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A REVIEW ON PHARMACEUTICAL VALIDATION AND ITS IMPLICATIONS

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 International Journal of Pharmacy and Biological Sciences
ISSN: 2321-3272 (Print), ISSN: 2230-7605 (Online)
IJPBS | Volume 8 | Issue 2 | APR-JUN | 2018 | 117-126
Review Article | Pharmaceutical Sciences | Open Access | MCI Approved|
|UGC Approved Journal |

A REVIEW ON PHARMACEUTICAL VALIDATION AND ITS IMPLICATIONS

Kiranbala Jain*1, Princy Agarwal1 and Meenakshi Bharkatiya2

1
M.Pharma Research Scholar, Department of Pharmaceutical Quality Assurance,
2
Associate Professor, Department of Pharmaceutics.
Bhupal Nobles Institute of Pharmaceutical Sciences, Bhupal Nobles University, Sevashram Road, Udaipur-
313001, Rajasthan, India.

*Corresponding Author Email: kiranbalajain17@gmail.com

ABSTRACT
Validation is one of the important steps in achieving and maintaining the quality of the final product. If each step
of production process is validated, we can assure that the final product is of the best quality. Validation is the art
of designing and practicing the designed steps alongside with the documentation. Validation and quality
assurance will go hand in hand, ensuring the thorough quality for the products. Process validation emphasize on
process design elements and maintaining process control during commercialization and communicate that it is an
ongoing program and align process validation activities with product lifecycle. The purpose of this review is to
present an introduction and general overview on process validation of pharmaceutical manufacturing with special
reference to the requirements stipulated by the US Food and Drug Administration (FDA).

KEY WORDS
validation, protocol, guidelines, quality, cGMP

INTRODUCTION adequate product and process design, control of the

Pharmaceutical Process Validation is the most process, and in-process and end product testing. Due to
important and recognized parameters of cGMPs. The the complexity of today’s medical products, routine end
requirement of process validation appears as the quality product testing alone often is not sufficient to assure
system (QS) regulation. The goal of a quality system is to product quality for several reasons. Some end-products
consistently produce products that are fit for their tests have limited sensitivity. [3] The principal objective
intended use. Process validation is a key element in of dosage form design is to achieve a predictable
assuring that these principles and goal are met. [1] therapeutic response to a drug included in a formulation
The concept of validation was first proposed by Food which is capable of large scale manufacture with
and Drug Administration officials in 1970 in order to reproducible product quality. Process Validation is one
improve the quality of pharmaceuticals. Process of the important steps in achieving and maintaining the
validation is assuring and documenting the process quality of final product. It is the key element to assure
within their specified and designed criteria, therefore the identity, purity, safety, efficacy and also maintaining
the manufactured product will meet its predetermined the quality of final product. [4] The basic principle of
criteria and quality attributes with reproducible and quality assurance is that a drug should be produced that
constant result. [2] Assurance of product quality is is fit for its intended use. In order to meet this principle,
derived from careful attention to number of factors a good understanding of the processes and their
including selection of quality parts and materials, performance is important. Quality cannot be

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adequately assured by in-process and finished product The pharmaceutical industries are concerned about
inspection and testing but it should be built into the validation because of the following reasons.
manufacturing processes. These processes should be ✓ Assurance of quality.
controlled in order that the finished product meets all ✓ Cost reduction.
quality specifications. Process validation is intended to ✓ Government regulation [6]
establish that the proposed manufacturing process is a
suitable one and yields consistently a product of the RESPONSIBLE AUTHORITIES FOR VALIDATION [7,8]
desired quality. i.e. that the process is suitable and The validation working party is convened to define,
under control. [5] investigate, progress, collate, co-ordinate and
ultimately approve the entire effort, including all of the
WHY IS VALIDATION REQUIRED? documentation generate. The working part would
The pharmaceutical industry uses expensive materials, usually involve the following staff members
sophisticated facilities & equipment and highly qualified ·Production manager
personnel. The efficient use of these resources is ·Head of Quality Control (Manager)
necessary for the continued success of the industry. The ·Executive-QC
cost of product failures, rejects, reworks, and recalls, ·Head of Engineering (Manager)
complaints are the significant parts of the total ·Production executive
production cost. Detailed study and control of the ·Validation Executive
manufacturing process- validation is necessary if failure ·Validation Manager
to be controlled and productivity improved. ·Head of Quality Assurance (Manager)

Table 1: Responsible authorities for Validation

Department/Designation Responsibility
Manager Production Responsible for manufacturing of batches and review of protocol and report.
Manager QC Responsible for samples collected
Executive QC Responsible for analysis of 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.

