Last Updated on October 24, 2025 by Hafsa J.

Why You Need to Prepare Your Procedures Now

If your cosmetic GMP procedures haven’t been updated in years, you’re not alone. Many manufacturers wrote their SOPs back when ISO 22716 was first introduced — and haven’t touched them since.

But here’s the issue: the industry has changed dramatically. Digital batch records, cloud-based documentation, and risk-based approaches are now standard expectations. Even before an official revision is released, auditors and regulators are already looking for modernization.

In my experience, the companies that start adapting before the new standard is published always handle transitions smoothly. Those who wait often rush under pressure — and pay for it later through non-conformities or costly rework.

This guide walks you through how to refresh your ISO 22716 procedures now, so you’re ready for the next evolution of cosmetic GMP.

Understanding the Trigger – What’s Driving ISO 22716 Updates

ISO 22716:2007 is nearly two decades old. It’s still solid, but the cosmetic world it was written for no longer exists.

Several global developments are pushing for updates:

• Regulatory shifts: The U.S. MoCRA (Modernization of Cosmetics Regulation Act) now emphasizes GMP compliance.
• Digital transformation: Manufacturers are moving toward electronic logs, real-time traceability, and automated systems.
• Sustainability trends: Ethical sourcing and environmental monitoring are becoming mainstream requirements.

These forces are already shaping audit expectations. Even if ISO’s next version isn’t published yet, it’s clear what direction it’s heading — toward digital, traceable, and risk-driven GMP systems.

Pro Tip: Don’t wait for the formal publication. Use this window to make incremental updates. You’ll avoid the typical “scramble period” after a revision.

Identifying Impacted Procedures – Where to Start Your Review

Not every SOP needs rewriting, but some will definitely need attention. Focus first on areas that auditors already probe more deeply.

ISO 22716 Section	Procedure Likely to Need Update	Why It’s Impacted
4 – Documentation	Document control, record retention	Rising expectations for digital records & traceability
5 – Personnel	Training, competence matrix	Inclusion of digital literacy & sustainability awareness
6 – Premises	Cleaning, hygiene, environment control	Shift toward risk-based validation and monitoring
8 – Production	Batch traceability, automation SOPs	Integration of electronic data and system validation
11 – Internal Audits	Audit procedure	Adaptation for remote and hybrid audit models

Pro Tip: Start with procedures that generate the most records — production, cleaning, and documentation control. They’re the heart of every audit.

How to Update Procedures Systematically

Step 1: Conduct a Pre-Revision Gap Analysis

Review each procedure against current industry practices and anticipated ISO 22716 updates.
Tag each SOP as compliant, minor update, or rewrite required.

Step 2: Create a Central Change Log

Set up a “Procedure Revision Register.” Log every change, version, date, and reason for revision. It helps you demonstrate controlled document evolution during audits.

Step 3: Integrate Digital and Risk-Based Thinking

Start adding clauses like:

• “Data entry validated by authorized user.”
• “Risk assessment conducted prior to procedural change.”
  It shows your system anticipates digital control and proactive risk management.

Step 4: Train Teams Before Rollout

Brief your staff on what changed and why. When people understand why the update exists, compliance becomes natural.
Pro Tip: Use short internal workshops — 30 minutes per topic works better than long seminars.

Step 5: Validate and Approve

Route every updated SOP through your document control process. Sign-off by QA or management ensures traceability and accountability.

Writing Style and Structure for the New ISO 22716 Era

Your SOPs shouldn’t read like legal documents. They should describe what people actually do — clearly and practically.

Here’s a simple structure that works every time:

1. Purpose – Why this procedure exists.
2. Scope – What it applies to.
3. Responsibilities – Who does what.
4. Procedure Steps – Short, action-based sentences.
5. Records & References – Where evidence is stored.

Keep formatting consistent. Avoid jargon unless it’s essential. And make sure risk-based steps are visible — for example:

“Before starting production, assess contamination risk and verify line clearance record.”

Pro Tip: During audits, inspectors often ask operators to describe their process. If what they say doesn’t match the SOP, it’s a red flag. Keep documents aligned with reality.

Verification – Making Sure Updates Actually Work

Once your new procedures are approved, test them. Don’t assume they’re effective just because they look good on paper.

Here’s a quick checklist:

• Conduct an internal audit using the updated SOP.
• Ask operators if any steps are unclear.
• Track deviations or near-misses for 30 days.
• Adjust instructions or training where needed.

Real Example:
A cosmetic plant in Thailand updated its cleaning validation SOP to include electronic log verification. Within a month, manual errors dropped by 30%. The update didn’t just meet future standards — it improved efficiency immediately.

Common Pitfalls When Updating ISO 22716 Procedures

From what I’ve seen in dozens of GMP refresh projects, these are the usual traps:

• Updating procedures one at a time without checking how they connect.
• Forgetting to revise linked forms or templates.
• Launching new SOPs without retraining staff.
• Leaving suppliers and contractors out of the update cycle.

Pro Tip: Always update supporting documents — forms, logs, and templates — at the same time. Mismatched versions are one of the most common audit findings.

FAQs – Clarifying Practical Concerns

Q1: Do I need to rewrite every procedure?
No. Focus on documentation, training, production, and digital traceability. These are the areas most likely to change.

Q2: Should I wait for the official revision before acting?
Not recommended. If you start aligning now, you’ll be ready when it arrives — instead of rushing later.

Q3: How much transition time will ISO allow?
Usually 1–2 years. But auditors will expect to see early action within months of release.

Turning Procedure Updates Into an Advantage

Updating your ISO 22716 procedures isn’t just about staying compliant — it’s about staying relevant. The next version of the standard will reward companies that embrace digitalization, risk-based control, and smarter documentation.

I’ve seen firsthand that those who treat procedure updates as a strategic project — not a paperwork chore — gain real benefits: fewer deviations, faster audits, and stronger team ownership.

Next Step:
Download QSE Academy’s ISO 22716 Procedure Update Checklist, or book a short consultation to review your current GMP documentation and prepare for the coming changes.