Other Chemicals and Pharmaceuticals Industry Terminology

Active Pharmaceutical Ingredient (API)

The biologically active component in a drug product responsible for the intended therapeutic effect; also called drug substance (DS) in regulatory contexts.

- Ibuprofen as the API in over-the-counter tablets - Insulin as the API in a sterile injection - Atorvastatin calcium as the API in tablets

ANDA (Abbreviated New Drug Application)

U.S. FDA application pathway for generics demonstrating bioequivalence to a reference listed drug without duplicating clinical efficacy trials.

- Filing an ANDA for a generic atorvastatin product - Conducting fasting/fed bioequivalence studies comparing Cmax and AUC - Citing an API Type II DMF via a Letter of Authorization in an ANDA

Analytical Method Validation

Demonstration that an analytical procedure is suitable for its intended purpose (e.g., accuracy, precision, specificity, linearity, range, robustness) per ICH Q2(R2)/Q14.

- Validating an HPLC assay for API potency and impurities - Validating a GC method for residual solvents per ICH Q2(R2) - Assessing robustness of a dissolution method using design of experiments

Aseptic Processing

Manufacture of sterile products by preventing microbial contamination, typically without terminal sterilization; relies on cleanrooms, isolators/RABS, and aseptic techniques.

- Filling sterile vials in a Grade A isolator with Grade B background - Performing aseptic filtration through a 0.22 um filter into sterile containers - Conducting media fill simulations to qualify aseptic operations

Batch Record

The complete manufacturing and control documentation for a specific batch, including materials, equipment, parameters, in-process checks, deviations, and outcomes (paper or eBR).

- Executed batch record (eBR) for lot 12345 of tablets - Including in-process checks and deviations in the batch record - Reviewing and approving the batch record prior to release

Biologics License Application (BLA)

U.S. FDA submission seeking approval to market a biologic; includes modules on quality (CMC), nonclinical, and clinical data.

- Submitting a BLA for a recombinant monoclonal antibody - Providing PPQ results and control strategy in Module 3 (CMC) - Responding to FDA information requests during BLA review

Biosimilar

A biological product highly similar to and with no clinically meaningful differences from a reference product; relies on totality-of-evidence (analytical, PK/PD, possibly clinical).

- Biosimilar trastuzumab demonstrating analytical similarity to the reference product - Stepwise totality-of-evidence approach including PK/PD - Conducting a switching study when required by regulators

CAPA (Corrective and Preventive Action)

A quality system process to investigate root causes and implement fixes to prevent recurrence (corrective) and occurrence (preventive) of nonconformities.

- Investigating an OOS result to identify root cause and implement a corrective action - Implementing a preventive maintenance program to avoid equipment failures - Updating procedures and training to prevent recurrence of deviations

cGMP (current Good Manufacturing Practice)

Regulatory standards ensuring products are consistently produced and controlled (e.g., 21 CFR 210/211, EU GMP, PIC/S); “current” implies use of contemporary best practices.

- Operating under 21 CFR 210/211 for small-molecule drug manufacturing - Performing cleaning validation and maintaining data integrity (ALCOA+) - Conducting Annual Product Quality Review (APQR)

Change Control

Formal quality system process to evaluate, approve, implement, and document changes to materials, methods, equipment, or facilities with risk assessment and regulatory impact.

- Changing an excipient supplier with documented risk assessment and approval - Modifying mixing time and updating batch records accordingly - Adding new manufacturing equipment and assessing regulatory impact

Contract Development and Manufacturing Organization (CDMO)

A third-party provider offering development and manufacturing services (e.g., process development, scale-up, clinical/commercial supply), often across small molecules and biologics.

- Outsourcing sterile fill-finish to a CDMO - Conducting process development and scale-up at a CDMO for Phase 2 supply - Performing technology transfer to a CDMO for commercial manufacturing

CTD/eCTD (Common Technical Document)

The harmonized format (paper/electronic) for regulatory submissions across ICH regions, organized into Modules 1–5; eCTD is the electronic specification.

