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A REVIEW ON PHARMACEUTICAL PROCESS VALIDATION OF SOLID DOSAGE

FORM [TABLETS]

Article · November 2015

DOI: 10.22270/jddt.v5i6.1109

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Journal of Drug Delivery and Therapeutics
Open access to Pharmaceutical and Medical research
© 2015, publisher and licensee JDDT, This is an Open Access article which permits unrestricted noncommercial use, provided the original
work is properly cited

REVIEW ARTICLE
A REVIEW ON PHARMACEUTICAL PROCESS VALIDATION OF SOLID DOSAGE FORM [TABLETS]
Parajuli Rishi Ram1*, Shrestha Saroj1, Lamichane Shreekrishna1,Pokhrel Priyanka2.
1
Production Pharmacist, TIME Pharmaceuticals Pvt. Ltd, Nepal
2
Dossier Pharmacist, TIME Pharmaceuticals Pvt. Ltd, Nepal
*Corresponding Author’s Email: [email protected]
Received 02 July 2015; Review Completed 29 Aug 2015; Accepted 29 Aug 2015, Available online 15 Nov 2015

ABSTRACT:
The article gives an introduction and general overview on process validation of pharmaceutical tablet manufacturing process.
Process Validation is one of the important steps in achieving and maintaining the quality of final product. Process validation
emphasizes the role of statistical tools and analyses, knowledge, detection, and control of variability and thus gives assurance
on consistency of quality product. The validation study provides the accuracy, sensitivity, specificity and reproducibility of the
established and documented test methods employed by the manufacturer. Thus, validation is an essential part of the quality
assurance. This review examines the need for pharmaceutical validation, the various approaches, process and steps to be
monitored during tablet manufacturing process.
Key words: Process Validation, Types, Validation Stages, Guidelines and Process.

1. INTRODUCTION:
The concept of validation was first proposed by two production phase. Validation necessarily includes
Food and Drug Administration officers, Ted Byers and process qualification (the qualification of materials,
Bud Loftus, in the mid 1970’s in order to improve the equipment, system, building, personnel), but it also
quality of pharmaceuticals. Pharmaceutical Process includes the control on the entire process for repeated
Validation is the most important and recognized batches or runs”.
parameters of CGMPs.1 The requirement of process
European Commission - 1991 - Validation - “Act of
validation appears of the quality system (QS)
proving, in accordance of GMPs that Any” process
regulation. The goal of a quality system is to
actually leads to expected results.
consistently produce products that are fit for their
intended use. The process validation is standardization European Commission - 2000 - Validation -
of the validation documents that must be submitted with “Documented evidence that the process, operated within
the submission file for marketing authorization.2 The established parameters, can perform effectively and
process validation is intended to assist manufacturers in reproducibly to produce a medicinal product meeting its
understanding quality management system(QMS) predetermined specifications and quality attributes”.6
requirements concerning process validation and has
general applicability to manufacturing process.3 WHO guidelines define validation as Validation is
documented act of proving that any procedure, process,
Some Defination of Validation: equipment, material, activity or system actually leads to
the expected results. Validation act of proving, in
According to FDA, 4
accordance of GMPs that any process actually leads to
Assurance of product quality is derived from careful expected results. Documented evidence that the process,
and systemic attention to a number of importance operated with in established parameters, can perform
factors, including: selection of quality process through effectively reproducibly to produce a medicinal product
in-process and end-product testing. meeting its predetermined specifications and quality
attributes.
According to US FDA in 1978, 5
2. Types of Validation 7
“A validation manufacturing process is one which has
been proved to do what it purpose or is represented to 2.1 Analytical Validation
do. The proof of validation is obtained through the
Analytical validation is the evaluation of product
collection and evaluation of data, preferably, beginning
quality attributes through testing, to demonstrate
from the process development phase and continuing the
reliability is being maintained throughout the product
© 2011-15, JDDT. All Rights Reserved ISSN: 2250-1177 CODEN (USA): JDDTAO
Parajuli et al Journal of Drug Delivery & Therapeutics. 2015; 5(6):1-7 2

