New requirements for control of elemental impurities went into effect at the beginning of 2018, replacing the longstanding requirements for heavy metals. Elemental impurities guidances — International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q3D, U.S. Pharmacopeia (USP) General Chapter <232>, European Pharmacopeia (EP) 5.20 — are based on modern safety considerations specific to the elements identified.
Using a risk management tool such as preliminary hazard analysis, a periodic review frequency can be identified and applied to qualified equipment. This will enable a timely review of the equipment by means of pertinent data such as manufacturing performance trend data, change history, and/or deviation history.
This is the first in a five-part article series, Identifying And Resolving Errors, Defects, And Problems Within Your Organization. This article will enhance your understanding and prime you for visual detection of real trends in your organization by looking at a couple of examples. (You will understand the relationship between this picture and your quest for the quantitative truth by the end of this article.)
When weighing the operational and product constraints — batch size, container throughput, cost per unit, equipment utilization, facility footprint, cost per square foot, etc. — it is important to consider all of the options available to provide the most effective processing approach for the product manufacturer and, importantly, the best quality product for patients.
When looking at most job descriptions in GMP companies, they now require a college degree. This leads to the question: Are we overvaluing educational degrees and undervaluing experience in our hiring practices and position expectations?
Proposals for the use of visual inspection (VI) as an analytical method for cleaning validation have been rising for several years now. This article recommends the use of statistical techniques, and suggests how VI could be implemented as part of a strategy in a cleaning validation program based on risk level.
This article describes the basic principles of inductively coupled plasma mass spectrometry (ICP-MS), which is one of the recommended techniques for carrying out the elemental determinations.
Are you ready to give the FDA more? “What?” you ask, as a manufacturer of API and finished goods. Are you ready to give them more data and information about your manufacturing process? You think, “Don’t they get all the necessary information from me during their inspections and from my filings?” Well, the answer is yes and no.
This article describes the use of alternative rapid microbial methodologies during remediation activities at Pfizer pharmaceutical manufacturing facilities after Hurricane María struck Puerto Rico in fall 2017.
Identifying the best risk control options can be a challenging process without the ability to view all the information needed for the investment. By using a risk-benefit analysis tool, the unique opportunity arises to see the potential negative impact and the positive impact an option may pose.
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