Acronyms

Below is a list of useful acronyms, initialisms and perhaps one or two abbreviations for the QA/QC microbiologist.

This list is easily searchable by typing CTRL-F (hold down the “control” key, then type “f”) and using your browser’s search function.

AADA Abbreviated Antibiotic Drug Application
ACE Adverse Clinical Event
ACRA Associate Commissioner for Regulatory Affairs (FDA)
ADE Adverse Drug Event
ADE/ADR Adverse Drug Event or Reaction
ADR Adverse Drug Reaction
ADRS Adverse Drug Reporting System
AET Antimicrobial Effectiveness Test (aka APE, PET)
AHLR Actual Helium Leak Rate
AIM Active Ingredient Manufacturer
aka Also Known As
AMP Adenosine Monophosphate
AMPAC Guidance on Post-approval Changes for Analytical Methods
ANADA Abbreviated New Animal Drug Application
ANDA Abbreviated New Drug Application
ANDI Analytical Data Interchange
ANPR Advance Notice of Public Rulemaking
AP Authorized Person
APA Aseptic Processing Area
APC Aerobic Plate Count
APE Antimicrobial Preservative Effectiveness Test (a.k.a. AET, PET)
API Active Pharmaceutical Ingredient
AOAC Association of Analytical Communities (previously Assoc. of Anal. Chemistry)
APR Annual Product Review
ASM American Society for Microbiology
ASQ American Society for Quality
ATCC American Type Culture Collection
ATP Adenosine Triphosphate
Aw Water Activity
B/F or BF Bacteriostasis/Fungistasis (obsolete term for Method Suitability Test as part of the Sterility Test)
B/F/S Blow-Fill-Seal
BA/BE Bioavailability/Bioequivalence
BACPAC Guidance on Scale-up and Post-approval Changes for Bulk Actives
BAM Bacterial Analytical Manual (FDA Publication)
BBB Bad Bug Book
BCC Biopharmaceutics Coordinating Committee (internal CDER/OPS committee)
BCE Beneficial Clinical Event
BCS Biopharmaceutics Classification System
BDU Brain Dead User (common IT explanation of computer problem)
BET Bacterial Endotoxin Test
BI Biological Indicator
BIND Biological Investigational New Drug
BLA Biologics License Application
BMBL Biosafety in Microbiological and Biomedical Laboratories (CDC Publication)
BOHICA Bend Over, Here It Comes Again
BPC Bulk Pharmaceutical Chemical
BSC Biological Safety Cabinet
BSE Bovine Spongiform Encephalopathy (Mad Cow Disease)
BSL Biological Safety Level (pathogenicity risk)
BTC PQRI Biopharmaceutics Technical Committee
C of A Certificate of Analysis (also CoA)
CANDA/CAPLA Computer-assisted New Drug Application/Product License Application
CAPA Corrective Action and Preventative Action
CBA Columbia Blood Agar
CBE Changes Being Effected
CBER Center for Biologics Evaluation and Research
CCC Compliance Coordinating Committee (CDER)
C-CEList Cleanrooms and Controlled Environments Email Discussion Group
CD Chlorine Dioxide
CDC Centers for Disease Control and Prevention (USA)
CDDI Collaboration on Drug Development Improvement (or Initiative)
CDER Center for Drug Evaluation and Research
CDMO Contract Development and Manufacturing Organization
CDRH Center for Devices and Radiological Health
CEN Centre for European Norm
CFR Code of Federal Regulations
CFSAN Center for Food Safety and Applied Nutrition
CFU Colony Forming Unit
CFW Carbon Filter Water
CGMP Current Good Manufacturing Practice
CHMP Committee for Medicinal Products for Human Use (EU)
CIP Clean in Place
CLO Career Limiting Opportunity
CMC Chemistry and Manufacturing Controls section of applications
CMCCC Chemistry and Manufacturing Controls Coordinating Committee (internal CDER/OPS committee)
CMO Contract Manufacturing Organization
CoA Certificate of Analysis (also C of A)
COMIS Center Office Management Information System