life cycle and that the precision, accuracy, specificity, (c) Concurrent validation
LOD, linearity, selectivity, strength, purity and
It is similar to prospective, except the operating firm
specification has not been compromised. The analytical
will sell the product during the qualification runs, to the
method gives the detail steps necessary to perform an
public at its market price. This validation involves in
analysis. This may include: preparation of samples,
process monitoring of critical processing steps and
standards and reagents, use of apparatus and use of
product testing. It is the repetition of a validation
formula for the calculation and many more.
process or a specific part of it. This is carried out when
2.2 Equipment Validation there is any change or replacement in formulation,
equipment, and plant or site location. The justification
Validation of equipments is known as qualification.
or conducting concurrent validation must be
Equipment validation is divided into Installation
documented and the protocol must be approved by the
Qualification (IQ), Operational Qualification (OQ), and
Validation Team. A report should be prepared and
Performance Qualification (PQ). An IQ documents
approved prior to the sale of each batch and a final
specify static attributes of a facility or item to prove that
report should be prepared and approved after the
the installation of the unit has been correctly performed
completion of all concurrent batches. It is generally
and the installation specifications of the manufacturer
considered acceptable that a minimum of three
have been met. After installation it must be ensured that
consecutive batches within the finally agreed
the equipment can deliver operating ranges as specified
parameters, giving the product the desired quality
in the purchase order. This is called OQ. The PQ is
would constitute a proper validation of the process.
concerned with proving the process being done by the
machine as it is supposed to do. (d) Revalidation
2.3 Process Validation Re-validation is usually performed to the confirmation
of initial validation for a Periodic review. Re-validation
Process validation is “A documented procedure which
provides the evidence that changes in a process and /the
provides a high degree of assurance that a specific
process environment that are introduced do not
process will consistently produce a product meeting its
adversely affect process characteristics and product
predetermined specification and quality attributes”.
quality.
Process validation is divided into different types as
follows:- 2.4 Process/ Product Validation:
(a) Prospective validation Process Validation is establishing documented evidence
which provides a high degree of assurance that a
It is defined as the establishment of documented
specific system will consistently produce a product
evidence that a system does what it purpose to do based
meeting its predetermined specifications and quality
on preplanned protocol. This approach to validation is
attributes.
normally undertaken whenever a new formula, process
or facility must be validated before commercial routine Phases in Process Validation
pharmaceutical formulation commences. During the
Phase1: This is the Pre-validation Qualification Phase
product development phase the production process
which covers all activities relating to product research
should be broken down into individual steps. Each step
and development, formulation pilot batch studies, scale-
should be evaluated on the basis of experience or
up studies, transfer of technology to commercial scale
theoretical considerations to determine the critical
batches, establishing stability conditions and storage,
parameters that may affect the quality of the finished
and handling of in-process and finished dosage forms,
product. A series of experiments should be designed to
equipment qualification, installation qualification
determine the criticality of these factors. Each
master production document, operational qualification
experiment should be planned and documented fully in
and process capacity.
an authorized protocol.
Phase 2: This is the process validation phase. It is
(b) Retrospective validation
designed to verify that all established limits of the
It is defined as the establishment of documented critical process parameter are valid and that satisfactory.
evidence that a system does what it purpose to do based
Phase 3: Known as the validation maintenance Phase, it
on review and analysis of historical data. This is
requires frequent review of all process related
achieved by the review of the historical manufacturing
documents, including validation of audit reports, to
testing data to prove that the process has always
assure that there have been no changes, deviations
remained in control. For the purpose of retrospective
failures and modifications to the production process and
validation studies, it is considered acceptable that data
that all SOPs, including change control procedures,
from a minimum of ten consecutive batches produced
have been followed and all lots or batches produced will
be utilized. When less than ten batches are available, it
meet their intended specifications.
is considered that the data are not sufficient to
demonstrate retrospectively that the process is fully Various Approaches in Process Validation 8
under control. In such cases the study should be
supplemented with data generated with concurrent or Process Design: The goal of this stage is to design a
process suitable for routine commercial manufacturing
prospective validation.
that can consistently deliver a product that meets its
quality attributes.
© 2011-15, JDDT. All Rights Reserved ISSN: 2250-1177 CODEN (USA): JDDTAO
Parajuli et al Journal of Drug Delivery & Therapeutics. 2015; 5(6):1-7 3

