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QC Batch Release

Reliable and Timely Batch Testing

Ensure timely turnarounds and clear communication with our lot release testing services. Our testing team has extensive experience performing cGMP batch release testing on a diverse range of drug products. Whether your product is a small molecule, biologic, nucleic acid-based therapeutic, or combination product, we have the knowledge and expertise to verify that it complies with your product specifications.

Our team excels in a diverse array of identification, assay, impurity, potency, in vitro, and physical property testing for all your drug product batch release needs. All your test results and raw data are also available 24/7 via our PacePort data portal, keeping you informed about the progress of your testing to meet your timelines.

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Batch Release Testing Process

1
Analytical Method Transfer and Validation
2
Sample Transfer
3
Analytical Testing
4
Report Results and Raw Data
5
Stability and Storage Testing
Analytical Method Transfer and Validation

We transition established methods through comparative method transfers, co-validation, or re-validation to accommodate your program’s current parameters and constraints. If you need support with earlier phase testing, consider our analytical method development services.

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Sample Transfer

Once your samples arrive onsite for testing they are entered into our LIMS system, and you are able to track their status within PacePort. This visibility continues as the samples undergo testing, providing you with updates throughout the project.

Analytical Testing

Our team conducts batch testing to support the lot release of your products. We apply the highest standards to ensure your latest batch upholds the quality your team has worked hard to establish.

Report Results and Raw Data

As results are generated and each test is completed and reviewed, raw data is made available in PacePort. This accessibility allows you to track progress and next steps without having to wait for the full data package. Once all tests are completed, the full data package is then made available online.

Stability and Storage Testing

Integrated laboratory services support both batch release testing and associated stability testing to consolidate points of contact and knowledge sharing.

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Secure Data Accessibility

Analytical methods, including both the Client Laboratory Methods (CLM) and Laboratory Methods (LM), are available for your access and review in PacePort®. PacePort® is our secure client data access portal and web-based data delivery system where you have access to methods, specifications, stability protocols, pull schedules, stability reports, final reports, sample receipt data, instrument raw data, and additional information at any time, from any location.

The copies are offered in high-resolution and in color, giving your team easy and clear viewing for review. Scanned images are of sufficient quality that they are often used during quality and regulatory (US FDA) audits. The information available via PacePort® is thorough and complete, such that most, if not all, aspects of a data audit are available so your audit could be conducted remotely, guided by our Quality Assurance personnel.

Integrated Laboratory Services  

When your team needs additional support, our scientists & professional services are ready. Our state-of-the-art facilities and highly trained experts add power to your project.

Additional Resources

Pace® is a registered facility with the U.S. Food and Drug Administration (FDA), demonstrating our commitment to meeting regulatory requirements for quality and safety in the industries we serve.
Pace® holds a registration with the Drug Enforcement Administration (DEA), allowing us to handle controlled substances and support the specific needs of our clients in regulated industries.
Pace® adheres to current Good Manufacturing Practices (cGMP), ensuring that our laboratory facilities and processes meet the highest quality standards set by regulatory authorities for the pharmaceutical, biopharmaceutical, and medical device industries.
Pace® is accredited to ISO/IEC 17025, the international standard for competence in testing and calibration laboratories, validating our technical competence and commitment to delivering accurate and reliable results.