- Compiling Module 3 (Quality) for an eCTD submission - Publishing eCTD sequence 0000 for an initial NDA - Managing lifecycle submissions through subsequent eCTD sequences

DMF (Drug Master File)

A confidential submission to FDA (e.g., Type II for DS) providing detailed CMC information that applicants can reference via a Letter of Authorization.

- Filing a Type II DMF for an API with the FDA - Granting a Letter of Authorization for an ANDA applicant to reference the DMF - Submitting annual updates to keep the DMF current

Drug Product (DP)

The finished dosage form (e.g., tablet, injection) that contains the API and excipients, along with packaging and labeling.

- Immediate-release tablet containing API and excipients - Prefilled syringe with sterile solution and labeling - Blister-packaged capsules ready for distribution

Drug Substance (DS)

The API as manufactured before formulation into the final dosage form; includes characterization and control of impurities, solid form, and process.

- Crystallized API with defined polymorphic form - Characterizing and controlling process-related impurities - Establishing DS specifications and stability studies

Elemental Impurities (ICH Q3D)

Inorganic impurities (e.g., As, Cd, Pb) with permitted daily exposure limits; controlled via risk assessment and analytical testing (often ICP-MS).

- Performing ICP-MS testing for As, Cd, Pb, and Hg - Conducting a risk assessment of excipient contributions to elemental impurities - Setting controls to meet permitted daily exposure limits

Environmental, Health and Safety (EHS)

Organizational systems and practices to protect workers, the public, and the environment; covers industrial hygiene, process safety, waste, and compliance.

- Implementing a PPE and industrial hygiene program for potent compounds - Managing solvent waste and environmental emissions compliance - Conducting process safety reviews and incident investigations

Excipients

Inactive ingredients formulated with the API to aid manufacture, stability, or delivery (e.g., binders, disintegrants, stabilizers); may be compendial (USP–NF/Ph. Eur.).

- Using lactose as a filler/diluent in tablets - Adding polysorbate 80 as a stabilizer in biologics - Using microcrystalline cellulose as a binder

FMEA (Failure Modes and Effects Analysis)

A structured risk assessment tool that prioritizes potential failures by severity, occurrence, and detectability to guide mitigations.

- Evaluating failure modes in tablet compression and coating - Prioritizing risks by calculating RPN (severity x occurrence x detectability) - Updating the FMEA after process changes to reflect mitigations

GHS (Globally Harmonized System)

Worldwide system for classifying and labeling chemicals with standardized hazard statements, pictograms, and SDS requirements; EU implements via CLP.

- Applying flame and skull pictograms on solvent labels - Creating SDS documents according to GHS Rev. 7 - Classifying chemicals under EU CLP regulation

GLP (Good Laboratory Practice)

Quality system for nonclinical safety studies (e.g., toxicology) ensuring data integrity and traceability, often per OECD GLP and 21 CFR Part 58.

- Conducting a GLP-compliant 28-day toxicology study - Performing QA audits and archiving of raw data and specimens - Maintaining a master schedule and study director responsibilities

GxP

Umbrella term for regulated practices such as GMP, GLP, GCP, GDP, and GVP covering quality across development, manufacturing, distribution, and pharmacovigilance.

- GMP for commercial manufacturing operations - GCP for clinical trial conduct and monitoring - GDP for storage and distribution of finished goods

HAZOP (Hazard and Operability Study)

A systematic process hazard analysis for chemical processes using guidewords (e.g., “No Flow,” “High Pressure”) to identify risks and safeguards.

- Using guidewords like 'No Flow' and 'High Pressure' to analyze a reactor process - Identifying safeguards such as pressure relief and interlocks - Assigning action items to mitigate identified hazards

HPAPI (High-Potency API)

APIs with very low OELs requiring advanced containment and controls (e.g., isolators, closed transfers); common in oncology and ADCs.

- Processing an OEB 5 cytotoxic compound in an isolator - Using closed transfers with split butterfly valves to reduce exposure - Verifying containment performance with surrogate testing

ICH Guidelines

Harmonized guidelines from the International Council for Harmonisation across Quality (Q), Safety (S), Efficacy (E), and Multidisciplinary (M) topics (e.g., Q8–Q14, M7, Q3D).

