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Indian Journal of Novel Drug Delivery 9(4), Oct-Dec, 2017, 214-222

Indian Journal of Novel Drug Delivery


IJNDD
An Official Publication of
Karnataka Education and
Scientific Society

Review Article
Comprehensive Study of Pharmaceutical Process Validation of Solid
Dosage Forms: Quality Assurance Point of View
KOMAL M JADHAV1, JAMEEL AHMED S MULLA2*, RAJENDRA C DOIJAD3,
1Department of Quality Assurance, Shree Santkrupa College of Pharmacy, Ghogaon, Tal- Karad, Dist- Satara, Maharashtra, India
2 Department of Pharmaceutics, Shree Santkrupa College of Pharmacy, Ghogaon, Tal- Karad, Dist- Satara, Maharashtra, India
3 Department of Pharmaceutics, Krishna Institute of Medical Sciences Deemed University’s Krishna Institute of Pharmacy, Karad,

Dist- Satara, Maharashtra, India


ARTICLE DETAILS ABSTRACT
Article history: The purpose and interest of this overview on pharmaceutical process validation of
Received on 12 September 2017 immediate release tablets, is to highlight the critical process parameters to be
Modified on 15 November 2017 validate during the activity of validation of solid dosage form. It is the most
Accepted on 20 November 2017
common dosage form for orally administration of drug. The Process validation
Keywords: should confirm that the control strategy is sufficient to support the process design
Pharmaceutical Process Validation, and the quality of the product. This validation review covers the solid dosage form
Process Validation Stages, of process validation. The process is developed in such a way that the required
Validation Acceptance Criteria parameters are achieved and it ensures that the output of the process will
consistently meet the required parameters during routine production, the process
is validated. A manufacturer can assure through careful design of the device,
processes, process controls and process variable that all manufactured units will
meet specifications and have uniform quality. This review provides info on
objectives and advantages of method validation, varieties of method validation,
major phases in validation and regulative aspects. Guidelines and strategy for
process validation of solid dosage form validation and regulatory aspects.
Guidelines and strategy for process validation of solid dosage form are also
discussed.
© KESS All rights reserved

