The Mexican Official Standard NOM-259-SSA1-2022 outlines comprehensive regulations covering various aspects of good manufacturing practices for cosmetic products. These include personnel, physical facilities, equipment, raw materials, quality control, transportation, and more. The standard, which applies to all entities and premises involved in producing or importing cosmetics in Mexico, aims to ensure consumer safety, product quality, and effectiveness. It sets guidelines for manufacturing processes and health controls, requiring adherence to GMPs. Importers face additional obligations, such as providing information on the products' manufacturing processes and traceability. The standard's effective date is September 3, 2022, with certain requirements related to documentation becoming enforceable on January 1, 2023, and facility-related requirements on March 2, 2023. Compliance with NOM-259-SSA1-2022 presents challenges for the industry and may result in health authorities conducting verifications and taking regulatory actions at both the federal and state levels.
It's worth noting that this standard applies not just to activities conducted within Mexican territory, but also to products imported into Mexico. In essence, it covers the entire traceability of processes until the products reach the end consumer.
Personnel
To maintain health and hygiene in cosmetic product manufacturing, personnel must follow specific guidelines. This includes
Wearing clean attire and protective gear when entering production, quality control, and storage areas to prevent contamination.
Regular handwashing, especially after restroom use and eating.
Avoid jewelry, clean short nails, no direct material contact, and refraining from carrying removable items.
Coughing and sneezing near materials are discouraged, and individuals showing signs of illness should not handle products.
Smoking, eating, and personal item storage are prohibited in these areas.
Good Manufacturing Practices training for those involved in manufacturing, emphasizing ongoing and updated instruction in workplace attire and hand hygiene.
Visitors, whether internal or external, must adhere to facility guidelines and wear appropriate attire when entering designated areas.
Physical Facilities.
The establishment should have distinct, segregated areas for various activities, including production, conditioning, quality control, and storage. Adequate space should be provided to enable smooth reception, storage, and production processes. A well-defined flow of materials, products, and personnel is essential to prevent cross-contamination. Furthermore, external facilities must be both resistant to environmental conditions and well-maintained.
In the production area, surfaces including floors, walls, ceilings, windows, and doors must be constructed to allow for easy cleaning and disinfection and should be maintained in a clean and sound condition. The floors must be water-resistant, uniform, and designed to prevent flooding. Accumulation of dirt should be prevented on ceilings and walls and windows, vents, and doors must be equipped with effective safeguards to keep out dust, rain, and harmful wildlife.
Sanitary Facilities.
Employees must have access to clean and conveniently located restroom facilities, which, when necessary, should include areas for showering and changing clothes. These restrooms should be separated from production areas and equipped with essential handwashing amenities, such as soap, paper towels or air dryers, and waste containers with swing or pedal-operated lids. Clear signs must be prominently displayed to remind staff to wash their hands before and after using the restrooms.
Services.
The requirements emphasize the importance of having accessible potable water for personal hygiene, cleaning, and equipment. Adequate facilities for water storage and distribution are required, with periodic water quality assessments following established standards. It is essential to protect cisterns and water storage tanks and only open them for specific maintenance and cleaning purposes. Various water treatment systems must be well-maintained to ensure the required water quality. The process water treatment system should allow for cleaning and disinfection, with equipment designed to prevent stagnation and contamination. Precautions must be taken to ensure that steam used on product-contact surfaces does not compromise product quality.
The lighting in all areas must be adequate and sufficient for operations, with special care for spotlights and lamps over exposed products. Adequate ventilation should be provided as necessary, and drains must be leak-free and protected. Establishments should have an effluent and wastewater evacuation system. Pipes, drains, and ducts should be designed to prevent contamination and condensation issues. Furthermore, cleaning of facilities and specific cleaning and disinfection products should be stored properly and clearly identified.
Cleaning of equipment, Maintenance, pest control and Waste Management
Proper equipment maintenance and hygiene protocols, as outlined by the company, are crucial in cosmetic product manufacturing. For equipment used continuously or for successive production of the same item, regular cleaning and disinfection are essential to prevent contamination. If the same equipment is employed for different products, the cleaning method's effectiveness in preventing cross-contamination must be demonstrated. Cleaning and disinfection agents should follow manufacturer instructions or internal procedures to ensure they work correctly, aligning with the process and product requirements.
