Audits for Pharmaceutical Booklet Labels
At ATL, audits (internal and external) are taken very seriously, with involvement from all levels of personnel. Our pharmaceutical and booklet labels must pass a rigorous "batch inspection process" performed by our Quality Assurance group. ATL's cGMP compliant Quality Management System has formalized Standard Operating Procedures in place. All complex medical device projects have formal, written control plans. Our machines and processes are validated to assure your product quality.
On-going quality is maintained through "Systems Validation Protocol." This includes IQ (Installation Qualification) of machines, OQ (Operational Qualification) of machines, and PQ (Performance Qualification) of machines and processes. We express our quality in six-sigma terms, or "defects per million." Employee training is constant as we keep ATL personnel "up to date" with all aspects of process improvement and external regulations.
In the last decade, ATL has successfully passed dozens of pharmaceutical audits (21 CFR 210, 211) performed by teams from Novartis, Bristol-Myers Squibb, Schering-Plough, Aventis, Abbott Laboratories, Pfizer, Johnson & Johnson, Eli Lilly, and many others.