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FORMULATINGSAFETY ANDQUALITYComprehensive CMC Testing
Solutions
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Taking Drug Candidates from Trial to Trusted
The chemistry, manufacturing, and control (CMC) testing of drug
substances and products performs a critical function in
guaranteeing the quality of pharmaceuticals entering clinical
trials. These validated methods and technologies can also play a
vital role in commercial manufacturing, as one component of a
complete quality control regimen.
With CMC testing, pharma manufacturers document acceptable
limits and analytical methods used to ensure the identity,
strength, quality, and purity of the drug substance and drug
product, including enough information to support stability.
Our solutions help you quickly develop and commercialize new
small- and large-molecule entities through to CMC compliance,
with:
n Proven analytical solutions and services to alleviate method
development and validation challenges
n Enhanced security software capabilities to meet 21 CFR Part 11
requirements
n Comprehensive services offering from instrument IQ/OQ through
validated SOPs
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You can ensure drug substance quality and safety by performing
tests to identify any impurities or adulterants. Excipients are
critical to the
finished drug product as well, and must be analyzed to the same
exacting standards. Our advanced analytical tools provide the data
to mitigate
compliance risk and guide your GMP standards compliance for the
identification of incoming raw material testing, drug substance
assays, and
excipient quality.
Click the images below to read more about drug substance and
excipients testing.
Drug Substance AssayAll drug substances should undergo a
specific, stability-
indicating assay to determine their strength and content.
Analytical testing and acceptance guidelines include
universal and specific test criteria established by ICH Q6
and
methods described in the specific monograph for raw APIs.
Paving Your Path to CMC Quality
Drug Substance Assay
Cleaning Validation
Raw Materials ID
Excipient Characterization
Polymorphic Forms
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-
You can ensure drug substance quality and safety by performing
tests to identify any impurities or adulterants. Excipients are
critical to the
finished drug product as well, and must be analyzed to the same
exacting standards. Our advanced analytical tools provide the data
to mitigate
compliance risk and guide your GMP standards compliance for the
identification of incoming raw material testing, drug substance
assays, and
excipient quality.
Click the images below to read more about drug substance and
excipients testing.
Drug Substance Assay
Cleaning Validation
Raw Materials ID
Excipient Characterization
Polymorphic Forms
Cleaning ValidationWith advances in analytical technology,
residues from the
manufacturing and cleaning processes can be detected at
very low levels. Regulatory bodies require written SOPs
detailing cleaning processes used in CMC testing. Our
advanced instrumentation, services, and consumables can
help your cleaning-validation testing efforts so you can
remain GMP compliant.
Paving Your Path to CMC Quality
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-
You can ensure drug substance quality and safety by performing
tests to identify any impurities or adulterants. Excipients are
critical to the
finished drug product as well, and must be analyzed to the same
exacting standards. Our advanced analytical tools provide the data
to mitigate
compliance risk and guide your GMP standards compliance for the
identification of incoming raw material testing, drug substance
assays, and
excipient quality.
Click the images below to read more about drug substance and
excipients testing.
Raw Materials IDPharmas must have complete knowledge of the
manufacturing process and the potential impurities that can
appear in the drug substance and excipient. So it’s
important that you have a high-throughput method for
analyzing raw materials in a loading bay or warehouse,
while also preventing sample exposure to avoid
contamination.
Paving Your Path to CMC Quality
Drug Substance Assay
Cleaning Validation
Raw Materials ID
Excipient Characterization
Polymorphic Forms
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-
You can ensure drug substance quality and safety by performing
tests to identify any impurities or adulterants. Excipients are
critical to the
finished drug product as well, and must be analyzed to the same
exacting standards. Our advanced analytical tools provide the data
to mitigate
compliance risk and guide your GMP standards compliance for the
identification of incoming raw material testing, drug substance
assays, and
excipient quality.
Click the images below to read more about drug substance and
excipients testing.
Excipient CharacterizationExcipients improve solubility and
absorption, enhance
disintegration, and increase stability for
biologics/parenteral
formulations, including injectables. And because 90% of
medicines are made up of excipients, it’s important that
these materials are pure and unadulterated. Our solutions
help you control every step of the
excipient-characterization
process to help meet GMP guidelines.
Paving Your Path to CMC Quality
Drug Substance Assay
Cleaning Validation
Raw Materials ID
Excipient Characterization
Polymorphic Forms
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-
You can ensure drug substance quality and safety by performing
tests to identify any impurities or adulterants. Excipients are
critical to the
finished drug product as well, and must be analyzed to the same
exacting standards. Our advanced analytical tools provide the data
to mitigate
compliance risk and guide your GMP standards compliance for the
identification of incoming raw material testing, drug substance
assays, and
excipient quality.
