Life Sciences Glossary
Definitions of the pharmaceutical, GxP, manufacturing and clinical terms that come up in regulated work, each with the practical detail behind the one-line answer.
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- 21 CFR Part 11Quality & Compliance
- 21 CFR Part 11 is the FDA regulation that sets the conditions under which electronic records and electronic signatures are treated as equivalent to paper and handwritten signatures, covering audit trails, access control, system validation and record retention.
A
- Active Pharmaceutical IngredientManufacturing & Supply
- The active pharmaceutical ingredient is the component of a medicine that produces its therapeutic effect — the drug substance itself, before it is combined with excipients and made into a dosage form.
- ALCOA+Quality & Compliance
- ALCOA+ is the set of principles regulators use to judge whether GxP data can be trusted: attributable, legible, contemporaneous, original and accurate, plus complete, consistent, enduring and available.
- Aseptic ProcessingSterile Manufacturing
- Aseptic processing is the manufacture of a sterile product by separately sterilising the drug, the container and the closure, then combining them under conditions that prevent contamination — used when the finished product cannot survive terminal sterilisation.
B
- BiosimilarModalities
- A biosimilar is a biologic medicine shown to be highly similar to an already-approved reference biologic with no clinically meaningful differences in safety, purity or potency — the biologic analogue of a generic, but never an identical copy.
C
- CDMOManufacturing & Supply
- A CDMO is a contract organisation that both develops and manufactures drug products for other companies, combining process development and analytical work with commercial manufacturing capacity under the sponsor's regulatory filing.
- cGMPQuality & Compliance
- cGMP is the FDA's enforceable standard for how medicines must be manufactured, requiring that a drug's identity, strength, quality and purity are built into the product by the process rather than tested into it afterwards.
D
- DSCSAManufacturing & Supply
- The DSCSA is the US law requiring an interoperable, electronic, package-level traceability system for prescription drugs, so that any unit can be traced through the supply chain and verified as legitimate.
E
- eCTDRegulatory Affairs
- The eCTD is the electronic format regulators require for drug submissions, structuring an application into five standard modules and maintaining it as a cumulative lifecycle in which each sequence amends what came before.
- ExcipientFormulation
- An excipient is any substance in a drug product other than the active ingredient — included deliberately to make the product manufacturable, stable, deliverable or usable, and never genuinely inert.
G
- GAMP 5Quality & Compliance
- GAMP 5 is ISPE's risk-based guidance for validating computerised systems in regulated life sciences, organising software into categories and scaling validation effort to patient risk rather than applying one procedure to everything.
- GxPQuality & Compliance
- GxP is the collective name for the Good Practice regulations governing regulated life-sciences work — GMP for manufacturing, GCP for clinical trials, GLP for non-clinical safety studies, GDP for distribution — where the x stands in for the discipline.
I
- ICHRegulatory Affairs
- ICH is the body through which regulators and industry from major regions agree common technical guidelines for drug development and registration, so that one set of studies can support applications in multiple countries.
- ICSRSafety & Pharmacovigilance
- An ICSR is the structured record of an adverse event experienced by a single patient with a single medicine, and it is the unit of exchange in pharmacovigilance — the format regulators require for reporting safety data.
L
- LyophilizationSterile Manufacturing
- Lyophilization is the removal of water from a frozen product by sublimation under vacuum, producing a dry cake that is stable at ambient temperature and reconstituted before use — the standard route to shelf-stable biologics and vaccines.
P
- PharmacovigilanceSafety & Pharmacovigilance
- Pharmacovigilance is the science and practice of detecting, assessing, understanding and preventing adverse effects of medicines, running continuously from first-in-human dosing through the entire commercial life of a product.
- Process ValidationQuality & Compliance
- Process validation is the documented evidence that a manufacturing process, operated within defined parameters, consistently produces product meeting its quality attributes — established as a lifecycle rather than a one-time exercise.
Q
- Quality by DesignFormulation
- Quality by Design is a development approach in which product quality is designed into the process from a foundation of scientific understanding, rather than being demonstrated afterwards by testing finished batches.