation of any limitations or uncertainties associated with the
validation study
3. Recommendations for future improvements or modifications to the
validated process, system, or product

• Appendices:
1. Supporting documentation, such as validation protocols, test procedures,
and data tables
2. List of abbreviations and definitions used in the report
3. Contact information for the validation team members and other relevant
parties
 VALIDATION ANS QUALIFICATION OF MEDICAL DEVICE

 VALIDATION REPORT

The validation report should be written in clear and concise

language, with sufficient detail to allow readers to understand the
validation process and results. It should also include references to
any relevant standards or regulations that were used as a basis for
the validation study. The report should be reviewed by all members
of the validation team and other relevant stakeholders before it is
finalized and submitted.
mdkhushnoor786@gmail.com

+91 885 178 3393

New Delhi