|
INTERNATIONAL JOURNAL OF SCIENTIFIC DEVELOPMENT AND RESEARCH International Peer Reviewed & Refereed Journals, Open Access Journal ISSN Approved Journal No: 2455-2631 | Impact factor: 8.15 | ESTD Year: 2016 open access , Peer-reviewed, and Refereed Journals, Impact factor 8.15 |
Imp Links for Author
Imp Links for Reviewer
Research Area
Subscribe IJSDR
Visitor Counter
Copyright Infringement Claims
Indexing Partner
|
Published Paper Details
|
|
| Paper Title: | Pharmaceutical Validation and Process Controls Approaches: A Review |
| Authors Name: | Ankush Pralhad Jadhav , Tejashree Radhakisan Kedar , Rushikesh Narayan Jagtap |
| Unique Id: | IJSDR2206011 |
| Published In: | Volume 7 Issue 6, June-2022 |
| Abstract: | The overall validation study provides us the accuracy, stability, sensitivity and reproducibility of the test methods results based into the documented forms. The validation is an essential part of the quality assurance as well as quality control in organization. This whole process includes not only equipment but also raw material inspections as well as in process controls parameters. Process controls are mandatory to maintain good manufacturing practice i.e. G.M.P. and according to it validation studies are required to be done as per predefined protocols, the minimum that should be validated. Validation is an integral part of quality assurance, it include process, cleaning and testing as a result such control procedure stablish to monitor the output and validation of manufacturing processes that may be responsible for variability of drug product. |
| Keywords: | Major phases in validation, Strategy for the validation of methods, Environmental considerations- cleaning and clean room standards, Process validation, Validation report. |
| Cite Article: | "Pharmaceutical Validation and Process Controls Approaches: A Review", International Journal of Science & Engineering Development Research (www.ijsdr.org), ISSN:2455-2631, Vol.7, Issue 6, page no.75 - 79, June-2022, Available :http://www.ijsdr.org/papers/IJSDR2206011.pdf |
| Downloads: | 000346989 |
| Publication Details: | Published Paper ID: IJSDR2206011 Registration ID:200556 Published In: Volume 7 Issue 6, June-2022 DOI (Digital Object Identifier): Page No: 75 - 79 Publisher: IJSDR | www.ijsdr.org ISSN Number: 2455-2631 |
|
Click Here to Download This Article |
|
| Article Preview | |
|
|
|
Major Indexing from www.ijsdr.org
| Google Scholar | ResearcherID Thomson Reuters | Mendeley : reference manager | Academia.edu |
| arXiv.org : cornell university library | Research Gate | CiteSeerX | DOAJ : Directory of Open Access Journals |
| DRJI | Index Copernicus International | Scribd | DocStoc |
Track Paper
Important Links
Conference Proposal
ISSN
 |
 |
DOI (A digital object identifier)
  Providing A digital object identifier by DOI How to GET DOI and Hard Copy Related |
Open Access License Policy
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License
|
 |
 |
 |
Social Media
Indexing Partner |
|||
| Copyright © 2024 - All Rights Reserved - IJSDR | |||
Facebook Twitter Instagram LinkedIn