Call Now: +1 813 906 8113
Gmp Audited

CGA’s ISO 22716 Program offers third-party assessments and audits to help cosmetic manufacturers implement and maintain GMP-compliant systems.

What is ISO 22716?

ISO 22716 is the international standard for Good Manufacturing Practices (GMP) in the cosmetics industry. It provides a structured framework for controlling production, quality, hygiene, and documentation. The standard ensures products are consistently manufactured and meet safety and regulatory expectations, being widely used to support compliance with global regulations, including those in the EU and other key markets.

ISO 22716 GMP Certification Requirements

Below are the general ISO 22716 GMP certification requirements and serves as a practical checklist to understand what the standard requires: 


Section

What Is Required

Assessment Requirements

1. Organization & Personnel

Defined roles for GMP oversight and quality responsibilities

Org chart, job descriptions, GMP accountability
Documented GMP training program for all staffTraining records, onboarding + periodic refreshers
Personal hygiene procedures and controlsPPE use, hand hygiene, behavior on floor
2. Facility RequirementsLogical flow to prevent contaminationZoning (raw vs finished), process flow
Cleaning schedules and facility upkeepCleaning logs, maintenance records
Controlled water, air, and waste systemsWater testing, HVAC controls
3. EquipmentEquipment suitable for intended useEquipment list, qualification records
Cleaning procedures and preventive maintenanceCleaning logs, calibration records
Measurement equipment accuracyCalibration certificates and schedules
4. Raw Materials & PackagingApproved supplier systemSupplier qualification records
Verification of raw materialsCOAs, inspection records
Controlled storage conditionsLabeling, segregation, FIFO/FEFO
5. ProductionDefined manufacturing instructionsBatch records, consistency checks
Measures to prevent contaminationLine clearance, cleaning validation
Monitoring during productionQC checkpoints, test records
6. Finished ProductsFormal release by authorized personnelQA approval records
Defined product standardsProduct specs, testing results
7. Quality Control LaboratoryRaw material and finished product testingLab results, test methods
Shelf-life validationStability studies, reports
8. Documentation & RecordsWritten procedures for all critical operationsSOP library, version control
Complete and traceable recordsBatch records, logs
Accuracy and reliability of recordsControlled edits, audit trails
9. Storage & DistributionControlled storage environmentTemperature logs, segregation
Product traceability post-productionShipment records, tracking
10. Complaints & RecallsSystem to capture and investigate complaintsComplaint logs, CAPA actions
Ability to recall products effectivelyMock recall tests, procedures
11. SubcontractingOversight of outsourced processesAgreements, audits of contractors
12. Deviations & CAPAIdentification and documentation of issues alongside the presence of root cause analysis and corrective actions within SOPs
Deviation reports, CAPA records
13. Internal AuditsAn SOP present for regular GMP internal auditsAudit reports, follow-ups
14. Change ControlControlled process for changesChange logs, approvals
15. Risk ManagementIdentification of GMP risksRisk assessments, mitigation plans

CGA Assessment Process

Below is the simple 3-step CGA ISO 22716 GMP Assessment process: 

Step 1: GMP Gap Assessment

The CGA technical experts begin with a structured evaluation of your current operation against ISO 22716 requirements.

What is evaluated:

  • Review your facility layout, material flow, and hygiene zoning
  • Assess existing SOPs, batch records, and documentation structure
  • Evaluate supplier approval processes and raw material controls
  • Identify cross-contamination risks, especially on shared equipment or lines
  • Review storage, labeling, and traceability practices
  • Review storage, labeling, and traceability practices

Once the evaluation is completed, CGA’s technical team submits a complete package that includes: 

  • A clear gap assessment report focused on what actually matters for certification
  • A prioritized action plan based on audit risk, not theory
  • Early identification of critical issues that could delay certification

Step 2: ISO 22716 System Development & Implementation

This is the most critical step towards building an ISO 22716 GMP system. Based on the previous assessment, the CGA team assists facilities in building a comprehensive GMP structure:
The program development involves:

  • Develop and refine SOPs aligned with ISO 22716 requirements
  • Establish batch documentation, traceability flow, and record-keeping systems
  • Define cleaning procedures, line clearance, and contamination control measures
  • Set up supplier approval, material verification, and incoming inspection controls
  • Align roles, responsibilities, and training expectations across teams

Step 3: Pre-Audit Readiness Review

Once the GMP program is established, the CGA team supports the facility in preparing for the official audit. Prior to the certification audit, our technical team assesses your system under real audit conditions.

