Leading pharmaceutical and medical companies trust ATL based on their regular audits of our quality systems, validation protocols, and products' traceability.
Every new design for labels manufactured in our facility has a systematic review before production. These reviews include APQP (Advanced Product Quality Planning) for specifications, risk analysis, materials, tooling, control plans, performance qualifications, and batch inspection records.
Our quality system has "Travelers" and "Hold Points" that assure line clearance, product integrity, and cGMP compliance. Only our quality assurance department is authorized to release products at each hold point, and only after conformity to specifications is achieved.
Clinical trial and commercial pharmaceutical labels are manufactured in highly-efficient and well-equipped facilities that are ISO 13485:2016 certified, FDA registered, and compliant to cGMP 21 CFR 210, 211, and 820. For customers that require high-level air quality control, products can be manufactured in ISO Class 7 and ISO Class 8 certified cleanrooms.