ISO 80369-7 is the newly published standard that replaces the ISO 595 series of standards. The ‘Part 7’ standard is [...]
Modern cleaning validation procedures must be implemented to prove that the equipment is reasonably free of any residue. It must be documented to be safe, causes no product quality concerns, and the process is contaminant-free in accordance with FDA, cGMPs, and USP guidelines.
Quality Assurance Units must provide assurance that the validation process has produced the expected results as per the requirements of USP General Chapter <233> Elemental Impurities in accordance with <1225> Validation of compendial procedures
Pharmaceutical products should contain low levels of residual solvents as determined by safety data. The presence of residual solvents in pharmaceutical products needs to be determined through testing
Three years ago, the executive management of Whitehouse Laboratories implemented a major reorganization plan. Over the previous ten years, the company had experienced many areas of growth to include e
implementing an intern program for college students specific to engineers, chemistry, biology and material science students can lead to a mutually rewarding results