| μS |
micro-Siemens, conductivity value (1S = 1/Ohm) |
| AANDA |
Abbreviated Antibiotic New Drug Application |
| ABPI |
Association of British Pharmaceutical Industries |
| ADE |
Acceptable Daily Exposure |
| AHU |
Air handling unit |
| AISI |
American Iron and Steel Institute |
| ANADA |
Abbreviated New Animal Drug Application |
| ANDA |
Abbreviated New Drug Application |
| ANOVA |
ANOVA Analysis of Variance |
| ANSI |
American National Standards Institute |
| AP |
Applicants Part of the Active Substance Master File |
| API |
Active Pharmaceutical Ingredient |
| API |
Analytical Profile Index (quick Bacterial Identification System) |
| APIC |
Active Pharmaceutical Ingredient Council |
| AQL |
Acceptable Quality Level / also: Acceptable Quality Limit |
| ASHRAE |
American Society of Heating, Refrigeration, and Air-Conditioning Engineers |
| ASME |
American Society of Mechanical Engineers |
| ASME-BPE |
American Society for Mechanical Engineers-Bioprocessing Equipment |
| ASMF |
Active Substance Master File |
| ASTM |
American Society for Testing and Materials |
| ATP |
Analytical Target Profil |
| ATCC |
American Type Culture Collection |
| ATMP |
Advanced Therapy Medicinal Product |
| BCF |
Bead and Channel Free = Butt-welding technology by GeorgFischer for plastic parts & pipes e.g. PVDF |
| BFS |
Blow/Fill/Seal |
| BIER |
Biological Indicator Evaluation Resistometer |
| BLA |
Biologic License Application |
| BMS |
Building Management System |
| BP |
British Pharmacopoeia |
| BPC |
Bulk Pharmaceutical Chemicals |
| BPE |
Bioprocessing Equipment |
| BPE |
Bulk Pharmaceutical Excipients |
| BR |
Batch Record |
| BSE |
Bovine Spongioform Encephalopathy |
| BSE |
Bovine Serum Albumin |
| CANDA |
Computer Assisted New Drug Application |
| CAPA |
Corrective Action Preventative Action |
| CAT |
Committee for Advanced Therapies |
| CBER |
Center for Biologics Evaluation and Research |
| CDER |
Center for Drug Evaluation and Research |
| cEDI |
continuous EDI |
| CEFIC |
European Chemical Industry Council |
| CEP (CoS) |
Certificate of Suitability of the EP |
| CFR |
Code of Federal Regulations (e.g. 21 CFR) |
| CFR 21 part 11 |
Code of Federal Regulations Title 21 part 11 Electronic records, electronic signatures |
| CFU |
Colony Forming Unit (bacteria count number) |
| cGMP |
current Good Manufacturing Practices |
| CIA |
Cross Impact Analysis |
| CIM |
Computer Integrated Manufacturing |
| CIP |
Cleaning In Place |
| CMC |
Chemistry, Manufacturing and Controls |
| CMS |
Change Management System |
| CMS |
Concerned Member State |
| COA |
Certificate of Analysis |
| COP |
Cleaning off place |
| COTS |
Commercial Off The Shelf |
| CpK |
Process Capability Index |
| CPMP |
Committee for Proprietary Medicinal Products |
| CPP |
Critica Process Parameter |
| CPU |
Central Processor Unit |
| CPV |
Continuous Process Verification (ICH Q 8, Annex 15) |
| CPV |
Continued Process Verification (FDA Process Validation Guidance, 2011) |
| CTMP |
Cell Therapy Medicinal Product |
| CQA |
Critical Quality Attribute |
| CS |
Clean Steam |
| CS |
Control Strategy |
| CSV |
Computer System Validation |
| CTD |
Common Technical Document |
| CTX |
Clinical Trial Excemption |
| CV |
Computer Validation |
| CVM |
Center for Veterinary Medicine |
| DAMOS |
Drug Application Methodology with Optical Storage |
| DCS |
Distribution Control System |
| DEHS |
Diethylhexylsebacat (test substance for HVAC-Qualification) |
| DfSS |
Design for Six Sigma |
| DHSS |
Department of Health and Human Services (UK) |
| DIN |
Deutsche Industrie Norm (German Industrial Standard) |
| DMF |
Drug Master File |
| DoE |
Design of Experiments |
| DOH |
Department of Health (UK) |
| DOP |
Dioctylphthalat |
| DP |
