What are the GLP requirements for labeling of reagents purchased directly from manufacturers?
All reagents used in a nonclinical laboratory have to be labeled to indicate identity, titer or concentration, storage requirements, and...
Month: September 2022
What is an Organization ID Number (Org ID)?
Org ID is a system-generated number assigned to a new organization during the User Fee account creation process that uniquely...
How does the FDA interpret the regulations (21 CFR Part 211)
How does the FDA interpret the regulations (21 CFR Part 211) regarding the establishment of expiry dating for chemicals, reagents,...
When billing for anesthesia time, What is the proper way to bill?
When billing for anesthesia time, are we supposed to round incomplete units of anesthesia time up or down, or leave...
How do I know if my 990 has been filed?
To check the status of your electronic filing, log into the Form 990 Electronic Filing System (e-Postcard) and go to...
What are the 5 main components of good manufacturing practice?
The Five P’s of GMP in Pharmaceutical Careers People and GMP Training. The GMPs for a manufacturing facility must be...
Recommended Minimum Requirement for the Height of the Bed Rails
Is there an accepted recommended minimum requirement for the height of the bed rails above the top of the mattress...
Credit Memorandum – Overview, Definition and Example
A credit memo or credit memorandum is a document issued by the seller of goods or services to the buyer,...
ISO 2768 – General Geometrical Tolerances and Technical Drawings
ISO 2768 and derivative geometrical tolerance standards ISO 2768–mk and ISO 2768–fh are intended to simplify drawing specifications for mechanical...
What is GxP impact?
The GxP impact assessment is carried out to determine if the computer system has an impact on product quality, patient...
