EUROPEAN JOURNAL OF
PHARMACEUTICAL AND MEDICAL RESEARCH

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical, Medical & Biological Sciences

An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)

European Journal of Pharmaceutical and Medical Research (EJPMR) has indexed with various reputed international bodies like : Google Scholar , Indian Science Publications , InfoBase Index (In Process) , SOCOLAR, China , Research Bible, Fuchu, Tokyo. JAPAN , International Society for Research activity (ISRA) , Scientific Indexing Services (SIS) , Polish Scholarly Bibliography , Global Impact Factor (GIF) (Under Process) , Universal Impact Factor , International Scientific Indexing (ISI), UAE  , Index Copernicus , CAS (A Division of American Chemical Society) USA (Under Process) , Directory of Open Access Journal (DOAJ, Sweden, in process) , UDLedge Science Citation Index , CiteFactor , Directory Of Research Journal Indexing (DRJI) , Indian citation Index (ICI) , Journal Index (JI, Under Process) , Directory of abstract indexing for Journals (DAIJ) , Open Access Journals (Under Process) , Impact Factor Services For International Journals (IFSIJ) , Cosmos Impact Factor , Jour Informatics (Under Process) , Eurasian Scientific Journal Index (ESJI) , International Innovative Journal Impact Factor (IIJIF) , Science Library Index, Dubai, United Arab Emirates , Pubmed Database [NLM ID: 101669306] (Under Process) , IP Indexing (IP Value 2.40) , Web of Science Group (Under Process) , Directory of Research Journals Indexing , Scholar Article Journal Index (SAJI) , International Scientific Indexing ( ISI ) , Scope Database , Academia , 

 ISSN 2394-3211

Impact Factor: 7.065

 ICV - 79.57

Abstract

PHARMACEUTICAL QUALITY DURING PRODUCT LIFE CYCLE – A NEED OF HOLISTIC APPROACH

Nirmal Kumar* and Prof. Ajeya Jha

ABSTRACT

The famous quote- “Quality is not inspected rather it is inbuilt”, suits perfectly in case of pharmaceutical business. Quality is the most vital aspect of medicines and hence pharmaceutical business. Once the pharmaceutical product is in market, there is no scope to rectify the defects at the users end; hence it becomes imperative to evaluate the quality of pharmaceutical product, during its life cycle. A pharmaceutical quality professional has to evaluate the product starting from its development stage up to delivered to patients. The pharmaceutical products are manufactured in batches (batch size ranging up to billion) and if defect is prevalent in one unit of product there is probability that it would affect the billions of consumers. Ideally, the pharmaceutical products should be designed properly, monitored during production process and care should be taken during distribution to protect the quality attributes to undergo any unforeseen deterioration. Quality by design (QbD) and further operation under aegis of Quality Risk Management (QRM) are the safest techniques in pharmaceutical world. Standard Operating Procedures (SOP) and adequate training to professions across the product life cycle is the key to deliver quality product. To ensure quality products consistently, the stake holders of pharmaceutical business should possess a holistic approach during all three stages of pharmaceutical business – Product Development, Good Manufacturing and Distribution in market.

Keywords: Pharmaceutical Quality System, Product Quality Life Cycle, CGMP, ICH, USFDA, QbD.


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Google Scholar Indian Science Publications InfoBase Index (In Process) SOCOLAR, China Research Bible, Fuchu, Tokyo. JAPAN International Society for Research activity (ISRA) Scientific Indexing Services (SIS) Polish Scholarly Bibliography Global Impact Factor (GIF) (Under Process) Universal Impact Factor International Scientific Indexing (ISI), UAE Index Copernicus CAS (A Division of American Chemical Society) USA (Under Process) Directory of Open Access Journal (DOAJ, Sweden, in process) UDLedge Science Citation Index CiteFactor Directory Of Research Journal Indexing (DRJI) Indian citation Index (ICI) Journal Index (JI, Under Process) Directory of abstract indexing for Journals (DAIJ) Open Access Journals (Under Process) Impact Factor Services For International Journals (IFSIJ) Cosmos Impact Factor Jour Informatics (Under Process) Eurasian Scientific Journal Index (ESJI) International Innovative Journal Impact Factor (IIJIF) Science Library Index, Dubai, United Arab Emirates Pubmed Database [NLM ID: 101669306] (Under Process) IP Indexing (IP Value 2.40) Web of Science Group (Under Process) Directory of Research Journals Indexing Scholar Article Journal Index (SAJI) International Scientific Indexing ( ISI ) Scope Database Academia