SOP for Abbreviations
1.0 OBJECTIVE:
To lay down the list of Abbreviation used in routine day to day activity in documents preparation for convenience.
2.0 SCOPE:
This SOP applies to all the abbreviation used in preparation of documents at [Company name].
3.0 RESPONSIBILITY:
All HOD’s : To ensure compliance
4.0 PROCEDURE:
4.1 The list of abbreviation is prepared to provide the convenience in preparation of documents.
4.2 Whenever the abbreviation is used in any document, first time it shall be prefixed by writing in full name followed by abbreviation in closed bracket. Then after the word shall be used by abbreviation throughout the documents.
4.3 The list of official abbreviations given in USP are as under:
CFR |
: |
U.S. Code Of Federal Regulations |
EP |
: |
European Pharmacopoeia |
FDA |
: |
U.S. Food and Drug Administration |
ISO |
: |
International Organization for Standardization |
JP |
: |
Japanese Pharmacopoeia |
USP |
: |
United State Pharmacopoeia |
WHO |
: |
World Health Organization |
cm |
: |
centimeter |
dL |
: |
deciliter |
dm |
: |
decimeter |
Eq |
: |
gram-equivalent weight |
g |
: |
gram |
Hz |
: |
hertz |
Kg |
: |
Kilogram |
kHz |
: |
kilohertz |
L |
: |
Liter |
m |
: |
meter |
mcg |
: |
microgram |
mEq |
: |
miliequivalent |
MeV |
: |
million electron volts |
mg |
: |
miligram |
MHz |
: |
Megahertz |
ml |
: |
mililiter |
mol |
: |
gram-molecular weight |
mv |
: |
milivolts |
ng |
: |
nanogram |
nm |
: |
Nanometer |
pg |
: |
picogram |
psi |
: |
pounds per square inch |
v/v |
: |
volume/volume |
w/v |
: |
weight in volume |
w/w |
: |
weight/weight |
4.4The list of other abbreviations used in the organization are as under:
ACPH |
: |
Air Changes Per Hour |
ADL |
: |
Analytical Development Laboratory |
AHU |
: |
Air Handling Unit |
ANDA |
: |
Abbreviated New Drug Application |
AQL |
: |
Acceptance Quality Level |
AR No. |
: |
Analytical Report Number |
BMR |
: |
Batch Manufacturing Record |
BOD |
: |
Biochemical Oxygen Demand |
BOPP |
: |
Biaxialy Oriented poly propylene |
BP |
: |
British Pharmacopoeia |
BPR |
: |
Batch Packing Record |
BSE |
: |
Bovine Spongiform Encephalopathy |
BSR |
: |
Bonded Store Room |
CCF |
: |
Change Control Form |
CCP |
: |
Change Control Proposal |
CFU |
: |
Colony Forming Unit |
CGMP |
: |
Current Good Manufacturing Practice |
COD |
: |
Chemical Oxygen Demand |
CQA |
: |
Corporate Quality Assurance |
DMF |
: |
Drug Master File |
DO |
: |
Dissolved Oxygen |
DT |
: |
Disintegration Time |
ENG |
: |
Engineering |
EPA |
: |
Environmental Protection Agency (USA) |
ETP |
: |
Effluent Treatment Plant |
FBD |
: |
Fluidized Bed Drier |
FDV |
: |
Forced Draught Ventilation |
FG |
: |
Finished Goods |
FIFO |
: |
First In First Out |
FO |
: |
Furnace Oil |
FPM |
: |
Feet Per Minute |
FRR |
: |
Finished Release Report |
GC |
: |
Gas Chromatography |
GLP |
: |
Good Laboratories Practices |
GMP |
: |
Good Manufacturing Practices |
GRN |
: |
Goods Receipt Note |
GSM |
: |
Grams Per Square Meter |
GTP |
: |
General Testing Procedure |
HDPE |
: |
High Density Poly Ethylene |
HEPA filters |
: |
Hi Efficiency Particulate Air Filters |
HPLC |
: |
High Performance Liquid Chromatography |
HRA |
: |
Personnel and Administration |
HSD |
: |
High Speed Diesel |
HVAC |
: |
Heating Ventilation and Air Conditioning |
IP |
: |
Indian Pharmacopoeia |
IPQA |
: |
In-Process Quality Assurance |
KFR |
: |
Karl Fisher Reagent |
KPa |
: |
Kilopascal |
LAF |
: |
Laminar Air Flow |
LDO |
: |
Light Diesel Oil |
MLT |
: |
Microbial Limit Test |
MMD |
: |
Master Manufacturing Document |
MOC |
: |
Material Of Construction |
MPCR |
: |
Master Production Control Record |
MRM |
: |
Management Review Meeting |
MRN |
: |
Material Receipt Note |
NCR |
: |
Non Conformances Reports |
NDA |
: |
New Drug Application |
NF |
: |
National Formulary |
OOS |
: |
Out Of Specification |
Pa |
: |
Pascal |
PET |
: |
Preservative Efficacy Test |
PM |
: |
Packing Material |
PO |
: |
Purchase Order |
ppb |
: |
Parts Per Billion |
PPC |
: |
Production Planning And Control |
PPM |
: |
Planned Preventive Maintenance |
ppm |
: |
Parts Per Million |
PVC |
: |
Polyvinyl Chloride |
PVDC |
: |
Polyvinyl Dichloride |
QA |
: |
Quality Assurance |
QAD |
: |
Quality Assurance Department |
QC |
: |
Quality Control |
QCD |
: |
Quality Control Department |
QCM |
: |
Microbiology |
QMS |
: |
Quality Management System |
RH |
: |
Relative Humidity |
RLAF |
: |
Reverse Laminar Air Flow |
RM |
: |
Raw Material |
RMG |
: |
Rapid Mixture Granulator |
RO |
: |
Reverse Osmosis |
RPM |
: |
Revolution / Rotation Per Minute |
RSD |
: |
Relative Standard Deviation |
RTD |
: |
Resistance Temperature Detector |
SCP |
: |
Standard Cleaning Procedure |
SD |
: |
Standard Deviation |
SMF |
: |
Site Master File |
SMR |
: |
Supplementary Material Requisition |
SOP |
: |
Standard Operating Procedure |
SUPAC |
: |
Scale up Post Approval Changes |
TAB |
: |
Production (Tablet / Capsule) |
TAD |
: |
Technical Analytical Document |
TAVC |
: |
Total Aerobic Viable Count |
TBC |
: |
Total Bacterial Count |
TDS |
: |
Total Dissolved Solids |
TFC |
: |
Total Fungal Count |
TLC |
: |
Thin Layer Chromatography |
TMD |
: |
Technical Manufacturing Document |
TOC |
: |
Total Organic Carbon |
TQM |
: |
Total Quality Management |
TSE |
: |
Transmissible Spongiform Encephalopathy |
UV |
: |
Ultraviolet |
WAR |
: |
Warehouse (RM/PM/BSR Store) |