GMP Checklist for Cosmetic Manufacturers: A Practical Compliance Guide

Manufacturing cosmetic products safely, consistently and to the required quality standards depends on more than having the right formulation. Effective quality controls must be applied throughout the entire manufacturing process.

Good Manufacturing Practices (GMP) provide a structured framework for managing critical manufacturing activities, from personnel and equipment to raw materials, documentation, storage and quality control.

In the European Union, cosmetic products must be manufactured in accordance with GMP principles under Regulation (EC) No 1223/2009 on cosmetic products. Article 8 of the Regulation requires compliance with GMP and states that conformity with the relevant harmonised standards provides a presumption of compliance with these requirements.

One of the key references for the cosmetics industry is ISO 22716:2007 Cosmetics – Good Manufacturing Practices (GMP).

The following GMP checklist for cosmetic manufacturers outlines the main areas companies should review when assessing their manufacturing processes, identifying compliance gaps and preparing for GMP inspections.

What Is GMP?

Good Manufacturing Practices (GMP) are a set of principles designed to ensure that products are manufactured consistently and under controlled conditions in accordance with defined quality standards.

In the cosmetics industry, GMP is particularly important for:

• Preventing product contamination
• Reducing manufacturing errors
• Ensuring traceability of products and raw materials
• Maintaining hygiene standards
• Standardising manufacturing processes
• Managing quality control activities
• Identifying and managing non-conformities

GMP does not apply only to activities on the production line. Personnel training, facility design, equipment management, documentation, storage, quality control, complaint handling and product recall procedures are also integral parts of an effective GMP system.

GMP Checklist for Cosmetic Manufacturers

1. Personnel and Training 

The competence of personnel involved in manufacturing and quality activities can have a direct impact on product quality.

Manufacturers should review the following:

• Are personnel roles and responsibilities clearly defined?
• Have employees completed training appropriate to their responsibilities?
• Is GMP training refreshed regularly?
• Are training records documented and maintained?
• Is appropriate protective clothing used in manufacturing areas?
• Are hand hygiene and personal hygiene procedures implemented?
• Are food, beverages and other potential contamination sources controlled within manufacturing areas?
• Is access to production areas appropriately managed for personnel who may present an illness or infection risk?

Training should not be limited to employee onboarding. Personnel should also receive appropriate training whenever responsibilities, processes or procedures change.

2. Premises and Manufacturing Areas 

Manufacturing premises should be designed and maintained in a way that reduces the risk of product contamination.

Key questions include:

• Are manufacturing areas appropriately sized for the activities performed?
• Are raw material, manufacturing, filling and packaging areas separated where necessary?
• Are floors, walls and other surfaces made from materials that can be effectively cleaned?
• Is adequate ventilation and lighting available?
• Are environmental conditions such as temperature and humidity monitored where required?
• Are cleaning and sanitation programmes established?
• Is an appropriate pest control system in place?
• Are waste materials removed from manufacturing areas in a controlled manner?
• Are measures implemented to prevent cross-contamination?

The US Food and Drug Administration’s (FDA) cosmetic GMP inspection approach also identifies appropriate facility design, cleanable surfaces, adequate ventilation, water supply and sanitation infrastructure as important control areas.

3. Equipment Management

The design, condition and maintenance of manufacturing equipment can directly affect product quality.

Manufacturers should assess whether:

• Manufacturing equipment is suitable for its intended use.
• Product-contact surfaces are made from materials that do not introduce contamination risks.
• Written procedures are available for equipment cleaning.
• Cleaning activities are documented.
• Preventive maintenance is performed at appropriate intervals.
• Measuring instruments are calibrated where required.
• Calibration and maintenance records are retained.
• The cleanliness and operational status of equipment are checked before use.

Where different products are manufactured using the same equipment, manufacturers should also assess and control potential cross-contamination risks.

4. Raw Material Controls

The quality of a cosmetic product begins with effective control of its raw materials.

Manufacturers should check whether:

• All raw materials are clearly identified and labelled.
• Raw material lot or batch numbers are recorded.
• Materials are sourced from approved suppliers.
• Incoming materials are assessed against established acceptance criteria.
• Certificates of Analysis or conformity documentation are verified where applicable.
• Accepted and rejected materials are physically or electronically segregated.
• Materials are stored under appropriate temperature, humidity and light conditions.
• Expiry dates or retest dates are monitored.
• Appropriate inventory management principles such as FIFO or FEFO are applied.

