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PDA Technical Reports List - Product Catalog - Parenteral ...

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PDA Technical Reports List - Product Catalog - Parenteral ...

PDA Technical Reports No. TITLE Paper Version Digital Version 1 ... 20 Report on Survey of Current Industry Gowning Practices 1990 01020 41239 21 Bioburden Recovery Validation 1990 01021 41258 ... 25 Blend Uniformity Analysis: ...

https://store.pda.org/TableOfContents/PDA_Technical_Reports_list.pdf

Date added: October 8, 2012 - Views: 518

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Technical Report No. 15 Revised 2009 Validation of Tangential ...

2 © 2009 Parenteral Drug Association, Inc. Technical Report No. 15 1.0 Introduction Technical Report No. 15: Industrial Perspective on Validation of Tangential Flow Filtration in Biopharmaceutical

http://store.pda.org/tableofcontents/tr1509_toc.pdf

Date added: January 14, 2013 - Views: 52

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THE USE OF STRATIFIED SAMPLING OF BLEND AND DOSAGE UNITS TO ...

statistical analysis such as the use of methods described in PDA Technical Report 254 should be applied to assess the situation. ... Technical Report No. 25, Blend Uniformity ... The stratified sampling criteria defined in this document are acceptable for

http://www.pqri.org/pdfs/DTC/Articles/Final_BUWG_Stratfied_Sampling.pdf

Date added: April 11, 2012 - Views: 26

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Technical Report No. 48 Moist Heat Sterilizer Systems: Design ...

Technical Report No. 48 Moist Heat Sterilizer Systems: Design, Commissioning, Operation ... • PDA Technical Report No. 1, Revised 2007, (TR 1) ... 25 Sterilizer Design • Cycle time and throughput

http://www.pda.org/docs/default-source/website-document-library/chapters/presentations/new-england/pda-technical-report-48-moist-heat-sterilizer-systems.pdf?sfvrsn=6

Date added: July 31, 2014 - Views: 1

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PDA Draft Technical Report No. 29 - Pharmanet

PDA Technical Report No. 29 Points to Consider for Cleaning Validation DRAFT March 30, 1998 ... 25 Swabs and Wipes ..... 25 Rinse Sampling ... PDA Draft Technical Report No. 29 Author: MADSEN

http://www.pharmanet.com.br/pdf/tr29-002.pdf

Date added: April 30, 2012 - Views: 365

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PDA Technical Report 43 (Revised) - Parenteral Drug Association

Technical Report No. 43 (Revised) Glass Containers ... Nonconformities in Molded and Tubular Glass Containers, for Pharmaceutical Manufacturers 1 Roger Asselta, Genesis Technical Advisors NE PDA Meeting November 13, 2013 ... © 2013 Parenteral Drug Association 25 . Technical Report No. 43 ...

http://www.pda.org/docs/default-source/website-document-library/chapters/presentations/new-england/pda-technical-report-43-(revised).pdf?sfvrsn=6

Date added: September 5, 2014 - Views: 1

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Monitoring isolator air - 800ezmicro - Microbiology International

As a PDA technical report states: “An isolator is sealed or is ... for isolators: No interference with the normal usage of ... USP 25, Chapter 1116, Microbical Evaluation of Cleanrooms and other Controlled Environments, 2002. 4.

http://www.800ezmicro.com/component/docman/doc_download/266-monitoring-isolator-air.html

Date added: October 24, 2012 - Views: 28

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CIP Cycle Development and Cleaning Validation - ISPE

PDA Technical Report #49 - Points to Consider ... Biotechnology Perspective, PDA, 1996 – Validation study design and acceptance criteria . Cleaning Validation ... (2.5 hr - 2.0hr) / cycle = 25 hrs / month = 275 hr / year

http://www.ispe.org/great-lakes/2012cleaningvalidation.pdf

Date added: September 12, 2012 - Views: 133

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“Detection and Mitigation of 2,4,6 PDA: A Global Association

PDA Technical Report No. 55 “Detection and Mitigation of 2,4,6 Tribromoanisole and 2,4,6 Trichloroanisole ... Melamine EFSA TDI 2007 25 mg/day Diethyl phthalate WHO TDI 2003 250 mg/day Diethylene glycol SCF ADI 1986 25 mg/day TBA ...

http://www.piapr.org/clientuploads/10th%20PIA-FDA%20RegConf%20PP%20(June%2021,%202012)/PDA%20Technical%20Report%20No.%2055%20(by%20Anil%20Sawant,%20Johnson&Johnson).pdf

Date added: October 22, 2013 - Views: 6

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Evaluation, Validation and Implementation of New ...

