GMP for cosmetic products

The Technical Regulation on Cosmetic Products requires that the manufacturing of cosmetic products must comply with Good Manufacturing Practice (GMP).

Compliance with GMP is a mandatory condition that must be met before cosmetic products, both domestic and foreign, are placed on the market.

The responsibility to ensure this compliance rests with the Responsible Person. Additionally, the Responsible Person must include a statement (declaration) of GMP compliance in the product information file.

   
What is GMP?
Cosmetic products must be manufactured in such a way that ensures they are suitable for their intended use and do not expose consumers to risks due to insufficient safety and quality.

Good Manufacturing Practice (GMP) – is a set of comprehensive guidelines that ensure the quality, reproducibility, and safety of a cosmetic product during its production. GMP is the part of quality management that guarantees products are manufactured and controlled according to quality standards appropriate for their intended use.

GMP helps minimize the risks of contamination, degradation, or misuse of the product, which could lead to adverse effects and other health consequences for consumers. GMP does not provide specific details on how products must be manufactured but outlines the expected outcomes of the processes. As a result, each manufacturer can have unique methods for achieving these results.

Compliance with GMP is assumed if the production is carried out according to the established national standard.

Good Manufacturing Practice can be demonstrated by adhering to the relevant national standard – DSTU EN ISO 22716:2015 “Cosmetics. Good Manufacturing Practice (GMP). Guidelines on Good Manufacturing Practice” (hereinafter referred to as the standard), which is identical to the international standard EN ISO 22716:2007. Compliance with this standard provides a presumption of conformity.

Adhering to the requirements of DSTU EN ISO 22716 is not a legal requirement. Companies may use other good manufacturing practices, but in this case, they must demonstrate that their system achieves the same objectives as the principles of DSTU EN ISO 22716.

Requirements of the ISO 22716 

This standard is specialized for the cosmetics industry and provides organizational and practical recommendations for managing human, technical, and administrative factors that affect product quality at each stage of production.

The standard covers the production, control, storage, and shipment of cosmetic products, and therefore applies to all parties involved in these activities: manufacturers, importers, distributors, and trademark owners.

However, it does not cover aspects of personnel safety (ISO 45000 series) or environmental protection (ISO 14000 series).

The standard’s requirements apply to the following:

• Personnel
  All employees must be aware of their duties and the actions they must perform in the production, control, storage, and shipment processes. Personnel must have appropriate training, skills, and documentation to produce cosmetic products.
  
• Facilities
  The environment for cosmetic product production must be safe and hygienic. Facilities must provide protection for the product, undergo regular maintenance, cleaning, and disinfection, and their layout and arrangement must minimize the risk of cross-contamination.
  
• Equipment
  The equipment used in cosmetic product manufacturing must be suitable, used only for its intended purpose, regularly maintained, and cleaned to prevent product contamination.
  
• Raw materials and packaging materials
  Raw materials and packaging must come from reliable, verified suppliers selected based on certain criteria. The supply chain for raw materials must be well-documented to ensure traceability in the event of issues. Any water used in the production of cosmetic products must be properly treated and regularly tested.
  
• Production
  The production process must be documented in detail. Quality control points must be defined for the product. The product must have a batch number for easy identification and proper labeling. Cleanliness of the facilities and equipment should be checked before production begins.
  
• Finished products
  Finished products must meet established quality criteria, which must be verified before the product is placed on the market. The quality of the product must remain consistent during storage, shipment, and return.
  
• Quality control laboratory
  Quality control must be implemented for the product, raw materials, and packaging to identify any items that do not meet specifications.
  
• Non-compliant products
  Investigation of rejected products, raw materials, and packaging should be conducted by authorized personnel. Reprocessing of such products should follow approved methods and rules.
  
• Waste
  Waste generated during production and quality control must be identified, clearly labeled, and disposed of in a controlled and sanitary manner.
  
• Subcontracting
  When outsourcing tasks such as production, packaging, testing, or cleaning, the company must develop a contract with the subcontractor that specifies the requirements for meeting the company’s acceptance criteria. Subcontractor selection should be based on specifications.
  
• Deviations
  Identified deviations in production must be documented and justified, and corrective actions should be taken to prevent recurrence.
  
• Complaints and recalls
  Any complaints or issues with the product must be investigated, including considering actions to prevent recurrence. Problematic batches must be checked for compliance. Recall procedures should be able to be implemented quickly.
  
