When addressing the requirements of analytical test procedures, 21 CFR 211.160 states: “Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.” 21 CFR […]
The WHO has a draft July 2013 guidance document titled “Deviation Handling and Quality Risk Management” that addresses the concept that not all Quality Events are equivalent and provides consideration for the classification of events. For example, an incident would be an event that does not: “…affect a product attribute, manufacturing operational parameter or the […]
Working in the pharmaceutical industry, you can sometimes hear science and compliance talked about as if they are separate and unrelated. Two examples of what can be heard: “Oh well, that is more of a compliance risk than a scientific concern.” “You need to consider the compliance aspect of that change and then the scientific […]
I think we would all agree that the above saying very much applies to addressing any issues with the health of any firm’s Quality Management System. It is far less painful when your own Quality Oversight (QO) system self-identifies events rather than having them pointed out by a regulator during a health agency inspection, which […]
A review of recent Form 483s and Warning Letters shows that investigations continue to be a focus of FDA inspections, where the following citation is commonly issued: There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether […]
For the last several years, there has been a push in the industry to take a systematic approach and design quality into your systems and processes by establishing up front requirements such as QTPP for process validation and ATP for analytical methods. Such an approach provides invaluable benefits to the public whereby, the manufacturer has […]
ICH Q7 refers to the need to establish the impurity profile for an Active Pharmaceutical Ingredient (API): “An impurity profile describing the identified and unidentified impurities present in a typical batch produced by a specific controlled production process should normally be established for each API. The impurity profile should include the identity or some qualitative […]
The FDA has issued a white paper on “CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development.” The paper details a program the center intends to establish whereby the goal is to promote QMM throughout the industry. Lachman recently issued a blog relating to this initiative that can be found here. […]
Reference standards are used ubiquitously within a Quality Control laboratory and are integral to many test procedures. A laboratory should have defined controls for the use, handling, inventory management, and characterization of these standards, as well as consulting the WHO’s Annex 3 for “General guidelines for the establishment, maintenance, and distribution of chemical reference substances,” which […]
When a firm is evaluating the effectiveness of their investigation program (as part of assessing the effectiveness of the Quality Management System (QMS)) the focus tends to be towards evaluating the quality / robustness of the resulting investigations. However, one of the questions that should also be asked is are investigations being initiated when required? […]
