FREE HEART SURGERIES CONDUCTED BY PRATHIMA FOUNDATION @ KARIMNAGAR , TELANGANA

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WHAT IS BONUS?

Initially there was a concept of salary to be given on weekly basis to the workers in India. But when Britishers started ruling India they came up with concept of Monthly salary. 

Therefore, if we consider 4 weeks in a month, 13 salaries should be distributed and as per monthly structure they were giving only 12 in a year.

In later days people realized it that its a loss to them in terms of one salary. There were many rallies in oppose of this in Maharashtra during 1930-1940. To come up with a solution to this problem, Britishers had a discussion with leaders about how to distribute this 13th Salary and unanimously they decided as per Indian tradition, Diwali is the biggest festival of India, so they will distribute this 13th Salary durring Diwali, today known as Diwali Bonus.
This was implemented from 30th June 1940. 

Today many people doesn't know this, hence, sharing this letter.
Do inform your colleagues.

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ABBREVATIONS MOSTLY USING IN PHARMA INDUSTRY

AADA: Abbreviated antibiotic drug application

ADE: Adverse drug event

ADME: Absorption, distribution, metabolism, and excretion

AHU: Air Handling Unit

ANDA: Abbreviated new drug application

ANVISA: Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency Brazil)

AP: Applicants Part (of EDMF)

API: Active pharmaceutical ingredient

APR: Annual product review (APQR – Annual product quality

         review)

AQL: Acceptable quality level

AR: Analytical Reagent

ASHRAE: American Society of heating, Refrgeration and

 Air Conditioning Engineers

ASM: Active Substance Manufacturer

ASMF: Active Substance Master File

AST: Accelerated stability testing

ASTM: American Society for Testing and Materials

BA/BE:Bioavailability/bioequivalence

BCS: Biopharmaceutical classification system

BET: Bacterial Endotoxin Test

BFS: Blow Fill Seal

BI: Biological Indicator

BMR: Batch Manufacturing/Processing Record

BOD: Biological Oxygen Demand

BOM: Bill of Materials

BOPP: Biaxially Oriented Polypropylene

BP: British Pharmacopoeia

BPR:  Batch Packaging Record

BRMS: Biologics Regulatory Management System

BSE: Bovine spongiform encephalopathy (mad cow disease)

CAPA: Corrective and preventive action

CBE: Changes being effected

CBER: Center for Biologics Evaluation and Research (FDA)

CCIT: Container closure integrity test

CDER: Center for Drug Evaluation and Research (FDA)

CDSCO: Central drug standard control organization (India)

CEP: Certification of suitability of European Pharmacopoeia monographs

CFR: Code of Federal Regulations

CFU: Colony Forming Unit

cGMP: Current Good Manufacturing Practices

CIP: Clean in place

CMC: Chemistry, manufacturing and controls

CMS: Continuous monitoring system

COA: Certificate of analysis

COS: Certificate of suitability

COPP: Certificate of Pharmaceutical Products

CPP: Critical Process Parameter

CQA: Critical Quality Attribute

CTD: Common technical document

DMF: Drug master file

DOP: Dioctyl Phthalate

DQ: Design Qualification

EDMF: European drug master file

EDQM: European Directorate for the Quality of Medicines

EH&S: Environmental health and safety

EIR: establishment inspection report (FDA)

EMEA: European Medicines Agency (formerly European Medicines Evaluation Agency)

EP: European Pharmacopoeia

EPS: Expanded polystyrene

ETP: Effluent Treatment Plant

EU: Endotoxin unit

EU: European Union

FAT: Factory Acceptance Testing

FBD: Fluid-bed dryer

FDA: Food and Drug Administration, United States

FDC: Fixed Dose Combination

FEFO: First expiry first out

FG: Finished Goods

FIFO: First in first out

FMEA: Failure modes and effect analysis

FOI: Freedom of information

GAMP: Good automated manufacturing practice

GC: Gas Chromatography

GCLP: Good clinical laboratory practice

GCP: Good clinical practice

GDP: Good distribution practice

GEP: Good engineering practice

GGP: good guidance practice

GIT: Gastrointestinal Tract

GLP: Good laboratory practice

GMO: Genetically modified organism

GMP: Good manufacturing practice

GPT: Growth Promotion Test

GRAS/E: Generally recognized as safe and effective

GRP: Good review practice

HACCP: Hazard analysis critical control point

HDPE: High Density Polyethylene

HEPA: High efficiency particulate air (filter)

HPLC: High performance liquid chromatography 

HSA: Health Sciences Authority, Singapore

HVAC: Heating, ventilating, and air conditioning

ICAH: International Conference on Harmonisation

IH: In house

IM: Intramuscular

IND: Investigational new drug

INDA: Investigational new drug application

IP: Indian Pharmacopeia

IPA: Isopropyl Alcohol

IPS: In process control

IQ: Installation qualification

IR: Immediate release

ISO: International Organization for Standardization

ISPE: International Society for Pharmaceutical Engineering

IV: Intravenous

JP: Japanese Pharmacopoeia

KOS: Knowledge organization system

LAF: Laminar air flow

LAL:  Limulus Amoebocyte  Lysate

LD: Lethal dose

LD50: Lethal dose where 50% of the animal population die

LDPE: Low Density Polyethylene

LIMS: Laboratory Information Management System

LIR:  Laboratory Investigation Report

LOD: Loss on drying

LOD: Limit of detection

LOQ: Limit of quantification

LR: Laboratory Reagent

LVPs: Large Volume Parenterals

MA: Marketing Authorisation

MAA: Marketing Authorisation Application

MAC: Maximum Allowable Carryover

MCC: Medicines control council (South Africa)