PDA TECHNICAL REPORT NO.33 EVALUATION, VALIDATION AND IMPLEMENTATION OF NEW MICROBIOLOGICAL TESTING METHODS Table of Contents Part One: Selection of New Microbiological Methods

http://cdn2.hubspot.net/hub/54227/file-14538112-pdf/docs/tr33.pdf

Date added: November 22, 2013 - Views: 19

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Qualification of temperature-controlled storage areas

WHO Vaccine Qualification of temperature-controlled storage areas Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time and

http://www.who.int/medicines/areas/quality_safety/quality_assurance/TS-qualification-storage-areas-final-sign-off-a.pdf

Date added: June 5, 2014 - Views: 2

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USP Controlled Room Temperature Range Expansion

revision—as yet unproposed in PF—of USP's definition for Controlled Room Temperature from 20°–25° to 2°–30°. BACKGROUND . The design of stability studies during pharmaceutical product development and ... (see PDA Technical Report 53). 4.

http://www.thermosafe.com/blog/wp-content/uploads/2014/02/S20102.pdf

Date added: June 3, 2014 - Views: 3

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Technical Report #3 - Penn State College of Engineering

This Document is Technical Report #3 for 5th year senior thesis in the Architectural Engineering Departments at The Pennsylvania State University. In this report the existing reinforced concrete shear wall cores will be analysis and ... 25 Shear Strength Check ...

http://www.engr.psu.edu/ae/thesis/portfolios/2011/mrp5082/images/Tech3.pdf

Date added: February 14, 2012 - Views: 29

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Temperature mapping of storage areas - World Health Organization

1 PDA Technical Report No. 39: Guidance for Temperature Controlled Medicinal Products: ... temperature range (e.g. hot spots identified between +23°C to +25°C in a room with a specified temperature range +15°C to +25°C). Technical Supplement: ...

http://www.who.int/medicines/areas/quality_safety/quality_assurance/TS-mapping-storage-areas-final-sign-off-a.pdf

Date added: June 8, 2014 - Views: 2

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In this issue: p~LAL UPDATE® - Associates of Cape Cod, Inc.

Depyrogenation, PDA Technical Report No.3, PDA, Philadelphia, PA). Three parametersappropriatedfrom the theory of sterilization that are frequently encountered in the discussions of depyrogenation are D value. z value and Fvalue. ... 25 0.5 1.5 Time [hr]

http://www.acciusa.com/pdfs/newsletter/LAL_Vol.11No.5.pdf

Date added: March 14, 2012 - Views: 10

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A New Vision - bioMerieux | In Vitro Diagnostics ...

Media Fill Test (MFT) ... PDA Technical Report No. 36, Current Practices in the Validation of Aseptic Processing – 2001. ... after 8 days of incubation at 20-25°C on culture media from different suppliers. After 8 days at 20-25°C, ...

http://www.biomerieux-usa.com/upload/Media%20Fill%20Brochure-1.pdf

Date added: October 28, 2012 - Views: 12

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Libero. New dimensions. The independent PDF Data Logger.

... conform with PDA Technical Report No 39 ... Libero Sample Analysis Report . elproLibero Synergy between Datalogger & Adobe® PDF/A Seite 4 von 12 Libero Display – Explanations: Bat.End ... 25 to 40°C 2 days 8 to 25°C 6 days

http://www.nordealer.com/pdf-032008/Libero%20spec.%20tecniche.pdf

Date added: October 4, 2011 - Views: 7

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Autoclaves Qualification & Validation - Надлежащая ...

PDA Technical Reports • PDA Technical Report No. 1, ... 25 of 39 Autoclaves: Qualification & Validation Holger Fabritz ... prolonged sterilisation run of empty autoclave after runs with bio-indicators) - PQ / PV - 31 of 39 Autoclaves: ...

http://www.gmpua.com/Equipment/Sterility/Sterilization/QualificationofAutoclaves.pdf

Date added: October 19, 2011 - Views: 143

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SporeNews MesaLabs - Mesa Labs Biological Indicators

Section 8.1 of PDA Technical Report No. 51 suggests that re-running the cycle with a different lot of BIs or re-running the cycle with duplicate or triplicate BIs in the same location may be necessary.3 ... 25, 101-121. Created Date:

http://biologicalindicators.mesalabs.com/wp-content/uploads/sites/31/2014/03/Spore-News-Vol-9-No4.pdf

Date added: August 4, 2014 - Views: 1

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Cleaning Verification / Validation of Pharmaceutical ...

