GMP Analytical--Product Release/Product Retain

PharmaCore offers trusted analytical support for release testing of bulk drug and many finished pharmaceutical dosage forms. Using state-of-the-art equipment in our modern analytical laboratories, our experienced scientists can perform analyses that are fully compliant with USP/NF and other compendia. We can also analyze samples according to ACS and FCC methodologies and monographs, or in compliance with methods you or your vendor provide. Whatever your requirements or time lines, our dedicated scientists will work diligently to meet your needs.

PharmaCore can also take over administration of your product retain program. Upon arrival, your retain samples are logged into our retain system and then taken to our retain storage area, where our scientists place them into the appropriate storage conditions. When samples are received from a third party manufacturer, PharmaCore can also perform a GMP quality check. This check can include, but is not limited to, label quality, lot number, print quality, container quality and container closure. The inspection can be tailored to meet your standards and specifications.

Reserve samples can be scheduled for physical observation analysis per your requirements. We pull the samples as scheduled and log the samples due for testing into our sample logbook. All steps of the storage and testing process are tightly controlled and accurately documented.

We welcome client visits and audits to verify our strict compliance with current GMP requirements and to demonstrate the experience of our scientists.

PharmaCore's scientists bring a wealth of real-world experience to the table to help meet your needs. Our analytical operations are based on written, detailed SOPs and stringent quality assurance practices, and all of our work is performed in compliance with cGMP requirements.

For more information on our method development and validation capabilities or any of our pharmaceutical capabilities, please call PharmaCore at 336-841-5250, extension 159 (Mark Shapiro, Director GMP Analytical) or extension 101 (Kelly Tilyard, Marketing Manager).