Sunday, November 10, 2024
HomeQuality AssuranceSOP for Abbreviations

SOP for Abbreviations

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)

 5.0 ANNEXURE(S) :

 Nil. 

RELATED ARTICLES

LEAVE A REPLY

Please enter your comment!
Please enter your name here

Most Popular

Recent Comments