PDA Technical Report No. 29, Revised 2012: ... Bioburden NMT 25 cfu per 25 cm2 – This level is readily dealt with by typical SIP processes. ... • The work of the PDA Technical Committees and National Regulatory Authorities . Discussion.

http://www.aaps.org/uploadedFiles/Content/Sections_and_Groups/Regional_Discussion_Groups/Southern_California_Pharmaceutical/Announcements/SC%20PDG%20Cleaning%20Verification%2019%20SEP%202013.pdf

Date added: October 30, 2013 - Views: 18

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2 Manuscript Title - ECVS INC

13 This article describes a method for achieving the load equivalence model described in PDA Technical 14 Report 1 (TR1), ... 25 minimizing time and qualification requirements for new equipment qualification for similar loads/use,

http://ecvs-inc.com/Library/Risk%20Based%20Approach%20to%20Variable%20Load%20Configuration%20Validation%20in%20Steam%20Sterilization_Final%20Manuscript%20for%20PDA.pdf

Date added: June 7, 2012 - Views: 15

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The Parenteral Drug Association presents 2013 PDA Europe ...

special group rate until 25 January 2013, Code: PDA. Reservation link: Marriott Hotel Housing at the selected hotel will be in high demand, ... 11:30 About RMM Validation/Technical Report No. 33 Michael Miller, Microbiology Consultants 12:00 Q & A, Discussion

http://www.tiselab.com/pdf/2013_Microbio_Brochure.pdf

Date added: November 13, 2013 - Views: 12

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WATER AND SANITATION for HEALTH PROJECT

Field Report No. 315 September 1990 WATER AND SANITATION for HEALTH ... Technical Report No. 57. April 1989. Final Evaluation of the CARE/Bolivia Child Survival and Rural Sanitation Project. ... 25 4.3.1 O verview ...

http://pdf.usaid.gov/pdf_docs/PDABB807.pdf

Date added: August 5, 2013 - Views: 1

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Libero. The Overview of the Models. - Bancolini

Features / Models Libero Ti1 Libero Ti1-S Libero Ti1-L Libero Te1-N ... • +/- 0.2°C in the range of -10° to 25°C ... conform with PDA Technical Report No 39 Start-Up Delay 0 minutes to 1 day Battery (built-in) Life time

http://www.bancolini.com/interne/brochure/LIBERO_TechSpecs_en.pdf

Date added: May 13, 2013 - Views: 2

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Training to Excellence - Nanyang Polytechnic

and SIP processes such as those in PDA Technical Report No. 26, examples of stepthrough simulations of proper SIP processes of common system designs will be examined.. ... 25 May 2014 / 18 August 2014 DATE: 29 - 30 April 2014 LOCATION: Pall Singapore, Centre of Excellence.

http://www.nyp.edu.sg/pdc/display_file.cfm?file_name=NYP+-+Pall+Training+Brochure+2014.pdf&ff=Y

Date added: April 6, 2014 - Views: 2

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Design of Experiments to Establish Temperature and Humidity ...

to Establish Temperature and Humidity Limits for Temperature Excursions ... •PDA Technical Report No. 39, Guidance for Temperature-Controlled Medicinal Products: ... and the shelf life at 25 °C at 60 %RH must be

http://www.mbswonline.com/upload/presentation_5-24-2011-19-20-3.pdf

Date added: October 17, 2012 - Views: 5

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Developing Thermostable Vaccines

stored at room temperature (up to +25 C) for a single period not exceeding 9 months. Record the period of ... PDA Technical Report 39 (2007) Pharma Industry Survey (2009) Long-Term Guidance Guidance References ICH and WHO Follow ICH

http://mediaserver.aaps.org/meetings/2010PSWC/Slides/11-15-Monday/1330_sessions/Room_244-245/Chen.pdf

Date added: May 11, 2013 - Views: 17

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Report # MATC-UI: 117 Final Report - Mid-America ...

Performing Organization Report No. 25 -1121 0003 117 9. ... The challenges that face autonomous vehicle are still significant. ... PDA personal digital assistant PRT personal rapid transit RSU road-side units RUC road use charging

http://matc.unl.edu/assets/documents/matcfinal/Schwarz_TowardsAutonomousVehicles.pdf

Date added: February 15, 2014 - Views: 2

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LIBERO PDF Logger Benefits A most cost efficient solution!

