Testing and Regulatory Glossary

Testing laboratories and regulatory agencies use precise terminology that is difficult to navigate without context. This glossary explains the terms, standards, abbreviations, and instruments used across Auriga Research services in plain language.

91 entries.

21 CFR Part 11

US FDA Regulation for Electronic Records and Signatures

Governs electronic records and electronic signatures in regulated environments. Auriga's YLIMS is 21 CFR Part 11 compliant.

Regulatory BodiesPharmaceuticalInstruments and Methods

Aflatoxin

A mycotoxin produced by Aspergillus moulds in grains, spices, and nuts. A Group 1 carcinogen with strict FSSAI and EU limits.

Food and BeverageInstruments and Methods

Used in LC-MS/MS

Allergen

Food Allergen

A substance capable of causing an allergic reaction. FSSAI and EU require mandatory declaration of 14 major allergens on food labels.

Food and Beverage

ANDA

Abbreviated New Drug Application

The USFDA submission for approval of a generic drug product.

PharmaceuticalRegulatory Bodies

APEDA

Agricultural and Processed Food Products Export Development Authority

Recognises labs for pre export testing of agri commodities. Auriga APEDA recognised since 2004.

Regulatory BodiesFood and Beverage

Used in Food Testing

API (Ayurvedic)

Ayurvedic Pharmacopoeia of India

The official reference for Ayurvedic raw materials and formulations. Manufacturers must test against relevant API monographs for AYUSH licence.

Herbal and AYUSH

Used in Herbal and AYUSH Testing

ASTM F88

Standard Test Method for Seal Strength of Flexible Barrier Materials

Used in medical device packaging validation.

PharmaceuticalInstruments and Methods

AYUSH

Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy

Regulates Ayurvedic, Siddha, Unani, and herbal formulations in India.

Regulatory BodiesHerbal and AYUSH

Used in Herbal and AYUSH Testing

Bhasma

Ayurvedic metal and mineral preparations calcined to ash form. Subject to strict AYUSH heavy metal limits that differ from conventional food or pharmaceutical limits.

Herbal and AYUSHInstruments and Methods

Used in ICP-MS

BIS

Bureau of Indian Standards

Sets mandatory product standards under IS numbers. Cosmetics, packaged water, and many consumer products require BIS compliant testing.

Regulatory BodiesCosmetics

Used in Cosmetics Testing

BOD

Biochemical Oxygen Demand

Measures dissolved oxygen consumed by biological organisms in water. A key CPCB wastewater compliance parameter.

Water and Environment

CDISC

Clinical Data Interchange Standards Consortium

Sets SDTM and ADaM data standards mandatory for FDA submissions.

Clinical and CRO

CDSCO

Central Drugs Standard Control Organisation

India's regulatory body for pharmaceuticals, medical devices, cosmetics, and diagnostics. All clinical trials in India require CDSCO approval.

Regulatory BodiesPharmaceuticalClinical and CRO

Used in CDSCO Approved Lab

Chromameter

An instrument measuring skin colour (L*, a*, b* values). Used in skin brightening, anti pigmentation, and anti redness efficacy studies.

CosmeticsInstruments and Methods

COA

Certificate of Analysis

Confirms a batch has been tested and meets specified quality standards. Required by customers, importers, and regulatory authorities.

Instruments and MethodsPharmaceuticalFood and Beverage

COD

Chemical Oxygen Demand

Measures total oxygen required to oxidise all matter in water. Always equal to or greater than BOD for the same sample.

Water and Environment

Corneometer

An instrument measuring skin hydration by electrical capacitance. Used in moisturisation efficacy studies for cosmetic claim substantiation.

CosmeticsInstruments and Methods

CPCB

Central Pollution Control Board

Sets discharge standards for industrial effluents and ambient air quality norms in India.

Regulatory BodiesWater and Environment

Used in Environmental Testing

CSR

Clinical Study Report

The formal report of a completed clinical trial, prepared per ICH E3.

Clinical and CRO

Used in Medical Writing

CTD

Common Technical Document

The internationally harmonised format for regulatory submissions to CDSCO, FDA, EMA, and other agencies. Comprises 5 modules.

PharmaceuticalRegulatory Bodies

Cutometer

An instrument measuring skin elasticity by suction. Used in anti ageing and firming efficacy studies.

CosmeticsInstruments and Methods

DCGI

Drugs Controller General of India

The head of CDSCO. Approves new drugs, clinical trials, and medical devices for marketing in India.

