Documented procedures
Standard Operating Procedures guide production. Internal audits support cGMP practices and a compliant working environment.
Contract manufacturingConfidence comes
Confidence comes
from the process.
Documented procedures, validation and in-house testing support OraLabs’ approach to quality and continuous improvement.
Quality built into the process.
A shared responsibility across the people, procedures and testing behind each program.
Validation & testing
Laboratory and manufacturing validation address regulatory and customer requirements. Testing methods follow applicable 21 CFR requirements.
Batch testing
The in-house microbiology laboratory tests every batch before it leaves the facility, as described in OraLabs’ quality program.
Quality assurance
Accountability at every step.
OraLabs manufactures cosmetic, OTC and medical device products under the requirements applicable to each product. FDA and customer audits complement internal quality oversight.
Employees are encouraged to report quality deficiencies so they can be addressed promptly. Continuous improvement and customer requirements inform the quality system.