INTRODUCTION and the validation is one of them. It is through


Validation is an integral part of quality careful design and validation of both the process
assurance; it involves the systematic study of and process controls that a manufacturer can
systems, facilities and processes aimed at establish a high degree of confidence that all
determining whether they perform their manufactured units from successive lots will be
intended functions adequately and consistently acceptable. Successful validation of a method
as specified. A valid method is one that has been could cut back the dependence upon intensive in-
incontestable to supply a high degree of process and finished product testing. In most
assurance that uniform batches are created that cases, end-product testing plays a major role in
meet the specified specifications and has so been assuring that quality assurance goals are meet. A
formally approved. Validation in itself does not valid method is one that has been incontestable
improve processes but confirms that the to produce a high degree of assurance that
processes have been properly developed and are uniform batches are made that meet the desired
under control [1]. The objective of the design and specifications and has so been formally
manufacture of the immediate release tablet is to approved. Validation in itself doesn't improve
deliver orally the correct amount of drug in the processes however confirms that the processes
proper form, over a period of time and in the are properly developed and are under control [2].
desired location, and to have its chemical
integrity protected to that point. Numerous Process Validation Definition [3]
features are required to ensure product quality According to US FDA, in 1978, “A validation
manufacturing process is one which has been
proved to do what it purports or is represented
*Author for Correspondence: to do. The proof of validation is obtained through
Email: jameelahmed5@rediffmail.com the collection and evaluation of data, preferably,
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beginning from the process development phase and process control designed to assure that the
and continuing the production phase. Validation drug products have the identity, strength, quality
essentially includes method qualification (the and purity they purport or are represented to
qualification of materials, equipment, system, possess.
building, personnel), however it conjointly
includes the management on the entire method Objective of Process Validation [5]
for continual batches or runs’’. 1. To reduce variation between various
batches.
In 1987, “Process validation is establishing
2. To provide a high degree of assurance of
documented evidence which provides a high
quality of the product.
degree of assurance that a specific process (such
3. To decrease the risk of defect costs and
as the manufacture of pharmaceutical dosage
regulatory noncompliance.
forms) will consistently produce a product
4. To ensure the consistency of the
meeting its predetermined specifications and
manufacturing operation and
quality characteristics”.
reproducibility of the Process.
In 2008, “Process Validation is defined as the 5. To demonstrate the robustness of the
collection and evaluation of data, from the process.
process design stage throughout production,
which establishes scientific evidence that a Advantages of Process Validation [6,7]
process is capable of consistently delivering 1. It is simple process and moisture sensitive
quality products”. and heat sensitive products can also be
In 2011, “The revised guidance also provides processed.
recommendations that reflect some of the goals 2. Expanded real time monitoring and
of FDA’s initiative entities “Pharmaceuticals adjustment of process.
CGMPs for the 21st century – A Risk-Based 3. Decreases the risk of preventing problems
Approach,” particularly with regards to the use and thus assure the smooth running of the
of technological advances in pharmaceutical process.
manufacturing, as well as implementation of 4. Enhanced ability to statistically evaluate
modern risk management and quality tools and process performance and product variables
concepts”. e.g. individuals; mean; range; control limits.
5. Enhanced data and evaluation capabilities
According to EMEA, in March 2012, “Process and increased confidence about process
validation can be defined as documented Reproducibility and product quality.
evidence that the process, operated within 6. Improved ability to set target parameters
established parameters, can perform effectively and control limits for routine production,
and reproducibly to produce a medical product correlating with validation results.
meeting its predetermined specifications and 7. Enhanced reporting capability.
quality attributes.”
Elements of Validation [8]
The Regulatory Basis for Process Validation Design Qualification (DQ): it's documented
[4]
review of the planning, at Associate in nursing
Once the concept of being able to pre-directs applicable stage of stages within the project, for
process performance to meet user requirements agreement to operational and restrictive
evolved, FDA regulatory officials established that expectations.
there was a legal basis of requiring process
validation. The ultimate legal authority is in 1. GMPs and regulatory requirements
section 501(a)(2)(B) of the FD&C Act, which 2. Performance criteria
states that a drug is deemed to bead ultimate 3. Facility air flow, movement flow &
differ the methods used in or the facilities or pressure regimes
controls used for its manufacture, processing, 4. Reliability& efficiency
packing or holding do not conform to or 5. Commissioning requirements
administrated in conformity with CGMP. The 6. Construct ability & installation of
CGMP regulations for finished pharmaceuticals equipment
21CFR 210 and 211 were promulgated to enforce 7. Maintenance& access to critical equipment
the requirements of the act which states that: & instrumentation
There shall be written procedures for production 8. Safety& environment impact
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Installation Qualification (IQ) Three Stages of Process Validation [9]