Click the images below to read more about drug substance and
excipients testing.
Polymorphic FormsOrganic molecules can adopt more than one
crystalline
form during manufacture, which can affect the
performance of an API. Whichever crystallization method is
used to generate solid samples, it’s important to identify
which polymorphic form has been produced by using a
variety of analytical techniques, primarily scanning
calorimetry (DSC) and thermogravimetric analysis (TGA).
Paving Your Path to CMC Quality
Drug Substance Assay
Cleaning Validation
Raw Materials ID
Excipient Characterization
Polymorphic Forms
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Whether tablet, capsule, or injectable, a finished dosage form
contains both drug substance and excipient, and drug products have
to be GMP
compliant to be released for commercial use. A drug product must
pass rigorous testing for identity, strength, and purity before it
can be
considered suitable for its intended purposes. Our analytical
instrumentation, informatics solutions, and service and support
inspire confidence in
the quality of your product and in the compliance of your
processes.
Click the images below to read more about drug product
testing.
Drug Product Assay
Dissolution Testing
Content Uniformity
Primary Packaging
Protein Characterization
Drug Product AssayA whole host of analytical testing and
acceptance criteria
apply to drug products – including universal and specific
test criteria established by ICH Q6 guidelines and methods
described in the monograph for the finished dosage form.
All drug substances should undergo a specific, stability-
indicating assay to determine their strength and content.
Less Risk, More Production
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Whether tablet, capsule, or injectable, a finished dosage form
contains both drug substance and excipient, and drug products have
to be GMP
compliant to be released for commercial use. A drug product must
pass rigorous testing for identity, strength, and purity before it
can be
considered suitable for its intended purposes. Our analytical
instrumentation, informatics solutions, and service and support
inspire confidence in
the quality of your product and in the compliance of your
processes.
Click the images below to read more about drug product
testing.
Dissolution TestingWith the importance of dissolution testing to
the
CMC workflow, it’s become a key concern for
regulatory bodies – so the dissolution testing
methods you depend on must provide the most
accurate and reproducible results available.
Less Risk, More Production
Drug Product Assay
Dissolution Testing
Content Uniformity
Primary Packaging
Protein Characterization
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-
Whether tablet, capsule, or injectable, a finished dosage form
contains both drug substance and excipient, and drug products have
to be GMP
compliant to be released for commercial use. A drug product must
pass rigorous testing for identity, strength, and purity before it
can be
considered suitable for its intended purposes. Our analytical
instrumentation, informatics solutions, and service and support
inspire confidence in
the quality of your product and in the compliance of your
processes.
Click the images below to read more about drug product
testing.
Content UniformityContent uniformity is an essential quality
measurement
during the production of finished dosage forms and
requires the best blend uniformity – particularly
important for ensuring consistency and uniform API
concentration in the final dosage form.
Less Risk, More Production
Drug Product Assay
Dissolution Testing
Content Uniformity
Primary Packaging
Protein Characterization
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Whether tablet, capsule, or injectable, a finished dosage form
contains both drug substance and excipient, and drug products have
to be GMP
compliant to be released for commercial use. A drug product must
pass rigorous testing for identity, strength, and purity before it
can be
considered suitable for its intended purposes. Our analytical
instrumentation, informatics solutions, and service and support
inspire confidence in
the quality of your product and in the compliance of your
processes.
Click the images below to read more about drug product
testing.
Primary PackagingA plastic material is deemed well-characterized
for its
intended use if characteristics such as identity,
biocompatibility, general physicochemical properties,
and composition are established. The testing and
qualification of packaging and components are
covered in USP “Plastic Packaging Systems for
Pharmaceutical Use,” Chapter .
Less Risk, More Production
Drug Product Assay
Dissolution Testing
Content Uniformity
Primary Packaging
Protein Characterization
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-
Whether tablet, capsule, or injectable, a finished dosage form
contains both drug substance and excipient, and drug products have
to be GMP
compliant to be released for commercial use. A drug product must
pass rigorous testing for identity, strength, and purity before it
can be
considered suitable for its intended purposes. Our analytical
instrumentation, informatics solutions, and service and support
inspire confidence in
the quality of your product and in the compliance of your
processes.
Click the images below to read more about drug product
testing.
Protein CharacterizationProtein characterization involves
upstream protein
purification optimization and downstream characterization
of purity, structure, and function. Our solutions help you
make critical decisions sooner in the protein development
workflow and select optimal protein attributes and relevant
parameters earlier in the process.