Regulatory BodiesPharmaceuticalClinical and CRO

Used in Clinical Trials

DIAAS

Digestible Indispensable Amino Acid Score

The WHO recommended replacement for PDCAAS that measures digestibility of each essential amino acid individually.

Food and Beverage

DMPK

Drug Metabolism and Pharmacokinetics

The study of how drugs are absorbed, distributed, metabolised, and excreted, essential for clinical trial design.

Clinical and CROPharmaceutical

E&L

Extractables and Leachables

Chemical entities that migrate out of packaging or device materials into a product during storage or use.

PharmaceuticalInstruments and Methods

Used in GC-MS

EIC (Certificate)

Export Inspection Certificate

The certificate issued by EIA to confirm a food consignment has passed inspection and testing for export.

Food and BeverageRegulatory Bodies

EIC/EIA

Export Inspection Council, Export Inspection Agency

Recognises labs for pre export testing of food and dairy products. Auriga EIC recognised since 2007.

Regulatory BodiesFood and Beverage

Used in Food Testing

FBO

Food Business Operator

Any person or entity involved in food business requiring an FSSAI licence or registration.

Food and BeverageRegulatory Bodies

Fingerprinting

Chromatographic Fingerprinting

Chromatographic profiling of a herbal product to create a characteristic pattern that confirms identity and consistency of botanical raw materials. Performed by HPTLC.

Herbal and AYUSHInstruments and Methods

Form 39

CDSCO Form 39 Cosmetics Test Report

The CDSCO test report format for cosmetics sold in India. All cosmetics must be tested and reported on Form 39 for regulatory compliance.

CosmeticsRegulatory Bodies

FSS Act

Food Safety and Standards Act 2006

The principal food safety legislation in India, replacing the Prevention of Food Adulteration Act 1954 from August 2011.

Food and BeverageRegulatory Bodies

FSSAI

Food Safety and Standards Authority of India

Regulates food safety under the FSS Act 2006. FSSAI approves labs for food testing and issues Food Business Operator licences.

Regulatory BodiesFood and Beverage

Used in FSSAI Notified Lab

GCP

Good Clinical Practice

International standard for conducting, recording, and reporting clinical trials. Governed by ICH E6 R3.

Clinical and CRO

Used in Clinical Trials

GLP

Good Laboratory Practice

A quality system for non clinical safety studies ensuring data integrity.

PharmaceuticalClinical and CRO

GMO

Genetically Modified Organism

FSSAI requires testing for unauthorised GM events in food products. India has zero tolerance for unapproved GM crops.

Food and Beverage

GMP

Good Manufacturing Practice

Quality standards governing pharmaceutical manufacturing. WHO GMP is required for export to regulated markets.

Pharmaceutical

HMP

Herbal Medicinal Product

A finished medicinal product containing only herbal substances as active ingredients. Term used in EU Traditional Herbal Registration (THR) context.

Herbal and AYUSH

HRIPT

Human Repeat Insult Patch Test

A 9 week study on 50 to 200 volunteers assessing sensitisation potential of cosmetic products.

Cosmetics

Used in Cosmetics Testing

ICH

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

Sets globally harmonised standards for pharmaceutical development, testing, and registration.

PharmaceuticalClinical and CRORegulatory Bodies

ICH E3

Structure and Content of Clinical Study Reports

Defines the format for the final report of a clinical trial submitted to regulatory authorities.

Clinical and CRO

Used in Medical Writing

ICH E6 R3

Good Clinical Practice

Good Clinical Practice guideline for clinical trials. Effective May 2025, supersedes E6 R2.

Clinical and CRO

Used in Clinical Trials

ICH E9(R1)

Statistical Principles for Clinical Trials

Introduces the estimand framework now required by FDA and EMA.

Clinical and CRO

Used in Biostatistics

ICH M7

Assessment and Control of DNA Reactive Mutagenic Impurities

Covers nitrosamines such as NDMA and NDEA. Quantitation typically by LC-MS/MS.

PharmaceuticalInstruments and Methods

Used in LC-MS/MS

ICH Q1A

Stability Testing of New Drug Substances and Products

Specifies accelerated (40 C / 75 percent RH) and long term (30 C / 65 percent RH Zone IV) conditions.

Pharmaceutical

Used in Pharmaceutical Testing

ICH Q1B

Photostability Testing of New Drug Substances and Products

Defines light exposure conditions for assessing photodegradation.

