August 4, 2017

Creating Certificates of Analysis (C of A)

This procedure requires Adobe Acrobat Pro, Microsoft Word, company letterhead, and Topaz signature encryption software.  High-risk products like ophthalmic products, flammable products, and oxidizing tooth whiteners must be certified by the company to protect it from losses or litigation.  Low-risk products like shampoos and conditioners may not require certification but it is good practice to always certify them to our customers to increase their trust in the company’s products.

If no template exists for a particular formula/product, create one by following these steps.

  1. Open the file SERVER LOCATION REDACTED and click File>Save As and then change the name to remove the word Template and add the formula name.
  2. Fill in as much of the information as you can.  Copy all of the parameters from the batch record into the Analysis and Specification columns but don’t provide any values in the Results column.  Leave out any information that will be different each time the new template is used.
  3. Save the file, Close it, and make the Read Only property of the file true or checked.

To create a C of A from a template, follow these steps.

  1. Open the appropriate template located in SERVER LOCATION REDACTED.
  2. Save the C of A to the appropriate folder in SERVER LOCATION REDACTED changing the word Template to the formula name and lot number.
  3. Copy all of the Quality Control information onto the form from the Batch Record.  Certificates should show all of the information collected by the QCU or QCA when releasing the certified product for sale.
  4. Sign and Print the document to Adobe PDF and save the file in SERVER LOCATION REDACTED.
  5. Send a copy of the correct Certificate of Analysis to the client with each shipment of product and by any other means they request.

When creating a Certificate of Analysis you are required to begin with a template and not the previous C of A for that product.  If a mistake exists on the previous C of A, that mistake may propagate to future documents which could damage the company’s reputation and/or regulatory compliance status if discovered.

(The above procedure was created as part of the SOP Manual System at a previous employer. Sensitive information has been redacted and no proprietary information has been disclosed.)