ISO 22716 GMP
Achieve ISO 22716 Certification for Cosmetics GMP
Expert, end-to-end consulting to help Sri Lankan cosmetics manufacturers navigate the new NMRA requirement and achieve international GMP standards.
New Standard for Cosmetics
A Major Shift: NMRA Adopts ISO 22716
In a significant move to align with global best practices, the National Medicines Regulatory Authority (NMRA) has announced a major change for all local cosmetics manufacturers. As of May 2024, the NMRA will no longer conduct its own GMP inspections for cosmetics
plants.
Instead, the NMRA will now rely on ISO 22716:2007 (Cosmetics GMP) certification issued by the Sri Lanka Standards Institution (SLSI) or another accredited body.
“This is to inform you that you are requested to obtain the ISO 22716 / 2007 certification for the cosmetics manufacturing plant… NMRA has decided, not to conduct a Good Manufacturing Practice (GMP) Inspections for cosmetics manufacturing plants further and NMRA will rely on the ISO 22716 GMP certification… ”
— CEO / NMRA (May 29, 2024)
This change means that achieving ISO 22716 certification is now mandatory for all local cosmetics manufacturers to maintain their license and market their products. RAQ provides the expert guidance you need to make this transition smoothly and efficiently.
Compliance Deadline
Understanding Your Transition Timeline
The NMRA has provided specific timelines based on your current status. It is crucial to understand which category your facility falls into.
Already Have NMRA GMP?
If your manufacturing site is already approved by the NMRA, you have been granted a two-year grace period to obtain ISO 22716 certification.
Deadline: May 31, 2026
Application Already Submitted?
If you have already applied for GMP inspection, the NMRA will conduct one final inspection. After that, you are required to obtain ISO 22716 certification within two years.
Deadline: May 1, 2026
Planning a New Facility?
For all new applications, you must first submit a site master file to the NMRA to receive an acknowledgement. You will then use this acknowledgement to apply for ISO 22716 certification with the SLSI.
Deadline: Effective Immediately
End-to-End ISO 22716
Your Strategic Partner for Certification
Achieving ISO 22716 certification is a detailed process that requires expertise in quality management systems. We provide a complete, end-to-end consulting service to guide you through every step.
Gap Analysis & Strategic Planning
We conduct a thorough assessment of your current operations against the ISO 22716 standard to identify all gaps and create a detailed action plan.
Quality Management System (QMS) Development
We help you develop and write all necessary documentation, including the Quality Manual, Standard Operating Procedures (SOPs), batch records, and other critical documents.
Implementation & Staff Training
We guide your team in implementing the new procedures across all departments—from raw material handling to production, quality control, storage, and shipment—and provide comprehensive staff training
Internal Audit & Management Review
Before the official audit, we conduct a rigorous internal audit to ensure your system is working effectively and help you prepare for the final management review.
SLSI Application & Audit Support
We assist with the formal application to the SLSI (or other accredited body) and provide on-site support during the official certification audit to ensure a smooth process.
RAQ Advantage
Why Choose RAQ for Your GMP Certification?
Deep Regulatory Insight
We don’t just know the ISO standard; we understand the NMRA’s expectations. Our dual expertise ensures your certification process is aligned with both local regulatory requirements and international standards.
A Practical, Hands-On Approach
We provide more than just advice. We work alongside your team to develop practical systems and documents that are tailored to your specific operations, ensuring the QMS is effective and sustainable.
Achieve More Than Compliance
ISO 22716 is not just a certificate; it’s a commitment to quality that can improve efficiency, reduce waste, and open doors to new export markets. We help you build a system that adds real value to your business.
Call to Action
Secure Your License to Operate and Elevate Your Quality Standards.
Don’t wait until the deadline. Contact us today to start your journey towards ISO 22716 certification.