COMIS Center-wide Oracle Management Information System (COER)
COSTART Coding Symbols for Thesaurus of Adverse Reaction Terms
COTS Commercial Off The Shelf software
CPG Compliance Policy Guide (FDA)
CPMP Committee on Proprietary Medicinal Products (EU; obsolete – see CHMP and CVMP)
CPP Critical Process Parameters
CQA Critical Quality Attributes
CRADA Cooperative Research and Development Agreements
CRAMS Contract Research and Manufacturing Services
CRO Contract Research Organization
CSA Canadian Standards Association
CSE Control Standard Endotoxin
CSO Consumer Safety Officer (FDA)
CTD Common Technical Document
CTFA Cosmetics, Toiletries and Fragrance Association (obsolete name – see PCPC)
CTO Contract Testing Organization
CV% Coefficient of Variation
CVM Center for Veterinary Medicine
CVMP Committee for Medicinal Products for Veterinary Use (EU)
DD Division Directors in CDER or District Directors in the field
D-value Decimal Reduction Time (log-linear kill kinetics)
DDMAC Division of Drug Marketing, Advertising, and Communications
DHF Design History File
DHHS Department of Health and Human Services
DHR Device History Regulation
DHR Device History Report
DI Deionized (water)
DIN Deutsche Industrie Norm (German Industrial Norm)
DIS Draft Intemational Standard
DMF Drug Master File
DNA Deoxyribonucleic Acid
DO Division Directors in CDER or District Directors in the field (FDA)
DOP Dioctylphthalate
DPRF Drug Products Reference File
DPTC PQRI Drug Product Technical Committee
DQ Design Qualification
DRLS Drug Registration and Listing System (FDA)
DSMZ Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH (German Collection of Microorganisms and Cell Cultures)
DSP Downstream Processing
DSTC PQRI Drug Substance Technical Committee
EA Environmental Assessment
EBR Electronic Batch Record
EDMS Electronic Document Management System
EFPIA European Federation of Pharmaceutical Industries Associations
EFTA European Free Trade Association
EHS Environmental Health and Safety
EIR Establishment Inspection Report
ELA Establishment License Application
ELN Electronic Laboratory Notebook
EM Environmental Monitoring
EMA European Medicines Agency (aka EMEA)
EMEA European Medicines Agency (aka EMA)
EMB Eosin Methylene Blue
EO Ethylene Oxide
EP European Pharmacopoeia
EPA U.S. Environmental Protection Agency
EQ Equipment Qualification
ER Extended release
ESO Equipment Superior to Operator (IT expression for equipment repair issue)
EU MDD European Union’s Medical Device Directive, Council Directive 93/42/EEC of 14 June 1993, as amended
FAR Field Alert Reports
FAT Factory Acceptance Testing
FD&C Food, Drug & Cosmetic (Act)
FD&C Act Federal Food, Drug and Cosmetic Act
FDA Food and Drug Administration
FDA 483 Form for listing FDA inspectional citations
FDAMA FDA Modernization Act
FDIS Final Draft International Standard
FIFO First In, First Out
Fluid-D Diluting Fluid D (Sterility Test; peptone w/polyysorbate 80)
FMEA Failure Mode Effects Analysis
FMECA Failure Mode, Effects, and Criticality Analysis
FOIA Freedom of Information Act
FONSI Finding of No Significant Impact
FPAP First-person Audit Program
FR Federal Register
FTIR Fourier Transform Infrared Spectroscopy
FTM Fluid Thioglycollate Medium
FUBAR Fouled Up Beyond All Recognition
GAMP Good Automated Manufacturing Practices
GC Gas Chromatography
GCLP Good Control Laboratory Practice (European GMP term)
GCP Good Clinical Practices
GDP Good Documentation Practices
GERM Good Electronic Records Management
GGP Good Guidance Practices
GIGO Garbage In, Garbage Out (bad data leads to bad conclusions)
