FREQUENTLY ASKED QUESTIONS



  • What guarantee do we have that you will make our solutions according to our method?Learn More
    • Manufacturing cannot proceed until a Product Definition Form has been reviewed and signed by the client.

      The Product Definition Form includes information on solution formulation, packaging, labeling, any requested QC testing, and contact addresses. This form can also include a documentation of your preferred (or proprietary) method of manufacture. Additionally, QA must sign off on the accurate transfer of the formula to the mixing instruction sheet. Both documents are part of the SOP controlled batch record.


  • How are solution expiration dates determined?Learn More
    • To determine the shelf life of your particular solution and to assign an accurate expury, it is necessary to conduct a stability study. CHATA offers custom studies for mobile phases, buffers, diluents, and dissolution media. The studies result in a data supported expiration date that is printed on each Certificate of Analysis and solution label.


  • What information is printed on CHATA's labels?Learn More
    • Our labels include the Lot Number, Part Number, Product Name, Product Composition, CAS Number (if required), HMIS Codes, Expiry (dictated by your SOP or stability testing), and CHATA contact information. Additional information can be added to any label by request.


  • Does CHATA provide a Certificate of Analysis?Learn More
    • A Certificate of Analysis is provided with each lot and includes: Product Name, Product ID Number, Lot Number, Manufacturing Date, Expiry (if a stability study has been performed), and the results of any analytical tests performed.


  • Has CHATA's facility been audited by the FDA?Learn More
    • CHATA does not manufacture drug products or medical devices. As a result, we are not subject to direct FDA audits. We are subject to vendor audits, which are performed by our clients. Our facilities have been audited by nearly all of the major North American pharmaceutical manufacturers.