Pharmaceutical

ICH Q2(R1)

Validation of Analytical Procedures

Defines specificity, linearity, accuracy, precision, detection limit, quantitation limit, and robustness.

PharmaceuticalInstruments and Methods

ICH Q3A/Q3B

Impurities in New Drug Substances and Drug Products

Sets reporting, identification, and qualification thresholds for impurities.

Pharmaceutical

ICH Q3D

Elemental Impurities in Pharmaceuticals

Sets permitted daily exposure limits for 24 elements.

PharmaceuticalInstruments and Methods

Used in ICP-MS

ICH Q6A

Specifications for New Drug Substances and Products

Defines test procedures and acceptance criteria for release and shelf life testing.

Pharmaceutical

Used in XRD

IS 10500

Indian Standard for Drinking Water Quality

Sets acceptable and permissible limits for physical, chemical, and microbiological parameters in potable water.

Water and Environment

Used in Water Testing

IS 14543

Indian Standard for Packaged Drinking Water

Governs testing requirements for commercially packaged water.

Water and Environment

ISO 10993

Biological Evaluation of Medical Devices

International standard for biological evaluation of medical devices. Covers cytotoxicity, sensitisation, irritation, and other biocompatibility endpoints.

PharmaceuticalInstruments and Methods

Used in Medical Device Testing

ISO/IEC 17025

International Standard for Testing and Calibration Laboratory Competence

International standard for laboratory testing and calibration competence. The standard under which NABL grants accreditation to laboratories in India.

Regulatory Bodies

Used in NABL Accredited Lab

LOD

Limit of Detection

The lowest amount of an analyte that can be reliably detected but not necessarily quantified by an analytical method.

Instruments and MethodsPharmaceutical

LOQ

Limit of Quantitation

The lowest amount of an analyte that can be reliably quantified with acceptable precision and accuracy. Always higher than the LOD for the same method.

Instruments and MethodsPharmaceutical

Marker Compound

A chemically defined constituent of a herbal product used for identification and quantification, even if not responsible for therapeutic effect. Required for standardisation and label claims.

Herbal and AYUSH

MDR 2017

Medical Devices Rules 2017

Governs manufacture, import, sale, and testing of medical devices in India under CDSCO.

Regulatory BodiesPharmaceutical

Used in Medical Device Testing

Melamine

An industrial chemical found as an adulterant in dairy products. FSSAI limit is 0.15 ppm in liquid infant formula and 1 ppm in powdered infant formula.

Food and Beverage

MOU

Memorandum of Understanding

A formal agreement between two organisations defining the scope and terms of their collaboration. Auriga operates under MOU with several government and institutional testing partners.

Instruments and Methods

MRL

Maximum Residue Limit

The maximum concentration of a pesticide or contaminant permitted in food or feed. Set by FSSAI, EU EC 396/2005, and Japan's Positive List System.

Food and BeverageInstruments and Methods

Used in LC-MS/MS

NABL

National Accreditation Board for Testing and Calibration Laboratories

India's apex body for lab accreditation under ISO/IEC 17025:2017. A NABL accredited report is accepted by FSSAI, CDSCO, BIS, and most international buyers.

Regulatory Bodies

Used in NABL Accredited Lab

NDA

New Drug Application

The USFDA submission for approval of a new drug product.

PharmaceuticalRegulatory Bodies

NPPA

National Pharmaceutical Pricing Authority

Regulates drug prices in India under the Essential Commodities Act. Not a testing body but frequently referenced in pharmaceutical pricing dossiers.

Regulatory BodiesPharmaceutical

NTU

Nephelometric Turbidity Unit

Measures water cloudiness. IS 10500 acceptable limit is 1 NTU; permissible limit is 5 NTU.

Water and Environment

Nutritional Labelling

The mandatory declaration of energy, protein, carbohydrate, fat, and other nutrients per 100g or 100ml on packaged food labels under FSS Regulations 2011.

Food and Beverage

Used in Food Testing

OOS

Out of Specification

A test result that falls outside the pre defined acceptance criteria in a specification. Requires investigation and documentation before a batch can be released or rejected.

Instruments and MethodsPharmaceutical

OOT

Out of Trend

A result that is within specification but shows an unexpected trend when compared to historical data. Requires review but not necessarily rejection.

