A to Z, 38 entries

The glossary

Plain-language definitions for common tech transfer, process validation, drug product, CDMO, and regulatory CMC terms. Each definition distinguishes between what the term means and where it comes from in regulation or guidance.

Educational use only

These definitions are for learning purposes. Always verify current definitions against primary regulatory sources before using in quality documentation.

A 02 entries

AAVDrug Product: Adeno-Associated Virus. A small, non-enveloped viral vector engineered to deliver a therapeutic gene into target cells, the platform behind most approved and in-development gene therapies. AAV process validation contends with vector genome titer, capsid ratio, and potency assays that do not map cleanly onto small-molecule validation approaches.
AutologousDrug Product: A cell therapy manufactured from a patient's own cells and returned to that same patient, as opposed to allogeneic therapy made from a donor for multiple patients. Autologous manufacturing means every batch is a single patient lot, with chain of identity and chain of custody as validation-critical as the process itself.

B 01 entry

BLARegulatory CMC: Biologics License Application. The FDA marketing application for biologic products, including most cell and gene therapies and many advanced RNA-based therapeutics, submitted under the Public Health Service Act. The CMC section of a BLA has to be internally consistent with everything the process validation and tech transfer programs actually did.; Source21 CFR Part 601

C 05 entries

CAPACDMO Governance: Corrective and Preventive Action. The quality system process for investigating a deviation's root cause, fixing the specific occurrence, and preventing recurrence. A CAPA closed on the date its corrective action was implemented, with no effectiveness check confirming the failure mode actually stopped recurring, is one of the most common gaps a sponsor finds when reviewing a contract manufacturer's quality system.; SourceICH Q10
CCITDrug Product: Container Closure Integrity Testing. Deterministic or probabilistic methods that verify a container closure system maintains a microbial and physical barrier over its shelf life, in place of or alongside sterility testing. USP <1207> is the reference chapter for method selection and validation.; SourceUSP <1207>
Cpk / PpkProcess Validation: Process and performance capability indices. Cpk measures how well a process, once in a state of statistical control, fits within its specification limits; Ppk measures the same fit using overall process variation, including shifts and drifts over time. Both are standard evidence in a PPQ or CPV report.
CPVProcess Validation: Continued Process Verification. Stage 3 of the FDA process validation lifecycle: an ongoing program that collects and analyzes routine production data to provide statistical assurance the process remains in a state of control after PPQ. CPV is what keeps a validated process validated.; SourceFDA Process Validation Guidance (2011)
CTARegulatory CMC: Clinical Trial Application. The submission required by many non-US regulators, broadly the international equivalent of a US IND, authorizing a sponsor to begin a clinical trial in that jurisdiction. CTA CMC requirements often diverge from IND expectations enough to need a dedicated gap assessment.

D 02 entries

Design SpaceProcess Validation: The multidimensional combination of input variables and process parameters that has been demonstrated to provide assurance of quality, as defined under ICH Q8(R2). Operating within an approved design space is not considered a change requiring further regulatory approval, which is exactly why establishing one is worth the up-front characterization work.; SourceICH Q8(R2)
DOETech Transfer & NPI: Design of Experiments. A structured, statistical approach to varying multiple process parameters at once to understand their effects and interactions, instead of changing one variable at a time. DOE studies during characterization are what let you defend a proven acceptable range at PPQ and beyond.; SourceICH Q8(R2)

E 02 entries

E&LDrug Product: Extractables and Leachables. Extractables are compounds that can be pulled out of container closure, manufacturing, or delivery system materials under aggressive lab conditions; leachables are the subset that actually migrate into the drug product under normal storage and use. E&L assessments are central to selecting and qualifying primary packaging.; SourceUSP <1663>/<1664>
Engineering RunTech Transfer & NPI: A non-GMP or GMP trial batch run at scale before PPQ, used to confirm the process, equipment, and facility fit are ready, work out operational issues, and generate data that supports the PPQ protocol and sampling plan. A weak engineering run strategy is one of the most common reasons PPQ campaigns run into trouble.

F 01 entry

Fill-FinishDrug Product: The set of drug product manufacturing steps that take bulk drug substance or formulated bulk through final filling into vials, syringes, or cartridges, stoppering, sealing, inspection, and labeling. Fill-finish is frequently outsourced to a specialized CDMO even when drug substance manufacturing is not.

