According to the Code of Federal Regulations (CFR), 21 CFR 211.125 strict control shall be […]
Download the Emergent FDA 483 Report for free using promo code emergent-483 Recently Emergent BioSolutions […]
A company recently received the following observation: ….. The Quality Unit is not involved in […]
GMP Trends has seen multiple observations related to cleaning validation cited by the U.S. FDA […]
Do you have sufficient information in your complaint investigations? Do your investigation reports include conclusions […]
Management Review is all about reviewing the available data to confirm that adequate resources are […]
The purpose of stability testing is to provide evidence on how the quality of a […]
According to the Code of Federal Regulations (CFR), the device history record is a compilation […]
Good Documentation Practices, also known as GDocP, is an important function of Good Manufacturing Practices […]
Water is a versatile component used in the pharmaceutical industry. It can be used as […]