Blackmores ISO Consultancy Service: The creators of isology®

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

• isologyhub
• Blackmores ISO 22716 Implementation

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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