In response to the COVID-19 public health emergency, the FDA is limiting unnecessary contact by […]
Standard Operating Procedures (SOPs) are essential to your business. They explain how every job and […]
Proper storage of pharmaceutical products is important to ensure the identity, strength, quality, and purity […]
GMP training is an important part of your company’s compliance, and helps ensure that your […]
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 […]