Drug Product |
| DQ |
Design Qualification |
| DS |
Design Specifications |
| DS |
Drug Substance |
| DTS |
double tube sheet (two plates on the head of a heat exchanger with air gap for leakages) |
| DVGW |
Deutscher Verein des Gas- und Wasserfaches (German Certification Organization for Gas & Water installations) |
| EBR |
Electronic Batch Record |
| EC |
European Community |
| ECA |
European Compliance Academy |
| EDI |
ElektroDeIonisation |
| EDMF |
European Drug Master File |
| EDQM |
European Directorate for the Quality of Medicines & Healtcare |
| EFPIA |
European Federation of Pharmaceutical Industries’ Associations |
| EFTA |
European Free Trade Area |
| EHEDG |
European Hygienic Equipment Design Group |
| EIR |
Establishment Inspection Report |
| ELA |
Establishment Licence Application |
| ELISA |
Enzym linked Immunosorbent Assay |
| EMA |
European Medicines Agency (new name for EMEA since 2009) |
| EMEA |
European Agency for the Evaluation of Medicinal Products (old name for EMA) |
| EMS |
Environment Monitoring System |
| EN |
European Norm = European Industrial Standard |
| EP |
European Pharmacopoeia |
| EPA |
Environmental Protection Agency |
| EPDM |
Ethylen-Propylen-Dien-(Monomer) - rubber |
| ERP |
Enterprise Resource Planning |
| ETO |
Ethylenoxid |
| EU |
Endotoxin Units (also IU = International Units = Infection Units) |
| EU |
European Union |
| Eucomed |
European Confederation of Medical Suppliers |
| F&F |
Fill and Finish |
| F(D)S |
Functional (Design) Specifications |
| FAT |
Factory Acceptance Test |
| FD&C Act |
(US) Food, Drug and Cosmetic Act |
| FDA |
Food and Drug Administration |
| FDAMA |
Food and Drug Administration Modernization Act |
| FDIS |
Final Draft International Standard |
| FDS |
Functional Design Specification |
| FFU |
Filter Fan Unit |
| FIFO |
First in, First out |
| FIP |
Fédération Internationale Pharmaceutique |
| FIR |
Failure Investigation Report |
| FIRA |
Federal Insecticide, Fungicide and Rotenticide Act |
| FMEA |
Failure Mode and Effects Analysis (System for Risk Analysis of a System) |
| FOI(A) |
Freedom of Information Act (FDA) |
| FR |
Federal Register |
| FS |
Feasibility Study |
| FTA |
Fault Tree Analysis |
| GAMP® |
Good Automated Manufacturing Practice (GAMP® is a trademark of ISPE - http://www.ispe.org/gamp5) |
| GAP |
Good Analytical Practice |
| GC |
Gas Chromatography |
| GCLP |
Good Control Laboratory Practice |
| GCP |
Good Clinical Practice |
| GCVP |
Good Computer Validation Practices |
| GDP |
Good Distribution Practice |
| GEP |
Good Engineering Practice |
| GfI |
Guide for Inspection of |
| GLP |
Good Laboratory Practice |
| GMP |
Good Manufacturing Practice |
| GSP |
Good Storage Practice |
| GTMP |
Cell Therapy Medicinal Product |
| GWP |
Good Warehousing Practice |
| HACCP |
Hazard Analysis and Critical Control Points (Risk Analysis) |
| HAT |
Hardware Acceptance Test |
| HAZOP |
Hazard Operability Analysis |
| HDS |
Hardware Design Specification |
| HEPA |
High Efficiency Particulate Air (Filter) |
| HHS |
Department of Health and Human Services |
| HIMA |
Health Industries Manufacturers Association |
| HMI |
Human Machine Interface |
| HPLC |
High Pressure (Performance) Liquid Chromatography |
| HPW |
Highly Purified Water (= Aqua Valde Purificata) |
| HSE |
Health, Safety and Environment |
| HVAC |
Heating, Ventilation and Air Conditioning |
| I/O |
input/output |
| ICH |
International Council for Harmonisation of Tech. Requirements for Pharmaceuticals for Human Use |
| IEC |
International Electrotechnical Commission |
| IEEE |
Institute of Electrical and Electronic Engineers, Inc. |
| IEST |
Institute of Environmental Sciences and Testing |
| IFPMA |
International Federation of Pharmaceutical Manufacturers Association |