Libero. Cold Chain Monitoring: No software at destination ... and 25 °C to 70 °C • Resolution: 1/10 °C ... minute or more, programmable • Programmable temperature alarms: a) 2 limits or b) 5 multiple alarm ranges, conform wit PDA Technical Report No 39 (Cold Chain Guidance for Medical ...

http://nordealer.com/pdf/elpro_libero_folder_generale.pdf

Date added: May 13, 2013 - Views: 5

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Technical Assistance Program Guidelines Application

... February 25, 2014 Application deadline: April 2, ... Written Report Technical Tool Adopted Plan/Design Document Other ... The objective of the PDA Technical Assistance Program is to support discrete projects that will advance

http://www.mtc.ca.gov/planning/smart_growth/stations/PDA/Technical_Assistance_Program_Guidelines_Application.pdf

Date added: January 31, 2014 - Views: 3

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LIBERO: Innovation Leader in Cold Chain Monitoring

- Temperature accuracy of ± 0.2°C between -10°C..+25°C - 5 alarm / time zones - Simple Bracket - Alarm Bracket - Connectors for external probes Accessories. 5 ... to PDA Technical Report No 39 -Validation certificate-IQ/OQ documentation is made available IT Manager: Reliability and seamless

http://www.elpro.com/uploads/tx_elproindustries/LIBERO_Innovation_Leader.pdf

Date added: February 5, 2014 - Views: 1

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Regulatory oversight on the management of time and ...

1 Definition from PDA Technical Report No. 39, 2007. WHO working draft v1b. For comment only. DO NOT circulate ... Keep between +20 and +25oC with excursions permitted between +15 and +30oC. WHO working draft v1b. For comment only.

http://www.coolpack.com/admin/documents/213-guidance-v1b.pdf

Date added: June 14, 2013 - Views: 4

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2. PHARMA WATER QUALITY SPEC. & DESIGN CRITERIA

Stage 3 : 2.1 C 4.7 S/cm (25 ... PDATechnical Report No. 4 _ “Design Concepts for the Validation of a Water for Injection System ...

http://www.utekinco.com.tw/util/dl.php?ori=20120518150911_0.pdf&save=4____Stilmas.pdf&var=techNews.file

Date added: May 6, 2013 - Views: 16

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PMF NEWSLETTER - The Microbiology Network | Dedicated to the ...

taminated (PDA Technical Report No. 51). The bio-logical indicators used can be readily enumerated. The micro-organism used must be appropriate, that is ... has nearly 25 years of experience in the GMP industry, in-cluding Quality Control Microbiology, Quality Assurance

http://www.microbiologyforum.org/content/file/PMFNews.17.05.1105.pdf

Date added: December 8, 2013 - Views: 1

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Case Study: Computer Supplier Evaluation Practices of the ...

5.3 Other Lessons.....25 6 Conclusion ... Audit Audit performed in accordance with PDA Technical Report No. 32 and brokered by ARC for participating suppliers or supplied by

http://www.sei.cmu.edu/reports/03tr011.pdf

Date added: January 31, 2012 - Views: 14

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Terminal Sterilization vs. Aseptic Processing

PDA Technical Report #36 : Current Practices in the Validation of Aseptic Processing ... minimum dose of ≥25 KGy ? Can the formulation be filtered through ... Steam sterilization of terminal sterilization the reference

http://forums.pharmacyonesource.com/phos/attachments/phos/pharmacy_ops/1377/1/terminal%20sterilization%20v%20aseptic.pdf

Date added: June 4, 2012 - Views: 94

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Quality Control: Certified NRCM Workforce - Certification

The PDA Technical Report No. 35 discusses a competency-based training approach, “A crucial ... scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.25 NRCM Website - http://www.microbiologycert.org/ nrcm.asp Nicoll, T, D Ransom and D Singer. 2005. Path for

http://www.microbiologycert.org/documents/PMFNewsApril09article.pdf

Date added: March 27, 2012 - Views: 9

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A Consensus Rating Method for Small Virus-Retentive Filters ...

final consensus filter method was published in the 2008 update of PDA Technical Report 41. Virus Filtration. KEYWORDS: Virus retentive filtration, Virus safety, Bioprocessing ... absolute for 20-nm to 25-nm viruses and that non-absolute filters are known to show a range of particle or ...

http://www.mrzgroup.umd.edu/pdfs/2008_PDA_virus.pdf

Date added: April 3, 2014 - Views: 1

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Auxilium's QC micro automation - BioResearch

Lonza / 25 October 2011 ... PDA Technical Report No. 31 Validation and Qualification of Computerized Laboratory Data Acquisition Systems ...

http://bio.lonza.com/uploads/tx_mwaxmarketingmaterial/Lonza_Webinars_Auxiliums_QC_micro_automation_using_MODA_solution.pdf

Date added: May 4, 2013 - Views: 3

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Human Factors Guidance for the Use of Handheld Portable and ...