- Applying ICH Q9 quality risk management to process design - Setting impurity limits using ICH Q3A/Q3B - Controlling mutagenic impurities per ICH M7

IND (Investigational New Drug)

U.S. FDA authorization to begin clinical trials; includes CMC, nonclinical, and clinical plans; often preceded by a pre-IND meeting.

- Holding a pre-IND meeting to discuss CMC and clinical plans - Submitting an initial IND to begin Phase 1 trials - Filing annual reports and safety updates to maintain the IND

Key Starting Material (KSM)

A defined material from which the manufacturing process for the API is initiated; selection must be scientifically justified with supply chain and quality controls.

- Selecting an advanced intermediate as the KSM with justified boundaries - Qualifying multiple KSM suppliers with appropriate controls - Justifying KSM designation per ICH Q11 principles

LAL Test (Bacterial Endotoxins Test)

Assay using Limulus amebocyte lysate or recombinant factor C to detect endotoxins in parenterals and process water per compendial standards.

- Performing gel-clot testing on Water for Injection - Using kinetic chromogenic assay for endotoxin in finished product - Implementing recombinant Factor C as an alternative method

LIMS (Laboratory Information Management System)

Software to manage samples, tests, results, workflows, and data integrity in QC/QA laboratories; often integrates with instruments and ERP/MES.

- Logging samples and generating barcodes for QC testing - Importing instrument results directly into LIMS - Managing stability studies and CoA generation

MES (Manufacturing Execution System)

Software layer controlling and tracking manufacturing operations (e.g., eBR, equipment status, genealogy, scheduling) bridging ERP and shop floor systems.

- Executing electronic batch records in a system like Werum PAS-X - Tracking equipment status, calibration, and maintenance - Capturing genealogy and real-time process data on the shop floor

NDA (New Drug Application)

U.S. FDA application for marketing approval of a new small-molecule drug, including CMC, clinical, and nonclinical data; subject to PDUFA timelines.

- Submitting a 505(b)(1) NDA for a new small-molecule drug - Receiving a PDUFA action date and responding to review comments - Filing a 505(b)(2) NDA leveraging literature and bridging studies

Nitrosamine Impurities

Potentially carcinogenic nitrosamines (e.g., NDMA, NDEA) that can form during synthesis or storage; require risk assessments and control strategies.

- Performing a risk assessment for nitrosamine formation in an API route - Testing drug product for NDMA and NDEA using LC-MS - Modifying the process to eliminate nitrosating agents and nitrite sources

NOAEL (No Observed Adverse Effect Level)

The highest exposure level at which no adverse effects are observed in toxicology studies; used to derive safe starting clinical doses.

- Converting animal NOAEL to human equivalent dose (HED) - Selecting a safe starting dose for first-in-human studies - Establishing safety margins for repeat-dose toxicity

OEL/OEB (Occupational Exposure Limit/Band)

OEL is the maximum airborne concentration of a substance workers can be exposed to; OEB is a categorical banding used to select controls.

- Assigning an OEL of 10 ng/m3 to a cytotoxic compound - Classifying a compound as OEB 4 to guide facility controls - Defining PPE and containment based on OEB assignment

OOS/OOT (Out of Specification/Out of Trend)

OOS is a result outside approved specifications; OOT is a significant deviation from historical data. Both require investigation and potential CAPA.

- Investigating an OOS assay result following a structured SOP - Identifying an OOT trend in dissolution profiles via control charts - Implementing CAPA after confirming lab error as root cause

Orphan Drug Designation

Regulatory status for drugs treating rare diseases, granting incentives such as fee waivers, tax credits, and market exclusivity (region-specific).

- Requesting orphan designation for a therapy targeting a rare disease - Receiving seven-year market exclusivity in the United States - Obtaining FDA fee waivers and tax credits

PAT (Process Analytical Technology)

Tools and systems enabling timely measurements of critical quality/processing attributes to design, analyze, and control manufacturing in real time.

- Using NIR spectroscopy for real-time blend uniformity monitoring - Applying Raman for raw material identification at-line - Feedback control of granulation moisture using PAT sensors

Pharmacovigilance (PV)

Science and activities related to detection, assessment, understanding, and prevention of adverse effects post-approval; includes ICSR reporting, PSUR/PBRER, signal detection.

