As essential service providers in the pharmaceutical industry, contract research organizations (CROs), contract manufacturing organizations (CMOs), and contract development manufacturing organizations (CDMOs) are expected to prioritize quality control (QC), including QC microbiology (QC micro). In fact, a contract organization’s reputation for quality and compliance management can help distinguish them from its competition, since quality is one of the most important selection criteria.[i],[ii],[iii]
Because QC microbiology requires specialized expertise, equipment, and lab space, some contract organizations end up outsourcing this essential activity to other analytical labs. However, outsourcing QC microbiology comes with its own challenges that reduce or eliminate the benefits.
Profit Loss
First and foremost, outsourcing QC micro testing can reduce contract profits since you must pay others to do work you can’t complete. Additionally, a contract organization can miss out on projects where the prospective client is explicitly looking for a partner with QC microbiology capabilities, either as a standalone service or as a component of a broader scope.
Slower Time-to-Result
Outsourcing QC micro testing puts another layer in between you and your results, which creates costly delays that can limit your ability to resolve microbial contamination issues. Waiting on a contract testing lab to collect and submit your data can especially slow down manufacturing workflows, particularly if your provider uses manual data collection, entry, and analysis methods. Additionally, you won’t have any control over their lab operations, meaning that if the lab encounters bottlenecks, you’ll be forced to deal with the consequences without much say.
Compliance Uncertainties
Your contract organization in most cases has limited control over the processes and day-to-day operations at the laboratory providing QC microbiology services. Since they are removed from your immediate oversight, it can be difficult to determine whether that lab is fully complying with regulatory guidelines. When this goes wrong, these uncertainties can lead to regulatory compliance issues and expensive approval delays.
Thus, while outsourcing provides contract organizations with an avenue to “check off” QC microbiology, performing the work in-house provides contract organizations with more control—an extremely valuable outcome given the risk-averse nature of the pharmaceutical industry.
The Benefits of Having an In-House QC Microbiology Lab at Contract Organizations
By bringing QC micro lab testing in-house, your contract organization stands to benefit in a number of ways.
- In-house testing cuts outsourcing expenses, providing an opportunity to increase profit margins.
- With more direct time-to-results and control over timelines, in-house testing eliminates “middle-man” delays.
- It also provides greater control over your quality systems to ensure you are meeting regulatory guidelines.
- If you have the capacity and equipment to safely handle greater testing volumes, a contract organization could even take on QC microbiology work from clients or other contract organizations: thereby, creating another revenue stream in the process.
- Your organization also becomes more of a “one-stop shop.” In doing so, you can increase trust with your clients by ensuring that every aspect of the contract is fully controlled by your company.
How Automated RMMs Help Establish Efficient and Compliant QC Micro Labs
It is vital to note that the benefits of in-house QC micro testing hinge on the efficiency and efficacy of the lab. When many companies attempt to bring QC micro in-house, they often run into inefficient labor-intensive testing workflows and data management complexities. These complications create some of the same bottlenecks that originally justified outsourcing in the first place. Such challenges are further exacerbated when high-volume QC microbiology is performed using manual methods that rely heavily on human labor.
Thus, once you elect to bring a QC micro lab in-house, it is essential that you equip it with modern technologies. To solve the challenges posed by traditional methods and high-volume QC microbiology testing, leading labs are adopting next-generation QC laboratory processes that leverage automation and digitization. More specifically QC microbiologists are adopting automated rapid microbial methods (RMMs) that:
- Increase throughput
- Accelerate time-to-results and issue detection
- Cut human error
- Increase data integrity and transparency
- Reduce the burden of paper management
Rather than rely on human detection and interpretation, automated RMMs detect contaminations sooner and more objectively, so they can be resolved more quickly. For example, the Growth Direct® System effectively detects microbes using cellular autofluorescence, detecting contamination sooner than traditional manual count methods. Implementing automated RMMs also drastically cuts the need for employees to perform manual tests and analyses. As a result, employees can devote their time to higher-level work like identifying contaminations, performing investigations, and resolving issues that require immediate attention. You may also find that automation helps to keep teams lean without sacrificing productivity.
Automated RMMs are particularly valuable if they can be seamlessly integrated into a Laboratory Information Management System (LIMS) like the Growth Direct® System can. LIMS-integrated instrumentation vastly improves data integrity and transparency, while also offering potential cost savings.[iv] Since data integrity is central to site compliance,[v] this careful management of data goes a long way towards reducing patient risk and satisfying regulatory requirements. Furthermore, LIMS-integration also contributes to faster time-to-results and quicker detection of contamination issues.
While the benefits of bringing your QC microbiological testing in-house are clear, it’s critical to build a lab that is prepared for the future. Bringing an automated RMM into your new QC micro lab does just that, while clearly demonstrating that your contract organization can be trusted to deliver market-ready results.
For more information, download our whitepaper on the value of advanced QC microbiology testing for contract manufacturers. If you are curious about what the Growth Direct® installation process looks like, check out our blog on frequently asked set-up questions.
If you have additional questions or want to speak with an expert about our Growth Direct® automated RMM system, contact us today!
[i] ISR Reports. Sterile Injectable Drug Product Manufacturing. Outsourced Pharma. https://www.outsourcedpharma.com/doc/sterile-injectable-drug-product-manufacturing-market-overview-and-outlook-0001. Published March 11, 2021. Accessed August 30, 2021.
[ii] Connell B. Build CMO Relationships with Effective Management Practices. PharmTech. 2020; Supplement (3):s26–s28, s33. https://www.pharmtech.com/view/build-cmo-relationships-with-effective-management-practices
[iii] Alghabban A. What to Look for in Selecting a CRO/CMO and How to Ensure the Right Choice: A Quality Assurance Perspective. Pharmaceutical Outsourcing. https://www.pharmoutsourcing.com/Featured-Articles/172751-What-to-Look-for-in-Selecting-a-CRO-CMO-and-How-to-Ensure-the-Right-Choice-A-Quality-Assurance-Perspective/. Published March 25, 2015. Accessed October 12, 2021.
[iv] Carra N., Makarova E., Morell J., Ringel M., Telpis V. Digitization, automation, and online testing: Embracing smart quality control. https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/digitization-automation-and-online-testing-embracing-smart-quality-control. Published April 14, 2021. Accessed August 30, 2021.
[v] Parenteral Drug Association, Inc. Data Integrity Management System for Pharmaceutical Laboratories Technical Report No. 80. https://www.pda.org/bookstore/product-detail/4542-tr-80-data-integrity-management. Published August 2018. Accessed May 13, 2021.
Related articles:
Quality Control Infrastructure in Pharmaceutical Manufacturing Needs Critical Modernization
Designing the High Performing QC Lab
Planning the QC Micro Lab of the Future: Preparing for Tomorrow’s Challenges Today
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