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Process Validation In Medical Device Industry



Mr. Sanajay Shah


Unikal Consultants

Why carry out process validation?

To ensure that the output of the process will consistently meet the required parameters during routine production, the process is validated. The validation is to be carried out because it is regulatory requirement as per FDA’s QSR & ISO 13485: 2003 and also for Customer satisfaction, it is Customer Mandated for securing new business, for product liability, to reduce production costs (because process / product Validation leads to reduced inspections, testing, scrap and rework) and it supports improvements.

The goal of a quality system is to consistently produce products that are fit for their intended use. Process validation is a key element in assuring that these principles and goals are met.

Many technologies are used in the production of medical devices. The details of process validation will vary according to the nature of the medical device (e.g., sterile or non-sterile) and the nature and complexity of the process being validated.

Requirements for process validation

Where the results of a process cannot be fully verified by subsequent inspection and test, the process needs to 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.

Each manufacturer it advised to establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met and shall ensure that validated processes are performed by qualified individuals. For validated processes, the monitoring and control methods and data, the date performed, and, where appropriate, the individuals performing the process or the major equipment used shall be documented.

When changes or process deviations occur, the manufacturer shall review and evaluate the process and perform revalidation where appropriate. These activities shall be documented.

What is process validation? Basic Principles for process validation:

Establish that the process equipment has the capability of operating within required parameters.

Demonstrate that controlling, monitoring, and/or measuring equipment and instrumentation are capable of operating within the parameters prescribed for the process equipment.

Perform replicate cycles representing the required operational range of the equipment to demonstrate that the processes have been operated within the prescribed parameters for the process and that the output or product consistently meets predetermined specifications for quality and function.

Monitor the validated process during routine operation. As needed, re-qualify and recertify the equipment.

Definition of Validation:

Confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.

Definition of Process validation:

Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.

Stages of validation are: Installation qualification (IQ), Operational qualification (OQ) and Performance qualification (PQ).

Content of Validation protocol:

A written plan stating how validation will be conducted, including test parameters, product characteristics, production equipment, and decision points on what constitutes acceptable test results.

When should processes be validated?

Where process results cannot be fully verified during routine production by inspection and test, the process must be validated according to established procedures.

There is other critical aspect for validation which is in relation to Risk involved. For complex or critical processes, a risk analysis is normally conducted prior to establishing validation requirements. The risk analysis will reveal which output parameters should be concentrated upon, and assist in the development of appropriate tests.

Steps involved are:

Develop a Validation Program that Defines:

Responsibilities, Process Type Definition, Flow Chart with Decision Points, Methods, Forms, Documentation and Oversight

PROCESS VALIDATION MASTER PLAN preparation is a very critical step in the process. It provides the roadmap for conducting validations, establishes criticality of the process, defines the validation approach, documents rationale for decisions to “not validate”, provides documented evidence of the validation, provides an easy to follow trail to locate relevant validation documents and test data and establishes requirements for process changes.

Process Validation Summary Report (PVSR) is a controlled document which lists all current validation documentation to demonstrate that processes are validated and specifies any revalidation requirements.

Examples of processes requiring validation are:

Sterilization, Aseptic Transfer, Performance tests, Injection Molding of critical parts, blending / mixing of critical solutions etc.

The protocol plan requires following:

Title, Purpose, Scope, Hypothesis / Expected Outcome, Reference Documents, Sample Requirements, Test Description, Procedure, Disposition of Parts, Attachments,

The Protocol Report can include:

Title, Purpose & Scope, Reference Documents, Results, Discussion, Deviations & Additions and Conclusion. Revalidation is required when all or a portion of a validation that is required to be repeated when changes that affect the original validation are made.

e.g. Changes to product specifications, Process parameters, Equipment (type, function, location, control system, major repairs), Raw materials, Manufacturing materials etc.

The operational, monitoring and other production-related procedures are part of the device master record (DMR).

Copies of protocols and validation results are placed in the Design History File (DHF) or quality system record (QSR) file.

Qualification of Software is required for Critical Software Systems.

Critical software systems are those systems, which are used to support regulatory requirements and/or systems, which affect product fit, form, function, or processes. This is required for both purchased and proprietary software.

To conclude, process validation is an integral & critical part of any medical device manufacturing Quality Management System.

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