Cleaning validation

Presenter
NAME: Ravichandra Nadagouda
REG No. : NH0120008
Pharmaceutical Quality
Assurance

Introduction
Cleaning Validation
Cleaning method development
Validation of analytical method
Cleaning of equipment
Cleaning of facilities
Cleaning in place
Cleaning in sterile and non sterile
Computerized system validation
26-10-2021 PHARMACEUTICAL VALIDATION 2

VALIDATION
It is process of “Establishing documentary evidence that provide a
high degree of assurance that a specific process will consistently
produce a product meeting its predetermined specifications and
quality attributes”.
In the pharmaceutical industry, it is very important that in addition
to final testing and compliance of products, it is also assured that the
process will consistently produce the expected results.
Validation is action of proving in accordance with the principles of
good manufacturing practices, that any procedure, process,
equipment, material, activity or system actually leads to expected
results.

CLEANING VALIDATION
Cleaning validation is documented evidence with a high degree
assurance that one can consistently clean a system or a piece of
equipment to predetermined and acceptable limits.
The primary regulatory concern driving the need for cleaning validation
is cross contamination of the desired drug substance either by other
API from previous batch runs or by residues from the cleaning agents
used.
The prime purpose of validating a cleaning process is to ensure
compliance with federal and other standard regulations

Types of contamination
1. Cross contamination with active ingredients
Contamination of one batch of product with significant levels of
residual active ingredients from previous batch cannot be tolerated.
In addition to the obvious problems posed by subjecting consumers or
patients to unintended contaminants, potential clinically significant
synergistic interactions between pharmacologically active chemicals are
a real concern.

2. Contamination with unintended materials or compounds
While inert ingredients used in drug products are generally recognized
as safe for human consumption, the routine use, maintenance and
cleaning of equipment's provide the potential contamination with such
items as equipment parts, lubricants and chemical cleaning agents.

3. Microbiological contamination
Maintenance , cleaning and storage conditions may provide
adventitious microorganisms with the opportunity to proliferate within
the processing equipment.

Steps involved in Cleaning
Validation
Planning
phase
Execution
phase
Analytical
testing
phase
Reporting
phase

Cleaning Validation Protocol
The cleaning validation protocol should include:
1. The objective of validation process
2. Responsibilities for performing and approving the validation study
3. Description of the equipment to be used
4. The interval between the end of production and the beginning of the cleaning
procedure

5. Cleaning procedure to be used for each product, each manufacturing system or
each piece of equipment.
6. The number of cleaning cycles to be performed consequently.
7. Any routine monitoring requirement.
8. Sampling procedures including the rationale for why a certain sampling method
is used
9. Clearly defined sampling locations

10. Data on recovery studies where appropriate
11. Analytical methods including the limit of detection and the limit of quantitation of those
methods or reference to them
12. Acceptance criteria and limits
13. Details of product grouping
14. When revalidation will be required
15. A final validation report
The conclusion of this report should state if the cleaning validation has been validated successfully.

Personnel
Operators who perform cleaning routinely should be trained in the
application of validated cleaning procedures.
Training records should be validated for all training carried out.
It is difficult to validate a manual that is inherently variable/cleaning
procedure.
Therefore, operators carrying out manual cleaning procedure should be
supervised at regular intervals

Levels of cleaning
Level
1
Level
2
Level
3
Level
4

• Level 1 cleaning it is used only between steps in the same
manufacturing process.
• Level 2 cleaning it is used when cleaning between steps in the same
manufacturing.
• Level 3 cleaning it is performed when cleaning after an intermediate
or final product step or one product in preparation of an intermediate
step of another product.
• Level 4 cleaning it would be used after final product is ready.

• Validation of analytical procedure is the process by which it is
established by laboratory studies, that the performance
characteristics of the procedure meet the requirements for its
intended use.
• All analytical methods that are intended to be used for analyzing any
cleaning samples will need to be validated.
• Validation of analytical method is essential but time consuming
activity for most analytical development laboratories. It is therefore
important to understand the requirements of method validation in
more detail and the options that are available to allow for optimal
utilization of analytical resources in a development labrotary.

