Scribd Logo
Upload

Welcome to Scribd!

  • USP 43 NF 38 General Chapter 1116 Environmental Monitoring For Clean Rooms

    Uploaded by

    Dr usama El Shafey
    736 views12 pages
    USP 43 NF 38 General Chapter 1116 Environmental monitoring for Clean rooms

    Original Title

    USP 43 NF 38 General Chapter 1116 Environmental monitoring for Clean rooms

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Report this Document
    USP 43 NF 38 General Chapter 1116 Environmental monitoring for Clean rooms

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Flag for inappropriate content
    Download as pdf
    736 views12 pages

    USP 43 NF 38 General Chapter 1116 Environmental Monitoring For Clean Rooms

    Uploaded by

    Dr usama El Shafey
    USP 43 NF 38 General Chapter 1116 Environmental monitoring for Clean rooms

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Flag for inappropriate content
    Download as pdf
    of 12
    Usp 43 General Information (1116) 7833 OVERALL MANAGEMENT OF A MICROBIOLOGICAL CONTROL PROGRAM The management ofa succesful microbiological contol program nclues the falling: identification of suitable supplies of pharmacetical Ingredients and excipients that have good microbiological quoly; conducting a migrobial rk assestment tthe manufacturing proces and packaging sjstemy andthe establishment of an appropriate montoring and contol system, ‘ough enronentalcntarinaon by no means hemos agian eu of roster producrecalo contamination event envronmental monifonng may be a program agunct ta the mictooliogeal contol progr Microbial ‘monitoring isan assessment and isnot by tse @ contamination contra activity. There have been no sclenifclly controled utes demonavatng wat nage, an, ets bebveen arbome or suacemontonng ruts nd micoblgia safety of “the mroblologcl contamination control program should be developed for identifying and controling product sk, based on formal assessment of rsk modalities, The fiak anal shoud esulinthe entiation of eral conte points and should {acitate proper equipment selection, proces layout and design, and acity design requirements. Cite fates forte prevention of mcrobiigial contamination during nonserle product manufacturing are the contol ofthe microbiological quality of ingredients and water, along withthe development of proper cleaning and sanization procedures. Microbiologia! monitoring does nt mitigate rk but may serve asa serine ‘No monitoring program can provide the assurance of contamination control aseetvly a sound, proactive and preventive measures Consistent contol of contaminatlon canbe achieved mally by an overal process evaluation asesing each ofthe Control elements descibed above via ak sszessment- Ask sessment nay be coupled wth acive evaluation sthes Wo ensure that propriate measures are in pace to prevent condilons conducive t@ contamination, REFERENCES 1. Faust; Sathirapongsasut ff ead, tal- (2012) Microbial co-occurrence relationships inthe human microbiome. PLoS Comput Biot. 2012;8(7):e1062606. 2. Cundell AM. Risk based approsch to pharmaceutical microbiology. In: Miller Mi ed. Encyclopedia of Ropd Microbial Methods. River Grove, lL: Davis Healthcare Intemational Pushing: 2005, eee ie 3. 21.CFR 211. Good Manufacturing Practice for Finished Pharmaceuticals 4. FDA, Hazard analysis and control point principles and application guidelines. 1997. http://www fda.gov/Foody Guldancereguiavon/HAcce/ucmzooss01 hm. Accessed O7 February 2013 i ee '. Anderson AS, Bassett G, Burke MT, etal. Microbiological monitoring of environmental conditions for nonsterle ‘pharmaceutical manufacturing, Pharm Technol, 1997;21(3):S8-74. htp://www.ich.org/fileadmin/Public Web Site/ Ici Products/Guidelines/Qualty/Q9/step4/09_Guidelinepaf, Accessed 07 February 2013. 6. 150, 14644-1:1999, Cleanrooms and associated controlled envionments—part | classification of air cleanliness. 1999, hips /wvniso.orgiso/catalogue deta im?esnumber=25052. Accessed 07 February 2013, 7. ISPE. Baseline guide volume 2: orl solid dosage forms. 2009, htp:/wwwispe.org/basline-guides/oral-solid-dosage. ‘Accessed 07 February 2013. (1116) MICROBIOLOGICAL CONTROL AND MONITORING OF ASEPTIC PROCESSING ENVIRONMENTS Microbiol contrledenionments re wed or 3 at of puporeswinte heal duty. Ths gra information chapter provides information and recommendation for ervifonments where te rik of microbial contamination is controled through aseptic processing Products manufactured in such environments include pharmaceutical stele products, Buikstrle crug sobstanees sterle ntetmedlates, excplents, and, eran eases, medkca device Aseptic processing environment ae far more cal in terms of patient ik than controlled environments used for other manufacturing operations Tor example, equipment and component preparation, limited bioburden contol of nonsterie products, and processing of

    You might also like