OBJECTIVES OF PROCESS VALIDATION [9] PREREQUISTE OF PROCESS VALIDATION: [1,10]

1) The manufacturing process, in addition to the • Process Development Designee shall review the
individual equipment, must be validated. product development report, data from pilot scale,
2) The goal is to create a robust manufacturing process scale up batch and proposed master formula
that consistently produces a drug product with minimal document of product intended for manufacturing.
variation that adheres to quality criteria of purity, • Process Development Designee shall review/ensure
identity, and potency. the availability analytical method transfer report to
3) A validation plan for the manufacturing process the plant and plant preparedness for conducting
should be drafted and executed by engineers in order to validation testing and routine testing; function shall
satisfy guidelines. The validation plan usually involves co-ordinate with QC/QA in this regard.
just a PQ section. • Process Development Designee shall prepare
4) Just as equipment validation, major changes after the commercial/exhibit batch production and control
initial validation will result in the need for subsequent records which include the operational limits and
revalidation. overall strategy for process control based on
5) In the end, process validation will ensure a robust development report.
product that is highly reproducible over time. • The Process Validation is performed after the
facility, utility, and equipment, and laboratory test

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methods have been validated and released for following a thorough analysis of process data and
process validation activities. Where compendia formal discussion by the validation team.
method is used only limited analytical method
validation shall be conducted. PHASES OF PROCESS VALIDATION [13,14]
• All raw material and packaging material specification Pre-validation Phase or Qualification Phase:
shall be from approved vendors and shall be It covers all activities relating to product research and
approved by quality control. development, formulation pilot batch studies, scale-up
• All the equipment and instrument to be utilized are studies, transfer of technology to commercial scale
calibrated and preventive maintenance programs batches, establishing stability conditions and storage
are in place. and handling of in-process and finished dosage forms,
• Relevant SOPs are in place and training is completed equipment qualification, installation qualification,
on equipment, operation, manufacturing instruction master production document, operational qualification
and sampling strategy. and process capacity.
• Key process steps and process variables are Process Validation Phase (Process Qualification
identified, and their operating ranges have been phase):
established. It is designed to verify that all established limits of the
• All the master formula, manufacturing instruction, critical process parameter are valid and that satisfactory
packaging instruction, testing procedure & products can be produced even under the “worst case”
specification shall be approved before execution of conditions.
process validation batches. Validation Maintenance Phase:
• The cleaning of the area and equipment has been It requires frequent review of all process related
completed prior to the initiation of process documents, including validation of audit reports, to
validation. assure that there have been no changes, deviations
• The validation team and operational team shall be failures and modifications to the production process
trained from process engineer. and that all standard operating procedures (SOPs),
including change control procedures, have been
STRATEGY FOR VALIDATION OF METHODS [11,12] followed. At this stage, the validation team comprising
The strategy selected for process validation should be of individuals representing all major departments also
simple and straight-forward. The following five points assures that there have been no changes/deviations
gives strategy for process validation: that should have resulted in requalification and
1. The use of different lots of raw materials should be revalidation. A careful design and validation of systems
included. i.e., active drug substance and major and process controls can establish a high degree of
excipients. confidence that all lots or batches produced will meet
2. Batches should be run in succession and on different their intended specifications. It is assumed that
days and shifts (the latter condition, if appropriate). throughout manufacturing and control, operations are
3. Batches should be manufactured in the equipment conducted in accordance with the principle of good
and facilities designated for eventual commercial manufacturing practice (GMP) both in general and in
production. specific reference to sterile product manufacture
4. Critical process variables should be set within their
operating ranges and should not exceed their upper ELEMENTS OF PROCESS VALIDATION [15,16,17]
and lower control limits during process operation. Qualification is pre-requisite of validation. The
Output responses should be well within finished qualification includes the following:
product specifications. 1. Design Qualification (DQ)
5. Failure to meet the requirements of the Validation The documented verification that the proposed design
protocol with respect to process input and output of the facilities, systems and equipment is suitable for
control should be subjected to process the intended purpose.
requalification and subsequent revalidation In this qualification, compliance of design with GMP
should be demonstrated. The principles of design