The validation of analytical procedures is direct to the four most
common types of analytical procedures:
• Identification test
• Quantitative test for impurities content
• Limit tests for the control of impurities
• Quantitative tests of the active moiety in the sample of drug
substance or drug product or other selected component in the drug
product

• Specificity
• Linearity and range
• Accuracy
• Precision
• Limit of detection
• Limit of quantification
• Ruggedness
• Robustness
• Specificity
• Linearity
• Range
• Accuracy
• Precision
• Repeatability
• Intermediate
• Precision
• Reproducibility
• Limit of
detection
• Limit of
quantitation

• The analytical methods should be validated before the cleaning
validation is performed and the methods chosen should detect
residuals or contaminants specific for the substances being assayed at
an appropriate level of cleanliness (sensitivity).
• The detection limit for each analytical method should be sufficiently
sensitive to detect the established acceptable level of the residue or
contaminants.

Some of the analytical methods which can be used for the analysis of
cleaning validation samples include:
• HPLC
• GC
• HPTLC
• UV spectroscopy

Specificity
Specificity is the ability of the analytical method to assess the analyte in
the presence of components that may be expects to be present such as
impurities, degradation products, and matrix components.

Range
• The range of an analytical procedure is the interval between the
upper and lower levels of analyte in the sample for which it has been
demonstrated that the analytical procedure has a suitable level of
precision, accuracy and linearity.

Linearity
For establishment of linearity
minimum 5 concentrations are
recommended.
Linearity results should be
established by appropriate
statistical methods

Precision
The precision of an analytical procedures expresses the closeness of
agreement ( degree of scatter ) between a series of measurements
obtained from multiple sampling of the same homogenous sample
under the prescribed conditions.
Precision may be considered at three levels:
Repeatability
Intermediate precision
Reproducibility

PRECISION
Precision should be investigated using homogenous , authentic
samples. However if it is not possible to obtain a homogeneous sample
or a sample solution.
The precision of an analytical procedure is usually expressed as the
variance, standard deviation (SD) or coefficient of variation (CV) of
series of measurements.

Accuracy
The accuracy of an analytical
procedure expresses the closeness
of agreement between the value
which is accepted either as a
conventional true value or an
accepted reference value and the
value found.

Ruggedness
Ruggedness is the degree of reproducibility of results obtained by the
analysis of the sample under a variety of normal test conditions i.e.
different analysts, laboratories, instrument, reagents, assay,
temperature, different days etc.

Robustness
The robustness of an analytical procedure is a measure of its capacity
to remain unaffected by small, but deliberate variations in method
parameters and provides an indication of its reliability during normal
usage.
In case of liquid chromatography, examples of typical variations are:
Influence of variations of pH in a mobile phase
Influence of variations in a mobile phase composition
Different columns ie. Different lots or suppliers
Temperature, flow rate and wavelength

Limit Of Detection
Limit Of Quantification
LOD is the lowest amount of analyte in a sample that can be
detected, but not necessarily quantitated, under the stated
experimental conditions .
LOQ is the lowest amount of analyte in a sample that can be
quantitated with acceptable precision, under the stated
experimental conditions.

Cleaning validation program
Equipment cleaning validation may be performed concurrently with
actual production steps during process development and
manufacturing.
Validation program should be continued through full scale commercial
production. The concept “Test Until-Clean” should be applied.
This concept involves cleaning, sampling and testing with repetition of
this sequence until an acceptable residue limit is attained.

A validation program generally encompasses at least three consecutive
successful replicate to establish that the procedure is reproducibly
effective.
If the equipment of the similar size, design and construction is cleaned
by the same procedure, studies need not be conducted on each unit as
long as a total of three successful replicates are done on similar piece
of equipment; this concept is known as equipment grouping

Sampling Methods
The sampling procedure refers to the selection of which surfaces are
targeted for collecting residues for measurement and to the method of
collecting the residues from the surface so that they can be measured.
The sampling methods are
1. Swab sampling
2. Rinse sampling
3. Placebo sampling

Swab Sampling
This method of sampling is the most commonly used and involves
taking an inert material (e.g. cotton wool) on the end of a probe
(referred to as “swab”) and rubbing it methodically across a surface.
The swabs are added to the dilution solvent and these solvents are
analyzed by suitable analytical instruments for the presence of residue
of previous products per given area. i.e. 60-100 square inch.

Swab Sampling
The location from which the sample is taken should take into
consideration the composition of the equipment (e.g. glass or steel)
and the location (e.g. blades, tank walls or fittings).
Worst case location should be considered. Critical areas, i.e. those
hardest to clean, should be identified, particularly in large systems that
employ semi automatic or fully automatic clean-in-place systems.

