ISO 22716 - Good Manufacturing Practices in Cosmetics

 

What is ISO 22716?

ISO 22716 provides guidelines and requirements for the correct manufacturing procedures in the cosmetic industry. Ensuring that the cosmetic products are safe to use, correctly produced, controlled and stored.

These guidelines cover the quality aspects of the product, but as a whole do not cover safety aspects for the personnel engaged in the plant, nor do they cover aspects of protection of the environment.

Once certified, organisations can proudly promote themselves as certificate holders in any of their promotional materials and can include the URS certification logo free of charge.

 

Who requires an ISO 22716 certification?

Certification for ISO 22716 should be considered by any organisation operating in the cosmetics sector. This includes manufacturers, packagers, processors and distributors of cosmetic products.

How can a ISO 22716 certification benefit your business?

Becoming certified for ISO 22716 can bring a wide range of benefits to your organisation, including:

 

• Risk mitigation


• Improved efficiency


• Enhanced supply chain management


• Cost reduction

How can you prepare for ISO 22716 Certification?

Although the thought of starting the certification process may seem daunting, there are a variety of steps you can take to make the process to becoming certified far more streamlined:

 

• Familiarise yourself with the 22716 standard


• Conduct a gap analysis to highlight any areas that do not comply with the standard


• Provide training to all staff members to ensure that the compliance requirements are met


• Evaluate the suppliers of raw materials that are used to ensure they comply with the standard requirements

What are the key requirements ISO 22716?

When working towards becoming certified for ISO 22716, there are various areas that will be a focus during the audit. These areas include:

 

• Quality control system


• Raw materials


• Documentation for production processes

What clauses make up the structure of ISO 22716?

 

Clauses 1-2 – Introductory clauses:

The first two clauses of ISO 22716 provide an introduction to the standard and outline the scope and application of the requirements contained within. Clause 2 also provides an extensive list of terms and definitions that are used throughout the document.

 

Clause 3 – Personnel:

Clause 3 explores each of the requirements that accompany an organisation’s personnel. Including responsibilities, training and hygiene.

 

Clause 4 – Premises:

Clause 4 introduces scheme specific requirements that involve all elements of the premises an organisation uses. This covers the types of area, lighting, ventilation and cleaning.

 

Clause 5 – Equipment:

Clause 5 focuses its requirements on the equipment used during the manufacturing process. Areas of importance include ease of cleaning, calibration, and maintenance.

 

Clause 6 – Raw materials and packaging materials:

Clause 6 covers the use of raw materials and packaging materials and ensures that both meet the defined acceptance criteria. These criteria incorporate purchasing, identification and quality into the requirements.

 

Clause 7 – Production:

Clause 7 introduces requirements to each stage of the manufacturing operations to ensure the finished product meets the defined characteristics.

 

Clause 8 – Finished products:

Clause 8 focuses on ensuring that the final product meets the predetermined specifications. Through guidance, this section also involves requirements on returns and shipping to ensure the quality of the product is maintained.

 

Clause 9 – Quality control laboratory:

Clause 9 enforces the importance of maintaining the standards and processes that involve the quality control laboratory. The principles within involve personnel, premises, equipment and the documentation related to each.

 

Clause 10 – Treatment of product that is out of specification:

In the shortest section of the standard, clause 10 briefly touches on the requirements surrounding the treatment products that are out of specification. This includes the use of materials and products that are rejected and reprocessed.

 

Clause 11 – Wastes:

Clause 11 aims to ensure that wastes of all types are disposed of in a timely and sanitary manner; along with the containers used to store waste.

 

Clause 12 – Subcontracting:

Clause 12 requires all types of subcontracting used by an organisation to be established and controlled to guarantee the products compliance with contractual requirements.

 

Clause 13 – Deviations:

Clause 13 tackles a risk element of the process, and works to reduce the number of deviations that occur. Whilst making sure that any deviations that do take place are authorised with supporting data.

 

Clause 14 – Complaints and recalls:

Clause 14 provides useful guidance for the handling of complaints and recalls; protecting the organisation through the use of corrective actions to prevent reoccurrence.

 

Clause 15 – Change control:

Clause 15 reiterates the same guidance provided in clause 13 for deviations, and highlights in the same way that changes should be authorised by personnel.

 

Clause 16 – Internal audit:

Clause 16 introduces reducing risks and incidents through the means of internal audits and corrective actions. This section covers all steps involved from the approach to the follow up; ensuring that any actions have been properly implemented.

 

Clause 17 – Documentation:

In the final section, clause 17 provides in-depth guidance surrounding documentation and processes involved. This includes production, revisions and archiving.

 

How long will your ISO 22716 certificate be valid for?

Your ISO 22716 certificate will be valid for at least three years; dependent on the type of site that is being certified.

 

Ready to get started? Apply using the quotation link below.