- Submitting ICSRs to FAERS and EudraVigilance - Performing signal detection using disproportionality analyses - Preparing PSUR/PBRER reports for periodic safety updates

PIC/S (Pharmaceutical Inspection Co-operation Scheme)

An international cooperative arrangement among regulatory authorities aiming to harmonize GMP standards and inspections.

- Aligning with the PIC/S GMP Guide (PE 009) during inspections - Participating in mutual reliance among PIC/S member inspectorates - Preparing facilities for PIC/S-style GMP inspections

QbD (Quality by Design)

Systematic development approach that builds quality into products/processes through understanding of critical quality attributes (CQAs), critical process parameters (CPPs), and design space.

- Defining CQAs and CPPs through risk assessment and knowledge management - Establishing a design space using DOE and multivariate models - Implementing a control strategy linked to product lifecycle

QMS (Quality Management System)

The organizational framework of policies, procedures, records, and resources to meet quality objectives and regulatory requirements across the product lifecycle.

- Operating document control and change management processes - Conducting internal audits and management reviews - Managing deviations, CAPA, and training records

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

EU regulation requiring manufacturers/importers to register chemicals, assess risks, and communicate safe use; includes SVHC and authorization lists.

- Registering a substance manufactured at >1 tonne/year - Communicating SVHC content down the supply chain via SDS - Applying for authorization for chromium VI uses

REMS (Risk Evaluation and Mitigation Strategy)

U.S. FDA-required safety program for certain products to ensure benefits outweigh risks; may include ETASU (e.g., prescriber certification, restricted distribution).

- Clozapine REMS requiring prescriber certification and patient monitoring - Implementing ETASU with restricted distribution for a teratogenic drug - Pharmacy enrollment and dispensing controls under REMS

RABS/Isolator (Restricted Access Barrier System)

Containment technologies that separate operators from the aseptic core to reduce contamination risk; isolators provide full physical separation.

- Performing aseptic filling inside a closed isolator with H2O2 decontamination - Using glove ports and RTPs to minimize interventions - Employing RABS to reduce contamination risk in Grade A areas

Scale-Up

Transition of a process from lab/pilot to commercial scale while maintaining quality, yield, and safety; involves mixing, mass/heat transfer, and kinetic considerations.

- Scaling a reactor from 10 L to 1000 L while maintaining kLa - Optimizing mixing time and impeller tip speed for larger vessels - Calculating heat transfer requirements for a crystallization step

SDS (Safety Data Sheet)

Standardized 16-section document conveying hazards, handling, PPE, spill, and disposal information for chemicals under GHS/OSHA HazCom.

- Providing an SDS for acetone with GHS classifications and pictograms - Maintaining the standardized 16-section format for all chemicals - Updating SDS content after a hazard reclassification

Shelf Life (Expiration Dating)

The period a product is expected to remain within specifications when stored under labeled conditions, established by ICH Q1 stability studies.

- Establishing a 24-month expiry based on ICH Q1 stability data - Using accelerated and long-term storage conditions to assign shelf life - Applying bracketing and matrixing in stability studies

Sterility Assurance Level (SAL)

Probability of a non-sterile unit after sterilization; typically 10^-6 for terminally sterilized products.

- Validating a 10^-6 SAL for moist heat sterilization cycles - Performing dose mapping for gamma radiation sterilization - Demonstrating F0 calculations to confirm sterilization lethality

Tech Transfer (Technology Transfer)

Structured transfer of product and process knowledge between sending and receiving units (e.g., R&D to manufacturing, company to CDMO) to ensure reproducible performance.

- Transferring a mAb process from development to a commercial site - Sharing process descriptions, FMEAs, and batch records with a CDMO - Executing engineering runs to qualify the receiving unit

TSCA (Toxic Substances Control Act)

U.S. law regulating industrial chemicals; includes TSCA Inventory listing, PMN for new substances, risk evaluations, and SNURs for significant new uses.

- Filing a PMN for a new chemical substance not on the TSCA Inventory - Certifying imports as TSCA-compliant at U.S. customs - Complying with a SNUR that restricts certain new uses