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should be such as to achieve the objectives of GMP with transmission). Performance Qualification reviews the
regard to equipment. Mechanical drawings and design critical parameters of the equipment using suitable test
features provided by the manufacturer of the methods. These procedures are documented in form of
equipment should be examined. test specifications. It is not mandatory to perform
2. Installation Qualification (IQ) Performance Qualification on all equipments or
Establishing confidence that process equipment and instruments. However, Performance Qualification is to
ancillary systems are capable of consistently operating be performed for all the process equipments and the
within established limits and tolerances. (FDA) The equipment that are critical. The question on whether
documented verification that the facilities, systems and not to carry out Performance Qualification is generally
equipment as installed or modified complies with the done on a case-to case basis.
approved design and the manufacturer’s
recommendations. TYPES OF PROCESS VALIDATION: [3,18,19,20]
Installation qualification should be carried out on new 1. Prospective validation
or modified facilities, systems and equipment. The 2. Concurrent validation
following main points should be included in the 3. Retrospective validation
installation qualification. 4. Revalidation
• Checking of installation of equipment, piping, 1. Prospective Process Validation: It is defined as the
services and instrumentation. established documented evidence that a system
• Collection of supplier’s operating working does what it purports to do based on a pre-planned
instructions and maintenance requirements and protocol. This validation usually carried out prior to
their calibration requirements. distribution either of a new product or a product
• Verification of materials of construction. made under a revised manufacturing process
• Sources of spares and maintenance. performed on at least three successive production-
3. Operational Qualification (OQ) sizes. (Consecutive batches)
The documented verification that the facilities, systems These should be incorporated into the Batch
and equipment, as installed or modified, perform as manufacturing and packaging record or into appropriate
intended throughout the anticipated operating ranges. standard operating procedures. Limits, frequencies and
Operational qualification should follow IQ. action to be taken in the event of the limits being
OQ should include the following: exceeded should be specified.
• Tests developed from the knowledge of the Prospective validation should include, but not be
processes systems and equipment limited to the following:
• Defining lower and upper operating limits. • Short description of the process.
Sometimes, these are called ‘worst case’ • Summary of the critical processing steps to be
conditions. investigated.
4. Performance Qualification (PQ): • List of the equipment/facilities to be used
“It is a documented verification that the equipment and (including measuring, monitoring/recording
ancillary systems as compared together can perform equipment) together with its calibration status.
effectively and reproducibly based an approved method • Finished product specifications for release.
and specification.” PQ is establishing confidence that • List of analytical methods, as appropriate.
the process is effective and reproducible, establishing • Proposed in-process controls with acceptance
confidence that a process in accordance with the design criteria.
qualifications. Performance Qualification is • Additional testing to be carried out, with
documented proof that the equipment functions in your acceptance criteria and analytical validation, as
facilities exactly as intended. This is insured by verifying appropriate.
the suitability of the equipment under the actual • Sampling plan.
operating conditions of the environment and according • Methods for recording and evaluating results.
to its intended task (e.g., compliance with safety • Functions and responsibilities.
regulations for accident prevention, traceable data • Proposed timetable.

