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? […]
CDER has issued the final guidance, ICH Q13 Continuous Manufacturing of Drug Substances and Drug Products, which provides for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM), applying to both drug substances and drug products for chemical entities, therapeutic proteins for new products, and conversion of existing products. A copy of the guidance […]
Most companies will recognize and state that their most important assets are the people who work for them, which is naturally also the case for the pharmaceutical industry. It goes without saying that the number of staff and their competency can have a consequential impact on product quality/patient safety, and this is recognized by health […]
ICH Q10 (here) states the following as it relates to outsourcing activities and purchasing materials (hereafter referred to as third party): “The pharmaceutical quality system, including the management responsibilities described in this section, extends to the control and review of any outsourced activities and quality of purchased materials. The pharmaceutical company is ultimately responsible to […]
Processing of the laboratory instrumentation output such as the processing of chromatographic raw data continues to be a focus of global health agency investigators. This is not surprising, as the investigator will be aware of the Data Integrity (DI) risks with such a manual operation, where there is the potential of selectively adjusting integration settings […]
The CDER has issued a final guidance titled Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA (here), addressing the role of comparability protocols (CPs) for post-approval changes to the CMC sections of NDAs, ANDAs, and BLAs where the CP is a prospectively written plan for […]
It is evident from reviewing recent health agency citations that the FDA expects that firms have a deep understanding of any systems that generate data/records and that this is reflected in the firm’s lifecycle management of those systems. What does that mean, in a practical sense? Well, a component of this understanding must extend to […]
Within the draft ICH Q14 “Analytical Procedure Development” guidance document (here), Section 6 refers to the Analytical Procedure Control Strategy. This should be developed prior to and confirmed via Analytical Method Validation. A key component of the Analytical Procedure Control Strategy is System Suitability (SST), but the guidance document also makes reference to sample suitability: […]
