+ We are certified according to ISO 9001:2000.
+ We have a document control system.
+ We operate our own quality control laboratories.
+ We train our employees and operators regularly.
+ We provide notification to the buyer on a timely manner and each time when a process, equipment or analytical method change, affecting the regul atory status.
+ We established written procedures for dealing with out-of-specification test results.
+ We established written procedures for dealing with deviations including documentation.
+ We perform on regular time intervals self-inspections
+ We established a waste handling and recycling program.
+ We follow ICH Q7A Guidance.
+ We use raw materials of qualified supplier only.
+ We perform on regular time on-site audit of our raw material supplier.
+ We test the product according to the agreed specification.
+ We supply a Certificate of Analysis with each delivery batch which states all analysis data.
+ We keep retain-samples of all production batches for future reference.
+ We maintain product stability/retest data for our products.