Buildings and/or equipment must be properly maintained. According to the Code of Federal Regulations (21 […]
A company recently received the following observation: …. Process validation does not always include inclusion […]
A company recently received the following observation regarding lab data: ….. Established laboratory control mechanisms […]
According to the Code of Federal Regulations (21 CFR 211.192 Production Record Review), the failure […]
According to the Code of Federal Regulations (21 CFR 211.22(a) Responsibilities of quality control unit), […]
A company recently received the following observation: …. Procedures to ensure that all purchased or […]
A company recently received the following observation: …..Written procedures are not established for the cleaning […]
On November 15, 2020 GMP Trends® posted Issue #1052. In this issue, it explains how […]
A company recently received this 483 observation: ….. The written stability program for drug products […]
A company recently received this 483 observation: ….. Establishment of the reliability of the container […]