Drug Substance and Excipient

Drug Products

Impurities Testing

Stability Testing

Services Page

Introduction

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Drug Substance and Excipient

Drug Products

Impurities Testing

Stability Testing

Services Page

Introduction

EVERYTHING COMES TOGETHER TO ENSURE QUALITYWhether you’re verifying and controlling the quality of your final products or assuring the quality of the processes involved in designing and manufacturing them, pharmaceutical QA/QC is a key part of compliance with regulatory mandates, as well as delivering a product the public can trust.

To that end, we offer everything to stay compliant each step of the way, from our analytical instrumentation to our unique OneSource® service and support. When these tools come together, they work as a system to create safe, quality products pharmaceutical manufacturers can feel confident about.

Good Manufacturing Practices (GMP) not only drive QA/QC inside your company, but they also guide development of the technologies, tools, and processes we build to assure you are meeting your regulatory obligations while you continuously manufacture compliant products.

INTRODUCTION

Primary Packaging

GMP Batch Release

API (Drug Substance) and Excipients

GMP Manufacturing

Drug Product (Finished Dosage Form)

GMP API + GMP Excipient

Data Integrity PAR & QbD

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DRUG SUBSTANCE AND EXCIPIENT

To ensure the purity, quality, and safety of a drug, you need to perform analytical tests to identify if any impurities or adulterants exist in both the active and inactive ingredients. If impurities are identified above the threshold level, the drug substance must be reevaluated, increasing the cost of production and time to market.

To comply with GMP standards, including identification of incoming raw material testing, drug substance assays, and excipient quality testing, you need the latest analytical tools and data.

For more information on drug substance and excipient assays, click on these images.

DRUG SUBSTANCES AND EXCIPIENTS: From identification to quantification

To ensure the purity, quality, and safety of a drug, you need to perform analytical tests to identify if any impurities or adulterants exist in both the active and inactive ingredients. If impurities are identified above the threshold level, the drug substance must be reevaluated, increasing the cost of production and time to market.

To comply with GMP standards, including identification of incoming raw material testing, drug substance assays, and excipient quality testing, you need the latest analytical tools and data.

For more information on drug substance and excipient assays, click on these images.

Drug Substance AssaysInspections of drug substances are designed to confirm that manufacturing plants, as well as quality control laboratories, follow GMP regulations. Read More

DRUG SUBSTANCE AND EXCIPIENT

DRUG SUBSTANCES AND EXCIPIENTS: From identification to quantification

To ensure the purity, quality, and safety of a drug, you need to perform analytical tests to identify if any impurities or adulterants exist in both the active and inactive ingredients. If impurities are identified above the threshold level, the drug substance must be reevaluated, increasing the cost of production and time to market.

To comply with GMP standards, including identification of incoming raw material testing, drug substance assays, and excipient quality testing, you need the latest analytical tools and data.

For more information on drug substance and excipient assays, click on these images.

Cleaning ValidationWith advances in analytical technology, residues from the manufacturing and cleaning processes can be detected at very low levels. Read More

DRUG SUBSTANCE AND EXCIPIENT

DRUG SUBSTANCES AND EXCIPIENTS: From identification to quantification

To ensure the purity, quality, and safety of a drug, you need to perform analytical tests to identify if any impurities or adulterants exist in both the active and inactive ingredients. If impurities are identified above the threshold level, the drug substance must be reevaluated, increasing the cost of production and time to market.

To comply with GMP standards, including identification of incoming raw material testing, drug substance assays, and excipient quality testing, you need the latest analytical tools and data.

For more information on drug substance and excipient assays, click on these images.

Raw Material IdentificationWe deliver a high-throughput method for raw materials to be analyzed in a loading bay or warehouse, while preventing sample exposure to contaminants. Read More

DRUG SUBSTANCE AND EXCIPIENT

DRUG SUBSTANCES AND EXCIPIENTS: From identification to quantification

To ensure the purity, quality, and safety of a drug, you need to perform analytical tests to identify if any impurities or adulterants exist in both the active and inactive ingredients. If impurities are identified above the threshold level, the drug substance must be reevaluated, increasing the cost of production and time to market.

To comply with GMP standards, including identification of incoming raw material testing, drug substance assays, and excipient quality testing, you need the latest analytical tools and data.

For more information on drug substance and excipient assays, click on these images.

