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Introduction

Pharmaceutical organizations need stringent quality assurance and quality control programs to ensure compliance at all times — and avoid the harsh penalties that come with failure to follow regulations. In the last fiscal year, the U.S. Food and Drug Administration Office of Manufacturing Quality issued 81 warning letters to manufacturers of finished medicinal products. Solely handling QA/QC processes internally, however, is not always the correct approach.

 

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Third-party QA/QC service providers give companies fresh sets of expert eyes on their operations. Issues that may have been ignored or overlooked could be quickly discovered and remediated with QA/QC assistance. Although not required, the FDA even recommends monitoring progress via a "periodic review performed by a qualified source, external to the organization."

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Furthermore, third-party personnel may bring knowledge in topics that are outside of the internal team's experience — such as the emerging best practices, or regulations associated with international markets.

The following are a few situations that may merit bringing in assistance from a QA/QC service provider. These scenarios show the variety of issues that can beset pharmaceutical manufacturers, as well as the relatively straightforward way to counteract them.

  1. Observations were found during an audit - or the organization is seeking to avoid this issue
    Meeting compliance requirements can be enabled by third-party or contract services providers. Knowledgeable and experienced consultants at the contract organizations can provide guidance as well as collaborate with internal teams to comply with regulatory policies both at the operational and training levels. Their expertise can also be leveraged to respond to an observation or a warning event from an audit, leading to successful compliance and streamlined manufacturing and QA/QC best practices.
  2. Data management and integrity processes are taking excessive time and effort
    Organizations cannot compromise on data collection, storage, management, and security. In recent years, the FDA has also emphasized data management and compliance. To prevent non-compliance in this area, as well as avoid distraction of high value scientific resources to resolve data related issues that arise, utilizing third-party partners or QA/QC service providers would be beneficial.
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  1. The organization is marketing to a new territory
    An external QA/QC support provider can enable companies to understand and comply with new regulatory environments, especially when those new territories are stricter or more demanding in their requirements. Compliance strategies may have to change or expand significantly to meet the expectations of regulatory agencies around the world.
  2. Changes in conditions have resulted in a spike in QA/QC demand
    Moving into a new region isn't the only action that can greatly increase the need for QA and QC assistance. Increase in demand or operational volume tend to occur from the opening of a new lab, an acquisition, or a change in internal policy. To alleviate the increase in workload, the efforts of current resources can be supplemented with partnerships with trusted service provider.

Selection criteria for a QA/QC service provider

An ideal QA/QC service provider has experience and a track record in the industry, and is cognizant of all relevant compliance requirements. Organizations that have spent time consulting for top pharmaceutical companies are able to help clients develop the quality-first company culture and mindset that helps drug manufacturers produce high-quality, safe drugs.

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While hiring a third-party for QA/QC is an investment, the potential penalties associated with poor practices far outweigh spending on these helpful additions to the team. Manufacturers are looking for ways to make sure their operations run smoothly, avoid regulatory penalties and provide customers with the best-quality medicines possible. Working with QA/QC partners is a way to pursue all these goals.

SOURCES

  1. ECA Academy. Batch Release without Determination of Identity and Strength and other GMP violations - A Look at FDA's Warning Letters over the Last Months. November 13, 2019 as referenced at: https://www.gmp-compliance.org/gmp-news/batch-release-without-determination-of-identity-and-strength-and-other-gmp-violations-a-look-at-fdas-warning-letters-over-the-la
  2. U.S. Food and Drug Administration. Guidance for Industry. September 2006 as referenced at: https://www.fda.gov/media/71023/download
  3. https://www.fda.gov/drugs/warning-letters-and-notice-violation-letters-pharmaceutical-companies/warning-letters-2018