A GMP Audit Checklist For Cosmetics Industry Leaders

Using a GMP Audit Checklist for Cosmetics is a widely accepted practice to ensure auditors stay on track and don’t miss any essential audit checkpoints. Our downloadable (and free) checklist template you can download here today focuses on the primary checkpoints laid out by the FDA for the cosmetics industry.

A GMP Audit Checklist for Cosmetics is a document utilized by manufacturers and processors of cosmetics to ensure Good Manufacturing Practices and compliance with regulations.

Our comprehensive checklist you can download for your cosmetic facility GMP audit is printable and in PDF format. However, if you find that a digital version would better suit your organization, we’ve got an app that is worth reviewing before you print copies of the GMP audit checklist for cosmetics.

Included in the GMP Audit Checklist for the Cosmetic Industry

Our GMP Audit Checklist for Cosmetics has twelve conveniently segmented sections to allow for easy organization and a categorical approach to the audit. Here’s a quick breakdown of each section. Feel free to bookmark this page and use it for training your team.

Administrative

No audit or inspection documentation is complete without the appropriate data concerning the auditor, date and audit report number, and facility information.

The Ten Data Checkpoint Categories

Each category is conveniently labeled at the top and includes four columns on the checklist:

  • Audited – The auditor can check each item as they review it to ensure no missing items.
  • Requirement – A descriptor for the intended checkpoint step of the GMP audit.
  • Rating – A rating to create a scoring system. We advise using a simple percentage-based scoring system to capture each item rating with accuracy adequately.
  • Notes – Any notes the auditor wishes to communicate for the audit item. 

Page One Audit Checkpoint Categories

  • Building and Facilities
  • Equipment
  • Personnel
  • Raw Materials
  • Production
  • Laboratory Controls

Page Two Audit Checkpoint Categories

  • (Reiteration of administrative data)
  • Records
  • Labeling
  • Complaints
  • Other Items

Notes and Sign-Off

Naturally, one would expect a sign-off region at the end of the audit document. Similarly, we’ve included a text area where your auditor might include further notes or information. 

How To Use The Cosmetic Industry GMP Checklist

Using the Cosmetic Industry GMP Checklist isn’t as hard as one might think, despite the complicated nature of the audit.

To use the GMP Audit Checklist for Cosmetics, begin by familiarizing yourself and your team with the twelve categories included in the document.

Next, section off each category and audit each item. Remember to use the rating system to capture each item’s rating accurately.

Finally, have your auditor sign off on the document to certify that the audit completion occurred correctly.

The Rating System Explained

Our GMP Audit Checklist for Cosmetics includes a convenient rating column. The checklist consists of 60 checkpoints throughout the ten auditing categories.

Therefore, to find the overall rating for the audit result, add all scores in the rating column and divide by 60. If you use ratings out of 100, there is no need for further calculations, as this formula will provide your average overall rating.

(Sum of Rating Column Scores)/60

Best Practices For Cosmetic Industry GMP Management

Concerning the best practices for Cosmetic industry GMP audits, there are two things you need to know right off the bat, adulterated and misbranded. These two key terms used by associations like the FDA are pivotal in defining the appropriate GMP audit checkpoints.

According to Sec. 601 of the Federal Food, Drug, and Cosmetic Act (of the USA and followed similarly by most other countries), an adulterated cosmetic is one that:

  1. May be harmful to users under normal conditions because it or its container includes a dangerous substance or substances.
  2. Contains filth.
  3. Contains a non-permitted, in some instances, non-certified color additive.
  4. The manufacturing or storage conditions are unsanitary and therefore create a situation where the product may become harmful to users or contaminated with filth.

Similarly, the FDA states in Sec.602 of the same act that a cosmetic is misbranded if it is one that:

  1. Possesses false or misleading labeling.
  2. Does not prominently and conspicuously display any information required by or under the authority of the Federal Food, Drug, and Cosmetic Act.
  3. Possesses a misleading container presentation or fill.

Best Practice Tip 1

Play by the rules and understand what regulations intend to do. Understanding the requirements makes it easier to work out effective strategies to ensure that products don’t fail quality control checks. Rigorous adherence to GMP via routine inspections is a must.

Document Controls

Assuming that your organization performs regular self-audits, you need to ensure that you are doing a few things with your GMP audits and documentation:

  1. Storage – You should store all GMP audit documentation in one secure location. You must easily retrieve documents for analysis.
  2. Analysis – Never have your auditors perform a GMP audit without the intention of actionable correcting inadequacies. A thorough analysis of every internal GMP audit is necessary to ensure that all measures required meet appropriate response and action.
  3. Follow Up-Action – As mentioned, with the intent to resolve issues, a GMP audit needs to follow up with the appropriate actions. Even when an audit produces verifiably good results, it’s always best practice to follow up with those involved to ensure compliance maintains. Furthermore, any resultant required action must have a simple and expedient follow-up strategy.

Best Practice Tip 2

I recommend using a separate follow-up action report to track any repairs, modifications, or other actions recommended by the GMP audit report. However, linking the two reports might be challenging if you still use a paper-and-pen methodology. That leads me conveniently to our third and probably most valuable tip for managing GMP audits and inspections.

Best Practice Tip 3

Use a digital reporting platform to make auditing processes more straightforward and efficient. Simultaneously, a robust reporting platform like 1st Reporting allows you to achieve much easier report management. The convenient manager’s report dashboard and report GPS map view make managing audits a breeze.

The mobile features let you manage your reports from anywhere, even reports your team completes in the field. The app simultaneously allows your team to conduct audits and reports from anywhere, even when they don’t have an internet connection.

Take a look at a few of these features and think about how they are going to help you manage your auditing and inspection teams:

  • Customized Notifications – When one of your team members completes an audit or report, you can have the app automatically notify the suitable supervisor immediately as soon as your team member submits their report document.
  • Dynamic Forms and Fields – Create customized forms and fields that relate directly to other reports. Remember how I mentioned tracking follow-up actions on a separate report? By dynamically linking the reports, you can easily keep all documents linked to the audit together and easily retrievable.
  • Customizable Forms With Form Builder – Design forms and checklists to meet your organization’s needs and particular purposes.
  • Robust Template Library – Save time by starting with one of our many templates built-in to the app. We’ve got all kinds of templates ready and at your disposal.

Not sure where to start integration? Book a free demo with one of our professionals today, and let’s work together to get your organization the best solutions!