Less Risk, More Production
Drug Product Assay
Dissolution Testing
Content Uniformity
Primary Packaging
Protein Characterization
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The EMA, FDA, and other regulatory bodies provide increasingly
stringent guidelines around impurity limits – so control of those
impurities
becomes exponentially more important to your QA/QC laboratory.
Implementing testing to control impurities is a crucial step on
your path to
compliance. We provide the tools and processes to take control
of impurities testing for both drug substances and drug products –
providing the
best technology for the identification and quantification of
elemental impurities and accurate measurement of residual
solvents.
Click the images below to read more about controlling
impurities.
Organic Impurities
Elemental Impurities
Residual Solvents
Extractables and Leachables
Foreign Particle Material Identification
Degradation Products
Organic ImpuritiesPharma labs identify and characterize actual
and potential
organic impurities likely to arise during the synthesis,
purification, and storage of drug substances and excipients.
Your lab needs to take into account the degradation
products observed during manufacture and stability studies
of the drug product before final dosage form.
Minimize Contamination, Maximize Compliance
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The EMA, FDA, and other regulatory bodies provide increasingly
stringent guidelines around impurity limits – so control of those
impurities
becomes exponentially more important to your QA/QC laboratory.
Implementing testing to control impurities is a crucial step on
your path to
compliance. We provide the tools and processes to take control
of impurities testing for both drug substances and drug products –
providing the
best technology for the identification and quantification of
elemental impurities and accurate measurement of residual
solvents.
Click the images below to read more about controlling
impurities.
Elemental Impurities The synthesis of APIs can require multiple
steps that
produce undesirable reaction byproducts or use solvents
that must be removed from the finished product. These
solvents and byproducts can be measured with headspace
gas chromatography for those volatile residual organic
solvents according to the USP Chapter and ICH Q3C
guidelines.
Minimize Contamination, Maximize Compliance
Organic Impurities
Elemental Impurities
Residual Solvents
Extractables and Leachables
Foreign Particle Material Identification
Degradation Products
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-
The EMA, FDA, and other regulatory bodies provide increasingly
stringent guidelines around impurity limits – so control of those
impurities
becomes exponentially more important to your QA/QC laboratory.
Implementing testing to control impurities is a crucial step on
your path to
compliance. We provide the tools and processes to take control
of impurities testing for both drug substances and drug products –
providing the
best technology for the identification and quantification of
elemental impurities and accurate measurement of residual
solvents.
Click the images below to read more about controlling
impurities.
Residual Solvents The synthesis of APIs can require multiple
reaction steps
that produce undesirable byproducts or use various solvents
that must be removed from the drug substance, excipient,
or product. These solvents and byproducts can be
accurately measured with headspace gas chromatography
for those volatile residual organic solvents according to
USP
Chapter and ICH Q3C guidelines.
Minimize Contamination, Maximize Compliance
Organic Impurities
Elemental Impurities
Residual Solvents
Extractables and Leachables
Foreign Particle Material Identification
Degradation Products
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The EMA, FDA, and other regulatory bodies provide increasingly
stringent guidelines around impurity limits – so control of those
impurities
becomes exponentially more important to your QA/QC laboratory.
Implementing testing to control impurities is a crucial step on
your path to
compliance. We provide the tools and processes to take control
of impurities testing for both drug substances and drug products –
providing the
best technology for the identification and quantification of
elemental impurities and accurate measurement of residual
solvents.
Click the images below to read more about controlling
impurities.
Extractables and Leachables Testing for extractables and
leachables is critical for
maintaining the quality of your drug product during CMC
and final batch release, in accordance with GMP guidelines.
The testing assesses whether drug products could be
exposed to any harmful leachable contaminants that might
impact drug safety and efficacy.
Minimize Contamination, Maximize Compliance
Organic Impurities
Elemental Impurities
Residual Solvents
Extractables and Leachables
Foreign Particle Material Identification
Degradation Products
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-
The EMA, FDA, and other regulatory bodies provide increasingly
stringent guidelines around impurity limits – so control of those
impurities
becomes exponentially more important to your QA/QC laboratory.
Implementing testing to control impurities is a crucial step on
your path to
compliance. We provide the tools and processes to take control
of impurities testing for both drug substances and drug products –
providing the
best technology for the identification and quantification of
elemental impurities and accurate measurement of residual
solvents.
Click the images below to read more about controlling
impurities.
Foreign Particle Material Identification Foreign particle
characterization in bulk APIs is an essential
component of CMC testing – a key step in the quality
control of medicines and to identify contaminants in drug
products that might affect their quality and safety.
