Good Documentation Practices for Laboratory Records

Danielle DeLucy, M.S.

Course description

In FDA’s Guide to Inspections of Pharmaceutical Quality Control Laboratories (7/93), it is stated The pharmaceutical quality control laboratory serves one of the most important functions in pharmaceutical production and control. A significant portion of the CGMP regulations (21 CFR 211) pertain to the quality control laboratory and product testing. Good documentation practices are expected to assure they are accurate, legible and traceable to name a few. The lack of such good documentation practices is routinely cited in FDA 483 observations.

This course is designed to provide sound training on good documentation practices in the laboratory. Good Documentation Practices (GDP) are a current industry practice that is reviewed and cited by federal regulators when audited. Pharmaceutical/Biological document are legal documents that are controlled by all regulatory agencies. The person or persons responsible for filling out these documents accepts the consequences if the documents are not filled out according to good documentation practices.

Upon completion of this course, you will be able to:

• Define good documentation practices (GDP)
• Cite examples of documentation practices that should be avoided.
• Summarize examples of good documentation practices and what they apply to.
• Describe practices for correcting mistakes or when space is limited for comments
• Explain FDA 483 citations given to companies

This training is one part of the 10-course series required for the GMP Laboratory Control Professional Certification Program. Attend this course as part of the certification process or as a stand-along course for personal career advancement and training.