GLP Good Laboratory Practice
GMP Good Manufacturing Practice
GPM General Purpose Medium
GNC Gram Negative Cocci
GNR Gram Negative Rods
GPC Gram Positive Cocci
GPQ Growth Promoting Quality
GPR Gram Positive Rods
GPRA Government Performance and Results Act
GPT Growth Promotion Test
GRAS Generally Recognized as Safe
GRASE Generally Recognized as Safe and Effective
GRP Good Review Practice
GTP Good Tissue Practices
GVC Gram Variable Cocci
GVR Gram Variable Rods
HACCP Hazard Analysis and Critical Control Point
HAZOP Hazard Operability Analysis
HEPA High Efficiency Particulate Air filter
HPAPI High Potency Active Pharmaceutical Ingredient
HPB Health Protection Branch (Canada)
HPC Heterotrophic Plate Count
HPFB Health Products and Food Branch (Health Canada)
HPLC High Performance Liquid Chromatography
HTS High Throughput Screening
HVAC Heating, Ventilation and Air Conditioning
ICCCS International Confederation of Contamination Control Societies
ICH International Conference on Harmonization
ID10T Idiot (the ID10T error is commonly found by IT professionals)
IDE Investigational Device Exemption
IEST Institute for Environmental Sciences and Technology
IFPMA International Federation of Pharmaceutical Manufacturers Associations
IND Investigational New Drug
INDA Investigational New Drug Application
INDC Investigational New Drug Committee
INN International Nonproprietary Name
IOM Investigations Operations Manual (FDA)
IP Intellectual Property
IPA Isopropyl Alcohol
IQ Installation Qualification
IR Immediate Release
IRB Institutional Review Board
IRC Institutes Review Committee
ISO International Organization for Standardization
ISPE International Society for Pharmaceutical Engineering
IT Information Technology
ITCC Information Technology Coordinating Committee (CDER)
IV/IVC In vitro / In vivo Correlation
IVD In vitro Diagnostics
IVD-IR/-MR In vitro dissolution-immediate release or modified release products
JCM Japanese Collection of Microorganisms
JITT Just in Time Training
JP Japanese Pharmacopoeia
KISS Keep It Simple, Stupid
LADP Locally-acting drug products
LAF Laminar Air Flow
LAL Limulous Amoebocyte Lysate (Bacterial Endotoxin Test)
LC/GC Liquid Chromatography/Gas Chromatography
LFH Laminar Flow Hood
LIMS Laboratory Information Management System
LMS Learning Management System
LOC Lab-on-a-Chip
LOD Limit of Detection
LOQ Limit of Quantification
LPS Lipopolysaccharide
LRW LAL Reagent Water
LTE Less Than Effective
LVP Large Volume Parenteral
MAb Monoclonal Antibody
MAC MacConkey Agar
MACB MacConkey Broth
MAH Marketing Authorization Holder
MALDI-TOF Matrix-assisted laser desorption/ionization Time-of-flight
MAPP Manual of Policy and Procedures
MBC Minimum Biocidal Concentration
MCA Medicines Control Agency (UK – obsolete term; see MHRA)
MCB Master Cell Bank
MCE Mixed Cellulose Esters
MCTA Microbial Content Test Agar (aka TSALT)
MDD Microbiological Data Deviation
MDI Metered Dose Inhaler
M-Endo M Endo Agar LES
MEA Malt Extract Agar
MF Membrane Filtration
mHPC Agar m-Heterotrophic Plate Count Agar (water testing)
MHLW Ministry of Health, Labor and Welfare (Japan)
MHRA Medicines Healthcare products Regulatory Agency (UK)
MIC Minimum Inhibitory Concentration
MKT Mean Kinetic Temperature
MLT Microbial Limits Test
MOU Memorandum of Understanding
MPCA Modified Plate Count Agar
MPCC Medical Policy Coordinating Committee (CDER)
MPN Most Probable Number
MRA Mutual Recognition Agreement
MRO Most Resistant Organism (disinfectancy testing)
MRSA Methicillin Resistant Staphylococcus aureus
MSA Mannitol Salt Agar
