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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.

21 CFR 111     CGMP for Dietary Supplements
21 CFR 210     CGMP In Manufacturing, Processing, Packing, or Holding of Drugs; General
21 CFR 211     CGMP for Finished Pharmaceuticals
21 CFR 212     cGMP for Positron Emission Tomography Drugs
21 CFR 820     Medical Devices: Quality System Regulation
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
AHU     Air Handling Unit  (HVAC)
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
AOAC     Association of Analytical Communities (previously Assoc. of Anal. Chemistry)
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
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 (see also BFS)
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
BFS     Blow-Fill-Seal (see also B/F/S)
BI     Biological Indicator
BIO     Biotechnology Industry Organization
BIND     Biological Investigational New Drug
BLA     Biologics License Application
BMBL     Biosafety in Microbiological and Biomedical Laboratories (CDC Publication)
BP     British Pharmacopoeia
BP     Base Pair
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
BUD     Beyond Use Dating (from USP <797> - Compounding Pharmacies)
C of A  or   CoA     Certificate of Analysis (also CoA)
CAMP     Comprehensive Antimicrobial Management Program
CANDA/CAPLA     Computer-assisted New Drug Application/Product License Application
CAPA     Corrective and Preventative Action
CBA     Columbia Blood Agar
CBE     Changes Being Effected
CBE 30     CBE with 30 days notice to FDA
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
CE     Capillary zone Electrophoresis
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)
CHO cells     Chinese Hamster Ovary Cells
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
CPV     Continued Process Verification
CQA     Critical Quality Attributes
CRADA     Cooperative Research and Development Agreement
CRAMS     Contract Research and Manufacturing Services
CRO     Contract Research Organization
CSA     Canadian Standards Association
CSE     Control Standard Endotoxin
CSO     Consumer Safety Officer (FDA)
CSP     Compounded Sterile Preparation (from USP <797> - Compounding Pharmacies)
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)
DCA     Direct Compounding Area (from USP <797> - Compounding Pharmacies)
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
DGCI     Drug Controller General of India (National Regulatory Body)
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
DIW     Deionized Water
DMF     Drug Master File
DNA     Deoxyribonucleic Acid
DO     Division Directors in CDER or District Directors in the field (FDA)
DOE     Design of Experiments
DOP     Dioctylphthalate
DPRF     Drug Products Reference File
DPTC     PQRI Drug Product Technical Committee
DQ     Design Qualification
DRLS     Drug Registration and Listing System (FDA)
DS     Drug Substance
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
EBKAR     Error Between Keyboard and Chair (Data Entry Error)
EBR     Electronic Batch Record
ECTD     Electronic Common Technical Document
EDC     Electronic Data Capture
EDMS     Electronic Document Management System
EDQM     European Directorate for the Quality of Medicines & Healthcare
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
ELISA     Enzyme Linked Immunosorbent Assay
ELN     Electronic Laboratory Notebook
EM     Environmental Monitoring
EM     Electron Microscopy
EMA     European Medicines Agency (aka EMEA)
EMB     Eosin Methylene Blue
EMEA     European Medicines Agency (aka EMA)
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     Food, Drug and Cosmetic Act
FDA     Food and Drug Administration
FDA 482     Federal form for announcing intention of FDA to inspect a facility
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
FT-IR     Fourier Transform Infrared Spectroscopy
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
GCP     Good Compounding Practice
GDP     Good Documentation Practices
GDUFA     Generic Drug User Fee Amandments
GEM     Genetically Engineered Microorganism
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
GPO     Group Purchasing Organization
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
GxP     Good xxxx Practice (see GMP or GLP or GCP)
HACCP     Hazard Analysis and Critical Control Point
HAZOP     Hazard Operability Analysis
HEPA     High Efficiency Particulate Air filters
HME     Hot Melt Extrusion
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
IPC     In-process Control
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
JPMA     Japanese Pharmaceutical Manufacturers Association
KISS     Keep It Simple, Stupid
KPP     Key Process Parameter
LADP     Locally-acting drug products
LAF     Laminar Air Flow
LAL     Limulous Amoebocyte Lysate (Bacterial Endotoxin Test)
LC/GC     Liquid Chromatography/Gas Chromatography
LER     Low Endotoxin Recovery effect
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
MBP     Microprecipitated Bulk Powder
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
MDR     Multidrug Resistant
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)
MW     Molecular Weight
NADA     New Animal Drug Application
NAl     No Action Indicated (FDA inspection classification)
NBE     New Biological Entity
NCE     New Chemical 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
NIRS     Near Infared Spectroscopy
NIST     National Institute of Standards and Technology
NLT     Not Less Than
NME     New Molecular Entity
NMR     Nuclear Magnetic Resonance
NMT     Not More Than
NOE     Naturally Occurring Endotoxin
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 Tolerance
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)
PAb     Polyclonal Antibody
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
PAPR     Powered Air Purifying Respirators
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
PEC     Primary Engineering Control (from USP <797> - Compounding Pharmacies)
PEG     Polyethylene Glycol
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
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
PTC     Points to Consider (FDA guidance)
PVC     Polyvinyl chloride
PVDF     Polyvinylidene Fluoride
PW     Purified Water
QA     Quality Assurance
QAU     Quality Assurance Unit
QbD     Quality by Design
QBR     Question-Based Review (generally of CMC sections of ANDAs)
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
RIA     Radioimmunoassay
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
SAR     Structure-Activity Relationship
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
SCUBA     Self-contained Underwater Breathing Apparatus
SD     Standard Deviation
SDA     Sabouraud Dextrose Agar
SDB     Sabouraud Dextrose Broth
SDMS     Scientific Data Management System
SDS     Sodium Dodecyl Sulfate
SDS-PAGE     Sodium Dodecyl Sulfate Poolyacrylamide Gel Electrophoresis
SEC     Size Exclusion Chromatography
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
SMEPAC     Standardized Measurement of Particulate Airborne Contamination
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
SNP     Single Nucleotide Polymorphism (DNA sequencing)
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
SUB     Single Use Bioreactor
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
SWAG     Scientific Wild Ass Guess
SWFI     Sterile Water for Injection
TAMC     Total Aerobic Microbial Count
TANSTAAFL     There Ain’t No Such Thing As A Free Lunch
TARFU     Things Are Really Fouled Up
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

 



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