'To stay in compliance with regulations, pharmaceutical, medical, and biotech companies must create qualtiy SOPs that build in the regulatory requirements into actions and describe personal flow, internal flow, flow of information, and processing steps. Quality Operations Proced…
Quality assurance is necessary to maintain quality and services in the pharmaceutical and life science industries. Quality assurance demonstrates that the logic and practice of problem solving can integrate both program efficacy and regulatory compliance. This title is divided i…
Cleaning validation: a practical approach
by Bismuth, Gil, Neumann, Shosh, CRC Press LLC
An examination of US law and governmental policy affecting domestic and multinational pharmaceutical manufacturing. It recommends pragmatic ways to interpret and comply with FDA current good manufacturing practice (CGMP) regulation and related criteria.
