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 |
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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) |
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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 |