What CGA performs:

  • Conduct a mock audit based on ISO 22716 requirements
  • Review documentation, records, and traceability from raw material to finished product
  • Walk through production areas to identify gaps in practice vs procedure
  • Highlight areas that are likely to be flagged by auditors
  • Verify that corrective actions have been properly implemented

Speak to an Expert

ISO 22716 is straightforward when it’s structured properly. If you’re considering GMP certification, the fastest way forward is a focused discussion on your current setup, products, and target markets.

The CGA technical team will walk you through:

  • Where you stand against ISO 22716
  • What gaps actually matter for certification
  • Expected timelines and scope
  • How to structure your GMP system efficiently

Reach out to an expert by calling +1 (813) 906 8113 or by completing our form.

Frequently Asked Questions (FAQs)

ISO 22716 itself is not always legally mandatory, but it is widely expected by regulators, retailers, and distributors. In markets like the EU and GCC, GMP compliance aligned with ISO 22716 is often treated as a baseline requirement for market access.

Timelines depend on your current level of readiness. Most facilities complete the assessment process within 2 to 8 weeks, while more complex operations may take longer. The biggest factor is how quickly gaps are addressed and systems are implemented.

No. Most companies begin with partial systems or gaps. CGA starts with a structured assessment and builds the GMP framework alongside your team, ensuring it aligns with your actual operations.

  • The most common issues include:Weak or incomplete documentation
    Poor traceability and batch records
    Lack of control over raw materials and suppliers
    Inconsistent implementation of SOPs on the production floor

These are areas CGA focuses on early to reduce audit risk.

ISO 22716 is a cosmetics-specific GMP standard, focused on production, hygiene, and product safety. ISO 9001 is a broader quality management system applicable across industries. Many manufacturers use both, but ISO 22716 is more directly relevant for cosmetic production.

You will need structured documentation including:

  • Standard Operating Procedures (SOPs)
    Batch manufacturing records
    Cleaning and maintenance logs
    Supplier approval and raw material verification records
    Training records

All documentation must be controlled, traceable, and consistently followed in practice.

Can’t find what you’re looking for?

Gmp Audited

CGA Technical Services provides expert GMP Consulting Services to help manufacturers across food, supplements, cosmetics, and other key industries.

General GMP Requirements 

Here are the general GMP requirements in accordance with the CGA GMP Standards we help facilities get under compliance with: 


GMP System Area

What CGA Auditors Verify

What Must Exist in Your Facility

1.Facility & Infrastructure

Building design, hygienic zoning, airflow, drainage, pest-proofing, contamination risk

Hygienic layout, physical segregation of raw & finished goods, controlled access, validated sanitation zones
2. Utilities & EnvironmentWater quality, compressed air, HVAC, lighting, waste controlPotable water testing, filtered air systems, waste management SOPs, environmental monitoring
3. Equipment & UtensilsCleanability, material suitability, maintenance, calibrationStainless steel or food-grade materials, maintenance logs, calibration records
4. Cleaning & SanitationCleaning methods, chemical control, validationWritten cleaning SOPs, approved detergents, sanitation schedules, verification records
5. Pest ControlRisk control without contaminating productsContracted pest control, trap maps, inspection logs
6. Raw Material ControlSupplier approval, COAs, risk classificationApproved supplier list, COAs, ingredient traceability, quarantine area
7. Receiving & StorageSegregation, FIFO, temperature, labelingClearly labeled materials, controlled storage, expiry management
8. Production ControlProcess consistency, error preventionMaster manufacturing records, batch production records, deviation handling
9. Cross-Contamination ControlAllergen, chemical, microbial riskPhysical segregation, cleaning validation, dedicated tools or validated changeover
10. Packaging & LabelingCorrectness, traceability, regulatory complianceLabel approval system, packaging logs, reconciliation process
11. Traceability & RecallAbility to trace forward & backwardLot coding, mock recall tests, distribution records
12. Quality Management System (QMS)Control of documents, changes, errorsSOPs, document control, CAPA system, internal audits
13. Nonconformance & CAPAHow failures are detected & correctedRoot cause analysis, corrective actions, effectiveness checks
14. Complaints & Adverse EventsHow product issues are handledComplaint logs, investigation reports, regulatory escalation
15. Personnel & TrainingGMP knowledge and hygiene disciplineTraining records, hygiene SOPs, job qualification
16. Warehousing & DistributionProduct protection after manufacturingTemperature control, loading hygiene, shipping logs (where applicable)
17. Regulatory ComplianceFDA, ISO, international GMP alignmentCFR-aligned SOPs, inspection readiness, audit history
18. Product Safety & RiskHACCP, contamination controlHazard analysis, CCPs, preventive controls

GMP Consultancy Roadmap

Our GMP consulting roadmap ensures every critical aspect of your manufacturing operation is reviewed, documented, and aligned with internationally recognized quality standards.

