ISO 22716 works by applying a systematic, process-based approach to ensure consistent product quality, safety, and regulatory compliance for cosmetics. In the UK and globally, the process involves establishing controlled conditions for all operations—from raw material receipt to finished product dispatch—implementing documented procedures, monitoring critical parameters, and taking corrective actions. This system creates a controlled environment where processes are standardised, risks are managed, and product integrity is maintained throughout the supply chain.

The Core Process Cycle for Cosmetic GMP:

Establish Quality and Safety Requirements:

Define specifications for personnel, premises, materials, and finished products.

Implement GMP Process Controls:

Deploy validated procedures for manufacturing, packaging, labelling, testing, and storage.

Operate with Documented Procedures:

Execute all activities according to approved instructions, batch records, and hygiene protocols.

Monitor Critical Parameters:

Track key control points in production, laboratory results, storage conditions, and personnel hygiene.

Analyse Performance and Deviations:

Investigate out-of-specification results, batch deviations, and non-conformities.

Implement Corrective Actions:

Address root causes of deviations to prevent recurrence.

Take Preventive Measures:

Proactively identify and mitigate potential risks to product quality.

Review System Effectiveness:

Conduct regular GMP audits and management reviews.

Handle Non-Conforming Product:

Control and dispose of any material or product that does not meet specifications.

Drive Continual Process Improvement:

Refine procedures and controls to enhance safety, quality, and compliance.

Core Principles for Cosmetic GMP (ISO 22716):

Consumer Safety & Product Quality Focus
Leadership Accountability for GMP Compliance
Process Control & Contamination Prevention
Data-Driven Quality Decisions
Controlled Supply Chain & Approved Suppliers
Proactive Culture of Compliance & Improvement

The Main ISO 22716 Clauses - Complete Breakdown

GMP System Scope

The scope defines the boundaries of your cosmetic GMP system, specifying which products, processes, and sites are covered. It sets clear expectations for audits, regulatory inspections, and customers (e.g., brands or retailers).

A concise scope should include:

Organisation: The specific legal entity or manufacturing unit covered.
Locations: All relevant sites (e.g., production, filling, primary packaging, warehousing).
Activities: The core GMP processes under the system (e.g., manufacturing, packaging, labelling, testing, storage, dispatch).
Products: The specific types of cosmetic products (e.g., creams, lotions, makeup, aerosols, oral care).

Guidance: Be accurate and truthful. The scope must reflect actual activities. All requirements of the standard apply within this scope—exclusions are not permitted as ISO 22716 is a complete code of practice. Avoid vague language; clarity is critical for auditability and regulatory credibility.

Quality Management System (Clause 4)

This clause establishes the mandatory documented framework for your cosmetic GMP system.

4.1 General: Requires the establishment, documentation, implementation, maintenance, and continual improvement of a quality management system in accordance with the standard's requirements.
4.2 Documentation Requirements: Defines the mandatory quality documentation, including a Quality Manual, documented procedures (e.g., for handling non-conformities, internal audits), specifications, manufacturing formulae, processing and packaging instructions, and records (e.g., batch records, training records).

Personnel (Clause 5)

Ensures an adequate number of competent personnel to achieve product quality.

5.1 Personnel (General): Mandates an organisational chart with defined responsibilities and authorities. Requires all personnel to be qualified and trained for their duties.
5.2 Responsibilities: Key personnel, such as the head of production and the head of quality control, must have specified, independent authority and responsibility.
5.3 Training: Requires initial and continuing training programs relevant to GMP, with records maintained. Hygiene training is specifically emphasised.
5.4 Personnel Hygiene: Establishes strict rules for health status, illness, injuries, and personal hygiene (e.g., clothing, handwashing, behaviour) to prevent product contamination.

Premises & Equipment (Clause 6)

Covers the physical infrastructure necessary for controlled cosmetic production.

6.1 Premises (General): Premises must be located, designed, constructed, and maintained to facilitate good hygiene practices and prevent contamination or mix-ups.
6.2 Production Area: Specifies requirements for workflow, ventilation, cleaning, sanitation, and separation of operations to minimize risk.
6.3 Storage Areas: Requires segregated and controlled areas for raw materials, packaging, and finished products.
6.4 Quality Control Areas: Mandates separate, equipped areas for sampling and testing.
6.5 Equipment: Equipment must be fit for purpose, designed to facilitate cleaning, maintained, and calibrated. Specific rules for pipes, valves, and filters are included.

Production (Clause 7)

The core of operational control for manufacturing and packaging.

7.1 Manufacturing Operations: Requires all operations to follow written procedures (master manufacturing documents) to ensure consistency. Critical steps must be verified.
7.2 Packaging Operations: Similar controls for packaging, ensuring that correct materials are used and that labels are accurate.
7.3 Finished Products: Defines rules for the release, storage, and dispatch of finished goods.

Laboratory Control (Clause 8)

Ensures reliable testing to confirm quality.

8.1 Control of Starting Materials & Finished Products: Requires testing against specifications before release.
8.2 In-Process Control: Mandates checks during production to monitor and adjust the process.
8.3 Water & Air Quality: Specific controls for the quality of water and compressed air used in production.
8.4 Microbiological Control: Requires a microbiological monitoring program for products, materials, and the production environment.

Treatment of Non-Conforming Product (Clause 9)

Mandates a system to handle any material or product that fails to meet specifications.

