Obligations have been imposed to improve and improve the operating conditions of the companies producing cosmetics, as a result of this, the GMP (Good Manufacturing Practices) system has been regulated for use in cosmetic production areas. Since the risk of microbiological contamination in the manual varies according to the product, different production stages should be used in accordance with the industrial hygiene conditions appropriate to the nature of the product in order to prevent any risk of contamination. Hygiene sanitation surveillance covers the whole production process from the acceptance of goods (raw materials, packaging materials, etc.) based on good production practices, from raw material, packaging and final product storage, production, laboratory conditions and shipment.
Facilities; It must be constructed, maintained and maintained to meet the conditions required by the activities to be carried out. The facility should be designed to prevent materials and products from intermingling, to ensure effective cleaning, sanitization and maintenance, and to ensure product quality is maintained. Precautions should be taken to prevent unauthorized persons from entering the facilities. Production, storage and quality control areas should not be used as a transit route by personnel not working in these areas.
Goods Acceptance and Shipment Areas; Unloading and loading platforms should be designed to protect materials and products from climatic conditions. It should be designed so as not to affect storage conditions during unloading and loading.
Storage Areas; Storage areas should have sufficient capacity to allow the storage of different categories of materials and products on a regular basis with a shelf and pallet system.
- Storage areas should be designed to include quarantine, acceptance and rejection areas for raw materials, packaging material and finished products.
- The placement of the products and materials in the storage areas should be done in a way to prevent dust and dirt accumulation, easy to clean, and to prevent the risk of contamination and cross contamination.
- Temperature and humidity control should be provided in accordance with the characteristics of the starting materials and products stored in the storage areas. Temperature and humidity measuring equipment should be kept in storage areas and the temperature and humidity conditions of the environment should be defined and followed and records should be kept.
- The materials stored in the storage areas are damaged by sunlight.
Preventive measures should be taken in order to prevent them;
- Rejection areas in the storage area should be formed as locked areas where entry and exit is blocked.
- Printed packaging materials should be treated with care and stored in places that cannot be accessed by unauthorized persons and under appropriate security conditions.
- Adequate and appropriate measures should be taken in production and storage areas where flammable, explosive, flammable raw materials and auxiliary materials are used. The storage conditions of these substances should be regulated so as not to pose a risk.
- Goods receiving and dispatch areas should be established as separated areas that will not affect storage conditions.
Production Areas; To prevent cross-contamination, there must be independent and self-contained spaces suitable for the production of cosmetic products.
- A ventilation system with a one or two stage prefilter should be installed which will provide at least suction and blowing in accordance with the characteristics of the products produced in the cosmetic production area. As part of the maintenance of the ventilation system, the efficiency and robustness of the filters must be checked and recorded at regular intervals.
-Special care should be taken since water is an important raw material. Water production equipment and water systems should provide quality water to guarantee the suitability of the finished product.
Processes to be applied to water such as deionization, filtration and distillation should be determined according to product requirements. The water system should be designed to eliminate the risk of stagnation and contamination. Equipment used for storage and transportation of water should be regularly maintained and inspected. The water system should be sanitized according to written procedures.
- The chemical and microbiological quality of the water used in production should be regularly monitored and recorded in accordance with written procedures. Any deviations identified should be reported and corrected by corrective actions.
- The equipment used in the water system and water distribution must be of material (preferably stainless steel) that does not affect water quality.
- The floors, ceilings, walls and windows of the production facility should be designed to be suitable for cleaning, maintenance and repair. These areas should be free of cracks and open joints, smooth, free of particulate matter and may be disinfected if necessary.
- The design of the pipes, outlets and ducts in the entire facility should be free of recesses, protrusions and cavities for easy cleaning.
- The layout and design of the equipment must be designed to prevent cross-contamination, dust and dirt accumulation and any factors that may adversely affect product quality in general, and ensure effective cleaning and maintenance.
- Distinctive marking and / or labeling should be used to indicate the status of any equipment used in the facility. (Eg clean, dirty, in maintenance, defective, etc.) Defective and / or defective equipment should be removed from the production or quality control area, if possible.
- Measurement, weighing, recording and control equipment used in production and control operations should be periodically calibrated and checked by the authorized institutions according to the appropriate methods and records should be kept.
- The calibrated equipment must be labeled with at least the calibration date and the next calibration date.
- Proper cleaning and sanitization methods should be defined in the procedures and instructions for the cleaning process, cleaning agents to be used in accordance with the fields and equipment should be defined and records of cleaning activities should be kept.
- Facilities should be designed and constructed to prevent the entry of pests, rodents, birds and other animals. Necessary measures should be taken in the fight against pests.
- Wastes that may occur in every area of the facility should be properly identified and kept in tightly closed areas.
- Quality control relates to sampling, specifications, testing, documentation, release procedures and procedures. Quality control is not limited to laboratory procedures. Quality should be involved in any decision on product quality. The quality control unit must demonstrate that the product and material quality meet the required acceptance criteria.
Quality Control Areas, Quality control laboratories should be separate from the production area and be designed in accordance with the processes to be carried out. There should be sufficient space to prevent interference and cross-contamination.
- In order to verify the conformity of the starting materials, packaging materials, intermediate and finished products with the acceptance criteria by the quality control laboratory, detailed records should be kept by analyzing them with appropriate methods according to the predetermined procedures.
- Laboratory reagents, solutions, reference standards should be prepared according to written procedures and stored in areas where temperature and humidity are monitored. These solutions and reagents must be labeled with the contents, date of preparation, and the name / signature of the person preparing the reagent.
- A full-packaged sample (including inner and outer packaging) from each batch / lot / lot of the finished product shall be stored at least 1 (one) year after the expiry date on the packaging, in accordance with the storage conditions of the finished product.
Auxiliary Areas, Personnel toilets, changing clothes and bathing sections should be easily accessible and appropriate to the number of users. Bathing and toilet areas should be separate from production and storage areas. Maintenance workshops should be separated from the production areas as much as possible. If spare parts and tools are kept in production areas, these parts and tools must be stored in rooms or cabinets reserved for this purpose.
Saniter Laboratory Surveillance Personnel
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