| IMP |
Investigational Medicinal Product |
| INADA |
Investigational New Animal Drug Application |
| IND |
Investigational New Drug Application |
| INN |
International Non-proprietary Names |
| IPAC-RS |
International Pharmaceutical Aerosol Consortium on Regulation and Science |
| IPC |
In Process Control |
| IPEC |
International Pharmaceutical Excipients Council |
| IQ |
Installation Qualification |
| ISO |
International Standard Organization |
| ISPE |
International Society of Pharmaceutical Engineers |
| IU |
International Units (WHO-name since 2000 for Endotoxine Units = EU) |
| JP |
Japanese Pharmacopoeia |
| K |
Kurtosis |
| KPI |
Key Performance Indicator |
| LAF (LF) |
Laminar Airflow |
| LAL |
Limulus Amebocyte Lysate (Endotoxin-Test) |
| LD 50 |
Lethal Dose 50 |
| LIMS |
Laboratory Information Management System |
| LOA |
Letter of Access (EU) |
| LOA |
Letter of Authorization (US) |
| LSL |
Lower Specificaton Limit |
| LVP |
Large Volume Parenterals |
| Lyo |
Lyophilisator |
| MA(H) |
Marketing Authorisation (Holder) |
| MAC |
Maximum Acceptable Carryover |
| MAL |
Material Air Lock |
| MBR |
Master Batch Record |
| MCB |
Master Cell Bank |
| MCL |
Maximum Contaminant Level |
| MDR |
Manufacturing Deviation Report |
| MES |
Manufacturing Execution System |
| MHLW |
Ministry of Health, Labour and Welfare (Japan) |
| MHRA |
Medicine and Healthcare Products Regulatory Agency |
| MIL |
Military Standardization Document |
| MMP |
Microbial Monitoring Programme |
| MMU |
10E6 (US Million) International Units |
| MOU |
Memorandum of Understanding |
| MRA |
Mutual Recognition Agreement |
| MRP |
Mutual Recognition Procedere |
| MSA |
Measurement System Analysis |
| MSD |
Multi Stage Distillation |
| MSDS |
Material Safety Data Sheet |
| MVC |
Minimum Valid Concentration |
| MVD |
Maximum Valid Dilution |
| n.a. |
not applicable |
| NADA |
New Animal Drug Application |
| NBE |
New Biological Entity |
| NCE |
New Chemical Entity |
| NDA |
New Drug Application |
| NDE |
New Drug Entity |
| NDL |
No designated limit |
| NF |
National Formulary |
| NIH |
National Institute of Health (USA) |
| NIR |
Near Infrared spectroscopie |
| NIST |
National Institute of Standards and Technology, Washington, USA |
| NLT |
Not less than (time / analytical) |
| NME |
New Molecular Entities |
| NMR |
Nuclear Magnetic Resonance |
| NMT |
Not more than (as an analytical limit) |
| NOEL |
NO Observable Effect Level |
| NOR |
Normal Operating Range |
| OECD |
Organization for Economic Cooperation and Development |
| OMCL |
Official Medicines Control Laboratory |
| OOE |
Out of Expectation |
| OOL |
Out of Limits |
| OOS |
Out-of-Specification (test results) |
| OOT |
Out of Trend |
| OPV |
Ongoing Process Verification (Annex 15) |
| OQ |
Operation Qualification |
| OQ |
Operational Qualification |
| ORA |
Office of Regulatory Affairs (FDA) |
| ORO |
(US FDA’s) Office of Regional Operations |
| OTC |
Over-the-Counter (medications) |
| PAI |
Pre-Approval-Inspection |
| PAL |
Personnel Air Lock |
| PAR |
Proven Acceptable Ranges |
| PAT |
Process Analytical Technology |
| PBR |
Production Batch Record |
| PC |
Personal Computer |
| PC-Agar |
Plate Count Agar |
| PCR |
Polymerase Chain Reaction |
| PCS |
Process Control System |
| PDA |
Parenteral Drug Association (USA) |
| PDE |
Permitted Daily Exposure |
| PES |
Peressigsäure |
| Ph.Eur. |
European Pharmacopeaia |
| PhD |
Doctor of Philosophy |
| PhRMA |
Pharmceutical Research and Manufacturer Associations (USA) |
| PIC |
Pharmaceutical Inspection Convention |
| PIC/S |
Pharmaceutical Inspection Cooperation Scheme |
| PID or P&ID |
Pipe and Instrumentation Drawing or Piping & Installation Diagram |
| PID or P&ID |