Swab Sampling

Rinse samples
In this method, a measured area of clean surface is rinsed or washed
with solvent and the solvent is collected and tested for traces of
contaminants.
This method allows sampling of a large surface, of areas that are
inaccessible or that cannot be routinely disassembled and provides an
overall picture. It is also suitable for checking the residue of cleaning
agents, e.g. detergents.

Rinse samples
Rinse sampling method should be used in combination with other
sampling methods such as surface sampling.
There should be evidence that samples are accurately recovered.
For example a recovery of > 80% is considered good, > 50% reasonable
and < 50% questionable.

Placebo Sampling
Placebo sampling involves manufacturing a placebo batch of the
subsequently manufactured product in the cleaned equipment
Following manufacture of the placebo product the placebo is analysed
for the target residue

ESTABLISHMENT OF LIMITS:
The rationale for selecting limits for product residues should be
logically based on a consideration of the materials involved and their
therapeutic dose. The limit should be practical, achievable and
verifiable.

The approach for setting limits can be:
Product specific cleaning validation for all products
Grouping into product families and choosing a “worst case” product
Grouping products according to risk, e.g. very soluble products,
products with similar potency, highly toxic or difficult to detect
products.

ACCEPTANCE CRITERIA
S No. Testing
Parameter
Acceptance criteria
1 Physical
determination
The equipment should be visually clean. i.e. no residue should be visible on equipment after
cleaning.
2 Chemical
determination
a) NMT 0.1% of the normal therapeutic dose of any product to appear in the maximum daily dose
of the subsequent product.
b) NMT 10 ppm of any product to appear in the next product (basis for heavy metals in starting
materials).
c) For certain allergic ingredients, penicillins, cephalosporins or potent steroids and cytotoxics,
the limit should be below the limit of detection by best available analytical methods.
3 Microbial
contamination
Total aerobic counts
a) NMT 10 cfu/100 ml by rinse method.
b) NMT 5 cfu/25 cm2 by swab method.

Determination of MACO
(Maximum Allowable Carry Over)
MACO = TDD previous × 𝑀𝐵𝑆
SF × TDD next
MACO = maximum allowable carryover
TDD previous = standard therapeutic dose of investigated product
TDD next = standard therapeutic dose of the daily dose of the next
product
MBS = minimum batch size for the next product
SF = safety factor ( normally 1000 is used in calculation based on TDD)

CLEANING OF
EQUIPMENT

Nature of equipment plays major role in cleaning validation
The cleaning method should consider the following points related to
equipment:
• Material of construction and its compatibility with cleaning agents
and cleaning medium.
• Complexity of the equipment from the pint of accessibility of the
various parts of the equipment so that the equipment so that the
equipment so that the equipment can be cleaned thoroughly . Here
one needs to consider that it is difficult to reach areas of the
equipment and then suitable devices and methods must be evolved
to achieve the cleanliness of such areas.

• Pharmaceutical equipment can be considered from various angles for
cleaning purpose. e.g.
Cleaning of equipment parts which come in contact with the
processing materials.
Cleaning of parts of equipment which do not come in contact with
the processing material
Mechanical side of the equipment e.g. motor, gear boxes, chain
drives, etc.
Electrical panels for the equipment, etc

• The cleaning procedure must clearly define the procedure for each of
the above aspects of the equipment.
Whether the equipment is movable or fixed.
Level of dismantlability of the equipment.
Feasibility of drying of the part or whole of the equipment after
cleaning.
Feasibility of protecting the cleaned equipment.

CLEANING OF EQUIPMENT
All the equipment and area used during the manufacture shall be
cleaned and sanitized at appropriate levels.
There are 2 types of cleaning equipment:
• Type A cleaning equipment
• Type B cleaning equipment

TYPE A CLEANING
EQUIPMENT
• The equipment shall be dismantled first and the dismantled parts
shall be transferred to the washing area.
• In the washing area all the dismantled parts of the equipment shall be
cleaned with the cleansing agent as mentioned under the respective
equipment SOP for the cleaning procedure.
• The parts that cannot be dismantled shall be cleaned in their
respective place as per their specifications.
• A rinse water sample can be collected after visually verifying the
equipment by the QA personnel. Example: Tablet punching machine

CLEANING OF EQUIPMENT
TYPE A IS APPLICABLE FOR THE FOLLOWING
1. Product to product changeover.
2. Batch to batch changeover of sample product but change in colour
or flavour.
3. Batch to batch changeover of sample product from higher to lower
strength.
4. After completion of 5 consecutive batches or completion of 120
hours.
5. After major breakdown where contact parts are contaminated.