MSDS Material Safety Data Sheets
MSPC Multivariate Statistical Process Control
MVD Maximum Valid Dilution (LAL Test)
NADA New Animal Drug Application
NAl No Action Indicated (FDA inspection classification)
NBE New Biological Entity
NCR Non-Conformance Report
NCTC National Collection of Type Cultures (UK)
NDA New Drug Application
NDC National Drug Code
NE-NT Neutralizer Efficacy/Neutralizer Toxicity Test (a.k.a. Method Suitability Test)
NIH Not Invented Here
NIH National Institutes of Health
NLT Not Less Than
NME New Molecular Entity
NMT Not More Than
NoE Notice of Event
NRCM National Registry of Certified Microbiologists (aka NRM)
NRM National Registry of Microbiologists (aka NRCM)
NSC Nomenclature Standards Committee
NTI Narrow-therapeutic index drugs
NTIS National Technical Information Service
O&M Operation and Maintenance
OAI Alert Official Action Indicated Alert  (a site has been found to have serious deficiencies)
OAl Official Action Indicated
ODE Office of Drug Evaluation I through V (NDA review offices)
OGC Office of the General Counsel
OGD Office of Generic Drugs (CDER)
OJT On-the-Job Training
ONDQA Office of New Drug Quality Assessment (CDER)
OOL Out of Limit (or Level)  (Environmental Monitoring event)
OOS Out of Specification (e.g., test results)
OOT Out of Trend (Environmental Monitoring event)
OPS Office of Pharmaceutical Sciences (FDA/CDER)
OQ Operational Qualification
ORA FDA Office of Regulatory Affairs
ORO FDA Office of Regional Operations
OSD Oral Solid Dosage Form
OSHA U.S . Occupational Safety and Health Administration
OTC Over the Counter
OTR Office of Testing and Research (CDERJOPS/OTR)
PAC-PAC Guidance on post-approval changes for packaging materials
PAC-SAS Guidance on scale-up and post-approval changes for sterile aqueous solutions)
PAHO Pan American Health Organization
PAI Pre-approval inspection
PAS Prior Approval Supplement
PAT Process Analytical Technology
PBE/IBE Population Bioequivalence/Individual Bioequivalence
PBS Phosphate Buffered Saline
PCR Polymerase Chain Reaction
PCPC Personal Care Products Council (formerly CTFA)
PDA Parenteral Drug Association
PDA Potato Dextrose Agar
PDG Pharmacopeial Discussion Group (harmonization body)
PDUFA Prescription Drug User Fee Act of 1992
PES Hydrophilic Polyethersulfone
PET Positron Emission Tomography
PET Preservative Effectiveness Test (aka AET, APE)
PFW Prefiltration Water
Ph. Eur. European Pharmacopoeia
PHARMIG Pharmaceutical Microbiology Interest Group (UK)
PhD Piled high and Deep
PhRMA Pharmaceutical Research and Manufacturers of America
PET Preservative Effectiveness Test (a.k.a. AET, APE)
PHS Public Health Service (Act)
PIC/S Pharmaceutical Inspection Convention;  Pharmaceutical Inspection Cooperation Scheme
PK Pharmacokinetics
PLA Product License Application
PLC Programmable Logic Controller
PM Preventative Maintenance
PMA Premarket Approval
PMFList PMF Email Discussion Group
PNSU Probability of Non-Sterile Unit
PO Purchase Order
POU Point of Use
PP Pyrophosphate
PPE Personal Protective Equipment
PQ Performance Qualification
PQRI Product Quality Research Institute
PRLB Phenol Red Lactose Broth
PSDGList Pharmaceutical Stability Email Discussion Group
PVC Polyvinyl chloride
PVDF Polyvinylidene Fluoride
PW Purified Water
QA Quality Assurance
QAU Quality Assurance Unit
QbD Quality by Design
QC Quality Control
QMS Quality Management System
QP Qualified Person
qPCR Quantitative Polymerase Chain Reaction
QRM Quality Risk Management
QSM Quality System Manual
QSR Quality System Regulation
QSR Quality System Report
