The pharmaceutical industry relies heavily on precise communication, which often involves a large number of abbreviations and acronyms. This glossary serves as a quick-reference guide to the most commonly used short forms across various functional areas, including Quality, Manufacturing, R&D, and Regulatory Affairs.
1. Quality Assurance (QA) & Compliance
Abbreviation | Full Form |
|---|---|
QA | Quality Assurance |
QMS | Quality Management System |
SOP | Standard Operating Procedure |
MFR | Master Formula Record |
BMR | Batch Manufacturing Record |
BPR | Batch Packaging Record |
CAPA | Corrective and Preventive Action |
RCA | Root Cause Analysis |
OOS | Out of Specification |
OOT | Out of Trend |
NCR | Non-Conformance Report |
DQ | Design Qualification |
IQ | Installation Qualification |
OQ | Operational Qualification |
PQ | Performance Qualification |
APR/PQR | Annual Product Review / Product Quality Review |
2. Quality Control (QC) & Analytical Testing
Quality Control focuses on testing raw materials, in-process samples, and finished products to confirm they meet specifications.
Abbreviation | Full Form |
|---|---|
QC | Quality Control |
HPLC | High Performance Liquid Chromatography |
GC | Gas Chromatography |
UV | Ultraviolet Spectrophotometer |
IR | Infrared Spectroscopy |
TLC | Thin Layer Chromatography |
LOD | Loss on Drying |
CFU | Colony Forming Unit |
MLT | Microbial Limit Test |
BET | Bacterial Endotoxin Test |
RSD | Relative Standard Deviation |
COA | Certificate of Analysis |
STP | Standard Testing Procedure |
3. Production / Manufacturing
These abbreviations relate directly to the materials and processes involved in the physical production of drug products.
Abbreviation | Full Form |
|---|---|
API | Active Pharmaceutical Ingredient |
RM | Raw Material |
PM | Packaging Material |
FP | Finished Product |
IPC | In-Process Control |
WFI | Water For Injection |
CIP | Clean In Place |
SIP | Sterilization In Place |
HVAC | Heating, Ventilation and Air Conditioning |
MCC | Microcrystalline Cellulose |
PVP | Polyvinylpyrrolidone |
HPMC | Hydroxypropyl Methylcellulose |
4. Research & Development (R&D)
The R&D stage involves drug discovery, formulation, and process optimization.
Abbreviation | Full Form |
|---|---|
R&D | Research and Development |
QbD | Quality by Design |
DOE | Design of Experiment |
F&D | Formulation and Development |
PQS | Pharmaceutical Quality System |
ICH | International Council for Harmonisation |
BCS | Biopharmaceutics Classification System |
POC | Proof of Concept |
TTD | Target Test Data |
FMEA | Failure Mode and Effect Analysis |
5. Regulatory Affairs (RA) & Global Agencies
These terms are critical for the submission and approval of new or generic drugs by health authorities worldwide.
Abbreviation | Full Form |
|---|---|
RA | Regulatory Affairs |
ANDA | Abbreviated New Drug Application |
NDA | New Drug Application |
DMF | Drug Master File |
CTD | Common Technical Document |
WHO | World Health Organization |
USFDA | United States Food and Drug Administration |
EMA | European Medicines Agency |
MHRA | Medicines and Healthcare Products Regulatory Agency |
6. Validation / Qualification (V&Q)
Validation ensures that a process or system consistently produces a result meeting its predetermined specifications.
Abbreviation | Full Form |
|---|---|
VP | Validation Protocol |
VR | Validation Report |
URS | User Requirement Specification |
DQ | Design Qualification |
IQ | Installation Qualification |
OQ | Operational Qualification |
PQ | Performance Qualification |
PPQ | Process Performance Qualification |
CSV | Computer System Validation |
7. Life Cycle Management (LCM)
LCM involves maintaining the product's quality, compliance, and market viability throughout its lifespan, often through formal change processes.
Abbreviation | Full Form |
|---|---|
LCM | Life Cycle Management |
CCF | Change Control Form |
CCR | Change Control Request |
RRF | Risk Review Form |
PDR | Product Development Report |
QTPP | Quality Target Product Profile |
CQA | Critical Quality Attribute |
CPP | Critical Process Parameter |