It is documented verification that every one Process validation involves a series of activities
aspects of a facility, utility or instrumentality taking place over the lifecycle of the product and
which will have an effect on product quality process.
adhere to approved specifications and square Stage 1 – Process Design: The business method
measure properly put in.Important IQ is outlined throughout this stage supported data
considerations are: gained through development and scale-up
1. Installation conditions (wiring, utilities, activities.
and functionality)
Stage 2 – Process Qualification: During this
2. Calibration, preventative maintenance,
stage, the process design is confirmed as being
cleaning schedules
capable of reproducible commercial
3. Safety features
manufacturing.
4. Supplier documentation, prints, drawings
and manuals Stage 3 – Continued Process Verification: On-
5. Software documentation going assurance is gained during routine
6. Spare parts list production that the process remains in a state of
7. Environmental conditions (such as clean control.
room requirements, temperature and
Humidity) Process Validation
8. Equipment design features (i.e. materials of
construction clean ability) Stage 1:
Process Design
Stage 3:
Operational Qualification (OQ) Continued
It is documented verification that everyone Process
aspects of a facility, utility or instrumentality that Verification
Stage 2:
may have an effect on product quality operate to
Process
intend throughout all anticipated ranges. OQ
Qualification
considerations include:
1. Process control limits (time, temperature,
pressure, line speed and setup conditions) Types of Process Validation [10]
2. Software parameters 1] Process Validation
3. Raw material specifications The documented proof that the method operated
4. Process operating procedures among established parameters will perform
5. Material handling requirements effectively and reproducibly to supply a
6. Process change control medicative product meeting its present
7. Training specifications and quality attributes.
8. Short term stability and capability of the
process. 2] Prospective Validation
9. Potential failure modes, action levels and Validation conducted prior to the distribution of
worst-case conditions. either a new product, or product made under a
revised manufacturing process, where the
Performance Qualification (PQ) revisions may affect the product’s
It is documented verification that each one characteristics. (FDA) Validation carried out
aspects of a facility, utility or instrumentality before routine production of products intended
perform as meant in meeting planned acceptance for sale.
criteria. PQ considerations include:
1. Actual product and method parameters 3] Concurrent Validation
and procedures established in OQ Validation carried out during routine production
2. Acceptability of the product of products intended for sale.
3. Assurance of process capability as
established in OQ 4] Retrospective Validation
4. Process repeatability, long term process Validation of a process for a product already in
stability. distribution based upon accumulated
production, testing and control data.
(FDA)Validation of a method for a product that
has been marketed primarily based upon
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accumulated producing, testing and management Strategy for Validation of Methods [12]
batch information. The validity of a specific method should be
demonstrated in laboratory experiments using
5] Re-Validation samples or standards that are similar to the
A repeat of the process validation to provide an unknown samples analysed in the routine. The
assurance that changes in the preparation and execution ought to follow a
process/equipment introduced in accordance validation protocol ideally written in a very step
with change control procedures do not adversely by step instruction format as follows: Develop a
affect process characteristics and product validation protocol or operating procedure for
quality. the validation.

Process Validation Phases [11] • Define the application purpose and scope
The activities relating to validation studies may of method.
be classified into three: • Define the performance parameters and
acceptance criteria.
Phase1: This is the Pre-validation Qualification • Define validation experiments.
part that covers all activities with reference to • Verify relevant performance characteristics
product research and development, formulation of the instrumentality.
pilot batch studies, scale-up studies, transfer of • choose quality materials, e.g. standards and
technology to business scale batches, reagents;
establishing stability conditions and storage, and • Perform pre-validation experiments;
handling of in-process and finished indefinite • Adjust method parameters and/or
quantity forms, instrumentation qualification, acceptance criteria, if necessary;
installation qualification master production • Perform full internal and external
document, operational qualification and method validation experiments;
capability. • Develop SOPs, for executing the method
routinely;
Phase 2: This is often the method validation • Define criteria for revalidation.
part. It’s designed to verify that everyone • Define sort and frequency of system
established limits of the vital method parameter suitableness tests and/ or analytical
are valid which satisfactory. Merchandise is often internal control (AQC) checks for the
created even underneath the worst conditions. routine; and Document validation
experiments and ends up in the validation
Phase 3: Known as the validation maintenance report.
section, it needs frequent review of all method
connected documents, as well as validation of Industrial Process Evaluation and Selection
audit reports, to assure that there are no for Tablets [13]
changes, deviations failures and modifications to Determine the unit operations needed to
the assembly method which all customary manufacture the tablets.
crepitating procedures (SOPs), as well as
modification management procedures, are 1. Mixing or Blending
followed. At this stage, the validation team Mixing or blending ensures production of
comprising of people representing all major uniform mixture of active pharmaceutical
departments conjointly assures that there are no ingredients and excipients that don't segregate
changes/deviations that ought to have resulted post mixing. Therefore this step is fastidiously
in requalification and revalidation. A careful style scrutinized and valid. Parameters to consider:
and validation of systems and method controls
• Mixing or blending technique
will establish a high degree of confidence that
each one heaps or batches created can meet their • Mixing or blending speed
supposed specifications. It’s assumed that • Mixing or blending time:
throughout producing and management, • Drug uniformity
operations area unit conducted in accordance • Excipient uniformity
with the principle of fine producing follow (GMP) • Equipment capacity/load.
each generally and in specific relevance sterile
product manufacture.

