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ISO 22716 sets out the framework for a quality management system for anyone involved in the manufacture of cosmetics and other healthcare related products. While this Standard’s focus is on the manufacture of cosmetics specifically, many of the requirements can apply to any manufacturing process, especially those that involve a risk of contamination.

On the surface, ISO 22716 may be considered a niche Standard, so why it is still so widely adopted?

Today, Mel is joined by Derek Hall, a Senior Consultant here at Blackmores, to discuss the key drivers behind ISO 22716, including legal EU requirements and other related regulations.

You’ll learn

• Why is ISO 22716 used as an industry Standard?
• What is ISO 22716’s relation to the Cosmetic Regulation (EC) No. 1223/2009?
• Who are these regulations applicable to?
• Other regulations and Standards applicable to cosmetics manaufacturing

Resources

• isologyhub
• Blackmores ISO 22716 Implementation

In this episode, we talk about:

[00:42] A brief summary of ISO 22716 – watch the last episode for a full summary

[01:25] Do you still need to comply with EU directives? Short answer – Yes, especially if you sub-contract parts of your manufacturing process / packaging or export product within the EU.

[02:00] Why was the Cosmetic Regulation (EC) No 1223 created? To streamline and modernize current legislation across Europe for Cosmetics (though this can also include hygiene products i.e. soaps, toothpaste, deodorants ect)

[03:30] What is the Cosmetic Regulation (EC) No 1223? This regulation establishes rules to be complied with by any cosmetic product made available on the market – to ensure a high-level of protection of human health

[04:21] ISO 22716 is the central pillar of the Cosmetic Regulation (EC) No 1223

[05:02] A bit of background to the EU adoption of ISO 22716 – On April 21^st 2011 – ISO 22716 officially became the Good Manufacturing Practices Standard for cosmetic product across Europe. This created a harmonised approach that ensured cosmetic products are safely manufactured, stored and shipped.   

[05:58] The whole regulation came into effect in July 2013. The laws for each nation had to follow this regulation – which included any relevant Standards or guidance affecting the cosmetic industry. This requirement also applies to any cosmetic manufacturers outside the EU that want to import into the EU.  

[07:36] Who are the regulations applicable to? Anyone involved in the cosmetic products chain (European and non-European). This includes raw materials producers, product assembly, distributors, exporters ect

[08:05] ISO 22716 provides guidance for most parts involved in cosmetic production i.e. production, control, storage and shipment. However, it does not cover: safety for personnel (this may fall more under ISO 45001), protection for the environment, is not appliable to research & development and not appliable to the distribution of finished product

[09:55] ISO 22716 is almost 20 years old – so environmental considerations weren’t as much at the forefront of product manufacturing as they are today. Any manufacturers should be doing what they can about their impact regardless of current regulations (new versions may add guidance around this, so keep up-to-date with regulatory changes)

[11:45] Other applicable standards include: The two part ISO 16128 Standard:

ISO 16128-1: Guidelines on technical definitions and criteria for natural and organic cosmetic ingredients and products

ISO 16128-2: Describes approaches to calculate natural, natural origin, organic and organic origin indexes that apply to the ingredient categories 

[13:58] COSMOS (standard Cosmetics Organic and Natural Standard) was created by many different International parties including BDIH (Germany), COSMEBIO & ECOCERT (France), ICEA (Italy), AISBL (Belgium) and Soil Association (UK). Its purpose is to define common requirements and definitions for organic and / or natural cosmetics.

[15:25] Standards are created collaboratively by technical committees made up of global experts of their respective fields – they take years to develop to establish best practice

[16:09] ISO 22716 has been approved by many regulatory bodies around the world, including the ICCR (The International Cooperation on Cosmetic Regulation), FDA (Food and Drug Administration), JCIA (The Japan Chemical Industry Association) and ASEAN Consultative Committee for Standards

[17:10] Through current regulations, there is increased responsibility in regards to: Ingredients toxicity, product labelling, more comprehensive product file and compulsory notification of new products introduced to the EU

[21:00] The current regulations have specific requirements for ingredient toxicity and product labelling

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ISO 22716 sets out the framework for a quality management system for anyone involved in the manufacture of cosmetics and other healthcare related products. This is not only limited to production but also the control, storage, and transportation of products, including the purchase of raw materials, components and packaging material.