FDA cosmetic GMP guidance also recommends identifying raw materials by identity, lot number and control status, and managing non-conforming materials in a way that prevents their unintended use.

5. Manufacturing Process Controls

The manufacturing process for each cosmetic product should be reproducible, controlled and adequately documented.

Manufacturers should verify that:

• An approved manufacturing formula is available.
• Written manufacturing procedures exist for each product.
• Raw material weighing and measuring activities are controlled.
• Raw material lot numbers are recorded in batch documentation.
• Critical process parameters have been identified.
• Relevant parameters such as mixing time, temperature or pH are monitored.
• Required in-process controls are performed.
• Each manufacturing batch can be uniquely identified.
• Deviations and manufacturing errors are documented.
• Rework or reprocessing activities are managed under controlled procedures.

The objective is to ensure that different batches produced from the same formulation consistently meet the required quality characteristics.

6. Packaging and Labelling

Errors during packaging and labelling may result in a correctly manufactured product becoming non-compliant.

Manufacturers should assess whether:

• Packaging materials are inspected before use.
• Compatibility between the product and its packaging has been evaluated.
• The correct labels are verified for each product.
• Controls are in place to prevent incorrect label use.
• The batch or lot number is clearly displayed on the product.
• Product identity is verified after packaging.
• Unused, obsolete or incorrect labels are managed under controlled procedures.

Where several products are packaged on the same line, appropriate line clearance procedures should be implemented to prevent product and label mix-ups.

7. Quality Control

Quality control should cover different stages of the manufacturing process rather than focusing solely on the finished product.

Manufacturers should review whether:

• Raw material specifications have been established.
• Finished product specifications are documented.
• Required physical and chemical tests are performed.
• Appropriate microbiological controls are implemented.
• Test methods are documented.
• Laboratory equipment is calibrated at appropriate intervals.
• Test results are recorded.
• Procedures are available for managing out-of-specification results.
• Reference or retain samples are stored where appropriate.

Microbiological contamination is an important quality and safety risk for cosmetic products. Appropriate microbiological controls should therefore form part of the overall manufacturing and quality management system.

8. Water Quality

Where water is used in cosmetic manufacturing, its quality should be appropriately specified, controlled and monitored.

Manufacturers should verify that:

• Quality specifications have been established for water used in manufacturing.
• The water system is regularly monitored.
• Chemical and microbiological analyses are performed as required.
• Appropriate sampling points have been defined.
• Maintenance and sanitation procedures are available for the water system.
• Test results, maintenance activities and sanitation records are retained.

FDA’s cosmetic GMP approach also includes controls designed to ensure that water used in cosmetic manufacturing is regularly tested against established chemical and microbiological specifications.

9. Storage and Distribution

Product quality must continue to be protected after manufacturing has been completed.

Manufacturers should assess whether:

• Raw material and finished product storage areas are appropriately organised.
• Storage conditions meet product requirements.
• Temperature and humidity are monitored where necessary.
• Released, quarantined and rejected products are appropriately segregated.
• Inventory can be tracked by batch.
• Distribution records can identify which customers received specific products.
• Products can be traced quickly in the event of a recall.

An effective traceability system is particularly important when managing potential quality issues or product recalls.

10. Documentation and Record Management

One of the fundamental principles of GMP is that manufacturing and quality activities should be documented and verifiable.

Manufacturers should review whether:

• GMP procedures are documented.
• Standard Operating Procedures (SOPs) are current and approved.
• Document version control is implemented.
• Obsolete documents are prevented from unintended use.
• Batch manufacturing records are maintained.
• Quality control records are retained.
• Personnel training records are available.
• Cleaning, maintenance and calibration records are maintained.
• Document retention periods are defined.
• Access permissions are controlled within electronic record systems.

Under the EU Cosmetics Regulation, the Product Information File (PIF) must also include a description of the manufacturing method and a statement confirming compliance with GMP.

11. Deviation and Non-Conformity Management

Deviations from approved manufacturing processes should be systematically recorded, assessed and managed.

Manufacturers should verify whether:

• Deviations are documented.
• The potential impact on product quality is assessed.
• Root cause analysis is performed where appropriate.
• Corrective and Preventive Actions (CAPA) are established.
• The effectiveness of CAPA activities is monitored.
• Recurring non-conformities are reviewed through trend analysis.

