Achieving Organization-Wide Integrated Commissioning, Qualification, and Validation Activities

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Achieving Organization-Wide Integrated Commissioning, Qualification, and Validation Activities

White Paper

Achieving Organization-Wide Integrated Commissioning, Qualification, and Validation Activities

Practical, Proven Strategies That Drive Efficiency


In recent years, it has become more critical than ever for biopharma and life sciences companies to drive efficiencies and lower costs while meeting regulatory requirements and achieving business objectives.

While many organizations are turning to integrated commissioning, qualification, and validation strategies to achieve their goals, several barriers exist.


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This white paper clarifies some of the complex interdependencies at play and offers a simple, compliant, and effective approach to CQV integration that includes practical and proven strategies for biopharma and life sciences companies to achieve their regulatory and business objectives, all while staying ahead of schedule and within budget.


The State of the Biopharma Contract Manufacturing Industry

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The State of the Biopharma Contract Manufacturing Industry

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The State of the Biopharma Contract Manufacturing Industry

Assessing the Impact of COVID-19, Industry 4.0 and Flexible Design


With growing demands, rising costs, and increasingly complex technologies, CMOs are in a more strategic position to serve as skilled providers of the industry’s most advanced manufacturing processes, giving biopharma companies access to expertise and equipment often not feasible to procure internally.

The demand for biopharma contract manufacturing services is at an all-time high. So how did we get here, and where is the industry going?


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Download this white paper to explore four factors influencing the growing CMO market and learn how to choose a CMO partner that’s right for you.




Ensuring Good Manufacturing Practices for Cell & Gene Therapies

Ensuring Good Manufacturing Practices for Cell & Gene Therapies

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Ensuring Good Manufacturing Practices for Cell & Gene Therapies

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Ensuring Good Manufacturing Practices for Cell & Gene Therapies

A 10-Point CQV Checklist


With the boom in demand and production of cell and gene therapies (CGT) over the last decade, biopharma manufacturers are continually adapting to capitalize on market trends and address necessary equipment and facility upgrades.

Manufacturers that can strike the right balance of technology, personnel, and partnerships can overcome the CGT market limitations and growing pains to establish and maintain good manufacturing practices (GMP) and capitalize on the market trajectory.


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Download this white paper to explore the current state of the U.S. CGT market and review ten commissioning, qualification, and validation strategies CGT companies can use to ensure GMP compliance.


Ensuring Good Manufacturing Practices for Cell & Gene Therapies


Guide to Maintaining Validation of Older Facilities

Guide to Maintaining Validation of Older Facilities

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Guide to Maintaining Validation of Older Facilities

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Guide to Maintaining Validation of Older Facilities

Guide to Maintaining Validation of Older Facilities: Why, When and How


There is no definitive guidance for the lifespans of specific equipment, utilities, and systems that make up manufacturing facilities — and aside from cleaning/sterilization equipment, very little guidance regarding how often each needs to be validated and maintained to comply with changing industry standards and production trends.

This guide explains some of the most common challenges found in aging facilities, tips for identifying when a facility requires revalidation, and how to assess aging facilities, utilities, systems, and equipment for revalidation or maintenance needs.


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Download this white paper to learn why, when, and how to maintain validation of aging facilities.


Guide to Maintaining Validation of Older Facilities


How to Prevent a Significant Source of 483s and Warning Letters in Drugs, Devices, and Biologics

Data Integrity: How to Prevent a Significant Source of 483s and Warning Letters in Drugs, Devices, and Biologics

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Data Integrity: How to Prevent a Significant Source of 483s and Warning Letters in Drugs, Devices, and Biologics

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Data Integrity: How to Prevent a Significant Source of 483s and Warning Letters in Drugs, Devices, and Biologics

5 Practical Ways to Proactively Avoid Data Integrity Issues for Improved Quality


Pharmaceutical and biotechnology companies are no strangers to FDA 483s and warning letters. In fact, the categories of Devices and Drugs accounted for the second- and third-most 483s issued by the FDA in 2019. Although not the top source of 483s, issues related to data integrity were responsible for a significant portion of 483s in these categories as well as in the growing field of Biologics.

Companies that can identify, remediate, and prevent data integrity issues will have a distinct advantage over those that continue to let data and procedures go unchecked. Download this white paper to learn five ways to address data integrity and process issues to minimize 483s and warning letters.


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How to Prevent a Significant Source of 483s and Warning Letters in Drugs, Devices, and Biologics