Pharmaceutical Validation and Process Controls Approaches: A Review
Ankush Pralhad Jadhav
, Tejashree Radhakisan Kedar , Rushikesh Narayan Jagtap
Major phases in validation, Strategy for the validation of methods, Environmental considerations- cleaning and clean room standards, Process validation, Validation report.
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.
"Pharmaceutical Validation and Process Controls Approaches: A Review", IJSDR - International Journal of Scientific Development and Research (www.IJSDR.org), ISSN:2455-2631, Vol.7, Issue 6, page no.75 - 79, June-2022, Available :https://ijsdr.org/papers/IJSDR2206011.pdf
Volume 7
Issue 6,
June-2022
Pages : 75 - 79
Paper Reg. ID: IJSDR_200556
Published Paper Id: IJSDR2206011
Downloads: 000347049
Research Area: Pharmacy
Country: Beed, Maharashtra, India
ISSN: 2455-2631 | IMPACT FACTOR: 9.15 Calculated By Google Scholar | ESTD YEAR: 2016
An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 9.15 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator
Publisher: IJSDR(IJ Publication) Janvi Wave