This approach should not only address the immediate issue but also reduce the likelihood of the same problem recurring.

12. Complaint Management

Complaints relating to products already placed on the market can provide important information about the effectiveness of the GMP system.

Manufacturers should assess whether:

• Consumer and customer complaints are recorded.
• Complaints are evaluated according to their potential quality or safety significance.
• The relevant batch number can be identified.
• Retain samples are investigated where appropriate.
• Recurring complaints are analysed.
• Significant quality issues are escalated through the quality management system.
• Appropriate corrective actions are initiated.

FDA’s cosmetic GMP inspection approach also identifies the recording of consumer complaints and information relating to possible product-associated injuries or reactions as important control areas.

13. Product Recall System

When a quality or safety issue is identified, manufacturers should be able to trace and retrieve affected products from the market efficiently.

Manufacturers should check whether:

• A written product recall procedure is available.
• Personnel responsible for managing recalls have been identified.
• Distribution records are complete and up to date.
• Batch-level traceability can be demonstrated.
• Recalled products are segregated from other stock.
• Recall effectiveness is assessed.
• Mock recall exercises are conducted where appropriate.

14. Internal Audits

Regular internal audits can help ensure that the GMP system remains effective over time and should not be conducted only before external inspections.

Manufacturers should assess whether:

• An internal audit programme has been established.
• Audit scope and frequency are determined using a risk-based approach.
• Audits are performed by competent personnel.
• Audit findings are documented.
• CAPA activities are established for identified non-conformities.
• Actions from previous audits are followed through to completion.

Internal audits can help identify potential GMP deficiencies before they result in product quality issues or are identified during an official inspection.

ISO 22716 and Cosmetic GMP Compliance

ISO 22716 is an international standard that provides GMP guidelines covering the production, control, storage and shipment of cosmetic products.

The European Commission has published EN ISO 22716:2007 as a relevant harmonised standard under Regulation (EC) No 1223/2009.

For companies placing cosmetic products on the European Union market, integrating ISO 22716 principles effectively into manufacturing operations can therefore play an important role in demonstrating GMP compliance.

However, GMP compliance should not be considered solely in terms of holding a certificate.

Manufacturers should ensure that GMP requirements are consistently implemented in day-to-day operations, that appropriate records are maintained and that the system remains effective over time.

Cosmetic GMP Requirements in the United States

The regulatory framework for cosmetic products in the United States has changed significantly following the Modernisation of Cosmetics Regulation Act of 2022 (MoCRA).

The FDA is working on the development of GMP regulations for cosmetic products.

Existing FDA cosmetic GMP resources provide manufacturers with guidance across areas including premises, equipment, personnel, raw materials, manufacturing operations, laboratory controls, records, labelling and complaint management.

The FDA has also indicated that its existing draft cosmetic GMP guidance will be reconsidered in light of the GMP rulemaking process required under MoCRA.

Companies placing cosmetic products on the US market should therefore monitor both current FDA requirements and further regulatory developments relating to cosmetic GMP.

How to Prepare for a GMP Inspection

Preparing for a GMP inspection requires more than reviewing the physical condition of the manufacturing facility.

Companies should consider the following steps:

1. Assess the current GMP system.
2. Conduct a gap analysis against applicable ISO 22716 requirements.
3. Identify critical non-conformities.
4. Review and update SOPs and records.
5. Complete required personnel training.
6. Conduct an internal audit.
7. Establish a CAPA plan for identified deficiencies.

The effectiveness of a GMP system depends not only on having written procedures but also on applying those procedures consistently throughout manufacturing operations.

How Can Obelis Group Support Your GMP Compliance?

Managing GMP requirements across different cosmetic regulatory frameworks can be complex, particularly for manufacturers operating in multiple international markets.

Obelis Group supports cosmetic companies throughout their regulatory compliance journey, helping them assess applicable GMP requirements and manage the regulatory processes required for their target markets.

Our regulatory experts can help companies identify potential compliance gaps, understand applicable cosmetic regulatory requirements and prepare for market access with a more structured compliance approach.

Professional regulatory support can also help identify potential non-conformities at an earlier stage and support the compliant placement of cosmetic products on their intended markets.

Discuss your GMP and cosmetic compliance requirements with our regulatory experts.