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We have recently coached a number of COSTCO GMP audit projects, which are very different from the regular customer audits, especially the standards adopted by the COSTCO GMP audit. The project mainly includes two audit reports of QMS and C&C, and also specifies ITS to adopt SQP.
At present, customers must entrust SGS, ITS and BV to conduct GMP audits.
There have been significant inconsistencies in the audit criteria used in previous audits. Since June 2015, COSTCO has redefined the adopted standards. The entire audit not only uses the scoring system, but also the scores of the final audit report. At the same time, it also needs to look at the problems found, such as minor/moderate/major/critical, etc., and also according to the level of red orange yellow green.
From the overall rating, it is mainly divided into 5 levels.
In addition, each level looks at the nature of the problem points involved. If the score is low or involves serious problems, the client will request a full or partial review. If the score reaches a certain level and there are no serious problems, the audit is valid for 1 year or half a year. Otherwise it will take 1-3 months for on-site review.
In addition, a written CAP is required in the Costco GMP audit and must be completed in English. There is a lot of content, high requirements, and sometimes even proof of improvement is required. The auditing company will review and check the submitted English CAP and the improved evidence one by one. In the past, many CAPs and improvement evidence submitted by many factories were repeatedly called back to the company for re-editing and submitting, which made the foreign trade factory annoying.
