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The International Pharmaceutical Certification Cooperation Organization (PIC/S) issued and took effect on July 1st the final guidelines for the "Good Practices for Data Management and Integrity in a Regulated GMP/GDP Environment"
The guide was first introduced in 2016, and a revised draft was released in 2018
PIC/S PI 041-1
GOOD PRACTICESFORDATAMANAGEMENT ANDINTEGRITYINREGULATED GMP/GDPENVIRONMENTS
Good practices for data management and integrity in a regulated GMP/GDP environment
Because the original text is too long, friends who need the full text can download it as follows:
Official original download
https://picscheme.
Chinese and English download
Link: https://pan.
Extraction code: smdh