TYPE B CLEANING EQUIPMENT
• The equipment shall be cleaned without dismantling the equipment
with vacuum cleaner.
• The equipment shall be cleaned and mopped with clean moist linen
cloth and later with a dry cloth.

TYPE B IS APPLICABLE FOR THE FOLLOWING
1. After completion of the batch.
2. Batch to batch change over of the same product of the same
strength, color and flavor.
3. Batch to batch change over from low strength to higher strength.
4. After minor breakdown, where the contact parts are not distributed
or contaminated.
5. Cleaning is done after the completion of preventive maintenance
work.

GENERAL INSTRUCTIONS TO
CLEAN EQUIPMENT
• All the equipment's shall be cleaned as per the SOP of cleaning of
equipment.
• Cleaning must be done using nylon brush and cleaning agent with
portable raw water.
• Use compressed air to dry the equipment's.
• After completion of cleaning the equipment shall be marked
“CLEANED”.
• Before using any equipment examine the equipment visually whether
it is clean if not re-cleaning procedures should be adopted.

Cleaning in sterile area
IMPORTANT NOTES
1. The alternative use of two or more disinfectant is recommended at
regular interval to prevent proliferation of resistant strain of micro
organisms.
2. The alternative should be of different chemicals type and preferably
possess different spectrum of anti-microbial activity.
3. Disinfectants of different chemical types should not be mixed and
disinfectants should not be mixed with cleaning agents. Mixing can results
in drastic reduction in anti microbial activity

4. Disinfectant and cleaning agents should be freshly
prepared. Only water for injection should be used for dilution
as per need.
5. Aqueous dilution should not be stored overnight as micro
organisms can grow on storage

CLEANING AGENTS USED IN
STERILE MANUFACTURING AREA
Category Cleaning agents Active ingredients Concentration
Disinfectant Lysol Sterile cresol 0.5%
Savlon Cyclohexidine gluconate
Cetrimide
Isopropyl alcohol
1.0%
Isopropanol Isopropyl alcohol 70%

CLEANING AGENTS USED IN NON
STERILE MANUFACTURING AREA
CATEGORY CLEANING AGENTS ACTIVE INGRDIENTS CONCENTRATION
Antiseptic Teepol Sodium benzene
sulphonate
Alcohol ether sulphonate
Alcohol ethyloxate
0.1%
Disinfectant Lysol Cresol in soap 1.0%
Savlon Chlorohexidine gluconate
Cetrimide
Isopropyl alcohol
1.0%
isopropanol Isopropyl alcohol 70%

CLEAN-IN-PLACE

Clean-in-place (CIP)
Clean-in-place (CIP) is a method of automated cleaning the
interior surfaces of pipes, vessels, equipment's, filters and
associated fittings, without major disassembly.
CIP is commonly used for equipment such as piping, tanks,
and filters without disassembly.
CIP employs turbulent flow through piping, or spray balls for
large surfaces. In some cases, CIP can also be accomplished
with fill, soak and agitate

Clean-in-place (CIP)
CIP has evolved to include fully automated systems with
programmable logic controllers, multiple balance tanks,
sensors, valves, heat exchangers, data acquisition and
specially designed spray nozzle systems.
The water used to clean pharmaceutical production equipment must
be as high quality as the water used for production.
This means purified water capacity must be sufficient to meet the
needs of cleaning, in addition to production volume.
Typically, systems are also taken apart twice a year for cleaning,
utilizing chemicals stronger than those of the typical CIP cleaning cycle.

CIP CYCLE
Pre-rinse with WFI (water for injection) or PW (purified water) which is
performed to wet the interior surface of the tank and remove residue. It
also provides a non-chemical pressure test of the CIP flow path.
Caustic solution single pass flush through the vessel to drain. Caustic is
the main cleaning solution.
Caustic solution re-circulation through the vessel.
Intermediate WFI or PW rinse
Acid solution wash – used to remove mineral precipitates and protein
residues.

Clean-in-place (CIP) Benifits
The benefit to industries that use CIP is that
• The cleaning is faster,
• Less labor-intensive
• More repeatable, and
• Poses less of a chemical exposure risk.

Disadvantages
• Expensive to install.
• Needs a professional personnel to operate.
• Experienced operators are not very cheap.
• Once you start cleaning, you cannot stop the process.
• CIP systems use a constant volume of water even if you just needed
to clean one pipe in the system.

Cleaning of facilities

• Every pharmaceutical site needs good hygiene and sanitation
over 24 hours and 365 days a year.
• 70% of the failure in sanitation and hygiene can be attributed
to lack of orientation and inadequate training.
• It is very commonly observed that the cleaning records are
filled mechanically.

FOLLOWING ARE THE CRITICAL AREAS
WHICH NEEDS ACTIVE ATTENTION FOR
CLEANING AND SANITATION
• Store areas where sugar, lactose and starch are stored in large
quantities.
• Liquid processing areas
• Equipment washing areas
• Water handling systems
• Containers/ closures cleaning and storage area
• Personal washrooms and primary change rooms.

• Refreshment and lunch rooms.
• Material receiving areas.
• Air handling systems.
• Packaging areas.
• Sampling and dispensing areas.
• Processes involving high dusting.
• Open critical wirings, electrical lamps etc

COMPUTER SYSTEM
VALIDATION

Computer System Validation
• The computer systems are involved in different departments of the
pharmaceutical industry:
Production
Quality assurance
Quality control
R and D

Computer System Validation
• Computer systems has naturally raised certain typical issuses of its
performance and security of information systems being handled by
the computer systems.
• With the increased use of computers it has become mandatory to
confirm the performance of such systems with respect to its
consistency, repeatability and accuracy of the results and reports.

What is Computer System
Validation?
The FDA defines software validation as:
“Confirmation by examination and provision
of objective evidence that software
specifications conform to user needs and
intended uses, and that the particular
requirements implemented through software
can be consistently fulfilled”

21 CFR PART 11
PART 11- ELECTRONIC RECORDS;
ELECTRONIC SIGNATURES
ELECTRONIC RECORDS:
11.10- Controls for closed systems.
11.30- Controls for open systems.
11.50- Signature manifestation.
11.70- Signature/record linking.
ELECTRONIC SIGNATURES:
11.100- General requirements
11.200- Electronic signature
components and controls.
11.300- Controls for
identification codes/
passwords.

11.10- Controls for closed system
An environment in which system access is controlled by persons who
are responsible for the content of electronic records that are on the
system.
11.30-Controls for open system :
An environment in which systems access is not controlled by persons
who are responsible for the content of electronic records that are on
the system.

11.50-signature manifestation
Signed electronic records shall contain information associated with the
signing that clearly indicates all the following:
• The printed name of the signer
• The date and time when the signature was executed
• The purpose of the signature(such as review, approval etc.).
• Each of these must be readable by display or printout.

11.70-signature/record linking
Electronic signatures and handwritten signatures executed to
electronic records shall be linked to their respective electronic
records to ensure that the signatures cannot be copied,
excised, transferred or falsified.

11.100- GENERAL REQUIREMENTS:
A. Unique
B. Verify the identity
C. certify

11.200- ELECTRONIC SIGNATURE COMPONENTS AND
CONTROLS
A. Non biometrics
B. Biometrics

11.300- CONTROLS FOR IDENTIFICATION CODES/
PASSWORDS
A. Uniqueness
B. Code and password periodically checked
C. Loss management
D. Safeguard to prevent unauthorized
E. Periodic testing of devices

GAMP
• GAMP means Good automated manufacturing
practice.
• GAMP guide for validation of automated systems in
pharmaceutical manufacture describes a set of
principles and procedures that help ensure that
pharmaceutical products have the required quality

GAMP
GAMP is a set of guidelines for manufacturers and users of automated
systems in the pharmaceutical industry.
More specially both a technical sub-committee of the international society
for pharmaceutical engineering (ISPE) guide and GAMP guide for validation
of of automated systems in pharmaceutical products have the required
quality.
One of the core principles of GAMP is that quality cannot be tested into
batch of product but must be built into each stage of the manufacturing
process.
As a result, GAMP covers all aspects of production from the raw materials,
facility and equipment to the training and hygiene of staff.
SOPs are essential process that can affect the quality of the finished product.

GAMP
GAMP guidelines are the most widely used internationally accepted
procedures for validation of computer systems. While GAMP addresses
a broad range of issues related to the validation of computer based
systems, another document that can assist in achieving and
maintaining 21 CFR part 11 compliances is the publication complying
with electronic records and electronic signature.
The aim of GAMP is to ensure the authenticity and integrity of
electronic records and related electronic signatures.

