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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 or alpha-numeric manufacturer code rather than listing the full name and address for the regulated products designated with Management of Change (MOC) codes 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 is proprietary information. This information is available to product End-users. End-users must create an account and 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.
Below are the site use instructions:

Obtain a Certificate of Analysis:
1. If you do not have a hardcopy of your Certificate of Analysis, you can obtain one online at http://www.avantormaterials.com/search.aspx?searchtype=cofa. You will need the 6-digit product number and the lot/batch number.
2. The manufacturer code is located at the bottom of the Certificate of Analysis, near the country of origin, for our regulated products.

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 $www homepage
2. Click on 'Sign in' found at the top of the webpage.
3. Enter your User ID and Password and click 'Login'.
4. Hover your curser over the Products tab and click on the 'Certificate of Analysis' link. This will direct you to our Certificate of Analysis inquiry page.
5. Click on the 'Manufacturer Data' tab.
6. You will be prompted to fill in the following fields: Product Number1, Lot/Batch Number2, Brand, and Manufacturer Reference Code.

1 Product Number field requires the 6-digit product code as of April 30, 2012 for all lot/batch numbers.
2 Lot Number is 6-character alpha-numeric code; Batch number is 10-numerical digits generated from SAP system.


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.
10. Click 'Back to Manufacturer Data' to enter another inquiry.

Login Instructions for Non-Registered Email Accounts:

1. Go to www.avantormaterials.com homepage.
2. Click on 'Create an account' found at the top of the webpage.
3. Enter the following information about yourself: Email Address, First & Last Name, User Name, Password, Organization, Title, Address and Phone Number.
4. At the end of the form, answer the three questions that best describes you.
1) Are you an existing Avantor Performance Materials distributor? Only select YES if you are a distributor.
2) Do you currently buy products directly from Avantor Performance Materials? Only select YES if you purchase directly from Avantor. If you are unsure, please keep the default answer to NO.
5. Verify that all the information is correct and click on 'Register Me' to proceed.
6. The following message will appear:

Thank you for registering on the website.
Your profile is not yet enabled for order placement. If authorized by your company to place orders, please send your request to
CommerceRequest@avantormaterials.com. Please be sure to include your name, phone number and company name, as they are required to complete the request.

7. Once registered, hover your curser over the Products tab and click on the 'Certificate of Analysis' link. This will direct you to our Certificate of Analysis inquiry page.
8. Click on the 'Manufacturer Data' tab.
9. You will be prompted to fill in the following fields: Product Number1, Lot/Batch Number2, Brand, and Manufacturer Reference Code.

1 Product Number field requires the 6-digit product code as of April 30, 2012 for all lot/batch numbers.
2 Lot Number is 6-character alpha-numeric code; Batch number is 10-numerical digits generated from SAP system.


10. Read the Terms of Use carefully.
11. If you agree to the conditions, click the 'Agree' checkbox, and click 'Yes, I agree'.
12. The information requested will display.
13. Click 'Back to Manufacturer Data' to enter another inquiry.



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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