Process Qualification: This stage has two elements:  Manufacturing Process

a.design of the facility and qualification of the  Review of Equipments / Utilities
equipment and utilities and b.process performance  Review of Raw Materials and Packing Materials
qualification (PPQ).  Review of Analytical and Batch Manufacturing
Records
Continued Process Verification: The goal of the third
 Review of Batch Quantities for Validation (Raw
stage is continual assurance that the process remains in
Materials & Packing Materials)
a state of control (the validated state) during
 HSE Requirements
commercial manufacture.
 Review of Process Parameters Validation
Procedure
 Sampling Location
 Documentation
 Acceptance Criteria
 Summary
 Conclusion.

Validation Master Plan11

A validation master plan is a document that summarizes
the company’s overall philosophy, intentions and
approaches to be used for establishing performance
adequacy. The Validation Master Plan should be agreed
. upon by management. Validation in general requires
preparation and careful planning of the various steps in
2.5 Cleaning Validation the process. In addition, all work should be carried out
in a structured way according to formally authorized
Cleaning validation is the methodology used to assure
standard operating procedures. All observations must be
that a cleaning process removes residues of the active
documented and where possible must be recorded as
pharmaceutical ingredient of the product manufactured
actual numerical results. The validation master plan
in a piece of equipment, the cleaning aids and ensures
should provide an overview of the entire validation
that all residues are removed to predetermined levels
operation, its organizational structure, its content and
(product contamination below the acceptable level) to
planning. All validation activities relating to critical
ensure the quality of the next product to be
technical operations, relevant to product and process
manufactured.
controls within a firm should be included in the
2.6 Vendor Validation validation master plan. It should comprise all
prospective, concurrent and retrospective validations as
It includes the qualification of the vendor who provides
well as re-validation. The Validation Master Plan
all the active material and the excipients required for
should be a summary document and should therefore be
formulation.
brief, concise and clear. It should not repeat information
2.7 Computer System Validation documented elsewhere but should refer to existing
documents such as policy documents, SOP’s and
Computer validation includes qualification of all
validation protocols and reports.
software and hardware, which has a direct or indirect
impact on the quality of a product. Pre-Requisites for Successful Validation
9
Responsible Authorities for Validation There are some elements or tools that are required for
conducting effective validations which are discussed in
 Head of quality assurance. the following sections:
 Head of Production.
 Head of Quality Control. 1) Understanding: The single most important
 Head of engineering & Maintenance. element required is a good understanding of what
 Specialist validation member of other related areas validation is. This understanding activity must be
anchored by sufficient years of practical experience
Validation Protocol 10 and knowledge. It will permit sound and logical
The validation protocol should be numbered, signed and decisions even under most intense situations 12.
dated, and should contain as a minimum the following 2) Communication: Communication is one of the
information: best methods of improving understanding and is
 Title essential for any activity that requires more than
 Objective & Scope one resource to complete as conducting effective
 Responsibility validation involves multi-departments.
 Protocol Approval 3) Co-operation,Plan and Focus: Multiple
 Validation Team departments are involving and interacting during
 Product Composition the validation process such as Quality Assurance,
 Process Flow Chart Production, Quality Control, Maintenance, project
© 2011-15, JDDT. All Rights Reserved ISSN: 2250-1177 CODEN (USA): JDDTAO
Parajuli et al Journal of Drug Delivery & Therapeutics. 2015; 5(6):1-7 4