Technical Report This document is available to the public through the National ... This report provides human factors guidance for the selection and use of handheld, portable, ... PDA Personal Data Assistant .

http://hf.tc.faa.gov/technotes/dot_faa_ct_05_15.pdf

Date added: February 12, 2012 - Views: 14

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/tardir/tiffs/a416880 - DTIC

the company had needed 25 people at each of its manufacturing sites. ... Audit performed in accordance with PDA Technical Report No. 32 and brokered by ARC for participating suppliers or supplied by subscribers as required by their level of subscription

http://www.dtic.mil/cgi-bin/GetTRDoc?AD=ADA416880

Date added: November 29, 2013 - Views: 5

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Supplier Assessments Audits - İKEV

PDA Technical Report 32 1. Quality System 2. Project Management 3. Methodology 4. Testing 5. Configuration Management 6. Manufacturing 7. Documentation and ... Computerized Systems Validation Supplier Assessment 25 Dr. Guenter Generlich After the Audit

http://www.ikev.org/haber/2003valid/10%20Supplier%20Audits.pdf

Date added: March 25, 2012 - Views: 91

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Oregon Research Institute

Oregon Research Institute The Eugene-Springfield Community Sample: Information Available from the Research Participants Lewis R. Goldberg ORI TECHNICAL REPORT Vol. 48 No. 1 March 2008 . 1 ... (25) Experimental Personality Survey (EPS), ...

http://projects.ori.org/lrg/PDFs_papers/ORI_TechnicalReport_ESCS_Mar08.pdf

Date added: May 3, 2013 - Views: 15

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20030329-01A Pharma and Life Sciences - Надлежащая ...

Particle Counting and Environmental Monitoring In Pharmaceutical / Life Sciences. www.golighthouse.com ... H NS 35000 200 0 NS 25 15 10 ... PDA Technical Report No. 13 Fundamentals of a

http://www.gmpua.com/CleanRoom/Monitoring/PharmLifeSciences.pdf

Date added: January 3, 2012 - Views: 35

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Event Guide - IBC Life Sciences

February 25 - March 1, 2013 Hyatt Regency Huntington Beach Resort & Spa Huntington Beach, CA. ... PDA Technical Report No. 50: Application of Non-Culture Testing Methodology for the Detection of Mycoplasma Barbara J. Potts, Ph.D., Senior Consultant,

http://www.ibclifesciences.com/upload/wysiwyg/biopharma_series/B13155/B13155guide.pdf

Date added: October 15, 2013 - Views: 4

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Review Article

(WHO) Technical Report Series, No. 953, ... – PDA Technical report 46, 2009 Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User (10) ... of the product is endangered by this temperature excursion.

http://xa.yimg.com/kq/groups/2299115/51192317/name/Stability%20Studies%20Biotech%20prod.pdf

Date added: October 7, 2012 - Views: 3

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Technical Report 47 – “Creating a Research Database on ...

CREATING A RESEARCH DATABASE ON HOLLAND’S THEORY AND PRACTICAL TOOLS: TECHNICAL REPORT NO. 471 By Elizabeth A. Ruff, M.S./Ed.S. Robert C. Reardon, Ph.D.

http://career.fsu.edu/documents/technical%20reports/Technical%20Report%2047/TR47.pdf

Date added: October 30, 2011 - Views: 48

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The Impact of the Microchip – Application of Modern ...

Each year, the PDA Annual Meeting provides the most valuable, scientific information affecting the industry. This year, the Program Planning Committee has chosen to build the conference around the theme, The Impact of the Microchip – Application of Modern

http://www.pharm.chula.ac.th/tjps/images_pharmacy/file2.pdf

Date added: April 1, 2014 - Views: 4

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Cleaning Validation with TOC - Insatech

Cleaning Validation with TOC • Jamie Thompson, ... Refer to PDA Technical Report 29 and 49 for further guidance 2. Key points: Safety factor depends on route of administration, different limits possible for ... INSA 25 / 14 Summary

http://www.insatech.com/downloads/Cleaning_Validation_Jamie_Thompson_GE_Power___Water.pdf

Date added: April 1, 2014 - Views: 2

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Embedded Data Collector (EDC) Evaluation Phase II ...

TECHNICAL REPORT DOCUMENTATION PAGE 1. Report No. 2. ... (EDC), the Pile Driving Analyzer (PDA), and the CAse Pile Wave Analysis Program (CAPWAP) ... EDC/PDA = 0.75, CV = 0.25). There is a need to continue this comparison for other sites with

http://ntl.bts.gov/lib/51000/51000/51043/FDOT-BDK75-977-24-rpt.pdf

Date added: January 29, 2014 - Views: 3