Excipients CharacterizationWhen you control every step of the excipient manufacturing process, you’re ensuring the excipient consistently meets required GMP compliance. Read More

DRUG SUBSTANCE AND EXCIPIENT

DRUG SUBSTANCES AND EXCIPIENTS: From identification to quantification

DRUG SUBSTANCES AND EXCIPIENTS: From identification to quantification

To ensure the purity, quality, and safety of a drug, you need to perform analytical tests to identify if any impurities or adulterants exist in both the active and inactive ingredients. If impurities are identified above the threshold level, the drug substance must be reevaluated, increasing the cost of production and time to market.

To comply with GMP standards, including identification of incoming raw material testing, drug substance assays, and excipient quality testing, you need the latest analytical tools and data.

For more information on drug substance and excipient assays, click on these images.

Polymorphic FormsWhen manufacturing finished dosage forms (solids), polymorphism can affect the performance of an active pharmaceutical ingredient (API). Read More

DRUG SUBSTANCE AND EXCIPIENT

DRUG PRODUCTS: Mitigating risk, maximizing production

DRUG PRODUCT

Whether in tablet, capsule or injectable form, every drug product or finished dosage form must be considered GMP compliant to be suitable for commercial use to the general public. We provide the tools you need to release safe and effective medicines, giving you the confidence that you’ll be able to effectively comply with audits.

For more information on drug products assays, click on the images below.

DRUG PRODUCTS: Mitigating risk, maximizing production

Whether in tablet, capsule or injectable form, every drug product or finished dosage form must be considered GMP compliant to be suitable for commercial use to the general public. We provide the tools you need to release safe and effective medicines, giving you the confidence that you’ll be able to effectively comply with audits.

For more information on drug products assays, click on the images below.

Extractables and LeachablesThese studies are critical for maintaining the quality of your drug product during development and final batch release, in accordance with GMP compliance. Read More

DRUG PRODUCT

DRUG PRODUCTS: Mitigating risk, maximizing production

Whether in tablet, capsule or injectable form, every drug product or finished dosage form must be considered GMP compliant to be suitable for commercial use to the general public. We provide the tools you need to release safe and effective medicines, giving you the confidence that you’ll be able to effectively comply with audits..

For more information on drug products assays, click on the images below.

Drug Product AssayAn extensive set of analytical testing and acceptance criteria is applicable to drug products –including universal and specific test criteria established by ICH Q6 guidelines. Read More

DRUG PRODUCT

DRUG PRODUCTS: Mitigating risk, maximizing production

Whether in tablet, capsule or injectable form, every drug product or finished dosage form must be considered GMP compliant to be suitable for commercial use to the general public. We provide the tools you need to release safe and effective medicines, giving you the confidence that you’ll be able to effectively comply with audits.

For more information on drug products assays, click on the images below.

Primary PackagingA plastic or glass material of construction is considered well characterized for its intended use if its identity, biocompatibility, general physicochemical properties, and composition are established. Read More

DRUG PRODUCT

DRUG PRODUCTS: Mitigating risk, maximizing production

Whether in tablet, capsule or injectable form, every drug product or finished dosage form must be considered GMP compliant to be suitable for commercial use to the general public. We provide the tools you need to release safe and effective medicines, giving you the confidence that you’ll be able to effectively comply with audits.

For more information on drug products assays, click on the images below.

Content UniformityContent uniformity requires the best blend uniformity, particularly important for ensuring consistency of API concentration in the final dosage form. Read More

DRUG PRODUCT

DRUG PRODUCTS: Mitigating risk, maximizing production

Whether in tablet, capsule or injectable form, every drug product or finished dosage form must be considered GMP compliant to be suitable for commercial use to the general public. We provide the tools you need to release safe and effective medicines, giving you the confidence that you’ll be able to effectively comply with audits.

For more information on drug products assays, click on the images below.

Dissolution TestingDissolution testing makes an impact at almost every step of the drug- making process, from early product development to late-stage quality control in commercial manufacturing. Read More

DRUG PRODUCT

DRUG PRODUCTS: Mitigating risk, maximizing production

Whether in tablet, capsule or injectable form, every drug product or finished dosage form must be considered GMP compliant to be suitable for commercial use to the general public. We provide the tools you need to release safe and effective medicines, giving you the confidence that you’ll be able to effectively comply with audits.

For more information on drug products assays, click on the images below.