management, accounting etc so they should have a designed product’s reliability, but can be used as a tool
commendable co-operation, focus and plan in order to maintain the consistency of how the product is made.
to get good team synergy.
In-process specifications establishment: In process
4) Experience: To get success in validation program specifications are established based on the previous
well experienced validation team are required. acceptable process average and process variability
5) Resources: Resources means personnel who will determined by the application statistical procedures
plan and execute equipment on which validations wherever appropriate. Samples must represent the batch
will be performed on materials with which to under analysis. Statistical quality control criteria as
conduct validations. condition of approval and release of batch must meet its
6) Budget: It is important to understand that a predetermined specifications.
successful validation must be done to completion
For Process validation of tablet, each and every step
and it should not be limited by a budget as
involved during formulation of tablet should be taken
validations cost money.
into consideration. Following are the steps and the
7) Standard Operating Procedures (SOP’s): The
parameter which should be considered during process
SOPs capture activities that routinely occur within
validation of tablet.
an organization so all the concerned department
must be trained about SOPs and its implementation. A. Raw Material Validation:
8) Quality Control lab support: During the
Active pharmaceutical ingredient
validations, some laboratory testing will be
required which are handled by the QC so well  Excipients
facilitated qc lab is required to get results in
expected time.  Variation in raw material is one of the major causes
9) Permission to conduct preliminary runs. of product variation or deviation from specification
10) Realistic completion dates.  API may represent the most uncontrollable
Objective of Process Validation 13 component.
1. To reduce variation between various batches.  State a good pre-formulation program at early
2. To provide a high degree of assurance of quality of phase of product
the product.
 Critical steps in the development cycle
3. To decrease the risk of defect costs and regulatory
noncompliance. Chemical characteristics
4. To ensure the consistency of the manufacturing
 Drug impurities, Impurity levels.
operation and reproducibility of the process.
5. To demonstrate the robustness of the process.  Physical properties:
6. A fully validated process may require less in-
process controls and end product testing. Drug morphology, solubility, particle size/surface
7. To ensure the existence of all necessary quality area, shape, drug density, hygroscopic nature
assurance system within organization. B. Analytical method Validation:
14
Guidelines for process validation of tablets:  Accuracy
Typical pharmaceutical manufacturing processes  Precision
comprise a serious of unit operations which includes:  Specificity
machinery, methods, people, material, measuring  Intra / Inter day variance
systems and environmental conditions, etc. To assure
 Between operator variation
batch uniformity and integrity of drug products, written
 Between instrument variation
procedures need to be established and followed to test
for each batch. Such control procedures are established C. Process evaluation, selection and validation: 16
to monitor the output and to validate the performance of
the manufacturing processes that may be responsible for 1. Dispensing:
causing variability in the characteristics of in-process Dispensing is done prior to formulation. Ensure
material and the drug product.15. dispensing booth is clean and line clearance is given as
Process control[4] per SOPs. Ensure that balance is calibrated and ensure
that the expiry date of product to be released is later
Modern methods of process control in process than that of batch expiry date. Check and ensure that the
validation are all materials are issued as per BMR. And all the rooms
such as granulation room, Compression room, coating
➢ Six sigma
room, packing room etc are clean and line clearance has
➢ Process capability index been done prior to processing.
➢ Statistical process control (SPC) include: 2. Mixing or Blending
Sampling plan, experimental design, variation Materials that have similar physical properties will be
reduction, process capability analysis, process easier to form a uniform mix or blend and will not
improvement plans,SPC will not improve a poorly
© 2011-15, JDDT. All Rights Reserved ISSN: 2250-1177 CODEN (USA): JDDTAO
Parajuli et al Journal of Drug Delivery & Therapeutics. 2015; 5(6):1-7 5

