The reliable product quality is the soul of AOLISEN's existence, we take responsibility for every product we produced and sent to our customers. We also accept laboratory and factory visits and on-site audits by our customers. We have written procedures for all areas of the operation, and all procedures are periodically reviewed and updated.
We have a procedure that defines the receipt of all raw materials.
A pharmaceutical ingredients supplier qualification program and only purchase raw materials from approved suppliers.
A written specification and require a COA for all incoming raw materials.
All raw materials issued on a first-expiry and first-out basis.
A written general housekeeping procedure.
A written pest control procedure.
Have procedures covering the rejection (labeling and segregation) of raw materials, packaging materials and finished products.
A procedure indicated how controlled documents are stored, issued, updated and retained.
A procedure that describes control, access, keeping and retention of electronic records.
A written job procedure for all personnel.
A written procedure for a training program including new employees.
We have procedures and methods for all analyses performed.
All methods and specifications are approved by Quality Assurance.
Testing or inspection is performed on raw materials, semi-finished and finished intermediate chemical products:
Nuclear Magnetic Resonance (HNMR, CNMR, FNMR)
Chromatography (HPLC, TLC, GC)
Mass spectrometry (LC-MS, GC-MS, MS)
KF testing; Infrared testing; Polarimetry; Elemental analysis; Titration
Have procedure for equipment cleaning and clearance.
Our manufacturing according to a written procedure (e.g. batch record) and customer specification, and all manufacture procedures are validated.
As one of the best pharmaceutical ingredient suppliers, we retain samples from each batch manufactured and each batch manufactured assigned a unique batch number.
Have procedures and specifications available for packaging components, packaging operations, labels and labeling.
Labeling procedures ensure proper controls of procedures to prevent mix-up.
We provide a Certificate of Analysis with each shipment that identifies the manufacturer address, material name, batch number, specifications, test results, retest data and so on.