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Batches made for process validation should be the same period, including any batches that failed to meet the
size as the intended Industrial scale batches. If it is specifications, and should be sufficient in number to
intended that validation batches be sold or supplied, the demonstrate process consistency. Additional testing of
conditions under which they are produced should retained samples may be needed to obtain the
comply fully with the requirements of Good necessary amount or type of data to retrospectively
Manufacturing Practice, including the satisfactory validate the process. For retrospective validation,
outcome of the validation exercise and the marketing generally data from ten to thirty consecutive batches
authorization. should be examined to assess process consistency, but
2. Concurrent Process Validation: It is similar to the fewer batches may be examined if justified. Some of the
prospective, except the operating firm will sell the essential elements for Retrospective Validation Batches
product during the qualification runs, to the public at its manufactured for a defined period (minimum of 10 last
market price. consecutive batches). Number of lots released per year.
• This validation involves in-process monitoring • Batch size/strength/manufacturer/year/period.
of critical processing steps and product testing. • Master manufacturing/packaging documents.
This helps to generate and documented • Current specifications for active materials/finished
evidence to show that the production process products.
is in a state of control. • List of process deviations, corrective actions and
• In exceptional circumstances it may be changes to manufacturing documents.
acceptable not to complete a validation • Data for stability testing for several batches.
programme before routine production starts. 4. Revalidation: It is the repetition of a validation
• The decision to carry out concurrent validation process or a part of it. This is carried out when there is
must be justified, documented and approved any change or replacement in formulation, equipment
by authorized personnel. plans or site location, batch size and in the case of
• Documentation requirements for concurrent sequential batches that do not meet product
validation are the same as specified for specifications and is also carried out at specific time
prospective validation. intervals in case of no changes.
3. Retrospective Process Validation: Retrospective It provides the evidence that changes in a process
validation is defined as the establishment of and/or the process environment that are introduced do
documented evidence that a system does what it not adversely affect process characteristics and product
purports to do on review and analysis of historical quality. Documentation requirements will be the same
information. The sources of such data are production, as for the initial validation of the process. Where no
QA and QC records. The issues to be addressed here are significant changes have been made to the validated
changes to equipment, process, specification and other status, a review with evidence that facilities, systems,
relevant changes in the past. Retrospective validation is equipment and processes meet the prescribed
only acceptable for well-established processes and will requirements fulfils the need for revalidation.
be inappropriate where there have been recent changes Revalidation becomes necessary in certain situations.
in the composition of the product, operating procedures Some of the changes that require validation are as
or equipment. The steps involved require the follows:
preparation of a specific protocol and the reporting of • Changes in raw materials (physical properties such
the results of the data review, leading to a conclusion as density, viscosity, particle size distribution and
and a recommendation. The source of data for this moisture etc that may affect the process or product).
validation should include, but not be limited to batch • Changes in the source of active raw material
processing and packaging records, process control manufacturer.
charts, maintenance logbooks, records of personnel • Changes in packaging material (primary
changes, process capability studies, finished product container/closure system)
data, including trend cards and storage stability results. • Changes in the process (e.g., mixing time, drying
Batches selected for retrospective validation should be temperatures and batch size)
representative of all batches made during the review

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• Changes in the equipment (e.g., addition of DOCUMENTATION [22,23]

automatic detection system). Documentation at each phase of the process validation
• Changes of equipment which involve the lifecycle is essential for effective communication in
replacement of equipment on a “like for like” basis complex, lengthy, and multidisciplinary projects.
would not normally require revalidation except that Documentation is important so that knowledge gained
this new equipment must be qualified. about a product and process is accessible and
• Changes in the plant/facility. A decision not to comprehensible to others involved in each phase of the
perform revalidation studies must be fully justified lifecycle. Information transparency and accessibility are
and documented. fundamental tenets of the scientific method. They are
also essential to enable organizational units responsible
VALIDATION PROTOCOL [21] and accountable for the process to make informed,
The validation protocol should be numbered, signed and science-based decisions that ultimately support the
dated, and should contain as a minimum the following release of a product to commerce.
information: A written protocol should be established that specifies
✓ Title how qualification and validation will be conducted. The
✓ Objective & Scope protocol should be reviewed and approved. The
✓ Responsibility protocol should specify critical steps and acceptance
✓ Protocol Approval criteria. A report that contain references, the
✓ Validation Team qualification and/or validation protocol should be
✓ Product Composition prepared, summarizing the results obtained,
✓ Process Flow Chart commenting on any deviations observed, and drawing
✓ Manufacturing Process the necessary conclusions, including recommending
✓ Review of Equipments / Utilities changes necessary to correct deficiencies. Any changes
✓ Review of Raw Materials and Packing Materials to the plan as defined in the protocol should be
Review of Analytical and Batch Manufacturing documented with appropriate justification. After
Records completion of a satisfactory qualification, a format
✓ Review of Batch Quantities for Validation (Raw release for the next step in qualification and validation
Materials) should be made as a written authorization.
✓ Review of Batch Quantities for Validation (Packing
Materials) VALIDATION LIFE CYCLE
✓ HSE Requirements Validation is a continuing and evolving process. The
✓ Review of Process Parameters Validation validation process which extends from very basic to very
Procedure broad theoretical and methodical investigation of how
✓ Sampling Location the system and processes perform. Its scope
✓ Documentation encompasses documentation revision control, training
✓ Acceptance Criteria and maintenance of the system and process. Evidence
✓ Summary of validation should be seen at the corporate level and
✓ Conclusion be reflected in the management structure. Validation is
a method for building and maintaining quality. [24]

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Figure 1. VALIDATION LIFE CYCLE