Elemental Impurities TestingElemental impurities in drug products can arise from a variety of sources, but however they got there, their levels need to be controlled. Read More

DRUG PRODUCT

IMPURITIES TESTING

The FDA, EMA, and other regulatory bodies put into place stringent guidelines around impurity limits, and these are changing all the time – meaning that controlling impurities becomes increasingly important on your path to compliance.

The suitability of a drug substance or product for its intended use is defined by identity, strength, and purity. We provide the tools and processes you need to take control of impurities testing, providing the best technology for the identification and quantification of elemental impurities and accurate measurement of residual solvents.

For more information on impurities testing, click on the images below.

TAKE CONTROL OF YOUR IMPURITIES TESTING

The FDA, EMA, and other regulatory bodies put into place stringent guidelines around impurity limits, and these are changing all the time – meaning that controlling impurities becomes increasingly important on your path to compliance.

The suitability of a drug substance or product for its intended use is defined by identity, strength, and purity. We provide the tools and processes you need to take control of impurities testing, providing the best technology for the identification and quantification of elemental impurities and accurate measurement of residual solvents.

For more information on impurities testing, click on the images below.

Organic Impurities TestingPharma labs summarize impurities that are most likely to arise during the synthesis, purification, and storage of drug substance and excipients. Read More

IMPURITIES TESTING

TAKE CONTROL OF YOUR IMPURITIES TESTING

The FDA, EMA, and other regulatory bodies put into place stringent guidelines around impurity limits, and these are changing all the time – meaning that controlling impurities becomes increasingly important on your path to compliance.

The suitability of a drug substance or product for its intended use is defined by identity, strength, and purity. We provide the tools and processes you need to take control of impurities testing, providing the best technology for the identification and quantification of elemental impurities and accurate measurement of residual solvents.

For more information on impurities testing, click on the images below.

Extractables and Leachables Studies about extractables and leachables are critical for maintaining the quality of your drug product during drug development and final batch release in accordance with GMP compliance. Read More

IMPURITIES TESTING

TAKE CONTROL OF YOUR IMPURITIES TESTING

The FDA, EMA, and other regulatory bodies put into place stringent guidelines around impurity limits, and these are changing all the time – meaning that controlling impurities becomes increasingly important on your path to compliance.

The suitability of a drug substance or product for its intended use is defined by identity, strength, and purity. We provide the tools and processes you need to take control of impurities testing, providing the best technology for the identification and quantification of elemental impurities and accurate measurement of residual solvents.

For more information on impurities testing, click on the images below.

Degradation ProductsIdentification and quantification of some degradation products require the use of analytical technologies, consumables, and services to ensure GMP compliance. Read More

IMPURITIES TESTING

TAKE CONTROL OF YOUR IMPURITIES TESTING

The FDA, EMA, and other regulatory bodies put into place stringent guidelines around impurity limits, and these are changing all the time – meaning that controlling impurities becomes increasingly important on your path to compliance.

The suitability of a drug substance or product for its intended use is defined by identity, strength, and purity. We provide the tools and processes you need to take control of impurities testing, providing the best technology for the identification and quantification of elemental impurities and accurate measurement of residual solvents.

For more information on impurities testing, click on the images below.IMPURITIES TESTING

Residual SolventsThe synthesis of active APIs may produce undesirable reaction byproducts or utilize various solvents that must be removed from the finished product. Read More

TAKE CONTROL OF YOUR IMPURITIES TESTING

The FDA, EMA, and other regulatory bodies put into place stringent guidelines around impurity limits, and these are changing all the time – meaning that controlling impurities becomes increasingly important on your path to compliance.

The suitability of a drug substance or product for its intended use is defined by identity, strength, and purity. We provide the tools and processes you need to take control of impurities testing, providing the best technology for the identification and quantification of elemental impurities and accurate measurement of residual solvents.

For more information on impurities testing, click on the images below.

Elemental Impurities TestingElemental Impurities in drug products can arise from a variety of sources, but however they got there, their levels need to be controlled. Read More

IMPURITIES TESTING

TAKE CONTROL OF YOUR IMPURITIES TESTING

The FDA, EMA, and other regulatory bodies put into place stringent guidelines around impurity limits, and these are changing all the time – meaning that controlling impurities becomes increasingly important on your path to compliance.

The suitability of a drug substance or product for its intended use is defined by identity, strength, and purity. We provide the tools and processes you need to take control of impurities testing, providing the best technology for the identification and quantification of elemental impurities and accurate measurement of residual solvents.

For more information on impurities testing, click on the images below.

