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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.

This Standard sets out clear guidance to help you ensure you align with Good Manufacturing Practices (GMP), but how do you go about implementing it?

In our last episode of the ISO 22716 series, we bring back Derek Hall once again to share his experience with implementing ISO 22716 and offer some top tips to get you started.

You’ll learn

  • What considerations do you need for every aspect of the manufacturing process?
  • How you can apply ISO 22716’s principles to your own processes
  • Derek’s experience with his clients

Resources

In this episode, we talk about:

[01:10] If you want a recap on the Standard – Watch our first episode in the ISO 22716 series  

[01:50] Key considerations for Personnel: Establish an Organisational Chart (with clear references for the responsibility and authority of quality issues), use a Skills matrix to help determine where training gaps are, develop procedures and processes to control what people can and can’t do in certain locations.

[08:33] Key considerations for Premises: Manufacturers should consider how the building is designed and laid out, ensure that there is a good flow for materials, have effective filling and packaging areas, introduce efficient sanitation programs, what can you do to minimise mix-ups?

[10:45] Key considerations for Premises: Manufacturing areas should only be accessed by authorised personnel, you should have effective measures in place to prevent pests – this includes the exterior as well as the interior of your buildings! You might want to consider external contractors for pest control.

[13:05] Key considerations for Equipment:  Ensure all equipment is fit for purpose, efficient and has the ability to be cleaned thoroughly, make sure any calibrations are assessed and documented, equipment should be laid out in a way to ensure a flow of materials, make sure there is a clear segregation of manufacturing and storage areas.

[16:45] Key considerations for Raw Materials and Packaging Materials:  – Raw materials should be well stored and clearly labelled, source your materials from trusted and accredited suppliers, have a controlled and quality approved list of suppliers and vendors (Do these suppliers provide proof of quality? Set out your minimum requirements for quality and ensure suppliers fulfill these)

[19:15] Key considerations for Production:  All raw materials and manufacturing batches should be identified by a unique code for control and traceability, regular quality control inspections should take place, determine what methods are used to ensure that products meet customer expectations, samples should be taken during set stages of manufacturing to check for quality.

[21:20] Key considerations for Finished Products:  Finished products should not be stored on the floor (use pallets), do what you can to minimise contamination during storage, ensure all staff know how to store products correctly and what to do if there is contamination, have defined acceptance criteria for products, have clear labelling, any faulty products should be labelled as ‘quarantined’ or ‘rejected’ and moved to a designated area.

[24:48] Key considerations for Quality Control:  Ensure all raw materials, components, bulk product and packed products pass established quality tests, obtain Certificates of Analysis, have acceptance criteria forms – fill these out at all relevant stages.

[26:30] Any products out of specification should be investigated by authorised personnel, only those responsible for product quality can decide to destroy or reprocess products.

[27:25] Key considerations for Wastes:  Identifiy different types of waste, ensure these wastes are disposed of in a timely and sanitary manner, have processes in place for collection, transportation, storage and disposal of waste.

[28:48] Key considerations for Wastes:  Where necessary, allocate a code in line with the European Waste Catalogue, ensure that correct waste carriers licenses are received and maintained.   

[29:19] Key considerations for Subcontracting:   You can subcontract a  lot of aspects i.e. cleaning, pest control, packaging ect. Ensure that any subcontractors are reviewed and approved, have clearly defined written agreements in place that outline roles and responsibilities (this can be a contract or just strictly in writing)

[32:10] Key considerations for Deviations: Deviations can happen anywhere, have a regime in place to investigate complaints, in the case of serious deviations that could affect health and safety – ensure you have an effective recall process in place.

[33:25] Key considerations for Complaints and Recalls:  All complaints should be communicated to the plant, all complaints should be investigated and followed-up, if a recall needs to happen – ensure that appropriate steps are taken to recall and then take corrective action.  

[12:05] Key considerations for Change Control: Have a change management system in place to document any changes (and define if they are fixes, enhancements or major revisions), you need to establish who can: request, approve, develop, test and implement these changes.

[36:35] Key considerations for Internal Audits: Internal audits need to be carried out in regular intervals, a minimum of 1 a year (but we recommend more!), track findings and document any corrective actions taken in a Continual Improvement Log.

[38:17] Key considerations for Documentation: Documents are used through the whole process – ensure all documents used are approved, signed and dated by authorised personnel, key documents should be version controlled.

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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.

As discussed in last weeks’ episode, having ISO 22716 is essential if you are manufacturing or distributing within the EU. Besides being a legal requirement for certain regions, what other benefits can ISO 22716 offer?

Today, Mel is joined by Derek Hall, a Senior Consultant here at Blackmores, to explain some of the key internal and external benefits of ISO 22716 and how it can work in tandem with other ISO Standards.

You’ll learn

  • The internal benefits of ISO 22716
  • The external benefits of ISO 22716
  • How can ISO 22716 work with other ISO Standards?

Resources

In this episode, we talk about:

[00:50] Adoption of standards such as ISO 22716 are often key requirements of Stakeholders

[01:15] One general benefit of implementing ISO 22716 is the ability to win new business by virtue of displaying compliance to EU regulations.

[01:40] What are the internal benefits? Firstly, it ensures you’re legally compliant  

[02:10] ISO 22716 put controls in place that can reduce risk and hazards with product manufacture, storage and distribution.  

[02:35] There can be tangible cost savings – Derek highlights a few clients who have taken a step back to correct and improve their internal processes, which in turn resulted in cost savings. Compliance can also help to avoid any fines

[03:29] It can help to avoid products being wrongfully distributed – which can be a very costly mistake, both in time, money and reputation.

[04:20] ISO 22716 can integrate seamlessly with other ISO Standards such as ISO 9001 (Quality Management), ISO 14001 (Environmental Management) and ISO 45001 (Health and Safety Management). They are all based on a similar framework and are designed to work together  

[06:15] ISO Standards can act as a roadmap for managing a business – especially for micro businesses

[08:05] ISO Standards are all scalable and can apply to any size of business. So, if you were to acquire more sites, you can simply roll out your management system across the expanding business

[08:43] ISO 22716 is very clearly laid out and easy to follow

[09:30] What are the external benefits? It’s an internationally recognised Standard, and can be used for various marketing and tendering opportunities

[10:47] ISO 22716 is a mark of quality and displays a brands commitment to delivering quality products

[11:10] It promotes ethical behavior through your supply chain  

[11:50] It promotes regulatory credibility – Ensures your products meet regulatory requirements

[12:05] It gives assurance that your product ingredients also meet legal requirements

[12:40] Some ISO Standards can reduce insurance costs – This is something we’ll explore in future episodes!

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

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

Stitcher | Spotify | YouTube | iTunes | Soundcloud

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

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 21st 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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