Minimize Contamination, Maximize Compliance
Organic Impurities
Elemental Impurities
Residual Solvents
Extractables and Leachables
Foreign Particle Material Identification
Degradation Products
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-
The EMA, FDA, and other regulatory bodies provide increasingly
stringent guidelines around impurity limits – so control of those
impurities
becomes exponentially more important to your QA/QC laboratory.
Implementing testing to control impurities is a crucial step on
your path to
compliance. We provide the tools and processes to take control
of impurities testing for both drug substances and drug products –
providing the
best technology for the identification and quantification of
elemental impurities and accurate measurement of residual
solvents.
Click the images below to read more about controlling
impurities.
Degradation Products Regulations often require drug
manufacturers to force or
accelerate product degradation to show that a drug has
undergone stability testing. And QC labs are usually able to
find background data for the specificity of a method from
literature or from the substance supplier. Mostly,
validation
is straightforward, with the parameters listed in USP
Chapter on validation of compendial methods.
Minimize Contamination, Maximize Compliance
Organic Impurities
Elemental Impurities
Residual Solvents
Extractables and Leachables
Foreign Particle Material Identification
Degradation Products
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Stability testing enables drug manufacturers to understand how
the quality of an API varies when different environmental factors
such as
temperature, humidity, and light are introduced. Stability
testing also includes the study of product-related factors that
influence the quality of a
drug, such as interaction of APIs with excipients, container
closure systems, and packaging materials.
Heat Mapping Drug products must be stored in controlled
conditions, and incubators and storage cabinets
used in accelerated stability studies must be
monitored. So storage-space temperature
mapping has become a key component of
validation. We provide GLP/GMP-compliant
thermal mapping studies, including
open-door restabilization testing
using equipment calibrated to
international standards.
Degradation Products Regulations often require drug
manufacturers
to force or accelerate product degradation to
show it’s undergone stability testing. And QC
labs are usually able to find background data
for the specificity of a method from literature
or from the substance supplier. Mostly,
validation is straightforward,
with the parameters listed in USP
Chapter on validation of
compendial methods.
Shelf Life and Storage Made Easy
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The Path To Lab Efficiency Starts Right Here In today’s complex
laboratory environments, every function must work in sync toward
the common goal: lab efficiency in the service of scientific
discovery and progress. And that’s the overarching goal of
OneSource® Laboratory Services. We deliver solutions that cover all
aspects of
scientific lab operations and can be customized for the
scientific workflows – and business outcomes – you’re driving
toward.
From everyday instrument repair and service to compliance and
validation, from laboratory IT service to consulting and scientific
staffing,
OneSource Laboratory Services can help streamline your lab
routines and get your scientists focused on what’s most important –
science.
Click the images below to read more about our laboratory
services.
Computer Systems Validation
Data Integrity
Instrument Qualification
GMP Radiosynthesis
Computer Systems ValidationThese services range from full
validation or commissioning for
new systems to change-control validation for existing
standalone and enterprise systems. Our team follows GAMP 5
and aligns with your site’s specific policies and procedures
as
they relate to the SDLC. Plus, we provide a range of
software
IQ/OQ offerings, including enhanced security products.
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-
The Path To Lab Efficiency Starts Right Here In today’s complex
laboratory environments, every function must work in sync toward
the common goal: lab efficiency in the service of scientific
discovery and progress. And that’s the overarching goal of
OneSource® Laboratory Services. We deliver solutions that cover all
aspects of
scientific lab operations and can be customized for the
scientific workflows – and business outcomes – you’re driving
toward.
From everyday instrument repair and service to compliance and
validation, from laboratory IT service to consulting and scientific
staffing,
OneSource Laboratory Services can help streamline your lab
routines and get your scientists focused on what’s most important –
science.
Click the images below to read more about our laboratory
services.
Data IntegrityMany regulatory agencies have determined that
electronic data is more secure than paper
documentation and less likely to be manipulated
over the phases of a product’s development
lifecycle. But that doesn’t mean electronic lab data
is perfect: It must comply with other stringent
regulations, including 21 CFR Part 11
and the EDQM Annex 11.
Computer Systems Validation
Data Integrity
Instrument Qualification
GMP Radiosynthesis
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-
The Path To Lab Efficiency Starts Right Here In today’s complex
laboratory environments, every function must work in sync toward
the common goal: lab efficiency in the service of scientific
discovery and progress. And that’s the overarching goal of
OneSource® Laboratory Services. We deliver solutions that cover all
aspects of
scientific lab operations and can be customized for the
scientific workflows – and business outcomes – you’re driving
toward.