Purpose of GAMP
1. To help users understand the requirements for prospective
validation of an automated system and the level to which the
validation should be performed.
2. To help suppliers ensure that systems are developed according to
good practice, and to provide documentary evidence that their
systems meet the agreed specification.

How to do computer
system validation

Master Validation Plan
(M.V.P)
The Master Validation Plan defines what will be validated and the approach you will use.
It also defines roles and responsibilities along with the most important part, the
Acceptance Criteria.
MVP includes:
• Identification of parties responsible for different parts of program
• Description of the equipment systems processes and assays to be validated
• Determination of acceptance criteria for each system, process and assay to be validated
• Determination of acceptance criteria for each system process and assay to be validated.
• defining of all SOPs and methodologies to be utilized in executing validation protocols
• Compilation of formats to be used for validation documentation
• Development of tentative validation project schedule.

User Requirements
Specification (URS)
The User Requirements Specification describes what the user
needs from the software and how they will use it.
It also contains any critical constraints such as regulations, safety
requirements, operational requirements, etc.

User Requirements
Specification (URS)
• For example, here’s a list of a few User Requirements that might be
needed for a lab system.
• System must track training of lab analysts on lab methods/techniques
• System must track samples coming into the lab
• System must automatically assign lab analysts to test samples based
on availability and training
• System must send sample testing pass/fail outcomes to the ERP
• System must comply with 21 CFR 11

Functional Specifications
(FS)
The Functional Specification document describes how
the software needs to work and look to meet the user
needs.
The document might include descriptions of how
specific screens and reports should look, or describe
data that needs to be captured.

Functional Specifications (FS)
• The Functional Requirements can also include logic
and calculations along with how it will comply with
regulatory requirements.
• For example, the Part 11 compliance requirements
might detail how passwords or the audit trail should
work.

Design Specifications (DS)
The Design Specification document is one that contains all of
the technical elements of the software or systems. This
includes:
•Database Design – file structures, field definitions, data flow
diagrams, entity relationship diagrams
•Logic/Process Design – pseudo code for logic and
calculations
•Security Design – virus protection, hacker protection

Design Specifications (DS)
• Interface Design – what data will move from one
system to another; how and how often, and failure
handling
• Architecture Design – required hardware, operating
systems, application versions, middleware, etc.
• Network Requirements
• Specific peripheral devices – scanners, printers, etc.

System Build
In the System Build step, you develop or purchase your
software and then configure it to the previous
specification documents.
This step includes unit testing and integration testing.

Installation Qualification
(IQ) Tests
The Installation Qualification tests provide confirmation
that the software or system is installed and setup
according to the Design Specification.
Usually the software is first installed in a test or
validation environment, but there can be exceptions in
situations such as manufacturing.

Operational Qualification (OQ)
Tests
Operational Qualification testing is often referred to as Functional
Testing or System Testing.
OQ tests confirm that all functionality defined in the Functional
Specification is present and working correctly, and that there are no
bugs.
OQ tests can also include confirmation of any design elements not
tested during IQ, such as configuration, are working as specified.

Performance Qualification
(PQ) Tests
Performance Qualification testing is often called User Acceptance
testing.
PQ testing confirms that the software will meet the users’ needs and is
suitable for their intended use, as defined in the User Requirements
Specification.
Testing can follow Use Cases, SOPs, user-defined scenarios, etc.
For simple software like reports or spreadsheets, OQ and PQ testing are
often combined

Reporting
The last step in this validation method is to write the Validation Report,
often called the Validation Summary or System Certification.
This report provides confirmation that all activities specified in the
validation plan have been completed.
The Validation Report summarizes the testing results and provides
confirmation that all acceptance criteria have been met and the
software is ready for deployment.

REFERENCE
1. PHARMACEUTICAL QUALITY ASSURANCE by M .A .Potdar (page
no.8.28 8.31)
2. DRUG REGULATORY AFFAIRS by V. Sai Kishore (page no. 213)
3. METHOD DEVELOPMENT AND VALIDATION OF CLEANING PROCEDURE
FOR FENBENDAZOLE RESIDUAL DETERMINATION IN
MANUFACTURING by Sunil Kumar Yelamanchi
4. U.S. Food and Drug Administration https://www.fda.gov
5. Clean-in-place (CIP) in Pharmaceutical Manufacturing – Grantek
https://grantek.com › clean-in-place-cip-in-pharmaceuti...
6. ICH Official web site : ICH https://www.ich.org

Cleaning validation

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