R2A Reasoner’s Minimal Agar Media for Recovery of Waterborne Microorganisms
RA Regulatory Affairs
RAC Reviewer Affairs Committee (CDER – disbanded 2000)
RCS Reuter Centrifugal air Sampler (an active air sampler)
REMS Risk Evaluation and Mitigation Strategy
RFI Request for Information
RFID Radio Frequency Identification
RFP Request for Proposal
RFQ Request for Quotation
RLD Reference Listed Drug
RLU Relative Light Unit
RM Registered Microbiologist
RMM Rapid Microbiological Method
RO Reverse Osmosis
RODAC Replicate Organism Detection and Counting
ROI Return on Investment
RSE Reference Standard Endotoxin
RTD Real Time Datalogger
RTFM Read the Freaking Manual
RVSEB Rappaport Vassiliadis Salmonella Enrichment Broth
S2D2 Same Stuff, Different Day
SAE Serious Adverse Event
SAL Sterility Assurance Level
SAS Surface Air System (an active air sampler)
SAT Site Acceptance Testing
SBA Summary Basis of Approval
SBA Sheep Blood Agar
SBNDA Supplemental New Drug Application
SCCS Standard Cubic Centimeter per Second
SCDA Soybean Casein Digest Agar (a.k.a. TSA)
SCDB Soybean Casein Digest Broth (a.k.a. TSB)
SCSO Supervisory Consumer Safety Officer
SD Standard Deviation
SDA Sabouraud Dextrose Agar
SDB Sabouraud Dextrose Broth
SEM Scanning Electron Microscopy
SIM Society for Industrial Microbiology
SIP Steam in Place; or Sterilize in Place; or Sanitize in Place
SISPQ Safety, Identity, Strength, Purity and Quality
SM Specialist Microbiologist (as per NRM)
SMA Sterilizable Microbiological Atrium
SME Subject Matter Expert
SMEWW Standard Methods for the Examination of Water & Wastewater
SMTC PQRI Science Management Technical Committee
SNAFU Situation Normal – All Fouled Up
sNDA Supplemental New Drug Application
SOP Standard Operating Procedure
SPC Standard Plate Count
SPC Statistical Process Control
SPV Sterile process validation
SS Stainless Steel
SSA Salmonella/Shigella Agar
SSD Site-specific Stability Data
SUPAC-IR/-MR/-TDS/-SS Guidances on scale-up and post-approval changes for immediate release products, modified release products, transdermal systems, and semi-solids
SUPAC Guidance on Scale-up and Post Approval Changes
SVP Small Volume Parenteral
SW Soften Water
TAMC Total Aerobic Microbial Count
TANSTAAFL There Ain’t No Such Thing As A Free Lunch
TBD To Be Determined
TC Technical Committee
TGA Therapeutic Goods Administration (Australia)
TFF Tangential Flow Filtration
TJA Tomato Juice Agar
TNTC Too Numerous to Count
TOC Total Organic Carbon
TQM Total Quality Management
TS Test Solution (as in USP’s “Saline TS”)
TSA Trypticase Soy Agar (a.k.a. SCDA)
TSALT Trypticase Soy Agar with Lecithin and Tween (aka MCTA)
TSB Trypticase Soy Broth (a.k.a. SCDB)
TSE Transmissible Spongiform Encephalopathies
TVAC Total Viable Aerobic Count
TVC Total Viable Count
TYMC Total Yeast and Mold Count
UF Ultrafiltration
ULPA Ultra-Low Penetration (or Particulate) Air
UPS Uninterrupted Power Supply
URS User Requirement Specification
USAN United States Adopted Name
USC United States Code
USCA U.S. Code Annotated
USDA US Department of Agriculture
USP United States Pharmacopeia
USP-NF United States Pharmacopeia-National Formulary
UV Ultra-Violet
VAl Voluntary Action Indicated
VAl Voluntary Action Indicated (FDA inspection classification)
VBNC Viable But Not Culturable
VHP Vaporized Hydrogen Peroxide (a.k.a. HPV)
VHPH Vapor phase Hydrogen Peroxide
VL Visual Limit
VMP Validation Master Plan
VRSA Vancomycin Resistant Staphylococcus aureus
WFI Water for Injection
WG Working Group
WHO World Health Organization
WL Warning Letter
XLD Agar Xylose Lysine Deoxycholate Agar
YMM Yeast and Mold Medium