From everyday instrument repair and service to compliance and
validation, from laboratory IT service to consulting and scientific
staffing,
OneSource Laboratory Services can help streamline your lab
routines and get your scientists focused on what’s most important –
science.
Click the images below to read more about our laboratory
services.
Instrument QualificationOur OneSource Instrument Qualification
methods
maximize your lab productivity while providing ongoing
compliance capabilities. We guide your lab through
automated, secure electronic or traditional paper
qualification procedures with standard recommended
protocols customized to your specifications.
Computer Systems Validation
Data Integrity
Instrument Qualification
GMP Radiosynthesis
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-
The Path To Lab Efficiency Starts Right Here In today’s complex
laboratory environments, every function must work in sync toward
the common goal: lab efficiency in the service of scientific
discovery and progress. And that’s the overarching goal of
OneSource® Laboratory Services. We deliver solutions that cover all
aspects of
scientific lab operations and can be customized for the
scientific workflows – and business outcomes – you’re driving
toward.
From everyday instrument repair and service to compliance and
validation, from laboratory IT service to consulting and scientific
staffing,
OneSource Laboratory Services can help streamline your lab
routines and get your scientists focused on what’s most important –
science.
Click the images below to read more about our laboratory
services.
GMP Radiosynthesis Our experienced chemists work with you to
design and prepare your radiochemical. You'll
have access to extensive technical support
resources, both during the specification process
and after delivery, to ensure your custom
product meets your exact specifications and
application needs.
Computer Systems Validation
Data Integrity
Instrument Qualification
GMP Radiosynthesis
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IntroductionDrug Substance & ExcipientsDrug Substance
AssayCleaning ValidationRaw Materials IDExcipient
Char.Polymorphic
Drug ProductControl of ImpuritiesStability TestingServices
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Button 28: Page 2:
Button 29: Page 2:
Button 30: Page 2:
Button 31: Page 2:
Button 32: Page 2:
Button 33: Page 2:
Button 1: Button 34: Page 3: Page 4: Page 5: Page 6: Page 7:
Button 35: Page 3: Page 4: Page 5: Page 6: Page 7:
Button 36: Page 3: Page 4: Page 5: Page 6: Page 7:
Button 37: Page 3: Page 4: Page 5: Page 6: Page 7:
Button 38: Page 3: Page 4: Page 5: Page 6: Page 7:
Button 39: Page 3: Page 4: Page 5: Page 6: Page 7:
Button 40: Page 3: Page 4: Page 5: Page 6: Page 7:
Button 4: Button 5: Button 6: Button 7: Button 8: Button 41:
Page 8: Page 9: Page 10: Page 11: Page 12:
Button 42: Page 8: Page 9: Page 10: Page 11: Page 12:
Button 43: Page 8: Page 9: Page 10: Page 11: Page 12:
Button 44: Page 8: Page 9: Page 10: Page 11: Page 12:
Button 45: Page 8: Page 9: Page 10: Page 11: Page 12:
Button 46: Page 8: Page 9: Page 10: Page 11: Page 12:
Button 47: Page 8: Page 9: Page 10: Page 11: Page 12:
Button 9: Button 10: Button 11: Button 12: Button 13: Button 48:
Page 13: Page 14: Page 15: Page 16: Page 17: Page 18:
Button 49: Page 13: Page 14: Page 15: Page 16: Page 17: Page
18:
Button 50: Page 13: Page 14: Page 15: Page 16: Page 17: Page
18:
Button 51: Page 13: Page 14: Page 15: Page 16: Page 17: Page
18:
Button 52: Page 13: Page 14: Page 15: Page 16: Page 17: Page
18:
Button 53: Page 13: Page 14: Page 15: Page 16: Page 17: Page
18:
Button 54: Page 13: Page 14: Page 15: Page 16: Page 17: Page
18:
Button 14: Button 15: Button 19: Button 16: Button 17: Button
18: Button 55: Page 19:
Button 56: Page 19:
Button 57: Page 19:
Button 58: Page 19:
Button 59: Page 19:
Button 60: Page 19:
Button 61: Page 19:
Button 20: Button 21: Button 62: Page 20: Page 21: Page 22: Page
23:
Button 63: Page 20: Page 21: Page 22: Page 23:
Button 64: Page 20: Page 21: Page 22: Page 23:
Button 65: Page 20: Page 21: Page 22: Page 23:
Button 66: Page 20: Page 21: Page 22: Page 23:
Button 67: Page 20: Page 21: Page 22: Page 23:
Button 68: Page 20: Page 21: Page 22: Page 23:
Button 22: Button 23: Button 24: Button 25:
