What is moving in pharma and biotech manufacturing, and what to do about it
Short, practical pieces from QLogixCMC on CMC, quality and compliance: the regulation as published, the way it is inspected, and an interactive figure in each post you can set to your own numbers.
Technology transfer3 min read
Onshoring drug manufacturing: the tech transfer and validation path to a US site
Onshoring moves a product's manufacturing to a site that has not made it before. The path is the same every time: a gap analysis between the sending and receiving sites, qualification of the facility and the equipment, transfer of the analytical methods, engineering batches, process performance qualification and a pre-approval inspection. The order in which those run decides whether the site is ready in a year or in two.
Read the postAI and digital quality3 min read
AI in the GMP quality system: what Annex 22 and your next inspector will ask
EU GMP Annex 22, published for consultation in 2025, is the first GMP text written for artificial intelligence. It allows AI in GMP work on conditions: a defined intended use, test data and acceptance criteria that show the model performs for that use, a person who reviews the output where the application is critical, and the model and its configuration under change control. Inspectors already ask the same questions of any site that has switched on an AI feature in its quality system.
Read the postSterile manufacturing3 min read
Annex 1 three years on: the contamination control strategy inspectors now read first
A contamination control strategy (CCS) is the document, required by the revised EU GMP Annex 1 since August 2023, that sets out how a sterile manufacturing site keeps microbial, pyrogen and particulate contamination out of its products: every control, from facility design and gowning to sterilization, aseptic process simulation and environmental monitoring, with the reasoning that connects them and the data that shows they work. Three years on, inspectors ask for it first, and the gap they find most is not a missing control but a missing connection between the controls and the data.
Read the postValidation3 min read
Computer software assurance: how much testing does your system actually need?
Computer software assurance (CSA) is FDA's risk-based approach to establishing confidence that software used in production and in the quality system does what it is intended to do. Its point is that testing effort follows the risk of each function: scripted, documented testing where a failure could affect product quality or patient safety, and unscripted or ad hoc testing, with the result recorded, everywhere else. Most validation packages still test every function the same way.
Read the postCMC and regulatory3 min read
Comparability for cell, gene and mRNA therapies: proving a process change left the product unchanged
Comparability is the evidence that a product made after a manufacturing change is still the product the clinical data describes. For cell, gene and mRNA therapies the change is almost certain: processes move from academic to commercial scale, from open to closed, from one site or vector supplier to another, often during the pivotal trial. The statistics are unforgiving. With three lots on each side, a real shift and ordinary lot-to-lot variability look alike, and the study fails for lack of data rather than lack of comparability.
Read the postInvestigations and CAPA3 min read
Why 21 CFR 211.192 stays the most-cited observation, and how a backlog really comes down
21 CFR 211.192 requires every unexplained discrepancy and every failure of a batch to meet its specifications to be thoroughly investigated, extended to other batches that may have been affected, and recorded with conclusions and follow-up. It has topped FDA's list of drug GMP observations for years because the failure is systemic rather than technical: too many open records, investigations that stop at human error, and CAPAs that are never checked. A backlog is arithmetic before it is anything else.
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Talk it through with someone who has run a plant
Bring your backlog, your submission timeline or the Form 483. We will tell you plainly what we would do first, what it would take, and what we would leave alone.
In the first meeting we cover
- What is on your mind: a backlog, a submission, a validation program, an inspection date or a system that is not working
- What we would assess first, and what we would leave alone
- Whether an engineer on your site, a fixed-scope assessment or a defined deliverable is the right way to start