Chemicals and Pharmaceuticals Industry Terminology

21 CFR Part 11

US FDA regulation governing electronic records and electronic signatures to ensure data integrity, audit trails, system validation, and secure user access for GxP processes.

We need Part 11-compliant audit trails in the LIMS; Validate the spreadsheet calculations per 21 CFR Part 11; QA will enable e-signatures for batch release under Part 11

ADC (Antibody-Drug Conjugate)

A targeted biologic in which a monoclonal antibody is linked to a potent cytotoxic small-molecule payload to deliver therapy selectively to antigen-expressing cells.

Our oncology pipeline includes two ADCs in Phase 2; ADC CMC challenges include linker stability and DAR control; We’re selecting a CDMO with HPAPI capability for our ADC

ADME

Absorption, Distribution, Metabolism, and Excretion; the key pharmacokinetic processes that determine exposure, efficacy, and safety of a drug.

We optimized ADME to improve oral bioavailability; Poor ADME properties drove attrition in lead series; The DMPK team will run ADME screens early

ANDA (Abbreviated New Drug Application)

US pathway for generic drug approval demonstrating bioequivalence to a reference listed drug with supporting quality/CMC data.

We’re targeting a Para IV ANDA filing next quarter; First-to-file ANDA may secure 180-day exclusivity; ANDA requires bioequivalence and CMC, not full clinical trials

API (Active Pharmaceutical Ingredient)

The biologically active substance in a pharmaceutical product responsible for therapeutic effect; manufactured via chemical synthesis, fermentation, or biologics processes.

The API plant is down for maintenance; We need an OEB 4 suite for HPAPI handling; Improving API yield boosts COGS

ATMP (Advanced Therapy Medicinal Product)

EU regulatory category covering gene therapies, somatic cell therapies, and tissue-engineered products with unique CMC, clinical, and facility requirements.

Our CAR-T qualifies as an ATMP in the EU; ATMP manufacturing requires specialized viral vector suites; EMA’s CAT will advise on our ATMP application

Batch Record

Controlled document detailing instructions and actual data for manufacturing a specific batch; key to traceability, review, and release decisions.

QA approved the master batch record revision; Deviation logged in the executed batch record; We’re moving to electronic batch records in MES

BLA (Biologics License Application)

US submission seeking approval to market a biologic product, including CMC, nonclinical, clinical, and manufacturing information.

Our BLA for the mAb targets a priority review; FDA asked for additional comparability data in the BLA; Potency assay is critical to the BLA package

CAPA (Corrective and Preventive Action)

A quality system process to eliminate causes of nonconformities (corrective) and prevent recurrence (preventive) through root cause analysis and effectiveness checks.

Root cause identified; CAPA plan drafted; QA will verify CAPA effectiveness in 90 days; Trend deviations to inform preventive CAPAs

CDMO (Contract Development and Manufacturing Organization)

A partner providing development, scale-up, and manufacturing services for APIs and/or drug products under quality and supply agreements.

We’ll outsource DP fill-finish to a CDMO; Capacity reservation at the CDMO mitigates supply risk; Our MSA and Quality Agreement with the CDMO are signed

Cleaning Validation

Documented evidence that cleaning procedures effectively and consistently remove residues to predefined acceptance criteria, preventing cross-contamination.

MACO limits set using PDE values; Swab and rinse recoveries validated for cleaning; Campaign length capped by cleaning validation data

CLP (Classification, Labelling and Packaging)

EU regulation aligning hazard classification, labelling, and packaging of chemicals with UN GHS; governs hazard pictograms, H- and P-statements.

We updated labels per CLP Annex VI entries; SDS classification aligns with CLP; New mixture requires CLP notification

CMC (Chemistry, Manufacturing, and Controls)

The body of information describing a product’s composition, manufacturing process, controls, specifications, stability, and quality systems supporting regulatory submissions.

CMC section of the IND covers process and specs; Post-approval CMC changes filed as a PAS; Comparability protocols pre-agreed for CMC flexibility

Certificate of Analysis (CoA)

Document summarizing test methods, specifications, and actual results for a batch of material, confirming it meets quality requirements.

Release shipment only upon CoA receipt; CoA results don’t match the approved specs; Implement electronic CoAs tied to LIMS data

COGS (Cost of Goods Sold)

Direct costs attributable to producing finished goods, including materials, labor, and manufacturing overhead; a key driver of margin and pricing.

Yield improvements cut API COGS by 12%; Continuous processing can reduce DP COGS; COGS pressure impacts gross margin post-LOE

Cold Chain

Temperature-controlled storage and distribution network ensuring product quality for thermosensitive biologics and vaccines.

Maintain 2–8°C with validated shippers; Investigate temperature excursions via GDP process; Use data loggers to prove cold-chain integrity

Continuous Manufacturing

A production approach where input materials are continuously fed and products continuously removed, enabling smaller footprints, faster scale-up, and real-time control.

FDA approved our continuous tablet line; Residence time distribution informs control strategy; PAT enables real-time release in continuous

Debottlenecking

Systematic identification and removal of capacity constraints in a process to increase throughput without major capital expansion.

Chromatography step is the bottleneck; increase column ID; Solvent recovery limits overall throughput; Shift to 24/7 ops to debottleneck drying

Deviation

A documented departure from approved procedures or specifications; investigated for root cause, product impact, and corrective actions.

Classify as major deviation due to GMP impact; Initiate root-cause analysis for the deviation; Batch impact assessment linked to the deviation

DoE (Design of Experiments)

Statistical planning and analysis of experiments to understand factor effects and interactions, enabling robust process and product design.

Run a factorial DoE to map CPPs vs CQAs; Use response surface DoE for optimization; DoE supports QbD design space claims

DSCSA (Drug Supply Chain Security Act)

US law mandating product serialization, traceability, and verification across the prescription drug supply chain to combat counterfeiting and diversion.

Achieve DSCSA interoperability using EPCIS; Aggregation needed for downstream trading partners; Verify serialized returns per DSCSA

EHS (Environment, Health, and Safety)

Organizational programs and compliance activities to protect workers, communities, and the environment in operations and laboratories.

EHS audit flagged solvent emissions; Upgrade local exhaust for EHS compliance; Implement waste minimization per EHS plan

EMA (European Medicines Agency)

EU agency responsible for scientific evaluation, supervision, and safety monitoring of medicines within the European Union.

We’ll file via the centralized EMA procedure; Awaiting CHMP positive opinion; Type II variation submitted to EMA

ERP (Enterprise Resource Planning)

Integrated software platform managing finance, procurement, inventory, production planning, and order fulfillment across the enterprise.

Integrate SAP ERP with MES for batch costing; ERP MRP run flagged API shortages; Serial numbers flow from ERP to WMS

ESG (Environmental, Social, and Governance)

Framework for measuring a company’s sustainability and ethical impact, increasingly influencing capital access, risk, and reputation.

Set Scope 3 targets in our ESG roadmap; ESG metrics tied to our sustainability-linked loan; Disclose to CDP and align with TCFD

FDA (Food and Drug Administration)

US regulatory authority overseeing drugs, biologics, medical devices, and food; evaluates INDs, NDAs, BLAs, inspections, and post-market safety.

Type C meeting with FDA on CMC strategy; We addressed FDA Form 483 observations; Warning letter risks delay approval

FMEA (Failure Mode and Effects Analysis)

Structured risk assessment method identifying potential failure modes, their effects, and mitigation priorities using severity, occurrence, and detectability.

Use FMEA to prioritize process risks; RPNs drove additional in-process controls; Update FMEA after change control

GCP (Good Clinical Practice)

International ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials.

Ensure informed consent per GCP; Monitoring plan aligns with ICH GCP E6(R2); Site audit checks GCP compliance

GDP (Good Distribution Practice)

Quality standards for proper distribution of medicinal products, ensuring identity, integrity, and traceability are maintained throughout the supply chain.

Warehouse temperature mapping for GDP; Qualify lane partners per GDP; GDP deviations handled via QMS

GHS (Globally Harmonized System)

UN system for classifying and communicating chemical hazards via standardized labeling and Safety Data Sheets.

Update labels with new GHS pictograms; SDS Section 2 reflects GHS classification; Train operators on GHS hazard statements

GLP (Good Laboratory Practice)

Quality framework for nonclinical laboratory studies to ensure data integrity, traceability, and reliability for regulatory submissions.

Our tox studies are GLP-compliant; QA audits GLP raw data integrity; Archiving per GLP requirements

GMP (cGMP)

Good Manufacturing Practice (current GMP) standards ensuring products are consistently produced and controlled according to quality requirements.

