INTRODUCTION
ISO 22716 is a comprehensive set of guidelines for Good Manufacturing Practices (GMP) in the cosmetics and personal care industry that was introduced in 2007. These guidelines cover a range of cosmetic products, from makeup and oral care to creams, deodorants, hair products, and fragrances, which are intended to enhance, cleanse, or alter a consumer’s face or body. The International Organization for Standardization (ISO) is a widely recognized non-governmental organization that establishes standards across many industries.
In 2007, the International Cooperation on Cosmetic Regulations (ICCR), comprised of the United States (US), Canada, European Union (EU), and Japan, decided that ISO 22716 would be the standard used when recommending or publishing cosmetic GMP guidelines for each country. Thus, ISO 22716 guidelines have become the global benchmark for cosmetics GMP standards.
The US Food and Drug Administration (FDA) updated its GMP guidelines in 2013, incorporating the recommendations set forth in ISO 22716. Good Manufacturing Practices (GMP), also referred to as current Good Manufacturing Practices (cGMP), highlight the need for companies to adopt tools and technologies that comply with current standards.
QUALITY MANAGEMENT SYSTEM
The ISO 22716 GMP related processes are integral to quality assurance and the guidelines help companies manufacture products that are consistently high in quality from batch to batch. It sets out the Audit schedule is based on a Quality Management System QMS approach using a 3 year cycle of initial certification followed by 2 annual surveillance visits. This allows the verification of the system over the 3 years reducing the audit time and costs based on the internal controls by the company.
Implementation
Implementing industry standard GMP according to ISO 22716:2007 requires considering the following GMP guidelines:-
Personnel:
To ensure the safety and quality of cosmetic products, employees of the cosmetics company should be properly trained, experienced, and qualified to produce, store, and control products to the company's specifications. The company should provide employees with necessary support, including full GMP training, supervision, safety equipment, personal protective equipment (PPE), education, and resources to perform their jobs and tasks efficiently and maintain good hygiene and cleanliness.
Premises:
The premises of a cosmetics manufacturer must meet GMP specifications, providing a safe and hygienic environment that minimizes the risk of contamination. The facilities should be organized to allow for adequate division of storage, production, quality control, washing, sanitization, toilet facilities, and any other supporting facilities, and ensure that cleaning and maintenance protocols are in place. This protects the cosmetic products being manufactured, minimizes the risk of mixing up products, ingredients, and packaging materials, and ensures cleanliness is kept to a high standard as part of the GMP process.
Equipment:
The equipment used in cosmetic production should be suitable for its purpose, adequately cleaned, sanitized, and maintained to prevent contamination, such as dust or moisture. The equipment should only be used for cosmetic product manufacture, stored properly, and calibrated periodically if needed. It is also essential to ensure that the equipment isn't made of any material that could interact with the ingredients, products, or cleaning agents. If broken or no longer suitable for use, equipment should be fixed, replaced, or disposed of adequately and safely.
Raw Materials and Packaging Materials:
All ingredients, raw materials, and packaging materials should meet acceptance criteria to ensure the quality of the finished product. They should be well organized and correctly labelled to prevent mix-ups with any products. The labels must contain batch/lot information so that they can be traced at any point in the manufacturing process. Regular inventories of stock should be carried out, and any discrepancies investigated.
Production:
Measures should be taken at every step of the production process to ensure that the finished product meets its specifications. Appropriate documentation and records should be created to capture all aspects of the production process. Standard operating procedures (SOPs) for all processes should be established, which include GMP for cosmetics guidelines, the new product formulation of the cosmetic product in percentages and weight/volume, a list of all raw materials used to include their batch numbers and quantities, and the method of manufacture.
Finished Products:
Finished products must meet the quality standards established by the company and reflect GMP. Before placing a finished product on the market, compliance with defined quality criteria must be verified. Strict rules of storage must be adhered to, ensuring appropriate conditions. Finished product storage containers should list the product's name, batch number, any relevant storage conditions, and quantity. Regular inventory checks ensure that products are stored adequately. Quality must be maintained during storage operations, shipping, and product returns.
Quality Control:
Quality refers to the stability of a cosmetic product, its preservation, and overall function. The tests required to check the quality of a product ensure that it remains at a high standard. Any product containing water is at risk of contamination or microbial growth and will require sampled quality checks to ensure stability and pass challenge tests. Samples must be identifiable by their name, concentration, expiration date, opening date, storage conditions, and the name of the person who prepared them. Samples should be taken in sufficient sizes so that any regulatory bodies can undertake analysis if required.
Complaints and Recalls:
Any complaints or adverse events reported about a cosmetic product must be reviewed, investigated, and followed-up on. This is a GMP for cosmetics ISO 22716 requirement and may be a legal requirement as part of cosmetics regulations. Complaints should be centrally recorded using a systematic complaint logging and review process. Investigating complaints should include steps to prevent.
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