Mr. Sanajay Shah
Why carry out process validation?
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
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.
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
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.
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.
changes or process deviations occur, the manufacturer
shall review and evaluate the process and perform
revalidation where appropriate. These activities shall
What is process validation? Basic Principles for
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
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.
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.
of validation are: Installation qualification (IQ),
Operational qualification (OQ) and Performance
Content of Validation protocol:
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?
process results cannot be fully verified during
routine production by inspection and test, the process
must be validated according to established procedures.
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
Steps involved are:
Develop a Validation Program that Defines:
Responsibilities, Process Type Definition, Flow Chart
with Decision Points, Methods, Forms, Documentation
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.
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:
Purpose, Scope, Hypothesis / Expected Outcome,
Reference Documents, Sample Requirements, Test
Description, Procedure, Disposition of Parts,
The Protocol Report can include:
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.
Changes to product specifications, Process parameters,
Equipment (type, function, location, control system,
major repairs), Raw materials, Manufacturing materials
operational, monitoring and other production-related
procedures are part of the device master record (DMR).
of protocols and validation results are placed in the
Design History File (DHF) or quality system record (QSR)
Qualification of Software is required for Critical
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
conclude, process validation is an integral & critical
part of any medical device manufacturing Quality