VALIDATION MASTER PLAN: concise and clear. It should not repeat information
A validation master plan is a document that summarizes documented elsewhere but should refer to existing
the company’s overall philosophy, intentions and documents such as policy documents, SOP’s and
approaches to be used for establishing performance validation protocols and reports
adequacy. The Validation Master Plan should be agreed The format and content should include:
upon by management. • Introduction: validation policy, scope, location and
Validation in general requires meticulous preparation schedule
and careful planning of the various steps in the process. • Organizational structure: personnel responsibilities
In addition, all work should be carried out in a structured plant/process/product description: rational for
way according to formally authorized standard inclusions or exclusions and extent of validation
operating procedures. All observations must be • Specific process considerations that are critical and
documented and where possible must be recorded as those requiring extra attention
actual numerical results. The validation master plan • List of products/ processes/ systems to be validated,
should provide an overview of the entire validation summarized in a matrix format, validation approach
operation, its organizational structure, its content and • Re-validation activities, actual status and future
planning. The main elements of it being the list planning
inventory of the items to be validated and the planning • Key acceptance criteria
schedule. All validation activities relating to critical • Documentation format
technical operations, relevant to product and process • Reference to the required SOP’s
controls within a firm should be included in the • Time plans of each validation project and sub-
validation master plan. It should comprise all project. [25]
prospective, concurrent and retrospective validations as
well as re-validation. The Validation Master Plan should
be a summary document and should therefore be brief,

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ADVANTAGES [26,27,23] conform to or were not operated or administrated in

➢ Consistent through output. conformity with CGMP. Assurance must be given that
➢ Reduction in rejections and reworks. the drug would meet the requirements of the act as to
➢ Avoidance of capital expenditures. safety and would have the identity and strength and
➢ Fewer complaints about process related meet the quality and purity characteristics that it
failure. purported or was represented to possess. That section
➢ More rapid and accurate investigations into of the act sets the premise for process validation
process deviation. requirements for both finished pharmaceuticals and
➢ More rapid and reliable start-up of new active pharmaceutical ingredients, because active
equipment. pharmaceutical ingredients are also deemed to be drugs
➢ Easier scale-up from development work. under the act. The CGMP regulations for finished
➢ Easier maintenance of equipment. pharmaceuticals, 21 CFR 210 and 211, were
➢ Improve employee awareness of processes. promulgated to enforce the requirements of the act.
➢ More rapid automation. Although these regulations do not include a definition
➢ Assurance of quality for process validation, the requirement is implicit in the
➢ Process optimization. language of 21 CFR 211.100 , which states: “There shall
➢ Reduction of quality cost. be written procedures for production and process
➢ Reduced testing in process and in finished control designed to assure that the drug products have
goods. the identity, strength, quality, and purity they purport
➢ More rapid and reliable start-up of new or are represented to possess.”
equipments.
➢ Easier scale-up form development work. APPROACH TO PROCESS VALIDATION [30]
➢ Easier maintenance of equipment. Stage 1: Process Design: The marketable manufacturing
➢ Improved employee awareness of processes. process is defined during this stage based on knowledge
➢ Expanded real time monitoring and adjustment gained through development and scale-up activities.
of process. Stage 2: Process Qualification: Throughout this stage,
➢ Enhanced ability to statistically evaluate the method design is estimated to determine if the
process performance and product variables. process is capable of reproducible marketable business.
e.g., individuals; mean; range; control limits. Stage 3: Continued Process Verification: Constant
➢ Enhanced data and evaluation capabilities and assertion is gained during routine production that the
increased confidence about process process remains in a state of control. [6]
reproducibility and product quality.
➢ Improved ability to set target parameters and CONCLUSION
control limits for routine production, Validation is the most widely used word in the areas of
correlating with validation results. drug development, manufacturing and specification of
➢ Enhanced reporting capability. finished products. The consistency and reliability of a
validated process to produce a quality product is the
THE REGULATORY BASIS FOR PROCESS VALIDATION very important for an industry. From the study it can be
[28,29] stated that Pharmaceutical Process Validation is the
most important and recognized parameters of cGMP.
Once the concept of being able to predict process Quality assurance techniques must be used to build the
performance to meet user requirements evolved, FDA quality into the product at every step and not just tested
regulatory officials established that there was a legal for at the end. Process validation involves a series of
basis for requiring process validation. The ultimate legal activities taking place over the lifecycle of the product
authority is Section 501(a)(2)(B) of the FD&C Act, which and process.
states that a drug is deemed to be adulterated if the
methods used in, or the facilities or controls used for, its
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*Corresponding Author:
Kiranbala Jain*
Email: kiranbalajain17@gmail.com

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