Obtain Manufacturer Name and Address for Regulated Products
Information
Question | I noticed a manufacturer code on the bottom of your Certificates of Analysis. What does this code mean? How can I access the manufacturer information? |
Answer |
As of April 24, 2006, the original Manufacturer Name and Address is referenced on the Certificate of Analysis as an alpha-numeric Manufacturer Code for the regulated products designated with Management of Change (MOC) codes RL- Regulated Limited, R - Regulated and HR - Highly Regulated. This practice is compliant with ICH Q7 Good Manufacturing Guidance for Active Pharmaceutical Ingredients (APIs), the International Pharmaceutical Excipients Council (IPEC) guidelines and cGMP requirements. Manufacturer Data, Name and Address Information is proprietary information and requires an active Non-Disclosure Agreement (NDA) for release to product end-users. This information is accessible to end-users at https://us.vwr.com/store/ with the creation of an enabled account and confirmation of an NDA. End-users must agree to the Terms of Use prior to this information being disclosed. Below are the instructions on how to Login and obtain the Manufacturer Name and Address using the Manufacturer Reference Code. Site use instructions: Note: Information needed to locate Manufacturer Data is available on the Certificate of Analysis of GMP, Regulated Products. Required Information:
The Manufacturer Reference Code is located at the bottom left of the Certificate of Analysis for our regulated products. To Obtain the Certificate of Analysis for a GMP, Regulated Product: 1. If you do not have a hardcopy of your Certificate of Analysis, see below: a. You may obtain one online at Advanced Search | Avantor (avantorsciences.com). You will need the 6-digit Product/Material Number and the Batch/Lot Number. b. You can also obtain one at https://us.vwr.com/store/ by clicking in the search window and selecting “certificates”. i. In the Certificate Search page type in 6-digit Product/Material Number and/or 10-digit Batch/Lot Number then select search. ii. Select the PDF link for Certificate of Analysis. Note: The Certificates of Analysis for our non-regulated products do not display a manufacturer code as the manufacturing information for these products is strictly confidential. For Registered Email Accounts: 1. Go to https://us.vwr.com/store/ Login Instructions for Non-Registered Email Accounts:
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File | Manufacturer Name and Address for Regulated Products.pdf |
Keyword | coa, 1193, manufacturer, disclosure, reference code, pbg, par, P0001001, manufacturing, manufacturer data, P0002001, P0003001, P0004001, P0005001, P0006001, P0007001, P0008001, P0009001, P0010001, P0011001, P0012001, P0013001, P0014001, P0015001, P001600 |