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How Mature is Your Quality Management Program?

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. […]

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How Well Do You Know Your Reference Standards?

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 […]

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Are You Initiating Quality Investigations When Required?

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? […]

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ICH Q13 – Continuous Manufacturing of Drug Substances and Drug Products

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 […]

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Investigations and Third Parties – Beware!

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 […]

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Are your Analytical Methods Processing Settings Part of Your Analytical Lifecycle Management Program?

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 […]

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Comparability Protocols

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 […]

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Know Your Systems!

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 […]

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Female chemist at work in laboratory.

System and Sample Suitability – Know the Whole Story!

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: […]

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