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[其他] 审核供应商时使用的标准

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发表于 2018-11-7 11:48:23 | 显示全部楼层 |阅读模式
本帖最后由 roadman 于 2018-11-7 12:08 编辑

Standards to use when auditing suppliers
by Dominic Parry | Jul 4, 2016
If you are working to Good Manufacturing Practice (GMP) then you will need to audit many of your suppliers.  These could be suppliers of chemicals and packaging components, as well as suppliers of analytical testing or calibration services.  GMP does not really tell you what pharmaceutical supplier standards  you should or could use when auditing your suppliers. So, below is a list of all the key standards to use when auditing suppliers to GMP requirements including links to all of the key documents and authorities.
Type of supplier
Standard to use
Available from
Active ingredientsUse Active Pharmaceutical GMP (EU GMP Part 2 or ICH Q7)Available for free from the European Union’s Eudralex website.
Excipients (chemicals that are not the active ingredient)Use the Joint IPEC – PQG Good Manufacturing Practices Guide for pharmaceutical excipientsAvailable for free from the International Pharmaceutical Excipient Councils (IPEC’s) website.
Contact packaging materialsUse either
ISO 15378 (Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001, with reference to GMP)
or
PS 9000 (Pharmaceutical Packaging Materials for Medicinal Products)
Available to buy from the International Standards Organisation’s website


Available for free from the Pharmaceutical Quality Group’s website.
Packaging materialsUse PS 9000 (Pharmaceutical Packaging Materials for Medicinal Products)Available for free from the Pharmaceutical Quality Group’s website.
External testing laboratoriesUse ISO 17025 (General requirements for the competence of testing and calibration laboratories)
AND
relevant parts of GMP (such as Chapter 6 of EU GMP)
Available to buy from the International StandardsOrganisation’s website

Available for free from the European Union’s Eudralex website
Calibration companiesUse ISO 17025 (General requirements for the competence of testing and calibration laboratories)Available to buy from the International Standards Organisation’s website
Contract manufacturersUse the relevant GMP standard for the country or region that they are in, such as EU GMPAvailable for free from the European Union’s Eudralex website.
Transportation companiesUse the EU’s Good Distribution Practice (GDP) guidelinesAvailable for free from the European Union’s Eudralex website
Other suppliersUse ISO 9001 (Quality management systems – Requirements)Available to buy from the International Standards Organisation’s website
I hope that list of standards to use when auditing suppliers is helpful.  Feel free to add any comments or any additional guidelines and standards that may be of interest.  If you are interested in supplier auditor training, then do consider our IRCA registered PQMS Pharmaceutical Lead Auditor training course.

发表于 2018-11-7 13:05:31 | 显示全部楼层
有中文翻译吗
发表于 2018-11-7 13:20:26 | 显示全部楼层
学好英语是多么的重要。
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