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Process Validation Concept

Process validation ensures that processes are capable of consistently producing quality products meeting specifications. It involves qualifying systems and equipment, and demonstrating through process design, qualification, and continued verification that quality is built into the system. The main reasons for process validation are to ensure quality assurance, reduce costs through fewer rejections, and ensure regulatory compliance. It is carried out through qualification activities like design, installation, operational, and performance qualification and includes process validation protocols and reports.

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193 views

Process Validation Concept

Process validation ensures that processes are capable of consistently producing quality products meeting specifications. It involves qualifying systems and equipment, and demonstrating through process design, qualification, and continued verification that quality is built into the system. The main reasons for process validation are to ensure quality assurance, reduce costs through fewer rejections, and ensure regulatory compliance. It is carried out through qualification activities like design, installation, operational, and performance qualification and includes process validation protocols and reports.

Uploaded by

Yousif
Copyright
© © All Rights Reserved
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Download as DOCX, PDF, TXT or read online on Scribd
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PROCESS VALIDATION CONCEPT

Introduction
The concept of validation was first proposed by two Food and Drug Administration
(FDA) officials, Ted Byers and Bud Loftus, in the mid 1970’s in order to improve the
quality of pharmaceuticals. The first validation activities were focused on the processes
involved in making these products, but quickly spread to associated processes including
environmental control, media fill, equipment sanitization and purified water production.
In a guideline, validation is act of demonstrating and documenting that any procedure,
process, and activity will consistently lead to the expected results. It includes the
qualification of systems and equipment. The goal of the validation is to ensure that
quality is built into the system at every step, and not just tested for at the end, as such
validation activities will commonly include training on production material and operating
procedures, training of people involved and monitoring of the system whilst in
production. In general, an entire process is validated and a particular object within that
process is verified. The regulations also set out an expectation that the different parts of
the production process are well defined and controlled, such that the results of that
production will not substantially change over time.

Why Is Validate a process:-


The main reasons for validation are
1. Quality assurance: Quality cannot be assured by daily quality control testing because
of the limitations of statistical samples and the limited facilities of finished product
testing. Validation checks the accuracy and reliability of a system or a process to meet the
predetermined criteria. A successful validation provides high degree of assurance that a
consistent level of quality is maintained in each unit of the finished product from one
batch to another batch.
2. Economics: Due to successful validation, there is a decrease in the sampling and
testing procedures and there are less number of product rejections and retesting. This lead
to cost-saving benefits.
3. Compliance: For compliance to current good manufacturing practices CGMPs,
validation is essential.

Department Responsible:-

 Site validation committee (SVC): Develop Site master Validation plan,


Prepare/execute/approve validation Studies
 Manufacturing department: Prepares the batches as a routine Production batch
 Quality assurance: Ensure compliance, see that documentations/procedures are in
place, approves protocols and reports
 Quality control: Perform testing and reviews protocol and report as needed.

Responsible Authorities For Validation:-


The validation working party is convened to define progress, coordinate and ultimately,
approve the entire effort, including all of the documentation generated. The working
party would usually include the following staff members, preferably those with a good
insight into the company's operation.

 Head of quality assurance


 Head of engineering
 Validation manager
 Production manager
 Specialist validation discipline: all areas

Department /Designation Responsibility

Manager Production Responsible for manufacturing of batches and review


of protocol and report.

Manager QC Responsible   for   analysis   of   samples

collected

Executive QC Responsible for samples collection and


submission to QC

Manager Maintenance Providing     utilities     and     engineering

support

Executive Production Responsible for preparation of protocol and


manufacturing of validation batches

Manager QA Responsible   for   protocol   authorization and


preparation of summary report.

Elements Of Validation:-

Qualification is pre-requisite of validation. The qualification includes the following:

1. Design Qualification (DQ):-


In this qualification, compliance of design with GMP should be demonstrated. The
principles of design should be such as to achieve the objectives of GMP with regard to
equipment. Mechanical drawings and design features provided by the manufacturer of the
equipment should be examined.

2. Installation Qualification (IQ):-


Installation qualification should be carried out on new or modified facilities, systems and
equipment. The following main points should be includes in the installation qualification.

 Checking of installation of equipment, piping, services and instrumentation.


 Collection of supplier’s operating working instructions and maintenance
requirements and their calibration requirements.
 Verification of materials of construction
 Sources of spares and maintenance

3. Operational Qualification (OQ):-


Operational qualification should follow IQ, OQ should include the following:
 Tests developed from the knowledge of the processes systems and equipment
 Defining lower and upper operating limits,. Sometimes, these are called ‘worst
case’ conditions.

4. Performance Qualification (PQ):-


After IQ and OQ have been completed, the next qualification that should be completed is
PQ. PQ should include the following:

 Tests using production materials, substitutes or simulated product. These can be


developed from the knowledge of the process and facilities, systems or
equipment.
 Tests to include conditions with upper and lower limits

Process Validation:

The U.S. Food and Drug Administration (FDA) has proposed guidelines with the
following definition for process validation:
Process validation is establishing documented evidence which provides a high degree of
assurance that a specific process (such as the manufacture of pharmaceutical dosage
forms) will consistently produce a product meeting its predetermined specifications and
quality characteristics.
According to the FDA, assurance of product quality is derived from careful and systemic
attention to a number of important factors, including: selection of quality components and
materials, adequate product and process design, and (statistical) control of the process
through in-process and end-product testing. Thus, it is through careful design
(qualification) and validation of both the process and its control systems that a high
degree of confidence can be established that all individual manufactured units of a given
batch or succession of batches that meet specifications will be acceptable.

This guidance describes process validation activities in three stages.

Stage 1 – Process Design: The commercial manufacturing 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 evaluated to
determine if the process is 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:-

1. Prospective Validation: It is establishment of documented evidence of what a system


does or what it purports to do based upon a plan. This validation is conducted prior to the
distribution of new product.

2. Retrospective Validation: It is the establishment of documented evidence of what a


system does or what it purports to do based upon the review and analysis of the existing
information. This is conducted in a product already distributed based on accumulated
data of production, testing and control.

3. Concurrent Validation: It is establishment of documented evidence of what a system


does or what it purports to do information generated during implemented of the system.

4. Revalidation: Whenever there are changes in packaging, formulation, equipment or


processes which could have impact on product effectiveness or product characteristics,
there should be revalidation of the validated process.

Conditions that require revalidation studies are:

 Changes in critical component


 Change in facility or plant
 Increase or decrease in batch size
 Sequential batches that fail to conform product and process specifications

Change Control:-
Change control is defined as “a formal system by which qualified representatives of
appropriate disciplines review proposed or actual changes that might affect a validated
status. The intent is to determine the need for action that would ensure and document that
the system is maintained in a validated state.”
Change control is a lifetime monitoring approach. Planning for well executed change
control procedures includes the following aspects:

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