9.1 General: Requires a procedure to identify, segregate, and evaluate non-conforming product.
9.2 Rework: Any rework of a non-conforming batch must be pre-authorised and follow a defined procedure.
9.3 Destruction: Requires secure destruction of rejected materials to prevent unauthorised use.

Waste Management (Clause 10,11)

Requires safe and sanitary collection, storage, and disposal of all waste (production, hazardous, general) to prevent contamination.

Subcontracting (Clause 11).

Controls the outsourcing of any manufacturing, testing, or storage activity.

11.1 General & Contract Giver: The subcontractor must be qualified and audited. A formal contract must clearly define responsibilities, including GMP compliance.
11.2 Contract Acceptor: The subcontractor must have adequate premises, equipment, and competence.

Deviations (Clause 12)

Requires the investigation of any deviation from procedures, specifications, or expected results. The root cause must be determined, and corrective actions must be implemented.

Complaints & Recalls (Clause 13)

Ensures a robust system for market surveillance and corrective action.

13.1 Complaints: All consumer or customer complaints must be recorded, investigated, and trended.
13.2 Recalls: Requires a documented, effective recall procedure that can be activated rapidly. Mock recalls must be conducted periodically to test the procedure.

Change Control (Clause 14)

Mandates that any planned change to materials, processes, equipment, or software is reviewed, authorised, and documented before implementation to evaluate its impact on product quality.

Internal Audit (Clause 15)

Requires planned, periodic internal audits of the GMP system to verify compliance with the standard and the organisation's own procedures. Findings require corrective action.

Management Review (Clause 16)

Top management must review the suitability and effectiveness of the GMP system at defined intervals. The review must use inputs (e.g., audit results, complaints, deviations) to make decisions about necessary changes and improvements.

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ISO 22716 Frequently Asked Questions

ISO 22716 certification cost in the UK 2025?

Small UK manufacturers (<50 employees):£4,000 - £10,000.
Medium manufacturers (50-250 employees):£8,000 - £20,000+.
Includes: Gap analysis, system development, audit fees,

and mandatory ongoing surveillance. Cost varies significantly with

product complexity (e.g., aerosols, sterile cosmetics).

ISO 22716 vs. EU GMP Cosmetics Regulation?

ISO 22716 is a voluntary international standard for cosmetic Good Manufacturing Practices (GMP).
EU Regulation (EC) No 1223/2009 is the mandatory law in the UK (retained post-Brexit) that requires GMP.
Key Point: Certification to ISO 22716 is the primary evidence used to demonstrate compliance with the UK's legal GMP requirements under the Cosmetics Regulation.

Is ISO 22716 mandatory for selling cosmetics in the UK?

Yes, but indirectly. The law (UK Cosmetics Regulation) mandates that all cosmetic products must be manufactured according to GMP.
Certification to ISO 22716 is not legally required, but it is the recognised and expected method to prove GMP compliance to the Office for Product Safety & Standards (OPSS), retailers, and distributors. Operating without it poses significant regulatory risk.

What are the top 5 failures in an ISO 22716 audit?

Clause 5.4 - Personnel Hygiene: Inadequate training records or enforcement of gowning/handwashing.
Clause 7 - Production Controls: Missing or incomplete batch manufacturing records(BMRs).
Clause 9 - Non-Conforming Product: Weak procedures for handling out-of-specification material.
Clause 13 - Complaints & Recalls: Ineffective complaint investigation or untested recall procedure.
Clause 6 - Premises: Poor facility design leading to cross-contamination risk or inadequate cleaning validation.

Do I need a Responsible Person (RP) for ISO 22716?

The roles are separate but linked.
The UK Responsible Person (RP)is a legal requirement under the Cosmetics Regulation for placing products on the market. They are responsible for product safety, notification, and labelling.
ISO 22716 certification applies to the manufacturer's quality system. The RP will require your ISO 22716 certificate as proof of GMP compliance.

How long does ISO 22716 certification take?

Typical timeline: 4-12 months.
Phases: Gap Analysis (1 month), System Development & Documentation (3-6 months), Implementation & Internal Audit (3-6 months), Certification Audit (Stage 1 & 2).
You will need to show that the system has been fully operational and producing compliant batches for a sufficient period before the audit.

Can a contract manufacturer (CMO) be ISO 22716 certified?

Yes, and it is a major commercial advantage. Brand owners (the "Contract Giver" per Clause 11) are legally responsible for ensuring their CMO complies with GMP. An ISO 22716 certificate from an accredited body is the standard proof they will require. The CMO must include subcontracting in their certified scope.

What is the difference between ISO 22716 and ISO 9001 for cosmetics?

ISO 9001is a generic quality management system focused on customer satisfaction.
ISO 22716 is a product-safety specific GMP code focused on preventing contamination, mix-ups, and errors. It has detailed, non-negotiable requirements for personnel hygiene, premises, equipment, and production controls (Clauses 5, 6, 7) that go far beyond ISO 9001.

What documentation is mandatory for ISO 22716?

Mandatory per Clause 4.2:Quality Manual, documented procedures (e.g., for hygiene, recalls, audits), Product Information Files (PIFs), Specifications for all materials/finished products, Manufacturing & Packaging Instructions, Batch Records, training records, and complaint/recall logs.

Does ISO 22716 cover microbiological testing?

Yes, per Clause 8.4. It requires a microbiological monitoring program for products, raw materials (where applicable), and the production environment (air and surface). You must define acceptance criteria, testing frequency, and action limits. This is critical for preservative efficacy and contamination control.