Like all other specialized industries, pharmaceutical engineering lingo is full of abbreviations. This can make it difficult to understand for people who haven't spent most of their lives in the industry. We have gathered the ones our experts use the most in the table below.
|
ADC |
Antibody Drug Conjugates |
| ADE |
Acceptable Daily Exposure |
|
API |
Active Pharmaceutical Ingredient |
|
ATEX |
Atmosphere Explosible (or Explosive) |
|
BAS |
Building Automation System |
|
BMD |
Building Module Diagram |
|
BMS |
Building Management System |
|
BU |
Black Utility |
|
CA |
Compressed Air |
|
CAD |
Computer Aided Design |
|
CBER |
Centre for Biologics Evaluation and Research (FDA) |
|
CBP |
Continuous Bioprocessing |
|
CDER |
Centre for Drug Evaluation and Research (FDA) |
|
cGMP |
Current Good Manufacturing Practice |
|
CIP |
Cleaning-in-place |
|
CNC |
Controlled Not Classified |
|
CP |
Continuous Processing |
|
CPP |
Critical Process Parameter |
|
CPV |
Continued Process Verification |
|
CQA |
Critical Quality Attributes |
|
CU |
Clean Utility |
|
DP |
Drug Product |
|
ECA |
European Compliance Academy |
|
EMA |
European Medicine Agency |
|
EMEA |
European Agency for the Evaluation of Medical Products |
|
EMI |
Electromagnetic Interference |
|
EMS |
Equipment Module Specification |
|
ERP |
Enterprise Resource Planning |
|
FAT |
Factory Acceptance Test |
|
FDA |
Food and Drug Administration |
|
GAMP |
Good Automated Manufacturing Practice |
|
GCP |
Good Clinical Practice |
|
GDP |
Good Documentation Practice / Good Distribution Practice |
|
GMO |
Genetically Modified Organism |
|
GMP |
Good Manufacturing Practice |
|
GTP |
Good Test Practice |
|
HPW |
Highly Purified Water |
|
HSE |
Health, Safety and Environment |
|
HVAC |
Heating, Ventilation, and Air Conditioning |
|
ICH |
International Conference of Harmonization |
|
ISO |
International Organization for Standardization |
|
ISP |
Injection Sterile Plant |
|
ISPE |
International Society of Pharmaceutical Engineers |
|
MAB |
Monoclonal Antibody |
|
MES |
Manufacturing Execution System |
|
MIS |
Manufacturing Intelligence Solution |
|
OSD |
Oral Solid Dosage (tablets/capsules) |
|
OSHA |
Occupational Safety and Health Administration |
|
PAT |
Process Analytical Technology |
|
PCS |
Process Control System |
|
PDA |
Parenteral Drug Association (USA) |
|
PMD |
Process Module Diagram |
|
PS |
Purified Steam |
|
PSD |
Process Design Specification |
|
PW |
Purified Water |
|
QA |
Quality Assurance |
|
QbD |
Quality by design |
|
QC |
Quality Control |
|
RABS |
Restricted Access Barrier System |
|
SAT |
Site Acceptance Test |
|
SHE |
Safety, Health, Environment |
|
SIP |
Sterilization-in-place |
|
SOP |
Standard Operating Procedure |
|
SPC |
Statistical Process Control |
|
SUS |
Single-Use Systems |
|
SUT |
Single-Use Technology |
|
URS |
User Requirement Specification |
|
WFI |
Water For Injection |