Step 1: Initial Consultation & Facility Understanding

The process begins with a technical consultation to understand your facility, production processes, and regulatory objectives.
During this stage we review:

  • Product categories and manufacturing scope
  • Current quality management systems
  • Target certifications or regulatory requirements
  • Existing SOPs and documentation
  • Export markets and compliance expectations

Step 2: GMP Gap Assessment

CGA consultants conduct a comprehensive GMP gap analysis to evaluate how your current operations compare with recognized GMP standards.
This assessment typically includes:

  • Facility layout and hygiene controls
  • Raw material management and supplier qualification
  • Production process controls
  • Equipment cleaning and maintenance procedures
  • Personnel hygiene and training programs
  • Documentation and recordkeeping practices
  • Traceability and recall procedures

A structured Gap Assessment Report is provided outlining compliance gaps and recommended corrective actions.

Step 3: Quality System Development

Once gaps are identified, our consultants work with your internal team to design and implement the documentation and procedures required for GMP compliance.
This phase may include development of:

  • Quality manuals and policies
  • Standard Operating Procedures (SOPs)
  • Batch production records
  • Cleaning and sanitation procedures
  • Supplier approval programs
  • Deviation and corrective action systems
  • Document control and record management systems

Step 4: Facility Controls & Operational Implementation

GMP requirements must be fully integrated into production activities. CGA assists facilities with implementing operational controls such as:

  • Production line segregation where required
  • Hygienic zoning and contamination prevention
  • Environmental monitoring procedures
  • Equipment validation and maintenance schedules
  • Storage and inventory control systems

Step 5: Employee Training & GMP Awareness

Employee training is essential for maintaining GMP compliance.
CGA provides structured training sessions covering:

  • GMP fundamentals for production teams
  • Hygiene and contamination prevention
  • Documentation and recordkeeping procedures
  • Responsibilities of supervisors and quality managers
  • Internal audit preparation

Step 6: Internal Audit & Mock Inspection

Before a formal certification or regulatory audit, CGA conducts a mock inspection to evaluate readiness. This includes:

  • Review of GMP documentation
  • Facility walkthrough inspection
  • Verification of records and logs
  • Evaluation of employee understanding
  • Identification of remaining non-conformities

Corrective actions are then implemented to ensure full audit readiness.

Step 7: Certification or Regulatory Audit Preparation

Once the facility demonstrates GMP compliance, CGA assists with final preparation for third-party audits or inspections.
This may include:

  • Certification body audit preparation
  • Regulatory inspection readiness
  • Documentation review and final corrections
  • Support during audit coordination

Facilities completing the roadmap are typically well positioned for successful certification outcomes.

Why Work with CGA Technical Services?

Carat Global Assurance combines technical consulting expertise with certification experience, allowing our team to understand both operational challenges and audit expectations.
Companies choose CGA because we provide:

  • Practical GMP implementation guidance
  • Industry-experienced consultants
  • Global compliance expertise
  • Support across multiple regulatory frameworks

Speak to a GMP Audit Expert

Get in touch with our GMP audit specialists by calling in at +1 813 906 8113 or simply completing the form here.

Start Your GMP Compliance Program

If your facility is preparing for GMP certification, regulatory inspections, or quality system improvements, CGA Technical Services can help.

Our consultants will evaluate your current systems and develop a structured plan to achieve GMP compliance efficiently.

Get in touch with our GMP consultants at +1 813 906 8113 or simply complete the form below. 

Frequently Asked Questions (FAQs)

GMP consulting helps manufacturers design and implement quality systems that ensure products are consistently produced according to regulatory standards.

Implementation timelines vary depending on the facility size and existing quality systems, but many facilities can achieve audit readiness within several months.

Yes. the CGA GMP systems often form the foundation for additional certifications such as HACCP, gluten-free, non-gmo, halal certification, and other compliance programs.

Can’t find what you’re looking for?

Halal Certification

This expert-led halal training program is designed for manufacturers, brands, and teams involved in manufacturing, logistics, and hospitality. The training will help equip your staff with the tools needed to develop a halal suitable programme. 

Our Halal Training Solutions

Halal Certification Technical Support

  • Halal Critical Control Points (HCCP) & SOP Development
  • Ingredient Verification & Risk Declarations
  • Halal Assurance System (HAS) Setup & Documentation
  • Halal Packaging, Logistics & Supply Chain Compliance
  • Cross-Contamination Prevention Systems
  • SOP Development

Halal Certification Technical Support

  • Staff roles and responsibilities in a halal-certified facility
  • GMP + Halal hygiene protocols
  • Real case scenarios, mock audits, and Q&A
  • Available for production, QA/QC, procurement, and logistics teams

Private Group Training

Tailored to your sector and facility. Conducted live onsite or via a virtual session to align with your team’s specific needs.