Maintenance is essential for maintaining the facilities and equipment in good working order. Regular maintenance, according to the company's program, is crucial, ensuring it doesn't affect product quality. After equipment maintenance or repair, inspections should be conducted to remove any residual materials. Broken or unused equipment should be clearly identified, taken out of service, and ideally isolated.
Pest control is critical, covering the entire establishment to prevent domestic animals and harmful wildlife from entering. Establishments handling pest control should have a health license, and stored pesticides must be secure, free from leaks. When outsourcing pest control, proper documentation of the services provided is necessary.
Waste management is vital for a clean and safe environment. Waste and byproducts should be regularly removed to prevent unnecessary accumulation, except in unavoidable situations. Waste collection schedules should align with the establishment's needs, with designated areas for temporary storage. Containers for waste and byproducts should remain covered and well-labeled. Managing waste should not disrupt production or laboratory activities. Handling, transportation, storage, and disposal should all prevent the risk of product contamination while adhering to relevant laws and regulations.
Equipment, Accessories And Utensils :
Production equipment should be designed, labeled, and maintained to serve its intended purpose without compromising product quality or the safety of personnel. During equipment installation, considerations should include operational, cleaning, and maintenance aspects. Materials used in the design and construction of equipment and related components in direct contact with solvents, formula ingredients, in-process products, or finished goods must not have reactive, additive, absorbent, or adsorbent properties that could jeopardize product hygiene. Transfer hoses and accessories not in use should be cleaned, possibly disinfected, and stored in a dry, protected environment to prevent contamination and should be inspected before reuse. Fixed or built-in machinery and equipment should have adequate spacing to facilitate personnel and material flow, as well as cleaning and potential disinfection. Bulk product containers must be shielded from dust and moisture to maintain product quality.
Calibration
Measuring instruments employed for assessing and ensuring product quality must undergo calibration following established procedures. In the event that calibration results fall outside the acceptable standards, these instruments must be labeled and removed from service until they are adjusted or repaired. Simultaneously, an investigation should be conducted to assess the potential impact on product quality, and corresponding corrective actions should be taken based on the findings of the investigation.
Raw Materials And Packaging Material.
The process of handling raw materials and packaging materials is governed by guidelines.
Before these materials are introduced to the production line, they undergo a meticulous inspection to ensure they meet the acceptance criteria and specifications.
The receipt of materials is conducted following predefined procedures, and the delivered items should match the purchase order or equivalent documents.
Upon reception, a careful check is made to ensure the packaging is free from any damage or deterioration that might affect the material's quality.
Containers are labeled with identification and, when applicable, lot numbers.
Any materials presenting defects that could compromise product quality are temporarily held until a decision is made.
Materials are categorized as accepted, rejected, or quarantined.
Packaging materials and containers should only be repurposed if they allow it, with labels and legends properly removed.
Materials are released for use based on approval with authorization granted by qualified quality personnel.
Analysis results or supplier quality certificates, only for qualified suppliers, can justify approval.
Storage conditions must be suitable for each material, and specific requirements must be monitored periodically.
Containers and materials should not be in direct contact with the floor.
Repackaged materials must be labeled with origin data preserved.
Inventory rotation is maintained according to the FIFO principle, with periodic inventory checks to ensure accuracy and timely correction of significant discrepancies.
Rejected or quarantined materials require dedicated storage areas or an equivalent control system.
In cases involving flammable substances, a designated area with proper safety measures should be established.
A system must be in place to re-evaluate raw materials and packaging materials at defined intervals to ensure continued suitability.
Production
Production operations adhere to a set of meticulous guidelines to ensure product quality and prevent cross-contamination. These measures are in place at each stage of production, and if simultaneous operations occur in the same area, precautions are taken to prevent cross-contamination. The entirety of production operations complies with company-established procedures.
Before production commences, several checks must be carried out including verifying availability of relevant documentation for each stage, ensuring all raw materials are released and ready, confirming the availability of appropriate equipment that's clean and, if necessary, disinfected, and making sure the area is free of materials from prior operations to prevent any mixing.
For traceability, an internal code or number is assigned to each bulk lot produced. This identifier doesn't have to be identical to the finished product label's lot number but should facilitate traceability.