MDD: Maximum daily dose

MFR: Master Formula Record

MEDSAFE: Medicines and medicinal devices safety authority (New zealand)  

MHRA: Medicines and Healthcare products Regulatory Agency (UK)

MOA: Method Of Analysis

MSDS: Material Safety Data Sheets

NCE: New chemical entity

NDA: New Drug Application

NF: National Formulary

NIR: Near Infra Red Spectroscopy

NON: Notice of non-compliance (Canada)

ODI: Orally Disintegrating Tablet

OQ: Operation Qualification

OSD: Oral Solid Dosage

OSHA: Occupational Safety And Health Administration

OTC: Over-the-counter

OOS: Out of specification

OOT: Out of trend

PAC: Post-approval changes

PAO: Poly alpha olefin

PAT: Process Analytical technology

PET: Preservative efficacy test

PET: Polyethylene

PIC/S:  Pharmaceutical Inspection Co-operation Scheme

PLC:  Programmable Logic Control

PQ: Performance Qualification

PVC: Polyvinyl Chloride

PVDC: Polyvinylidene Chloride

PW: Purified Water

QA :  Quality Assurance

QC:  Quality Control

QbD: Quality by design

QM: Quality Manual

QSD:  Quality System Dossier

QSM : Quality System Management

QMS: Quality Management System

RH: Relative humidity

RLAF: Reverse laminar air flow

RLD: Reference listed drug

RM: Raw material

RO: Reverse Osmosis

ROPP: Roll On Pilfer Proof

RS: Related Substance

SAL: Sterility Assurance Level

SAT: Site Acceptance Testing

SDN: Screening Deficiency Notice (Canada)

SIP: Sterilization in place/Steam in place

SLS: Sodium Lauryl Sulphate

SMF: Site master file

SOP: Standard operating procedure

SPE:  Society for Pharmaceutical Engineering

SUPAC: Scale-up and post approval changes

SVP:  Small Volume Parenteral

TC: Thermocouple

TDS: Total Dissolved Solids

TGA: Therapeutics goods administration (Australia)

TOC: Total organic carbon

TSE: Transmissible spongiform encephalopathy

USFDA: United states foods and drugs administration

USP: United States Pharmacopeia

USP-NF: United States Pharmacopeia-National Formulary

URS: User Requirement Specification

VAI: Voluntary action indicated

VMP: Validation Master Plan

WFI: Water for injection

WHO: World Health Organisation

WL: Warning letter

DEPARTMENTS IN QUALITY ASSURANCE (QA)

DEPARTMENTS IN QA

As per my knowledge I have mentioned following departments in QA , If anything i have missed please comment below

DOCUMENTATION: Issue, retrieval and storage of formats, logbooks, SOPs, Batch Cards etc.

TRAINING: Conduct training to all employees

VALIDATION: perform qualification of equipment’s, process validation, cleaning validation

QMS: Comes under Change control, deviation, CAPA, QRM

IPQA: Perform in process checks (testing) of all formulations (tablets, capsules, syrups, injections)

AQA:  Review the analytical data submitted by QC

VENDOR QUALIFICATION: Perform vendor qualification of Raw material, packing materials.

AUDIT COMPLIANCE: Review and close the audit points by internal or external audits.

RA SUPPORT: Support to RA For regulatory filing of documents.

MARKET COMPLAINTS: Investigate and review the market complaints.

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VARIOUS DEPARTMENTS IN PHARMACEUTICAL INDUSTRY

DEPARTMENTS IN PHARMA INDUSTRY

As  per my knowledge i have mentioned following departments and suitable qualifications for getting job in pharma industry , if any department i have missed kindly comment.

Formulation, Research and Development (FR&D):  M.pharm, B. Pharm, M.Sc.

Analytical, Research and Development (AR&D):  M.pharm, B. Pharm, M.Sc.

Regulatory Affairs (RA):    M.pharm, B. Pharm

Warehouse or Stores:  Any Degree

Production:  M.pharm, B. Pharm, B.Tech, Diploma

Packing:  M.pharm, B. Pharm, B.Tech, Diploma

Quality Assurance (QA):  M.pharm, B. Pharm, M.sc

Quality Control (QC):  M.pharm, B. Pharm, M.sc

Engineering: B.Tech Mechanical, Diploma

Environmental Health and Safety (EHS) :  B.Tech Chemical

Process Development or Technology Transfer (PDT OR TT): 
M.pharm, B. Pharm

Purchase: MBA or any Degree

Supply Chain Management (SCM):  M.pharm, B. Pharm, Pharma - MBA

Packaging Development: Diploma in Packing

NOTE : If you have Reference you can get job in any department irrespective of your qualification.

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