• Change management
  Changes in the production process that affect product quality must be approved, justified, and carried out by authorized personnel.
  
• Internal audits
  Internal audits must be conducted to ensure that the standard’s requirements are properly implemented.
  
• Documentation
  Documentation must be up-to-date and available, and it should demonstrate what happens during production, quality control, storage, and transportation of cosmetic products.
  

Compliance with the standard’s requirements is verified through internal audits.

However, it can also be verified by an external audit, conducted by a third party – a specialized service provider (a certification body).

The Regulation does not require GMP certification, but it can be performed voluntarily.

Compliance with the standard’s requirements must be demonstrated by a statement (declaration) that the products are manufactured in accordance with the DSTU EN ISO 22716 standard, and in the case of certification, with a DSTU EN ISO 22716 certificate.
   

Benefits of certification

GMP certification, carried out by a third party, is a widely used tool for confirming compliance with GMP standards and helps maintain the quality management system with continuous improvement.

Certification not only confirms that legal requirements are met, but also enables an intensive analysis of the company’s hygienic conditions. It is also important for marketing cosmetic products.

Thus, certification allows you to:

• Confirm compliance with ISO 22716 GMP requirements;
• Manufacture products that meet quality and safety requirements;
• Reduce the risk of contamination and errors;
• Decrease the risk of defective products and costs associated with correcting defects;
• Optimize production processes;
• Expand partnerships with leading international brands;
• Increase consumer and client trust;
• Boost company productivity and competitiveness;
• Facilitate access for Ukrainian manufacturers to European and international markets.

Therefore, DSTU EN ISO 22716 certification is recommended for all participants in the cosmetics industry involved in the production and distribution of cosmetic products.

When choosing a certification body for management system compliance with ISO 22716 requirements, it is necessary to verify and ensure that it is accredited at the national level (by the National Accreditation Agency of Ukraine (NAAU)) or internationally.
   

Development, implementation, and GMP certification 

Our company professionally provides GMP development and implementation services for cosmetic products, as well as staff training and certification support with accredited organizations.

Every company has a quality management system (QMS), even if it is undocumented: established practices, processes, and management-enforced rules. To implement GMP, we analyze, improve, and document the quality management system based on the requirements of the standard.

The identity of the national standard DSTU EN ISO 22716:2015 with the international EN ISO 22716:2007 allows us to ensure that the developed and implemented QMS complies with requirements for exporting products to the EU and other countries.

In many cases, we perform our work through 5 simple and clear steps:

1. Diagnostic audit. Our qualified employees conduct a pre-audit – studying existing business processes and documents, getting acquainted with staff, and discussing client preferences.
2. Roadmap. We prepare a roadmap – a plan and sequence of actions, distribute areas of responsibility, and agree on timelines.
3. Documentation development. We develop the documentation (quality manual, SOPs, instructions, logs) for the quality management system. This is the longest stage, during which numerous clarifications and approvals occur.
4. Documentation transfer and staff training. We transfer the developed documentation along with explanations and recommendations. Typically, we also conduct 2-3 training sessions for company employees.
5. Internal audit. An internal audit is necessary to check the system’s functionality, improve it, eliminate discrepancies, and prepare for the certification audit.

Optional: Certification audit. A certification application is submitted to the authorized organization to obtain a GMP certificate. We support the certification audit by being present at the company’s site. If necessary, we address comments and carry out corrective and preventive actions.
   

Our services 

Cratia offers comprehensive regulatory support and assistance throughout all stages of placing cosmetic products on the Ukrainian market:

• Regulatory intelligence, consulting and feasibility study;
• Outsourcing of the Responsible person in Ukraine;
• Filling of the Product Information File (PIF);
• Filling of the Cosmetic Product Safety Report (CPSR) and Ukrainian safety assessor; 
• Review and/or development of labeling, instructions, and advertising materials;
• Notification (registration) of the cosmetic product on the portal; 
• Compliance with UA CLP and UA REACH regulations;
• Compliance with the Technical regulation on aerosol dispensers;
• Legal and consulting support for manufacturers, responsible persons, or distributors (importers).

We possess the necessary knowledge and experience to conduct these tasks, and we are fluent in spoken and written English. We will manage and organize the process, help compile the necessary set of documents, and carry out the procedure within a short timeframe.