All raw materials involved in production are meticulously weighed or measured in suitable, properly labeled containers. Bulk product containers are clearly labeled with key information. Production controls and their acceptance criteria are defined in alignment with the product type. Any out-of-specification results are reported and investigated. Production must strictly follow established procedures, including details on the manufacturing process, necessary machinery, manufacturing orders, raw materials, and detailed operating modes.
In cases involving bulk storage, suitable containers are used, and maximum storage times are defined, with re-evaluation before use after reaching this limit.
For conditioning operations, thorough checks precede filling and packaging operations, including ensuring cleanliness and availability of relevant documentation, materials, equipment, and product identification codes. Packaging operations follow documented procedures that include equipment, packaging materials, and detailed packaging steps. Containers should be examined for good condition, cleanliness, and, if necessary, disinfection. Filling is conducted to prevent contamination, with special attention to separation and identification of containers to avoid mixing or labeling errors.
Each finished product unit is assigned a lot number and must meet acceptance criteria while being duly identified. Containers for finished products must bear important details, including product identification, lot number, storage conditions (if critical to quality), and quantity information.
Product release is authorized by designated personnel. Finished product lots are sorted according to the FIFO system, with specific criteria detailed in output records when required.
Finished products are stored in defined areas under appropriate conditions, with monitoring when necessary. Storage areas ensure proper organization and product preservation. Storage of released, quarantined, or rejected products follows secure procedures.
Transportation.
Cosmetic products during transportation should be safeguarded to prevent contamination or any alterations. For specific products requiring unique conditions, those requirements must be identified and documented. Vehicles used for transporting and distributing raw materials or finished products should be constructed from materials that are corrosion-resistant, smooth, waterproof, and non-toxic. These vehicles must be maintained in good condition and kept clean.
Quality Control
Inspections should be conducted using the test methods established by the company. Any results that deviate from the specified standards must undergo examination by authorized personnel from the establishment and be subject to a thorough investigation. The decision to perform a re-analysis must be substantiated and justified.
Reprocessed Finished Products And Bulk Products.
In case a batch of finished or bulk product doesn't meet acceptance criteria, the evaluation and reprocessing decision is made by responsible personnel following rejection guidelines. The reprocessing method, subject to quality control approval, must be defined. After reprocessing, the product's compliance with specified acceptance criteria is verified.
Complaints, Returns And Withdrawals.
For product complaints, a procedure is in place to review, investigate, and follow up on all complaints related to the standard's scope, especially those involving toxicity or allergens. In contracted operations, both parties agree on the complaint-handling process. Complaints related to defective products retain their original details and relevant information. Adequate follow-up is provided to the affected lots and potentially impacted lots until the case is resolved. Steps to prevent defect recurrence and complaints are periodically reviewed for trend analysis.
Regarding returns, finished product returns are properly identified and stored in designated areas. They are evaluated against company-established criteria to determine their status.
In the case of product withdrawals, measures are taken for timely and effective withdrawal within the standard's scope, including the implementation of corrective actions. Recalled products are stored separately in a secure area while awaiting a decision. Authorized personnel coordinate withdrawal processes, ensuring prompt and efficient recall operations. If a product withdrawal could impact consumer health, competent authorities are promptly informed. The product withdrawal procedure is adapted and periodically reviewed to align with the company's needs.
Documentation
The documents should be in Spanish, clear, legible, and well-organized, using simple vocabulary to describe their type, nature, purpose, and use. The format and design are the responsibility of the company, and they must be signed and dated by the responsible person, preserved for at least one year after relevant dates, backed up for electronic records, periodically reviewed and updated as necessary. These records must be accessible to the health authority when required.
Handwritten records must use permanent ink and can be corrected while preserving the original if still legible, with the reason for correction noted. The documents must be maintained and indicated with revision numbers, and records must remain unaltered and accessible throughout the process and when requested by the health authority.
In conclusion, adhering to Good Manufacturing Practices (GMP) for cosmetic products is of paramount importance to ensure product quality and safety. The requirements encompass various aspects such as personnel hygiene, equipment maintenance, facility design, and many other critical factors in the manufacturing process.
For personalized guidance and to kickstart your journey towards GMP compliance for cosmetics in Mexico, we invite you to contact Artixio today. Let us help you maintain the highest quality and safety standards in the manufacturing of cosmetic products. Your success in the Mexican cosmetic market begins with proper GMP compliance – get in touch with Artixio now to ensure your products meet the required standards.
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