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Obtain Manufacturer Name and Address for Regulated Products

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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:
  1. Product/Material Number field requires the 6-digit product code for all Batch/Lot Numbers
  2. Batch/Lot Number is 10-numerical digits.
  3. Manufacturer Reference Code is an Alpha Numeric Code that typically starts with a P and is located below the packaging site for Regulated and Highly Regulated products.
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:
  1. You may obtain one online at https://www.avantorsciences.com/en/certificate-sds-search.html. You will need the 6-digit Product/Material Number and the Batch/Lot Number.
  2. You can also obtain one at  https://us.vwr.com/store/ by clicking in the search window and selecting “certificates”.
  1. In the Certificate Search page type in 6-digit Product/Material Number1 and/or 10-digit Batch/Lot Number then select search.
  2. 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/
2. Enter your User ID and Password and click 'Login'.
3. Go to “My Organizations”
4. Select “Avantor Manufacturing Reference Code-VWR-US” (if not already selected) to enable access to manufacturer information and click ‘Submit’. This will only be available if you have an NDA and your account is enabled. If this is not available, please contact Technical.service@avantorsciences.com for support.
5. To access the Manufacturer Data, there are three (3) options.
  1. Select “My Account” under the ‘login’ information. Select ‘Manufacturer Data’ under the “Welcome to the Avantor Manufacturing Reference Code Resource Tool”.
  1. Select the ‘>’ next to ‘Advanced’ under the search bar. Then select ‘Manufacturer Search’.
  2. Click in the ‘search field’ and select ‘Manufacturer Data’.
6. Fill in the following fields: Product/Material Number, Batch/Lot Number, and Manufacturer Reference Code.
7. Read the Terms of Use carefully.
8. If you agree to the conditions, click the 'Agree' checkbox, and click 'Yes, I agree'.
9. The information requested will display and may be printed if desired.
10. Click 'Back to Manufacturer Data' to enter another inquiry.


Login Instructions for Non-Registered Email Accounts:
 
  1. Contact technical.service@avantorsciences.com to setup an account to obtain Manufacturer Information if you do not already have access.
  2.  Please be sure to include your name, phone number, e-mail address, company name and site address, as they are required to complete the request.
  3.  Technical Service will assist with initiating and confirming an active NDA to enable access Manufacturer Data.
  4.  Instructions to receive Manufacturer Information from your enabled account are available at above.
File 
Keywordscoa, 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

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