segregate as readily as materials with large differences. 5. Drying

Parameters to be considered are:
The type of drying technique (e.g., tray, fluid bed, and
 Mixing or blending technique: Diffusion (tumble), microwave) required for the formulation needs to be
convection (planetary or high intensity), or determined and justified. The type of technique may be
pneumatic (fluid bed). dependent on drug or formulation properties and
 Mixing or blending speed: Determine the intensity equipment availability. Changing dryer techniques
(low/high shear) and/or speed (rpm) of the mixing could affect such tablet properties as hardness,
or blending. Mixing the drug and excipient will disintegration, dissolution, and stability. The optimal
require more intense mixing than adding the moisture content of the dried granulation needs to be
lubricant to the final blend. determined. High moisture content can result in Tablet
 Mixing or blending time: The mixing or blending picking or sticking to tablet punch surfaces and Poor
time will be dependent on the mixing or blending chemical stability as a result of hydrolysis. An over
technique and speed. dried granulation could result in poor hardness and
 Drug uniformity: Content uniformity is usually friability.
performed to determine the uniformity of drug  Inlet/outlet temperature.
throughout the mix or blend. Representative  Moisture uniformity: Heat uniformity of the dryer,
samples should be taken throughout the mix or amount of granulation per tray, and incomplete
blend. The sampling technique and handling of the fluidization of the bed are factors that could affect
materials are key in obtaining valid content the moisture uniformity of the granulation.
uniformity results. For the final lubricated granules,
 Equipment capability/capacity: A larger load will
the sample taken should be equivalent to the weight
require more moisture to be removed on drying and
of a single tablet.
will affect the drying time.
 Excipient uniformity: Lubricant,Color  Airflow.
 Equipment capacity/load. 6. Milling
3. Wet Granulation The milling operation will reduce the particle size of the
dried granulation. The resultant particle size distribution
The type of wet granulation technique used will will affect such material properties as flow,
produce granules with different physical properties and compressibility, disintegration, and dissolution. An
will require monitoring of different processing optimal particle size/size distribution for the
parameters. formulation will need to be determined. Factors to
 Binder addition. consider in milling are:
 Binder concentration: The optimal binder  Mill type: impact or screen.
concentration will need to be determined for the  Screen size: The screen size will affect the particle
formulation. If the binder is to be sprayed, the size. A smaller screen size will produce a smaller
binder solution needs to be dilute enough so that it particle size and a greater number of fines.
can be pumped through the spray nozzle. It should  Mill speed.
also be sufficiently concentrated to form granules
 Feed rate.
without over wetting the materials.
 Amount of binder solution/granulating solvent. 7. Lubrication
 Binder solution/granulating solvent addition rate.
 Grade of the lubricant used.
 Mixing time.
 Compatibility with other ingredients.
 Granulation end point: Granulation end point is
 Mixing time:
determined or controlled by granulation end point
 Amount of lubricant added: Too much lubricant
equipment (e.g., ammeter) or by specifying critical
will form hydrophobic layer on the tablet resulting
processing parameters. For example, a drug or
in dissolution problems.
excipient mixture may be granulated by adding a
predetermined amount of water (granulating 8. Tablet Compression
solution) at a certain rate. The granulation is
Compression is a critical step in the production of a
completed after mixing for a set time after the
water has been added. tablet dosage form. The materials being compressed
will need to have adequate flow to flow from the hopper
4. Wet Milling onto the feed frame and into the dies. Inadequate flow
can result in “rat holing” in the hopper and/or
Wet granules need to be milled to break up the lumps
segregation of the blend in the hopper/feed frame. This
and enhance drying of the granulation. Factors to be
can cause tablet weight and content uniformity
consider are:
problems. Factors to consider during compression are as
 Equipment size and capacity. follows:
 Screen size.
 Tooling: The shape, size, and concavity of the
 Feed rate. tooling should be examined based on the
 Mill Speed.

© 2011-15, JDDT. All Rights Reserved ISSN: 2250-1177 CODEN (USA): JDDTAO
Parajuli et al Journal of Drug Delivery & Therapeutics. 2015; 5(6):1-7 6

formulation properties and commercial  Tablet filming

specifications.  Capping of the tablets
 Compression speed: The formulation should be  Tablet colored
compressed at a wide range of compression speeds  Assay.
to determine the operating range of the compressor.  Content uniformity
 Compression/ejection force: The compression  Beginning
profile for the tablet formulation will need to be  Middle
determined to establish the optimal compression  End
force to obtain the desired tablet hardness.
 Tablet hardness
The following in-process tests should be examined
during the compression stage:  Tablet friability

