兔死狐悲，看看加拿大发现了什么

beiwei5du

New comprehensive GMP Inspection Database available

Just recently a so called "inspection tracker" was launched by Health Canada. Now, the agency offers an additional database which contains 3,821 inspections (per March 2015) which have been performed since 2012 - many of them outside Canada, e.g. in Europe or Asia. The information is available in an online database. The use of the database is very easy and search results are excellent.

By using the database even inspections in progress can be displayed. This is a service no other agency can provide. The database also offers further information about past inspections at the same production site. No further search is necessary because the information about past inspections will be displayed in the search result for a given production site. The rating of the inspection is also provided, and in case of GMP non compliance a detailed and very structured information about the findings is provided. The quality of information about the outcome of the inspection available from the database is outstanding. Again, no other agency worldwide is able not only to list the observations but also link them to the concrete GMP regulation paragraph in a structured and numbered table.

The database also provides information about past and present non-compliance situations. However, it also shows when a company is currently licensed by Health Canada, as the company possibly improved its GMP status and was licensed again.

The database allows three different options to search for information. The first option contains 1,301 Inspections (per March 2015) from the past three years performed in Canada. A second option allows to access the non-compliance information. Currently 52 production sites with non compliance statements are listed in the database (some of the sites received their license again after re-inspection). The third option offers access to 2,520 inspections (per March 2015) performed outside of Canada.

To access the database please visit Health Canada Drug & Health product Inspections Webpage

GMP Inspection Report Card Summary

Establishment Name

Reference Number

Inspection Start Date

Type of Inspection

Inspection Rating

McKesson Canada Corporation1010762014-10-29Good Manufacturing Practices (GMP) - RegularNon-Compliant
Showing 1 to 9 of 9 entries
Show  entries

Filter items

Summary of Observations

Observation Number

Regulation

Summary of Observation

1C.02.013 – Quality Control Department

• There was no person on site or fully accessible to the quality control department who was responsible for making decisions concerning quality control requirements of the wholesaler.
• Deficiencies were noted with the process whereby a person on site or fully accessible to the quality control department was responsible for making decisions concerning quality control requirements of the wholesaler.
  

2C.02.015 – Quality Control Department

• Deficiencies were noted with procedures in place for various quality control operations.
• Deficiencies were noted with the procedure for the assessment of returned drugs being considered for resale
• The quality control department did not ensure that information concerning potentially defective products, other than complaints, was reviewed according to written procedures.
• Deficiencies were noted with customer complaint investigation and follow-up
• Deficiencies were noted with the implementation of guidelines put in place by the quality control department to ensure that storage conditions would maintain the quality and safe distribution of a drug.
  

3C.02.015 – Quality Control Department

• Deficiencies were noted with the implementation of guidelines put in place by the quality control department to ensure that storage conditions would maintain the quality and safe distribution of a drug.
  

4C.02.006 - Personnel

• Deficiencies were noted with the training of personnel with respect to GMP principles, relevant standard operations procedures and/or their specific job duties.
• Deficiencies were noted in the training program
• Personnel did not all have their specific duties recorded in a written description.
• Deficiencies were noted for the records of training in the principles of GMP that were maintained.
  

5C.02.015 – Quality Control Department

• Deficiencies were noted with the procedures for recording, handling, and tracking of deviations from standard processes.
  

6C.02.015 – Quality Control Department

• Deficiencies were noted with the implementation of guidelines put in place by the quality control department to ensure that storage conditions would maintain the quality and safe distribution of a drug.
  

7C.02.015 – Quality Control Department

• The quality control department did not ensure that information concerning potentially defective products, other than complaints, was reviewed according to written procedures.
  

8C.02.015 – Quality Control Department

• Deficiencies were noted with the qualification of equipment used to store refrigerated drug products.
  

9C.02.021 – Records

• Deficiencies were noted with documentation practices.
  

[url=]1[/url]

皇后

还是中文注解一下比较好

beiwei5du

@皇后 加拿大2015年上线的一个GMP检查数据库，能够看到一些不符合项具体内容（甚至也对不符合项目进行分类，比如属于质量控制部门，人员，文件还是记录等等方面），就像是FDA的warning letter

叶非

海正的消息，很早就听说了，但是这个检查结果，不知道是加拿大的检查还是共享的FDA的检查结果，但是FDA的警告信还没有查到！

一沙一叶

缺陷内容的链接在哪里啊

msdorothychen

好帖顶一顶。

msdorothychen

其实加拿大就是夹在欧美然并后面的那个