G 02 entries

GalNAcDrug Product: N-acetylgalactosamine conjugate. A targeting ligand chemically conjugated to an oligonucleotide therapeutic that binds the asialoglycoprotein receptor, concentrated on liver hepatocytes, to drive tissue-specific uptake without a separate delivery vehicle like an LNP. GalNAc conjugation changes the drug substance and drug product control strategy compared to an unconjugated or LNP-delivered oligonucleotide.
GAMP 5Process Validation: ISPE's risk-based framework for validating computerized systems, now in its second edition, published 2022. Categorizes a system by how it was built, infrastructure, non-configured, configured, or custom, to set the validation evidence a plan can build on; a Validation Master Plan's own GxP-impact risk tier still decides how deep that validation actually needs to go.; SourceGAMP 5 (2nd ed., 2022)

H 01 entry

Hold TimeProcess Validation: The maximum allowable duration a material, intermediate, or in-process sample can sit between defined process steps while remaining within specification. Hold time studies establish these limits with real stability data, not assumption, and gaps here are a common source of unplanned deviations during tech transfer.

I 02 entries

INDRegulatory CMC: Investigational New Drug application. The FDA submission that must be active before a sponsor can ship an investigational product across state lines for a clinical trial. The CMC section documents manufacturing, controls, and enough process and analytical understanding to support the proposed clinical risk.; Source21 CFR Part 312
INTERACT MeetingRegulatory CMC: Initial Targeted Engagement for Regulatory Advice on CBER Products. A nonbinding CBER meeting available before an IND, ahead of pivotal nonclinical safety studies, for early feedback on a novel product concept spanning CMC, pharmacology and toxicology, and clinical questions. Typically precedes the standard pre-IND meeting rather than replacing it.

L 02 entries

LNPDrug Product: Lipid Nanoparticle. A lipid-based delivery vehicle that encapsulates nucleic acid payloads such as siRNA or mRNA and protects them until they reach the target cell. LNP formulation and manufacturing, including microfluidic mixing and downstream processing, are highly sensitive to scale and equipment changes during tech transfer.
LyophilizationDrug Product: Freeze-drying. A drug product process that removes water from a formulation under vacuum after freezing, used to stabilize products that are not stable as a liquid for their intended shelf life. Cycle development, primary and secondary drying validation, and reconstitution testing are the core validation deliverables.

M 02 entries

MACOProcess Validation: Maximum Allowable Carryover. The calculated limit for how much residue from a previous product may remain in shared equipment before the next product is manufactured, without posing a safety risk. MACO drives cleaning validation acceptance criteria and swab or rinse sampling design.
MPICDMO Governance: Master Production Instructions. The controlled, step-by-step manufacturing instruction set for a process, the document that actually gets executed on the floor or transferred to a receiving site or CDMO. Every parameter, in-process control, and hold point in the process should trace back to the MPI.

N 01 entry

NPITech Transfer & NPI: New Product Introduction. The structured process of bringing a new product, process, or technology into a manufacturing site for the first time, covering technical readiness, facility fit, personnel training, and the risk assessments that precede the first engineering run.

