Validation of Sterile Water for Injection In Pharmaceutical Industry and Othersterile Facility
DOI:
https://doi.org/10.22270/ajprd.v7i1.444Keywords:
USFDA, SOPS, CGMP, HVAC, ICFU,FPMAbstract
Sterile facilities for all pharmaceutical product specially to parentral preparation, is a must important back bone of sterile formulation andor pharmaceutical dosage form. There is most important to sterile of the areas where the formulation process proceed from initial to final stage. The sterile injectable products are very critical and sensitive products as they are administered directly into blood circulation. These products are designed such that it should be free from micro-organisms, pyrogens and unacceptable particulate matter. Any failure in quality and purity of these products may directly affect the safety of patient being treated. FDA, WHO, ISO and Good Manufacturing Practiceshas established the guides to the development of sterile pharmaceutical preparation facilities for health care establishments.This report covers all summaries that the three batches of Methylcobalamine injection 2 ml have been validated with the support of process validation protocol.
Downloads
References
2. Agallow J. P., James E., Industrial Moist Heat Sterilization In Autoclave-Cycle development, validation and routine operation, PDA technical monograph No. 2001, 1,7-220.
3. Jadhav V. M., Gholve S. B., Kadam V. J., Validation of Pharmaceutical Water system: A review, Journal of pharmacy research, 2009, 2(5), 948-952.
4. Kastango E.S., Quality control analytical methods Compounded sterile preparation requirements and their relationship to beyond use dating, Int. J. of Pharmaceutical compounding, 2004,8(5), 393-397.
5. Martin-Moe S., Ellis J., Coan M., Validation of critical process input parameters in the production of protein pharmaceutical products: A strategy for validating new processes or revalidating existing processes, PDA J. Pharm. Sci. Technol. 2000, 54(4), 315–219
6. Potdar M. A., Pharmaceutical Process Validation, Nirali Prakashan, 2006,1, 5.5-5.8, 8.2, 8.6, 8.20-8.28.
7. Raymond G., Lewis P.E., Practical guide to autoclave validation, journal of pharmaceutical engineering, 2002, 2, 37-40.
8. Rathore A. S., Noferi J. F., Process validation how much to do and when to do it, BioPharm, 2002,18-28.
9. Schmidt O., Fda’ ,New requirement on process validation-an outlook on new FDA guidance , GMP Journal, 2008, 2(1),
10. Taisuke H.,Quality Management Systems - Process Validation Guidance, The Global Harmonization Task Force, 2004, 2, 7-17.
11. Usfda,“Current Good Manufacturing Practices; Proposed Amendment of Certain Requirements for Finished Products: Supplementary Information,” Federal Register, 1996,61(87).
Published
How to Cite
Issue
Section
AUTHORS WHO PUBLISH WITH THIS JOURNAL AGREE TO THE FOLLOWING TERMS:
Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 Unported License. that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
.