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Process Validation
Oral Solid Dosage , 16 April, (1 comment)
For Health Authorities Informs, It is necessary includes in the validation report (process), a stati ...

Time required to establish a containment.
Containment, 15 April, (3 comments)
How much time do you need to buy a containment system or modify an existing system. From the idea t ...

Potent powder Sterile filling.
Containment, 15 April, (1 comment)
For Sterile Filling of Potent powder, if there is no possibility of using Isolator and there is poss ...

Qualified Volunteers Needed for FDA Guidance Reviewers
Investigational Products, 11 April, (2 comments)
ISPE is seeking qualified individuals to review revisions to the FDA draft Guidance for Industry: An ...

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