Pharmaceutical Quality System (PQS) - Key Questions and Answers - II

#pharmaceutical #quality #pqs #fda #europa #who #gmp #ich
This learning video will discuss below questions and answers below in line with the regulatory guidelines.
If you have any question/s, please put your questions in the comment section. I will reply to you.
1. Whether GMP guidelines expect to have Quality KPIs (Key Performance Indicators)? Does the guideline use this KPI terminology?
2. As per the GMP guideline, an adequate number of personnel should be present. How to identify the personnel are adequate or not?
3. The self-inspection and Quality audits are same?
4. The internal audit reports can be accessed by FDA?
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[@ashokdara2115]

Hello Sir, I didn't find KPI in ICH Q7

[@hitendrakumarshah3718]

You need to refer APIC guide - interpretation of ICH Q7 guide

[@Kumar900]

Is self inspection only for production and QC.???

[@hitendrakumarshah3718]

No, it is applicable for all GMP impacting department/functions

[@vinayakdumka5247]

Good evening

[@hitendrakumarshah3718]

Thank you

[@seshukumari306]

Kkkkp​@@hitendrakumarshah3718

[@vinayakdumka5247]

Hello sir

[@hitendrakumarshah3718]

Hello