 Appearance  Impurity profile

 Hardness, Thickness 12. Labelling and packing:
 Tablet weight
 Friability Check and record the temperature of the heating roller
 Disintegration Time and sealing roller, over printing instructions on labels
 Weight uniformity and cartons. Check and verify that price overprinted on
label and carton is as per current price list. After
9. Tablet Coating ensuring the proper labeling of tablets, check, for
Tablet coating can occur by different techniques (sugar, correctness of cartons packing for the same.
film, or enteric) where film coating is the most Finished product analysis and release:
common. Factors to be considered for tablet coating are:
Finished product needs to be analyzed as per in-house
 Tablet properties: Tablet properties such as specification and product released only after
hardness, shape, are important to obtain a good predetermined specifications and quality attributes.
film-coated tablet. Process validation testing is generally done on the first
 Equipment type. three batches of product made in production-size
 rpm of the coating pan. equipment. Revalidation testing is only done when a
 Spray guns: Angle of spray. “significant” change has occurred.
 Application/spray rate: The optimal spray rate
Reason for choosing three consecutive batches for
should be determined. Spraying too fast will cause
Validation:
the tablets to become over wet, resulting in
clumping of tablets and possible dissolution of the Generally it is considered if we get the desired quality
tablet surface. Spraying too slowly will cause the in first batch it is accidental, second batch quality is
coating materials to dry prior to adhesion to the regulator, and quality in third batch is validation. When
tablets. two batches are taken as validation the data will not be
 Tablet flow. sufficient for evaluation and to prove reproducibility
 Inlet/outlet temperature and airflow. because statistical evaluation cannot be done on two
 Coating solution: The concentration and viscosity points, it needs minimum three points because two
of the coating solution will need to be determined. points always draw a straight line. Therefore, minimum
The stability of the coating solution should be three consecutive batches are evaluated for validation of
investigated to establish its shelf life. manufacturing process. More than three batches can be
 Coating weight: A minimum and maximum coating taken in validation but it involves the cost and time.
weight should be established for the tablet to Final Process Validation Report 17
provide a uniform appearance.
 Residual solvent level: If solvents are used for At the conclusion of validation activities, a final report
tablet coating, the residual solvent level will need should be prepared. This report should summarize and
to be determined. reference all protocols and results. It should derive
conclusions regarding the validation status of the
.10. In-process tests process and necessary recommendation for routine
 Moisture content of “dried granules” process. The final report should be reviewed and
approved by the validation team and appropriate
 Granulation particle size distribution
management.
 Blend uniformity
 Individual tablet/capsule weight  A validation report shall be prepared to assess the
 Tablet hardness and Tablet thickness adherence to the protocol after execution of
 Disintegration batches.
 Impurity profile  Data can be collected in pre design format during
execution wherever application but not limited to.
11. Finished product tests  Name of ingredients, quality of ingredients used
 Appearance and product batch number, Name of the equipments
 Tablet mottling used at each processing stage, equipments numbers
 Picking of the monogram and make/model/capacity of the equipments shall
© 2011-15, JDDT. All Rights Reserved ISSN: 2250-1177 CODEN (USA): JDDTAO
 Parajuli et al Journal of Drug Delivery & Therapeutics. 2015; 5(6):1-7 7

be checked against the formulation order of the team must identify the product and process
validation batch processing records. characteristics that must be studied and incorporate
 The environmental condition during batch specific validation tests to ensure that that product will
execution at each processing stage shall be checked meet all quality, manufacturing, and regulatory
against the formulation order of the validation requirements. The total program should begin with
batch processing records. validation of the active pharmaceutical ingredient (API)
 Stage of process, details of process variables the characteristics so that this material will be uniform
respective observations and recommendations shall batch after batch, providing a solid pillar under which
be checked against the formulation order of the the dosage form will be built. The parameters chosen
validation batch processing records. must be relevant indicators of a controlled process.
 Any work done in addition to that specific in the Continued awareness of validation requirements and a
protocol or any deviation from the protocol should diligent application of validation principles will thus
be formally noted along with an explanation. help to ensure that pharmaceutical products will be able
 All sampling location shall be specified. to be developed and produced with the quality and
 The actual yield obtained at different stages shall reproducibility required from regulatory agencies across
be checked against the formulation order of the the world.
validation batch processing records.
ACKNOWLEDGMENT:
CONCLUSION:
The corresponding author expresses deep gratitude to
It is concluded that Process validation is a step to assure Phr. Prawan Dahal and friends for their co-operation
the identity, strength, purity, safety and efficacy of and guidance in searching various articles and journals
pharmaceutical drug products, and it is the most for completion of this review and also grateful to
common word in the drug development, manufacturing authors, editors & publishers of all those articles,
and specification of finished product. Process validation journals and books from where the literature for this
is major requirement of cGMPs regulation for the article has been reviewed and discussed.
process efficiency. The multidisciplinary validation

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