Upcoming Training Calendar

DateTrainingFormatEnroll

August  2025
Halal TrainingOnline
Register

September 2025
Halal Staff Training for Packaging Plants
Onsite (Chicago)

Register
Group 322

Why CGA Halal Training?

At Carat Global Assurance technical services, we bring technical precision, regulatory insight, and practical halal compliance strategies to your team. Here’s what sets this training apart:

  • Halal Standards in Accordance With International Halal Regulators
  • Led by Islamic Affairs Advisors & Food Safety Experts
  •  Integrated with Existing FSQA Systems (FSSC 22000, etc.)
  •  Customized for Your Facility, Product Type & Market Goals

Who It’s For

01

Food & Beverage Manufacturers

02

Cosmetics & Personal Care Brands

03

Nutraceutical & Supplement Facilities

04

Packaging & Logistics Operators

05

Hospitality Sector

06

Co-Manufacturing Facilties

Pgoto Fir

Global Reach

CGA operates on a global scale, providing services to clients in various industries across multiple continents. Our extensive network of offices and partners ensures that we can offer localized expertise with global standards.

Frequently Asked Questions (FAQs)

We provide private group training tailored to your operations. Whether in-person or via live webinar, it’s ideal for teams preparing for audits or launching new compliance programs.

Self-paced courses can be completed at your convenience within one year. Live trainings typically range from half-day sessions to 2-day workshops, depending on the topic and depth.

Yes. Our trainers are credentialed experts with real-world experience in halal audits, systems, and global food safety frameworks.

We offer free consultations to help you choose the best path. Whether you need a gap audit, SOP development, or certification prep, our team will recommend the right mix of services.

Yes. Many of our self-paced modules are available in English and Spanish. Live training can also be arranged in other languages depending on trainer availability.

Can’t find what you’re looking for?


Halal Certification

CGA technical services provides exceptional halal consultation services to help manufacturers meet the latest halal certification standards..

What We Help With

We tailor every consultation to your operation, so you get exactly what you need—no filler, no fluff.

  • Halal Gap Assessments: We review your current processes and documentation against global halal standards—BPJPH, GSO, UAE.S, JAKIM, MUIS, and more. You’ll get a straightforward report showing what’s missing and what to fix.
  • Ingredient & Supplier Review: Our team helps you sort through your raw materials, flavorings, additives, and supply chain paperwork to flag any non-compliant items and recommend halal-friendly alternatives.
  • Process Flow & Contamination Control: We look at your production layout, equipment, cleaning SOPs, and handling procedures to spot cross-contamination risks—especially with najis materials—and show you how to avoid them.
  • Halal Assurance System (HAS) Documentation: We’ll help you develop it from the ground up or upgrade what you’ve got—aligned to BPJPH, GSO, and other certifying body expectations.
  • Team Training & Audit Prep: From your QA staff to your floor teams, we’ll train your people on what halal compliance looks like day-to-day—and how to handle the audit when the time comes.

Who This Is For

01

Companies preparing for their first halal audit

02

Manufacturers switching certifiers or expanding product lines

03

Exporters looking to access high-demand halal markets (Indonesia, GCC, Malaysia, etc.)

04

Private label or contract manufacturers working with halal brands

Pgoto Fir
Group 322

Why Work With CGA?

CGA technical services works with leading halal certification experts across several industries to help you integrate the halal program into your existing quality system.  

You’ll get:

  • Real-world halal expertise across several industries
  • Support that fits into your existing GMP, or ISO systems
  • Access to globally recognized halal certification pathways

Ready to Start?

If you’re interested in learning more about CGATS’ halal consultation services, schedule a call with our representative at +1 813 906 8113 or simply complete the form below. 

Frequently Asked Questions (FAQs)

Halal consultation helps you get ready for certification. We review your processes, ingredients, and documents to make sure everything aligns with halal standards before an audit. Certification is the official approval—consultation is the prep work.

If you’re adding new products, switching certifiers, or entering a new market like Indonesia or the GCC, consultation helps you avoid delays or non-conformities. Even certified companies benefit from a fresh set of eyes.

Yes. We’ll guide you through every section—from sourcing policies to training protocols—so your HAS meets the expectations of BPJPH, GSO, or any other authority you’re working with.

It depends on your scope. For a single-site food or cosmetics operation, it usually takes 2–4 weeks from discovery to delivery of your gap report and recommendations.

We support manufacturers, exporters, contract manufacturers, and brand owners across food, supplements, cosmetics, pharma, packaging and specialty chemicals.

Can’t find what you’re looking for?