Software as a Service (SaaS) is a cloud computing delivery model that promises various benefits, but also comes with unique risks. The life science sector has very slow cloud adoption rate. One of the potential reasons for this phenomenon, as highlighted by GAMP Cloud Special Interest Group (SIG ) is the lack of regulatory and […]

Successful product validation depends on operational readiness: facility and equipment, development knowledge with thorough analytical and process design documentation, trained cross functional staff at the manufacturing site and a robust formulation and process. Prior to the validation phase, successful technical transfer must be completed with robust information transfer from development to manufacturing. The validation process […]

This paper addresses how to qualify a Biological Safety Cabinet(BSC) and includes a description for Installation and Operational Tests that should be included as part of the Qualification process. Despite having robust design and environmental monitoring, cleanrooms are at risk for several sources of contamination. In this case, BSCs, if purchased with much consideration, are […]

In 2018, the FDA released “Data Integrity and Compliance with Drug cGMP, Questions and Answers, Guidance for Industry.” Between 2015 and 2019, the number of 483 observations written globally increased by more than 10%. The increase indicates that either the industry is still catching up to compliance expectations or the FDA is inspecting with greater […]

In drug manufacturing, keeping track of data is crucial for the drug’s approval from the FDA. The “Continued Process Verification” (CPV) data needs to be maintained for ensuring that the product outputs are within predetermined quality limits. In spite of rising demand for the creation of digital data directly at the source itself, some companies […]