To lay down the procedure for approved abbreviations commonly used in the Quality Documents
1.0 PURPOSE
To lay down the procedure for approved abbreviations commonly used in the Quality Documents.
2.0 SCOPE
2.1 This procedure is applicable in All departments
3.0 RESPONSIBILITY
3.1 Personnel-Concerned Department.
4.0 ACCOUNTABILITY
4.1 Manager-QA
5.0 PROCEDURE
5.1 The Following abbreviations only shall be used for the preparation of Quality documents but not limited to...
|
TERMS |
ABBREVIATIONS |
|
Active Pharmaceutical Ingredient |
API |
|
American chemical society |
ACS |
|
American society for testing and materials |
ASTM |
|
Ampere |
A |
|
Association for the advancement of medical instrumentation |
AAMI |
|
|
|
|
Batch Production and Control Record |
BPCR |
|
TERMS |
ABBREVIATIONS |
|
British Pharmacopoeia |
BP |
|
Bulk Density |
BD |
|
Centimeter |
cm |
|
Certificate Of Analysis |
COA |
|
Chemical abstracts service |
CAS |
|
Cleaning Validation |
CV |
|
Cubic Centimeter |
cm3 |
|
Current Good Laboratory Practice |
cGLP |
|
Current Good Manufacturing Practice |
cGMP |
|
Data Sheet |
DT |
|
Degree Centigrade |
° C |
|
Delivery Challan |
DC |
|
Design Qualification |
DQ |
|
European Pharmacopoeia |
EP |
|
Factory Acceptance Test |
FAT |
|
Finished Product |
FP |
|
First-In, First-Out |
FIFO |
|
Food chemical codex |
FCC |
|
Fourier Transform Infra-red |
FTIR |
|
Gas Chromatography |
GC |
|
General Test Procedure |
GTP |
|
TERMS |
ABBREVIATIONS |
|
Good Laboratory Practice |
GLP |
|
Good Manufacturing Practice |
GMP |
|
Gram |
g |
|
Health industry manufacturers association |
HIMA |
|
High Efficiency Particulate Air |
HEPA |
|
High Performance Liquid Chromatography |
HPLC |
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Hour (24 hrs. clock for a day shall be used) e.g. 9 PM shall be recorded as 21.00 hrs |
Hrs |
|
Indian Pharmacopoeia |
IP |
|
In-house Specification |
IHS |
|
Installation Qualification |
IQ |
|
International Conference on Harmonization |
ICH |
|
International Organization for Standardization |
ISO |
|
International union of pure and applied chemistry |
IUPAC |
|
Japanese pharmacopoeia |
JP |
|
Kilogram |
Kg |
|
Laminar Air Flow |
LAF |
|
Liter |
L |
|
Loss On Drying |
LOD |
|
Master Production and Control Record |
MPCR |
|
Material Received Report |
MRR |
|
TERMS |
ABBREVIATIONS |
|
Medicinal Control Agency |
MCA |
|
Medicines Control Council |
MCC |
|
Meter |
m |
|
Micro gram |
mg (mcg) |
|
Micro Liter |
mL |
|
Milligram |
mg |
|
Milliliter |
mL |
|
Millimeter |
mm |
|
Milli volt |
mV |
|
Minute |
min |
|
Nanometer |
nm |
|
Nanogram |
ng |
|
National Formulary |
NF |
|
National Institute of Standards and Technology |
NIST |
|
Non-Conforming Report |
NCR |
|
Operation Qualification |
OQ |
|
Out Of Specification |
OOS |
|
Packing Material |
PM |
|
Percentage |
% |
|
Performance Qualification |
PQ |
|
Pharmacopeial Forum |
PF |
|
TERMS |
ABBREVIATIONS |
|
Process Validation |
PV |
|
Quality Assurance |
QA |
|
Quality Control |
QC |
|
Raw Material |
RM |
|
Regulatory Affairs |
RA |
|
Relative Humidity |
RH |
|
Relative Standard Deviation |
RSD |
|
Second |
sec |
|
Specific Optical Rotation |
SOR |
|
Standard Deviation |
SD |
|
Standard Operating Procedure |
SOP |
|
Standard Test Procedure |
STP |
|
Therapeutic goods administration |
TGA |
|
Thin Layer Chromatography |
TLC |
|
U.S Code of federal regulations |
CFR |
|
U.S Environmental protection agency |
EPA |
|
U.S.Food and drug administration |
FDA |
|
Ultra Violet Spectrophotometer |
UV |
|
United states adopted names |
USAN |
|
United States Pharmacopoeia |
USP |
|
User Requirement Specification |
URS |
|
TERMS |
ABBREVIATIONS |
|
Working Standard |
WS |
|
World Health Organization |
WHO |
END OF DOCUMENT
Abbreviations, quality assurance, quality documents