Instruments and MethodsPharmaceutical

P-Alkalinity / M-Alkalinity

Phenolphthalein and Methyl Orange Alkalinity

Two endpoints in titrimetric alkalinity testing. P alkalinity measures hydroxide and half carbonate. M alkalinity measures total alkalinity including bicarbonate. IS 3025 Part 23 governs the method.

Water and EnvironmentInstruments and Methods

PDCAAS

Protein Digestibility Corrected Amino Acid Score

Measures protein quality based on amino acid composition and digestibility for label claims.

Food and Beverage

PET (Preservative)

Preservative Efficacy Test

Tests per ISO 11930 that a cosmetic's preservative system inhibits microbial growth throughout its shelf life.

Cosmetics

Phytochemical

Any chemical compound produced naturally by a plant. Phytochemical screening identifies the classes of compounds (alkaloids, flavonoids, tannins, etc.) present in a herbal product.

Herbal and AYUSH

PIPT

Primary Irritation Patch Test

A 48 hour occlusive patch test on human volunteers to assess the skin irritation potential of a cosmetic product.

Cosmetics

PK/PD

Pharmacokinetics and Pharmacodynamics

PK describes how the body processes a drug. PD describes what the drug does to the body.

Clinical and CROPharmaceutical

Used in LC-MS/MS

PSMF

Pharmacovigilance System Master File

Describes the pharmacovigilance system of a marketing authorisation holder.

Clinical and CROPharmaceutical

Used in Pharmacovigilance

PSUR

Periodic Safety Update Report

Submitted to health authorities summarising the safety profile of a marketed medicinal product.

Clinical and CROPharmaceutical

Used in Pharmacovigilance

QuEChERS

Quick, Easy, Cheap, Effective, Rugged, and Safe

The standard sample preparation method for multi residue pesticide testing in food matrices.

Food and BeverageInstruments and Methods

Reference Standard

A substance of known purity and identity used to calibrate and validate analytical methods. Primary standards are obtained from official pharmacopoeias; working standards are prepared and characterised in house.

Instruments and MethodsPharmaceutical

RSD

Relative Standard Deviation

A measure of analytical precision expressed as the standard deviation divided by the mean, expressed as a percentage. Also known as Coefficient of Variation (CV).

Instruments and Methods

SAP

Statistical Analysis Plan

A pre specified document detailing the statistical methods to be applied in a clinical trial before data is unblinded.

Clinical and CRO

Used in Biostatistics

SOP

Standard Operating Procedure

A written set of step by step instructions for a routine laboratory or operational task. All NABL accredited labs must maintain and follow validated SOPs.

Instruments and Methods

SPF

Sun Protection Factor

Measures UV B protection. SPF in vivo testing per ISO 24444 is required for SPF claims on sunscreens.

Cosmetics

SPOC

Single Point of Contact

A dedicated account manager assigned to every Auriga client managing all communication, sample tracking, and report delivery.

Instruments and Methods

TAT

Turnaround Time

The time from sample receipt to report delivery. Standard Auriga TAT is 5 to 7 working days; express options are available.

Instruments and Methods

TDS

Total Dissolved Solids

The total concentration of dissolved substances in water. IS 10500 acceptable limit is 500 mg/L; permissible limit is 2000 mg/L.

Water and Environment

USFDA

United States Food and Drug Administration

Auriga is USFDA registered, so analytical data from Auriga is accepted for ANDA, NDA, and other US regulatory filings.

Regulatory BodiesPharmaceutical

Used in Pharmaceutical Testing

Water Activity (aw)

Water Activity

A measure of the availability of water in a food product. Values above 0.85 aw support microbial growth. Critical for shelf life prediction.

Food and Beverage

WHO GMP

World Health Organization Good Manufacturing Practice

Good Manufacturing Practice guidelines issued by the World Health Organization. A key requirement for pharmaceutical manufacturers exporting to regulated markets.

Regulatory BodiesPharmaceutical

WHO PQ

World Health Organization Prequalification

Auriga's WHO PQ recognition means testing data is accepted for UN agency and Global Fund procurement tenders.

Regulatory BodiesPharmaceutical

Used in All Accreditations

YLIMS

Your Lab Information Management System

Auriga's in house AI enabled LIMS for real time sample tracking, barcoding, and digital report delivery since 2012.

Instruments and Methods

ZLD

Zero Liquid Discharge

An effluent treatment approach where all wastewater is treated and reused with no discharge to the environment. Required for certain industries under CPCB norms.

Water and Environment

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