Written Procedures
Second year mullein (Verbascum thapsus).
In biomimicry fashion, this represents to me a well defined documentation system with the outer leaves representing facility level procedures and the inner, smaller leaves, specific instructions required to manufacture a product. Each document plays a crucial role in producing the desired outcome, in this picture the emerging flower stalk.
Scattered throughout 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, is the phrase “You must establish and follow written procedures….”, clear in its directive, vague in details. This is good and bad. Good, in that you can define and create your written procedures however you wish. Bad, in that if you deviate too far from what is expected by FDA, your system will face more scrutiny and require more defense. What are some standard elements of a written procedure? Below are 10 items consistently used across regulated industries.
Approval Section - Every document should have an approval section that includes the author, approver, date of signatures, document revision, and document title. In some cases, a document number is also used to facilitate tracking. If a change control system is used, identify the change number that details the document changes.
2. Purpose - Specify what area this document is addressing. Give it a theme.
3. Scope - Identify the boundary of activities for the document. It may address what is applicable as well as what is not applicable. e.g. dietary supplement versus cosmetic goods.
4. References - Call out other relevant documents that enable the implementation of the procedure such as a form or another document. In some cases, it may reference the regulatory requirements by specifying a standard or code.
5. Definitions - List any terms that need a specific definition relevant to your process.
6. Responsibility - Identify who is ultimately responsible for ensuring the implementation of the activities specified. In some cases, it may be manager level or higher or a user level.
7. Procedure - This is the meat of the document that specifies what specific steps are needed to implement the procedure. Be as detailed as possible without being too restrictive. Procedure sections are often in outline format.
8. Records - Identify what records are generated from activities outlined in this procedure and what information they entail. This section is important as it provides proof that the procedure was followed as written.
9. Document History - As part of the document, and often at the end of the document, a brief table identifying each revision, reason for revision, and effective date provides a snapshot of how the document was modified and when the change occurred.
10. Header and Footer - This may seem trivial, but having information appear on each page completes the document. The header often includes the company name or logo and document title. In the footer is document number and current revision, and page number of total pages.
Circling back, none of these elements are specifically required by law and you can pick and choose which fit your organization. But having control over your documentation translates to control over your products and that, ultimately, gives FDA inspectors comfort. Take time to make the format of your first procedure one that can be duplicated easily throughout your system. Most importantly, create procedures that reflect what you do! The most detailed and thorough documents are worthless if you can’t or don’t follow them. Not sure where to start? Download one template from our list and edit it for your purpose. The first one is always the hardest to create!