P 07 entries

PAIRegulatory CMC: Pre-Approval Inspection. The FDA inspection of a manufacturing facility conducted before a marketing application can be approved, focused on confirming the process performs as described in the application and that the site can consistently execute it. PAI readiness is where tech transfer, validation, and CMC authoring all have to agree with each other.
PAS / CBE-30Regulatory CMC: Prior Approval Supplement and Changes Being Effected in 30 days, the two most common FDA post-approval submission vehicles under 21 CFR 314.70 for an NDA or 601.12 for a BLA. A PAS requires FDA approval before a change with major potential effect on identity, strength, quality, purity, or potency can be implemented; a CBE-30 change, with moderate potential effect, is implemented after a 30-day FDA review window unless the agency objects within it. A change with minimal potential effect is reported only in the product's Annual Report, with no pre-implementation filing at all.; Source21 CFR 314.7021 CFR 601.12
PDEProcess Validation: Permitted Daily Exposure. A toxicology-based safety threshold expressing the maximum daily dose of a residual substance considered safe by any route of administration. PDE values from ICH Q3D and cleaning validation risk assessments feed directly into MACO calculations.; SourceICH Q3D
PFSDrug Product: Pre-Filled Syringe. A drug product presentation where the syringe is filled and sealed at the manufacturer, ready for administration without a separate transfer or reconstitution step. PFS programs add container closure, siliconization, and device-combination considerations on top of standard fill-finish validation.
PIC/SProcess Validation: Pharmaceutical Inspection Co-operation Scheme. A network of participating regulatory authorities, including the FDA since 2011, MHRA, Health Canada, TGA, Swissmedic, and most EU member-state authorities, that harmonizes GMP inspection approaches and training. PIC/S publishes its own recommendations, including PI 006, Recommendation on Qualification and Validation, worth citing by current version in a Validation Master Plan built to satisfy more than one regulator.; SourcePIC/S PI 006-4
PIPCDMO Governance: Person-In-Plant. A sponsor representative stationed at a CDMO, full-time or campaign-based, to provide real-time technical oversight of manufacturing, review data as it is generated, and escalate deviations immediately rather than after the fact. A PIP program is the sponsor's eyes on a process it does not directly operate.
PPQProcess Validation: Process Performance Qualification. Stage 2 of the FDA process validation lifecycle: a defined number of full-scale commercial batches manufactured under an approved protocol to demonstrate the process reliably produces product meeting its predetermined quality attributes. PPQ success is the gate before a process can support commercial supply.; SourceFDA Process Validation Guidance (2011)

Q 02 entries

QbDProcess Validation: Quality by Design. A systematic development approach, defined in ICH Q8(R2), that builds quality into a product and process through defined quality target product profiles, critical quality attributes, and an understanding of how process parameters affect them, rather than testing quality in at the end. QbD output is what makes a defensible control strategy possible.; SourceICH Q8(R2)
Quality AgreementCDMO Governance: A written agreement between a sponsor and a contract manufacturer defining which party performs which GMP-relevant activity, described in FDA's 2016 guidance on contract manufacturing arrangements as the tool for keeping responsibility unambiguous across the relationship. A person-in-plant program's scope and escalation authority should trace back to language in this agreement, not to an informal understanding between individuals.; SourceFDA Contract Manufacturing Quality Agreements Guidance (2016)

R 02 entries

RMATRegulatory CMC: Regenerative Medicine Advanced Therapy. An FDA designation, established under the 21st Century Cures Act and granted by CBER, for a product intended to treat, modify, reverse, or cure a serious condition where preliminary clinical evidence suggests it can address an unmet medical need. Carries Fast Track and Breakthrough Therapy benefits plus more frequent FDA interaction and potential rolling review; it changes the pace of engagement, not the CMC evidentiary bar.
RTQRegulatory CMC: Review Team Question. An informal question from an FDA review division during an active IND, BLA, or NDA review, sent outside the formal information request or deficiency letter process and usually expecting a fast turnaround. How CMC and regulatory teams coordinate RTQ responses is a good early signal of review health.

T 02 entries

Tech TransferTech Transfer & NPI: Technology transfer. The documented process of moving a manufacturing process, analytical method, or product from a sending unit, a lab or development site, to a receiving unit, another site or a CDMO, without losing the process understanding that made it work. Covers protocol design, comparability, and acceptance criteria for the transfer to be declared successful.; SourceICH Q10
TFFDrug Product: Tangential Flow Filtration. A membrane filtration technique used to concentrate and buffer-exchange a drug substance, with the process fluid flowing parallel to the membrane surface rather than straight through it. TFF steps are common in both biologics and LNP or oligonucleotide drug substance processing and are frequent tech transfer risk points.

U 01 entry

USP <788>Drug Product: Subvisible Particulate Matter in Injections. The compendial chapter setting numerical limits and test methods, light obscuration and microscopic particle count, for subvisible particles in injectable products. Revised and retitled effective August 1, 2026 through PDG Stage 4 harmonization with European Pharmacopoeia 2.9.19 and the Japanese Pharmacopoeia, with applicability to intramuscular and subcutaneous routes made explicit.; SourceUSP <788>

V 01 entry

VMPProcess Validation: Validation Master Plan. The top-level document that defines the scope, strategy, responsibilities, and schedule for all validation activities at a site or for a program, including facilities, equipment, utilities, cleaning, computer systems, and process validation. Everything else in a validation package should trace back to it.; SourceICH Q10