Align with 21 CFR 210/211 and EU GMP; Annex 1 updates impact aseptic processing; Data integrity is a core cGMP focus

ICH (International Council for Harmonisation)

Global body that issues harmonized guidelines for quality, safety, efficacy, and multidisciplinary topics for pharmaceuticals.

Apply ICH Q8/Q9/Q10 across CMC; ICH M4 CTD format streamlines submissions; ICH Q1A guides stability protocols

IND (Investigational New Drug)

US submission seeking authorization to begin clinical trials, including preclinical, clinical protocol, and quality information.

File IND to start Phase 1; FDA clinical hold lifted after CMC update; IND includes nonclinical and CMC modules

Industry 4.0

Integration of cyber-physical systems, IoT, advanced analytics, and automation to digitalize manufacturing and quality operations.

Deploy digital twins for process optimization; IIoT sensors feed predictive maintenance models; Advanced analytics enable right-first-time

LIMS (Laboratory Information Management System)

Software platform for managing samples, tests, results, workflows, and data integrity in QC and R&D laboratories.

Automate sample tracking in LIMS; LIMS interfaces with instruments via CDS; Enforce ALCOA+ with LIMS audit trails

MES (Manufacturing Execution System)

System that manages and documents shop-floor execution, including work instructions, data capture, genealogy, and electronic records.

Implement electronic batch records in MES; Material genealogy is captured in MES; Enable Part 11 e-signatures through MES

NDA (New Drug Application)

US submission requesting approval to market a new small-molecule drug, including full CMC, clinical, and risk-benefit data.

Our NDA PDUFA date is in Q4; Priority review voucher accelerates NDA timeline; Label negotiations ongoing for the NDA

OEL/OEB (Occupational Exposure Limit/Band)

Quantitative limit or qualitative band describing acceptable airborne exposure to protect workers; drives containment, PPE, and facility design.

Compound is OEB 5; use closed transfer; Define OEL from tox data to select PPE; Containment strategy based on OEB

PAT (Process Analytical Technology)

Framework using in-line, on-line, or at-line measurements and models to understand and control processes for consistent quality.

Use NIR as a PAT tool for blend uniformity; Real-time release enabled by PAT; Integrate PAT with control strategy in continuous

Patent Cliff

A sharp revenue decline when key product patents expire and generics enter, pressuring price and market share.

Plan for LOE to manage the patent cliff; Authorized generic launch reduces erosion; Life-cycle management can soften the cliff

PDUFA (Prescription Drug User Fee Act)

US law establishing user fees that fund FDA drug review; defines target review timelines and performance goals.

Our PDUFA goal date is set; PDUFA fees included in budget; Reauthorization updated review timelines

Pharmacovigilance (PV)

Science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or other drug-related problems.

Aggregate reports in the PBRER/PSUR; Signal detection flagged a new safety concern; Maintain 24/7 QPPV coverage in the EU

Process Validation (PV)

Documented evidence that a process operates within control to consistently produce product meeting predetermined specifications over its lifecycle.

Complete three PPQ batches before launch; Stage 3 CPV uses continued monitoring; Revalidation triggered by significant change

QbD (Quality by Design)

Systematic development approach emphasizing product and process understanding and control, based on sound science and quality risk management.

Define design space via DoE; Link CQAs to CPPs in the control strategy; Risk assessment per ICH Q9 underpins QbD

QMS (Quality Management System)

Organizational framework of policies, procedures, processes, and resources to achieve and sustain product quality and compliance.

Harmonize SOPs in the global QMS; CAPA and change control modules are core QMS; Metrics dashboard tracks QMS effectiveness

REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals)

EU regulation requiring chemical registration and risk management across supply chains, including evaluation, authorization, and restrictions.

IUCLID dossier for REACH registration; SVHC candidate listing impacts use; Authorisation required for Annex XIV substance

Serialization

Assignment of unique identifiers to medicine packs and the exchange of traceability data to enable verification and prevent falsification.

Print 2D DataMatrix codes on each saleable unit; Aggregation to case and pallet is enabled; Exchange EPCIS events with trading partners

Stability Studies

Testing product quality over time under defined conditions to establish retest periods, shelf life, and appropriate storage.

Follow ICH Q1A long-term and accelerated; Bracketing and matrixing reduce sample counts; Define shelf life and storage conditions

Tech Transfer (Technology Transfer)

Structured transfer of product and process knowledge between sites or organizations to ensure reproducible manufacturing at target scale.

Transfer the API process to the CDMO; Execute a gap assessment and transfer plan; PPQ timing depends on successful tech transfer