GMP ISO 22716 Certification

A product recall, a failed regulatory inspection, or a rejected export shipment can devastate a manufacturing business overnight. In most cases, the root cause traces back to one thing — the absence of a certified, independently verified Good Manufacturing Practice system.

NORMEIRA is an accredited certification body that operates in accordance with internationally recognized accreditation frameworks and follows ISO/IEC 17021 auditing principles. We audit manufacturing facilities against recognized GMP requirements and issue certificates to organizations that genuinely meet the standard. We do not consult. We certify. Every certificate we issue is the result of an independent, impartial audit carried out by qualified GMP auditors.

What Is GMP Certification?

GGood Manufacturing Practice is a globally recognized quality assurance system ensuring products are consistently produced, controlled, and verified to standards appropriate for their intended use. It applies across pharmaceuticals, cosmetics, food and beverages, dietary supplements, nutraceuticals, and medical devices.

GMP certification is independent, third-party proof that your facility, processes, people, premises, and documentation meet established GMP requirements. Regulatory bodies, including the U.S. FDA, EU EMA, Saudi SFDA, UAE MOH, and Pakistan's DRAP, either mandate or strongly expect GMP compliance from manufacturers in regulated sectors.

The 5 Pillars of GMP Every Auditor Evaluates

Every GMP certification audit is structured around five core elements known as the 5Ps:

People- Training records, hygiene practices, and defined responsibilities for every person involved in manufacturing must be documented and verifiable.

Premises- Facility design, environmental controls, cleaning validation, and maintenance programs must meet GMP layout and contamination prevention requirements.

Processes- Every manufacturing step must be documented, validated, and consistently followed through written standard operating procedures.

Products- Raw material testing, in-process quality checks, finished product release, and batch traceability must all be formally documented and controlled.

Procedures including Paperwork- Batch records, deviation logs, change control records, and corrective action documentation are the auditable evidence that your GMP system functions in practice, not just on paper.

Who Needs GMP Certification?

GMP certification is relevant to any organization where product quality, safety, and consistency are subject to regulatory oversight or buyer requirements. This includes pharmaceutical manufacturers, cosmetics and personal care producers, food and beverage processors, dietary supplement and nutraceutical companies, medical device manufacturers, and contract manufacturers producing regulated products for third-party brands.

Certification is not only a regulatory requirement in many sectors. It is also a commercial necessity. Major retail chains, distributors, and international brands increasingly require GMP certification as a prerequisite before approving new manufacturing suppliers, regardless of geography.

Key Benefits of GMP Certification

• An independently issued GMP certificate removes doubt for buyers, regulators, and trading partners by confirming your manufacturing processes have been verified by a qualified third party.
• Certification reduces operational risk through documentation requirements, process validation protocols, and corrective action systems that catch errors early before products reach consumers.
• It directly lowers the likelihood of recalls, nonconformances, and regulatory penalties by building systematic controls into your manufacturing environment.
• Certified GMP systems open market access by meeting the baseline qualification requirements of major buyers and regulatory bodies across international markets.
• Organizations maintaining certified GMP systems consistently report stronger quality culture, better trained workforces, and lower long-term operating costs.

ISO 22716 Certification — GMP for the Cosmetics Industry

ISO 22716 is the international GMP standard written specifically for cosmetics and personal care manufacturers. Published by the International Organization for Standardization, it provides a dedicated framework covering the production, quality control, storage, and distribution of cosmetic products to ensure they are safe and fit for consumer use.

Where general GMP principles apply broadly across industries, ISO 22716 is tailored to the specific risks, processes, and regulatory expectations of cosmetics manufacturing. It addresses raw material sourcing and testing, production environment controls, filling and packaging operations, finished product quality control, labeling, and distribution procedures.

The EU Cosmetics Regulation (EC 1223/2009), along with Gulf and regional regulatory bodies, references ISO 22716 as the benchmark GMP standard for cosmetic manufacturers. For cosmetics businesses seeking to supply international brands, enter regulated export markets, or satisfy retail chain supplier qualification requirements, ISO 22716 certification from an accredited body is the most credible proof of manufacturing compliance available.

Our certified cosmetics manufacturers are ISO 22716 through the same structured, independent audit process applied to all GMP certifications.

GMP ISO 22716 Certification Process

Application and Document Review: Submit your quality manual, SOPs, batch records, cleaning programs, and training records. Our auditors assess documentation readiness before scheduling the on-site audit.

On-Site Certification Audit: Qualified auditors independently assess your entire manufacturing operation against GMP or ISO 22716 requirements. All findings are formally documented.

Corrective Action Review: Your facility addresses identified nonconformities and submits evidence. Our auditors verify that all findings are resolved before recommending certification.

Certification Decision: Our independent certification committee reviews audit findings and issues your official GMP or ISO 22716 certificate if requirements are met.

Surveillance and Recertification:Certificates are valid for one to three years with scheduled surveillance audits verifying continued compliance throughout the cycle.

Get GMP or ISO 22716 Certified

NORMEIRA is an accredited certification body specializing in GMP and ISO 22716 certification across the GCC and Pakistan. Our independent audit process gives your certificate the authority and credibility that regulators, buyers, and international partners trust.

Contact our team today to start your certification process.

Email: info@normeira.com

Get a Quote: : https://normeira.com/quotation

Phone: +971 800 888 2739

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