Foreign Particle Material IdentificationThis is a key step in the quality control of medicines, used to identify contaminants in drug products that might affect quality and safety. Read More

IMPURITIES TESTING

TAKE CONTROL OF YOUR IMPURITIES TESTING

Drug Substance and Excipient

Drug Products

Impurities Testing

Stability Testing

Services Page

Introduction

SHELF LIFE AND STORAGE

MADE SIMPLETypically, both drug substances and drug products are tested in at least two different storage conditions: long-term ambient storage temperature and accelerated conditions predicting product stability over time. We provide the tools you need so you have your shelf-life and storage temperature under control.

STABILITY TESTINGDegradation ProductsIdentification and quantification of some degradation products require the use of analytical technologies, consumables, and services to ensure GMP compliance. Read More

The Ups and Downs of Temperature-Controlled StorageThe guidance is clear: all chemical reference standards, drug product samples, and tissue and blood samples must be stored in appropriate conditions, while incubators and storage cabinets used for accelerated stability studies must be monitored. So storage-space temperature mapping has become a key component of validation.

Today, many labs have gaps in the validation records for temperature-controlled storage devices, with inadequate temperature-mapping studies with missing data and no open-door restabilization studies. Plus, labs don’t want to invest in test equipment or risk performing validation on their own using inexperienced operators

Our OneSource Laboratory Services provides GLP/GMP-compliant thermal mapping studies, including open-door restabilization testing using equipment calibrated to international standards. With OneSource, you get storage-space temperature-mapping validation done right – the first time. And fully automated reports and advanced techniques such as wireless temperature probes reduce human error and damage to instrumentation.

STABILITY TESTING

COMPLETE SERVICES FOR INCREASED PRODUCTIVITY AND EFFICIENCY

Today’s lab leaders are facing several challenges, from tighter deadlines to increased budget scrutiny to teams with various degrees of comfort with lab equipment. Time that could be spent getting ahead is utilized on noncore activities.

To help you overcome barriers to success, OneSource® Laboratory Services has built a team of trained scientists and engineers who bring their real-life knowledge to you, helping increase your productivity with recommendations on how to best utilize your assets. With this knowledge, you can get back to your core mission.

Labs of all sizes need to know their equipment will work as expected, every time they turn it on. From contracts and performance maintenance for our instruments as well as other manufacturers’ equipment to full lab asset management delivered globally, we can help you make the most of your important lab assets.

And for labs looking to introduce new equipment and techniques, we offer training at our facilities and at yours.

SERVICES

For more information on OneSource services, click on these images

COMPLETE SERVICES FOR INCREASED PRODUCTIVITY AND EFFICIENCY

For more information on OneSource services, click on these images

Laboratory Instrument

Qualification

Laboratory Instrument Qualification Instrument Qualification methods guide your lab through automated, secure electronic or traditional paper qualification procedures with standard protocols customized to your specifications.

We offer traditional qualification protocols and services for lab instruments, ensuring complete, consistent, and accurate data. Our services provide:

• Qualification protocols using calibration standards • Custom protocol development • Execution of customer-developed protocols

• IQ/OQ protocol library to leverage

In addition, the OneSource UOQ program provides an instrumentation qualification platform for maximum productivity and ongoing regulatory compliance capability. The program encompasses USP, EP, and JP compliance with a design and approach that streamlines documentation across all major models of laboratory instruments, regardless of manufacturer. SERVICES

COMPLETE SERVICES FOR INCREASED PRODUCTIVITY AND EFFICIENCY

For more information on OneSource services, click on these images

Computer Systems

Validation

Computer Systems Validation OneSource Computer Systems Validation services ensure your lab’s computerized systems, including hardware and software, meet regulatory requirements.

These 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. At the same time, we provide a range of software IQ/OQ offerings, including enhanced security instrument software products..

SERVICES

COMPLETE SERVICES FOR INCREASED PRODUCTIVITY AND EFFICIENCY

For more information on OneSource services, click on these images

Data Integrity Services

Data Integrity Services Many 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. GMP guidelines are an essential tool for laboratories to follow and direct compliance with access controls, lack of permissions, audit trails, backups, and disaster recovery procedures – all of which better enable you to comply with regulators’ expectations for data integrity.

OneSource works with you to assess your data integrity governance program and compliance to ALCOA by reviewing documentation and understanding laboratory systems configurations. From an assessment, a corrective action plan is proposed to give you the roadmap to regaining full compliance in your laboratory. SERVICES

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