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2. Wet Granulation 5. Milling


Different types of wet granulation techniques The edge operation will reduce the particle size
may be used like low shear (e.g., Hobart), high of the dried granulation. The resultant particle
shear (e.g., Diosna, GEI-Collette) or fluid bed (e.g., size distribution will have an impression on such
Glatt, Fluid Air). Every technique can turn out material properties as flow, softness,
granules with totally different physical disintegration, and dissolution. Associate in
properties and can need watching of various nursing best particle size/size distribution for
process parameters. Wet granulation parameters the formulation will ought to be determined.
to be considered during development and Factors to suppose in edge are:
validation are: • Mill kind
• Screen size
• Binder addition • Mill speed
• Binder concentration • Feed rate
• Amount of binder solution/granulating 6. Lubrication
solvent Lubricants are added to reduce the friction
• Binder solution/granulating solvent during tablet ejection between the walls of the
addition tablet and die cavity in which the tablet was
• Mixing time formed. Factors like amount of lubricant added,
• Granulation end point grade of lubricant used, compatibility with other
ingredients and mixing time must be considered.
3. Wet Milling
The wet granulation may have to be compelled to 7. Tablet Compression
be polished to interrupt up the lumps and Compression could be a vital step within the
enhance drying of the granulation. Wet granules production of a pill dose type. The materials
that have giant} mixture vary will result in being compressed can ought to have adequate
inefficient drying (long drying times and partly flow and compression properties. The fabric
dried large granules or lumps). Factors to ought to without delay be due the hopper onto
contemplate are: the feed frame and into the dies. Inadequate flow
• Equipment size and capacity may end up in “rat holing” within the hopper
• Screen size and/or segregation of the mix within the
• Mill speed hopper/feed frame. This could cause pill weight
and content uniformity issues. As for the softness
4. Drying properties of the formulation, it ought to be
The type of drying technique (e.g., tray, fluid bed, examined on associate degree instrumented pill
and microwave) needed for the formulation must press. Factors to think about throughout
be determined and even. The sort of technique is compression area unit as follows:
also keen about such factors as drug or • Tooling
formulation properties and instrumentality • Compression speed
accessibility. Dynamical appliance techniques • Compression/ejection force
may have an effect on such pill properties as The following in-process tests should be
hardness, disintegration, dissolution, and examined during the compression stage:
stability. The best wetness content of the dried • Appearance
granulation must be determined. High wetness
• Hardness
content may end up in pill selecting or projecting
• Tablet weight
to pill punch surfaces and poor chemical stability
• Friability
as results of reaction. Associate in Nursing over
dried granulation may end in poor hardness and • Disintegration
bearableness. Wetness content analyses will he • Weight uniformity
performed victimisation the standard loss-on- 8. Tablet Coating
drying techniques or such progressive Tablet coating will occur by totally different
techniques as close to infrared (NIR) techniques (e.g., sugar, film, or compression).
spectrographic analysis. Factors to be thought- Film coating has been the foremost common
about are: technique over recent years and can be the main
1. Inlet/outlet temperature focus of this section. Key areas to think about for
2. Airflow tablet coating embrace the following tablet
3. Wetness uniformity properties.
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• Equipment type Type of Documentation in Validation Process


• Coater load Validation: Type of documentation [14]
• Pan speed 1. Validation master plan (VMP)
• Spray guns: 2. Validation protocol (VP)
• Tablet flow 3. Validation reports (VR)
• Inlet/outlet temperature and airflow 4. Standard operating process (SOPs)
• Coating solution 1. Validation master plan
• Coating weight An approved written plan of objectives and
• Residual solvent level actions stating how and when a company will
9. In-process tests achieve compliance with the GMP requirements
• Moisture content of “dried granulation” regarding validation. VMP is a summary
• Granulation particle size distribution intention document stating the scope of the
• Blend uniformity validation and outlining the methods to be used
• Individual tablet weight to establish the performance adequacy. The
• Tablet hardness validation program ought to give a summary of
• Tablet thickness the complete validation operation, its structure,
it’s content and designing. The most components
• Disintegration
of its being the list/ inventory of the things to,
• Impurity profile
relevant to product and method controls at
10. Finished product tests intervals a firm ought to be enclosed within the
• Appearance validation program. It even holds the activity and
• Assay qualification of equipments, outline and
• Content uniformity conditions of Validation Protocol.
• Tablet hardness
2. Validation Protocol [15]
• Tablet friability
The validation protocol should be numbered,
• Impurity profile
signed and dated, and should contain as a
• Dissolution minimum the following information:
These key take a look at parameters area unit the • Title
yardsticks by that the foremost process variables • Objective & Scope
in solid dose forms area unit evaluated. Some • Responsibility.
process variables are: • Protocol Approval
• Mixing time and speed in blenders and • Validation Team.
granulators • Product Composition.
• Solvent addition rates in granulators • Process Flow Chart.
• Time, temperature, and airflow conditions • Manufacturing Process Review of
in dryers and coaters Equipments / Utilities
• Screen size, feed rate, and milling speed in • Review of Raw Materials and Packing
mills Materials Review of Analytical and Batch
• Machine speed and compression force in Manufacturing Records
tablet presses. • Review of Batch Quantities for Validation
Process validation testing is generally done on (Raw Materials)
the first three batches of product made in • Review of Batch Quantities for Validation
production-size equipment. Revalidation testing (Packing Materials)
is only done when a “significant” change has • HSE Requirements.
occurred. A significant change is one that will • Review of Process Parameters Validation
alter the in-process or final product specification Procedure
established during the validation program or a • Sampling Location.
change in formula, process, or equipment. • Documentation.
• Acceptance Criteria
Steps for Validation and Acceptance Criteria • Summary
The following steps (Table 1) are used in • Conclusion
industry for validation of tablets in wet
granulation process [13].

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Table 1: Steps for Validation and Acceptance Criteria

S.N. Steps Control Variable Critical Parameters to be Acceptance criteria


checked
1 Dry mixing Time Mixing time Mixing time:…………min
Impeller speed Mixing speed Impeller speed: ...
(slow/medium/high)±5RPM.
Content uniformity : 90%-110%
RSD : ±5%
2 Binder preparation Time Mode and time of addition Depending up on the formulation.
and addition. Temperature, solvent
used
3 Drying Inlet/outlet Inlet/outlet temperature Initial drying:…....°C Final drying : …….°C±5°C
temperature & time & Drying time Drying time: …….min. Loss on drying : ……….% below 3%
or depending on formulation

4 Lubrication Time Mixing time and speed Mixing time: ………min.


Blender/granulator Speed slow: ……..rpm.
speed Content uniformity:
Physical parameters – for
information.
5. Compression Pressure and turret Machine speed and Average weight: ….mg±5%, 7.5%,
speed compression pressure 10%.
Uniformity of weight : …. mg
Thickness : ………….mm
Hardness : …..KN or Kg/cm2
Disintegration time: NMT…..min.
Friability : NMT………%w/w
Assay : As per the label claim
Dissolution:…………….%
6. Coating Pan speed and spray rate Pan speed Inlet & outlet Average weight : …..mg±5%
temperature Spray rate Weight of 20 tablets :…..mg
Thickness : …….mm
Disintegration time: NMT….min.
Assay : As per the label claim
Dissolution: ……………

3. Validation reports [16, 17] specifications and needed records. These outline
A written report should be available after procedures, must be followed to claim
completion of the validation. If found acceptable, compliance with GMP principles or other
it ought to be approved and approved (signed statutory rules and regulations. The general
and dated). The report ought to embrace a aspects covered under the SOPs are the
minimum of the following: Title and objective of Preparation and maintenance of work area like
study. washing and sterilization, decontamination and
• Reference to protocol. testing area. Even the work done in the
• Details of material. Equipment. laboratory were documented, for example, the
• Programmes and cycles used. laboratory operations involving the receipt of
• Details of procedures and test methods. reagents, standards, preparation of reagents,
• Results (compared with acceptance labelling and storage, test procedures, reference
criteria). material, identification, handling, storage and use
• Recommendations on the limit and criteria deviations, errors. Even the details of the
to be applied on future basis. equipment sand their maintenance were also
involved [18].
4. SOP (Standard Operating Procedure)
Standard operative Procedures (SOPs) area unit Change Control [19]
issued to specifically instruct staff in areas of Process validation of a solid dosage form should
responsibility, work directions, applicable include an SOP to reassess a process whenever

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