The commissioning of a facility, equipment, or system for operation under GMP regulations involves qualification that all operations are suitable for the intended purpose. The facility owner must have traceable verification of the systems, minimizing punchlist items to improve start-up and eliminate problems up front.
This article presents the most recent publication of GMP drug product inspection data from the FDA's Center for Drug Evaluation and Research (CDER), which addresses drug inspections conducted in FY2017. It looks at five years of data from the FDA, examines data from 2017, and evaluates five years’ worth of trends in GMP inspection enforcement.
FDA officials and leaders in the pharma and medical device spaces agree artificial intelligence (AI) tools could enable a step change in quality management in those industries. Areas that could be impacted include supply chain management, lot release, manufacturing, compliance operations, clinical trial end points, and drug discovery, among others.
This article emphasizes the importance of implementing a regular routine maintenance for inductively coupled plasma mass spectrometry (ICP-MS) equipment, so problem areas associated with instrumental components that are most susceptible to sample blockage, drift, and signal instability can be avoided.
Looking forward, the U.S. pharmaceutical industry needs to be aware that the despite the FDA’s year-long delay in enforcement, the Drug Supply Chain Security Act (DSCSA, with its specific compliance deadlines, is still law and that it is only draft guidance from the FDA that identifies an intent not to enforce the DSCSA for one year.
This article discusses the potential use and application of new science-based, data-derived scales in cleaning failure modes and affects analysis (cleaning FMEA) to assist in measuring the risk of cleaning process failures, as well as how these scales can be applied to develop a cleaning risk dashboard. It will also explain how these scales can be utilized to accelerate new product introductions.
Secondary packaging, at times an overlooked element of product life cycle management, should provide protection for the material or product across all the process steps.
The process of establishing a defendable environmental monitoring (EM) sampling plan during performance qualification of a new facility can be broken into six phases. This article will discuss the sampling preparation phase and sampling execution phase.
Many organizations with very robust QMSs routinely find themselves in a state of disarray and facing compliance issues when key members of the quality leadership team leave the organization.
Ever participated on one of those benchmarking exercises? You know what I mean: a (usually) fresh-faced consultant asks lots of questions and fills in a spreadsheet comparing what you do with your competitors. Well, beware.
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