Piping and Installation Drawing |
| PKI |
Public Key Infrastructure |
| PL |
Product Licence |
| PLA |
Product Licence Application |
| PLC |
Programmable Logic Controller |
| PMA |
Pharmaceutical Manufacturers Association |
| PMAC |
Pharmaceutical Manaufacturer’s Association of Canada |
| PMDA |
Pharmaceuticals and Medical Devices Agency (Japan) |
| PMF |
Plant Master File |
| PMS |
Post Marketing Surveillance |
| PoU |
Point of Use |
| ppb |
parts per billion |
| PPE |
Personal Protection Equipment |
| PPQ |
Process Performance Qualification |
| PQ |
Performance Qualification (Annex 15, PIC/S PI 006) |
| PQ |
Process Qualification (FDA Process Validation Guidance, 2011) |
| PQR |
Product Quality Review |
| PQRI |
Product Quality Research Institute |
| PS |
Pure Steam |
| PSF |
Product Specification File |
| PSG |
PS-Generator |
| PTFE |
Poly-Tetra-Fluor-Ethyleen (vulgo „Teflon“) |
| PV |
Process Validation |
| PVDF |
Polyvinylidenfluorid |
| PW |
Purified Water (= Aqua Purificata) |
| QA |
Quality Assurance |
| QAU |
Quality Assurance Unit |
| QbD |
Quality by Design |
| QC |
Quality Control |
| QCU |
Quality Control Unit |
| QFD |
Quality Function Deployment |
| QHD |
Qualified Hygienic Design |
| QM |
Quality Management |
| QMS |
Quality Management-System |
| QOS |
Quality Overall Summary of the Active Substance Master File |
| QP |
Qualified Person |
| QRM |
Quality Risk Management (ICH Q9) |
| QTPP |
Quality Target Product Profile |
| R&R-Analysis |
Repeatability & Reproducibility Analysis |
| R+D |
Research and Development |
| RA |
Risk Analysis |
| RAS |
Rapid Alert System |
| RABS |
Restricted Access Barrier System |
| RCS |
Reuter Centrifugal Sampler |
| RH |
Relative Humidity |
| RMS |
Reference Member State |
| RO |
Reverse Osmosis |
| RODAC |
Replicate Organism Detection and Counting |
| RP |
Restricted Part of the Active Substance Master File |
| rpm |
revolutions per minute |
| RTR |
Real Time Release |
| RTRT |
Real Time Release Testing |
| SAL |
Sterility Assurance Level |
| SAT |
Site Acceptance Test |
| SCADA |
Supervisory, Control and Data Acquisition |
| SCS |
Swiss Calibration Service |
| SDI |
Silt Density Index (= Membrane Blocking Index, typically measured over 15min = then SDI15) |
| SDS |
Software Design Specification |
| SIP |
Sterilisation (Steaming) in Place |
| SK |
Skewness |
| SLA |
Service Level Agreement |
| SMF |
Site Master File |
| SOP |
Standard Operation Procedure |
| SPC |
Statistical Process-Control |
| SPC |
Summary of Product Characteristics |
| SS |
Stainless Steel |
| SUPAC |
Scale Up and Post Approval Changes |
| SVP |
Small Volume Parenterals |
| TAMC |
total (viable) aerobic microbial count |
| tbd |
to be defined |
| TEP |
Tissue Engineered Product |
| TH |
Technische Hochschule (Technical University) |
| TLC |
Thin Layer Chromatograpghy |
| TOC |
Total Organic Carbon |
| TPV |
Traditional Process Validation |
| TQM |
Total Quality Management |
| TSCA |
Toxic Substances Control Act |
| TYMC |
Total combined (viable) yeast/moulds count (KBE/ml-Test) |
| UCL |
Upper confidence limit (for particle statistics) |
| UF |
Ultrafiltration |
| ULPA |
Ultra Low Penetrating Filter |
| URS |
User Requirement Specification |
| USL |
Upper Specification Limit |
| USP |
United States Pharmacopoeia |
| VDMA |
Verband Deutscher Maschinen- und Anlagenbau (Society of German Machine and Plant Construction) |
| VHP |
Vaporized Hydrogen Peroxide (H2O2-gas for sanitisation clean rooms) |
| VMP |
Validation Master Plan |
| VPN |
Virtual Private Network |
| WCB |
Working Cell Bank |
| WCF |
Water conversion factor (ratio out to in qty water) |
| WFI |
Water for Injection |
| WHO |
World Health Organization |
| WIP |
Washing In Place |
