ICH guideline Q1A(R2), states that “the purpose of stability testing is to provide evidence on […]
Line clearance is an integral part of every facility’s standard operating procedure in order to […]
According to the Code of Federal Regulations (21 CFR 211.42 Design and Construction Features), any […]
A company recently received the following observation regarding CAPA: …. Procedures for corrective and preventive […]
January is a time when all facilities should revisit their quality strategy, and adjust it […]
Welcome 2023! May this new year be full of adventure and growth. To help you […]
The purpose of equipment and instrument calibrations is to ensure accurate measurements. The FDA defines […]
Second person verification is an essential part of GMP compliance. The job of the second […]
Employee training is a vital part of any robust quality management plan. GMP Trends Annual […]
According to 21 CFR 820.30(g), as part of the design validation process, risk analysis must […]