While this Standard’s focus is on the manufacture of cosmetics, many of the requirements can apply to any manufacturing process, especially those that involve a risk of contamination.

Today, Mel is joined by Derek Hall, a Senior Consultant here at Blackmores, to talk through the main structure of the Standard and how it can be applied.

You’ll learn

• What is ISO 22716?
• Who does ISO 22716 apply to?
• How is ISO 22716 structured?
• How ISO 22716 can be applied

Resources

• isologyhub
• Blackmores ISO 22716 Implementation
• The Checklist Manifesto

In this episode, we talk about:

[00:35] A description of ISO 22716 Good Manufacturing Practices – A supporting Standard for the manufacture of cosmetics

[01:20] Why are we talking about such a niche standard? It’s one of our most popular standards via website enquiry, so we’d like to share our knowledge 😊

[02:20] There is an EU directive pushing for the adoption of this Standard where applicable

[03:00] A more in-depth summary of ISO 22716 – Why it’s so important and why it was made

[04:01] What does ISO 22716 cover? Guidelines and practical advice on the management of the human, technical and administrative factors affecting product quality.

[04:58] A summary of the 17 clauses within ISO 22716

[07:55] What are the core elements of ISO 22716? Personnel, Premises and Equipment, Operations and Material Management, Quality Control and Cosmetics Quality Management System

[08:50] Personnel – Key considerations include: Restricted areas free from food and drink, visitor supervision, personnel authorisation, personnel uniforms (removal of rings, hair restraints, safety glasses, gloves ect)     

[11:25] Premises and Equipment: The layout of buildings and equipment placement need to be controlled, controls for sanitisation and cleaning, guidance for storage, proper access to materials and equipment.

[13:27] Premises: Pest control – should be very controlled to prevent contamination. This can be controlled via the building layout and cleaning controls. A pest control program should be created and followed. This extends to the exterior of your building too!  

[15:45] Equipment: Automated systems should be controlled in-line with ISO 22716. Equipment should be suitable for purpose and capable of regular cleaning and maintenance to avoid contamination.  

[17:02] Materials Management and Operation: How well do you control your materials? What controls do you have in place for manufacturing and packaging? How good is your storage? What is your delivery process? Do you keep documentation of all your purchasing and quality checks?

[18:15] Materials Management and Operation: Stock – Consider how you manage and store stock, include regular checks to ensure it’s all well within date. The Operations area in particular aligns with ISO 9001 – Quality Management.

[19:40] Materials Management: You need to set the criteria for quality during different stages of manufacturing i.e. specifications for raw materials, components and packaging material. This should also include release parameters.

[21:00] Materials Management criteria can be set out in a checklist. Mel mentions ‘The Checklist Manifesto’ as a recommended read

[24:15] Materials Management: Make sure you store in a way that avoids any contamination or mix-ups. Ensure all containers are stored off the floor. Use clear labelling to show if they are accepted, rejected or quarantined

[25:37] Operations: Should be carried out according to manufacturing documentation i.e. suitable equipment, product formula, details of the product process ect.

[27:15] Quality Control: Consists of sampling, specification testing, out of spec investigations and release. You may subcontract out quality control – in which case, you must ensure you get proof that they are conducting adequate tests.

[29:13] For subcontractors – Ensure you have a written contract OR agreement in place. If your subcontractor is subcontracting along the work, you need to ensure that process is controlled

[31:32] Deviations: These can happen at any point in operation and can be both internal and external in origin

[32:09] Complaints and Recall: You need to have processes in place to log and deal with complaints and recall. You should also regularly test your product recall process

[33:20] Change Control: Making sure you have effective processes and documentation to control any changes to existing operation. I.e. if you get different machinery that changes mixing times

[34:50] Internal Audits: You need to have an internal audit program in place and have competent independent personnel that can carry those audits out. This could be sub-contracted out

[36:10] Documentation: You will be documenting all throughout the manufacturing process, it’s integral. Ensure all staff know the importance of it and how to complete it correctly.

We’d love to hear your views and comments about the ISO Show, here’s how:

• Share the ISO Show on Twitter or Linkedin
• Leave an honest review on iTunes or Soundcloud. Your ratings and reviews really help and we read each one.

Subscribe to keep up-to-date with our latest episodes:

Stitcher | Spotify | YouTube | iTunes | Soundcloud