Monday, October 4, 2004

10/04/04 - Standard Operating Procedures (Operations Manual)



2006 UPDATE: The Vitamin Lawyer has a model Op Manual format for you! See: #07/05/06-3


For OTC and pharmaceutical companies, the Number One violation citation in FDA review letters is Failure to Establish or Implement SoPs.

As cGMPs (Current Good Manufacturing Practices) are imposed on the Vitamin Industry, similar concerns will become important to you.

One important step in getting ready for GMPs is to begin to document your procedures. Get a loose leaf note book and start to include the steps you need to take to meet cGMPs. Include at least the following areas:

1. SoPs - Some of the elements to consider in developing your SoPs -
Information gathering procedures
Laying the framework — components, types and formats
Who's responsible for writing, reviewing, approving, distributing and maintaining your company's SoP
How detailed should they be?
How frequently should they be reviewed and updated?
Steps for auditing your procedures
How to manage changes and updates
How to motivate staff to follow them
2. Adverse Event Reporting & Consumer Complaint Records
3. Packing and shipping procedures & records
4. Risk Managment Policy
5. Document Retention Policy
6. Banking Procedures
7. URL maintenance and management

Eventually, you will need to develop an Operations Manual encompassing the above and other issues. As a small business owner, you should be able to feel confident that you can absent yourself from the business and the normal business procedures will be sufficiently documented that others can carry on while you are... on vacation... learning new things... whatever!