Our GMP grade products are manufactured under a comprehensive quality system designed, implemented, controlled, and documented to ensure the quality of the product is as required in a risk-assessed manner.
QA for GMP Products
AnaSpec’s QA department monitors GMP manufacturing according to parts of 21 CFR 210 and 211 applicable for products intended use, as well as 21 CFR part 820 for Diagnostic applications.
Quality Management System
AnaSpec maintains a Quality Management System that ensures every employee operates within the guidelines of our standard operating procedures and fulfills our global quality policy.
Our state-of-the-art highly controlled GMP cleanroom areas for downstream processing are classified as ISO 7 (class 10,000).