Requirements of ISO 22716 for Good Manufacturing Practices in the Organization

ISO 22716 standard is an international standard that guides the production, control, storage, and shipment of cosmetic products. It deals with all features of the supply chain of cosmetic products. The guiding principle covers the quality and safety of the product, and they affect manufacturers, as well as suppliers, retailers, brand holders, and vendors of cosmetic products.

The ISO 22716 Good Manufacturing Practices (GMP) guide was designed to give guidelines for the production, control, storage, packaging, labeling, shipment, and distribution of cosmetic products. ISO 22716 is also organized to complement current management systems in place, like the ISO 9001. It provides the quality of cosmetic products to customers, as well the accountability and traceability in the production and distribution phases of products. ISO 22716 GMP protects all aspects of the supply chain of cosmetics.

Requirements to implement the ISO 22716 for Good Manufacturing Practices

Cosmetic companies, regardless of the complexity and size, can implement ISO 22716. Also, the ISO 22716 certification fits well with BRC customer products and ISO 9001. EU cosmetics GMP requirements are included in the EU Cosmetics Regulation. The regulation created requirements to make sure customers and those involved in the cosmetics sector, whether European or non-European, are safe. It covers essential processes like manufacturing, testing, labeling, packaging, distribution, etc…

GMP can prove their compliance either by an ISO 22716 certification or a statement showing that the products are produced according to ISO 22716 standards.

ISO 22716 has arranged the following specific requirements and principles:

• Personnel:

The personnel working in the organization, are responsible to improve the effectiveness of production, controller, and products that fulfill the requirements of quality standards. It includes some features and limitations, including an organizational chart, number of employees, key responsibilities of the management and workers, system awareness training, ISO 22716 auditor training, special hygiene and health of staff, guests, and inexperienced personnel.

• Equipment:

Equipment should be applicable and beneficial for the intended purpose. All parts of equipment must be cleaned, sanitized, and maintained. Also, usage and access to equipment should be provided to authorized persons only.

• Raw materials and packaging:

Both raw and packaging materials should fulfill the well-defined acceptance standards significant to the quality of end products.

• Premises and Locations:

Premises should be planned, built, placed, and utilized to assure the protection of the product, as well as efficient cleaning, sanitation, and maintenance and it helps to minimalize the risk of confusion in raw materials, packaging units, and products.

• Production:

Here, In every stage measures the manufacturing procedures and packaging operations to manufacture an end product that accomplishes the identified features.

Cosmetic companies should be able to ensure the availability of relevant documents, perform start-up checks, assigned batch numbers, and re-stock raw materials. They must identify in-process operations, in-process controls, and product storage during the manufacturing and packaging stages.

• Subcontracting:

Subcontracting means obtaining a product or service that follows the requirements of the defined contract of the contributor.

• Finished products:

Also, make sure that the end products fulfill the well-defined receiving criteria before distributing the products on the marketplace.

• Quality control laboratory:

The quality control laboratory must apply the principles recognized by ISO 22716 standard, equipment, premises, subcontracting, and documentation.

• Deviations:

Deviations must be determined by gathering enough data and taking corrective measures. Also, identify the behavior of a product that is out of description.

• Waste Management:

ISO 22716 standard requires companies to dispose of wastes in a sanitary, methodical, and appropriate manner.

• Conducting and Controlling Changes:

Official staff should agree and conduct changes that could affect the finished product’s quality based on acceptable data.

• Handling complaints and recalls:

ISO 22716 standards help to manage, investigated, review, and followed up on all complaints associated with the products.

• Performing an internal audit:

Every cosmetic company needs to monitor the implementation and position of the ISO 22716 Good Manufacturing Practices. According to that take action and plan if necessary.

• Proper documentation:

In the ISO 22716 standard, ISO 22716 documentation is a critical part of Good Manufacturing Practices. The ISO 22716 documents are available online with ready-to-use templates that make the overall documentation process easy and fast and help to describe GMP actions, secure evidence of processes and avoid confusion and loss of data.

Source: https://punyam.wordpress.com/2022/04/28/requirements-of-iso-22716-for-good-manufacturing-practices-in-the-organization/

Henry Nelson has published many articles regarding ISO Certification. Henry has rich experience as a online publisher and prepared various Certification documents as per ISO guideline since large amount of years in his professional career.