Lot release testing is a critical step in the pharmaceutical manufacturing process, verifying that each batch of a drug product meets all applicable quality standards before it can be distributed. Protheragen-ING Lab offers comprehensive lot release testing services, which are designed to meet the rigorous standards set by regulatory authorities worldwide, providing you with the confidence that your products are of the highest quality before reaching the market.
What is lot release testing?
Lot release testing is a crucial part of the pharmaceutical manufacturing process. It involves a series of stringent tests conducted on each batch (or lot) of a product to ensure that it meets predefined quality criteria. This testing verifies that the batch conforms to the specifications set during the product development phase and complies with regulatory requirements. Only after successful completion of lot release testing can a batch be released for distribution and sale.
Our lot release testing expertise
Lot release testing is a critical step in the pharmaceutical manufacturing process, verifying that each batch of a drug product meets all applicable quality standards before it can be distributed. Our team of experts specializes in performing the full suite of lot release tests required by regulatory agencies such as the FDA, including:
- Identity testing
- Strength/potency testing
- Purity/impurity testing
- Dissolution testing
- Sterility testing
- Endotoxin testing
- Particulate matter testing
- Container closure integrity testing
We work closely with our pharmaceutical clients to develop custom testing protocols tailored to the specific requirements of their drug products and manufacturing processes. Our rigorous quality control measures and dedication to regulatory compliance ensure accurate, reproducible results you can trust.
Our advanced analytical capabilities
Our pharmaceutical testing laboratory is outfitted with the most advanced analytical instrumentation to provide comprehensive characterization of drug substances and drug products.
Some of the key technologies we utilize include:
- High-performance liquid chromatography (HPLC)
- Gas chromatography-mass spectrometry (GC-MS)
- Ultraviolet-visible spectroscopy (UV-Vis)
- Fourier-transform infrared spectroscopy (FTIR)
- X-ray diffraction (XRD)
- Dynamic light scattering (DLS)
By leveraging these cutting-edge analytical techniques, we can provide in-depth analysis of critical quality attributes such as identity, purity, content uniformity, and stability. Our team of PhD-level scientists carefully interprets the data to deliver reliable, actionable insights to support successful lot release.
Regulatory compliance & quality assurance
Upholding the strictest quality standards is paramount in the pharmaceutical industry. Protheragen-ING Lab is fully committed to regulatory compliance and has implemented a robust quality management system aligned with cGMP, ISO, and other relevant guidelines. By choosing us for your lot release testing needs, you can have confidence that your drug products meet all necessary quality and safety requirements.
To learn more about our pharmaceutical lot release testing capabilities, please contact us today. We look forward to discussing how we can support the success of your next product launch.