2018 - Good Documentation Guideline (Chapter USP)

Areas Covered in the Webinar:
US Pharmacopeia General Chapter <1029>:
History of the chapter as to how and why it was created
Purpose of development of this chapter
Chapter outline:
Principles of Good Documentation
Data collection & recording
Different types of GMP Documents:
Laboratory records
Equipment-related documentation
Deviations and investigations
Batch records
Certificate of Analysis (C of A)*
Standard Operating Procedure (SOP)*
Protocols & reports*
Analytical procedures*
Training documentation
Retention of documents