According to the Code of Federal Regulations (21 CFR 820.100 Corrective and Preventative Action), each […]
On November 15, 2021 GMP Trends® posted Issue #1076 featuring observations pertaining to data integrity […]
A company recently received the following observation: …..Written MDR procedures have not been developed, maintained […]
According to the Code of Federal Regulations 21 CFR 820.90(b)(2): Each manufacturer shall establish and […]
Raw material testing is essential to ensure the identity, strength, quality, and purity of the […]
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 […]