Revised EU GMP Annex I Contamination Control Strategy in Pharmaceutical industry l CCS in Pharma 

Revised EU GMP Annex I Contamination Control Strategy in Pharmaceutical industry l CCS in Pharma industry Question and answers
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Questions covered:
Q. When EU GMP Annex I has been updated or what are the deadline for coming into operation ?
Q. What is contamination control strategy as per revised EU GMP Annex I ?
Q. What is the scope of contamination control strategy given in EU GMP Annex I or where it is applicable ?
Q. Which two concepts are highlighted in the new version of Annex-I ?
Q. What are the key components that a Comprehensive Contamination Control Strategy (CCS) should include ?
Q. What is purpose of revision of Annex I with respect to contamination control strategy ?
Q. What elements needs to be considered for preparing CCS ?
Q. As per revised Annex I, what parameters and attributes should contamination control strategy include ?
Q. What is the limit as per revised EU GMP Annex I for Maximum permitted particle concentration and microbial contamination ?
Q. What key components comes under the consideration of Contamination control Strategy i.e. CCS ?
Q. What you will need to prepare proper contamination control strategy ?
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