GMP for cosmetic products

This section of the website applies to requirements of the Technical regulations on cosmetic products that will become effective from August 3, 2022. For previous requirements please refer to the following page. 

The manufacture of cosmetic products must comply with the requirements for Good Manufacturing Practice (GMP). The responsible person (manufacturer or it’s representative) is obliged to ensure that the manufacturing conditions conform to GMP requirements and include a statement (declaration) of conformity in the product information file. 

By order of the SE “UkrNDNC” No. 198 dated 21/12/2015, the national standard DSTU EN ISO 22716:2015 “Cosmetics. Good Manufacturing Practice (GMP). Guidelines for Good Manufacturing Practice” was adopted, which is identical to the EN ISO 22716:2007 standard.

The EN ISO 22716 standard is the industry-specific standard for the cosmetics industry, offering organizational and practical guidelines for managing the human, technical and administrative factors that affect product quality at every stage of manufacturing.

Conformity of manufacture with GMP requirements is a prerequisite that must be met before the introduction of cosmetic products of national and foreign manufacturers into circulation.

What is GMP?

GMP stands for Good Manufacturing Practice. In the cosmetics industry, it is the international standard for quality management in manufacturing. GMP does not apply to studies, development and distribution of finished cosmetic products.

The International Organization for Standardization (ISO) has developed and published the standard EN ISO 22716:2007 for the European market. This version of the standard has been used by international manufacturers of cosmetic products since 2007 and is relevant today.

The GMP standard contains instructions and recommendations for organizing the manufacturing, control, storage and shipment of cosmetic products. The standard covers aspects of product quality but does not cover aspects of personnel safety (ISO 45000 series of standards) and environmental aspects (ISO 14000 series of standards).
GMP Standard Requirements
The standard includes requirements for:

• Personnel: activity management, core responsibilities, training, hygiene and health, visitors and untrained personnel.
• Rooms: types of rooms; space; the flow of materials and personnel; floor, walls, ceiling and windows; washbasins and toilets; lighting; ventilation; pipeline, drains and channels; cleaning and disinfection; maintenance; expendable materials; pest control.
• Equipment: design; installation; calibration; cleaning and disinfection; service; expendable materials; leave for work; spare systems.
• Raw products and packaging components: procurement and supplier selection; reception; identification and status; admission and use; storage locations; reassessment; water-treatment.
• Manufacture:
  • manufacturing operations: availability of documentation; start-up checks; lot number assignment; identification of activity in progress; in-process control; bulk product storage; re-storage of raw products;
  • packaging operations: availability of documentation; start-up checks; lot number assignment; identification of the packaging line; checking the equipment for operational control; in-process control; return of packaging components to the warehouse; identification and processing of work in progress.
• Finished products: release; storage; shipment; return.
• Quality control laboratory: analytical procedure; criteria for acceptance; findings; out-of-specification results; reagents, solutions, reference standards and culture media; a collection of specimens; storage of samples.
• Out of specification products: rejected finished products, bulk products, raw products and packaging components; reworked finished units and powder products.
• Waste: types of waste; waste flow stream; containers; disposal.
• Subcontract: types of the subcontract; Customer; acceptor of the agreement (Contractor); agreement.
• Deviations.
• Complaints and reviews: complaints about products, product recall from the market.
• Management of Change.
• Internal audits: assumption; approach; verification of performance.
• Documentation: types of documentation; development, approval and distribution; versioning; archiving.

Development, implementation and GMP certification of cosmetic products

Our company professionally carries out the development and implementation of GMP for cosmetic products, and also offers human resource training and certification support in accredited organizations.

Any enterprise has a quality management system, even if it is documented: past practices, established processes, rules introduced by management, etc. To implement GMP, we analyze, improve and document the quality management system, guided by the requirements of the standard.

The identity of the national standard DSTU EN ISO 22716:2015 to the international EN ISO 22716:2007 allows us to talk about the conformity of the developed and implemented QMS for exporting products to the EU market and other countries.

In most cases, we carry out work in 5 simple and understandable steps:

1. Diagnostic audit. Our professional experts carries out pre-audit – they study existing business processes and documents, get to know the staff, discuss the wishes of the client. 
2. Roadmap. We prepare a roadmap – a plan and path, distribute areas of responsibility and agree on a deadline.
3. Developing documentation. We develop documentation (Quality Guideline, SOPs, instructions, logbooks) for the quality management system.  This is the longest stage, during which a lot of clarifications and approvals go through.
4. Transfer of documentation and human resource training. We transfer the developed documentation, along with explanations and recommendations. We usually also conduct 2-3 training events for corporate employees.
5. Internal audit. Internal audit is required to check the system availability, improve it and eliminate nonconformities, and as a preparation for a certification audit.

Certification audit, voluntary.  The Application for certification is submitted to a certifying authority to obtain the GMP certificate. We accompany the certification audit, by attending at the enterprise. If necessary, we resolve observations, carry out corrective and preventive actions.

Our services and works

Cratia provides full regulatory support and accompanies at all stages of placing a cosmetic product on the Ukrainian market:

• outsourcing services of a responsible person in Ukraine;
• checking the composition of the product;
• creation of an information file;
• preparation of a safety report;
• verification/development of labeling, instructions and advertising materials;
• product notification;
• development and implementation of Good Manufacturing Practice in accordance with ISO 22716 (GMP);
• legal and consulting support of the manufacturer, Responsible person or distributor (importer). 

We have the requisite knowledge and experience in carrying out the work, we speak and write excellent English. We will take over the management and organization of the process, help to form a package of documents and carry out the procedure in a short time.