GMP accreditation
I have been asked to help a company with ISO 22716:2007 GMP accreditation.
Unfortunately, my experience is within the Pharmaceutical industry only working with the TGA, APVMA, and ACO for 25 years + so I have no knowledge of what is required to be ISO accredited.
I visited the company yesterday and it would be starting from scratch as they just make all-natural, non-toxic, vegan skin care products which are filled, packed, and sent straight out to online customers only.
There is no testing of raw materials, packaging, or finished product.....
They have no documentation at all established and I was wondering if they need to be ISO 9001 Quality Management as well as being accredited for ISO 22716 GMP compliant for Cosmetics?
The company is looking to expand into the USA market.
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
There is no mandatory requirement that cosmetic companies need to be certified according to the ISO 9001. ISO 22716:2007 does not require a quality management system in total. Understanding global cosmetics product safety is an essential factor in implementing ISO 22716.
In ISO 22716, there is no need for the Quality manual, Management review. It requires an internal audit, a system for deviation (corrective actions, non-conforming products, out of specification product). Of course, all procedures covering the production process, traceability, hygiene rules, and GMP requirements are necessary.
The combination of ISO 9001 and ISO 22716 connects cosmetic product safety with overall business improvement tools.
Here you can see some information regarding ISO 9001:
- Free Gap Analysis Tool https://advisera.com/9001academy/iso-9001-gap-analysis-tool/
- Should you use a gap analysis in your ISO 9001 implementation? https://advisera.com/9001academy/17/use-gap-analysis-iso-9001-implementation/
- Checklist of ISO 9001 implementation & certification steps https://advisera.com/9001academy/knowledgebase/checklist-of-iso-9001-implementation-certification-steps/
- ISO 9001 Implementation diagram https://info.advisera.com/9001academy/free-download/iso-9001-implementation-diagram
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Jan 08, 2021