USEFUL WEB SITE LINKS AND CONSULTING AFFILIATES

Purpose of this webpage (please read)

In an effort to make the SPS website as useful as possible, we have included a number of links to other websites and web documents that may be beneficial to you.  We realize that using these links will take you away from this website and we may lose you as a potential customer of SPS services because of that.  Nevertheless, we feel obligated to meet your needs for assistance in whatever way we can, even if that need is satisfied elsewhere!

Obviously, we think that SPS is your best choice for the consulting services we have to offer (see SERVICES webpage), or we wouldn’t feel confident enough to place these external links at your disposal.  Therefore, feel free to use these links, and remember that our goal is a satisfied customer.  Please come back to our website and contact us so that we can explore together the best way to satisfy your needs.

Consulting Affiliates
Professional Associations
Professional Conference Organizations
FDA (General)
FDA (Guidance Documents)
FDA (Warning Letters and Inspection Guides)
Code of Federal Regulations
Compendial and International Regulatory Websites

Consulting Affiliates     back to top

Though SPS is an independent consulting company, Dr. Soli also has working relationships with the following organizations (and others which do not have websites).  These groups provide additional services for which you may have needs in addition to what I can provide.  You may select the links to their Web sites to review their service information.  Alternatively you may contact me for a personal recommendation.  Please mention my referral if you utilize any of these organizations.

FDA Compliance Help Desk
(www.fdacompliancehelp.com)

Furthur Consulting, Inc.
(www.furthurconsulting.com)

GMP Systems
(www.gmpsystems.com)

Micro Reliance LLC
(Ken.Muhvich10@comcast.net)

PharmaDev Partners, LLC
(www.pharmadevpartners.com)

PharmaSys
(www.pharma-sys.com)

The Quantic Group Limited
(www.quanticgroup.com)

Water Consulting Specialists
(www.waterconsultingspecialists.com)

WHC Bio Pharma, Inc.
(whcharlton@prodigy.net)

 

Professional Associations     back to top

AAPS home page - American Association of Pharmaceutical Scientists
(www.aapspharmaceutica.com/index.asp)

ISPE home page - International Society for Pharmaceutical Engineering
(www.ispe.org)

ISPE Carolina-SouthAtlantic Chapter Homepage
(www.ispe.org/carolina-southatlantic/newsletters.htm)

PDA home page – an International Association for Pharmaceutical Science and Technology
(www.pda.org)

PDA Pharmaceutical Water Interest Group
(www.pda.org/InterestGroups/pharmawater/pharmawater.htm)

PhRMA home page - Pharmaceutical Research and Manufacturers of America
(www.phrma.org)

RAPS home page – Regulatory Affairs Professionals Society
(www.raps.org/s_raps/index.asp)

 

Government, Industry, and Professional Conference Organizations (for whom Dr. Soli has given presentations and workshops)     back to top

General index of upcoming pharmaceutical conferences and exhibitions
(www.pharmaceutical-technology.com/exhibitions)

Barnett International, Educational Services Division
(www.barnettinternational.com/edu-conf.cfm)

Bioprocessing and Process Development Group (North Carolina Biotechnology Center)
(www.ncbiotech.org/ouractivities/science/bpd-fg.cfm)

The Center for Professional Advancement
(www.cfpa.com)

Food and Drug Administration (Investigator Training)
(www.fda.gov)

High Peaks Associates
(www.highpeaks.us)

Institute for International Research (IIR)
(www.iirusa.com)

Institute for Validation Technology (IVT)
(www.ivtconferences.com)

The Microbiology Network
(www.microbiol.org)

PDA – Southeast Chapter
(www.pdase.org/home.html)

Pharmaceutical Technology
(ptech.adv100.com/pharmtech)

PharmaIQ, A Division of International Quality and Productivity Center (IQPC)
(www.iqpc.com/cgi-bin/templates/single.html?topic=237)

Pureflow, Inc.
(www.pureflowinc.com)

United States Pharmacopeia (Open Conferences)
(www.usp.org)

US Filter
(www.usfilter.com)

 

FDA (General)     back to top

FDA home page - gateway to all FDA sites
(www.fda.gov)

FDA new items - the latest (previous 4 weeks)
(www.fda.gov/opacom/hpwhats.html)

FDA news - more comprehensive "latest" news
(www.fda.gov/opacom/hpnews.html)

CDER home page - Center of Drug Evaluation and Research
(www.fda.gov/cder)

CBER home page - Center for Biologics Evaluation and Research
(www.fda.gov/cber/index.html)

CDRH home page - Center for Devices and Radiological Health
(www.fda.gov/cdrh/index.html)

CVM home page - Center for Veterinary Medicine
(www.fda.gov/cvm/default.html)

 

FDA (Guidance Documents)     back to top

CDER Guidance Documents
(www.fda.gov/cder/guidance/index.htm)

CBER Guidance Documents
(www.fda.gov/cber/guidelines.htm)

CDRH Guidance Documents
(www.fda.gov/cdrh/guidance.html)

CVM Guidance Documents
(www.fda.gov/cvm/guidance/published.htm)

CDER Quality Systems Guidance Document
(www.fda.gov/cder/guidance/6452dft.pdf)

CDER Pharmaceutical cGMPs for the 21st Century - A Risk-Based Approach
(www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm)

 

FDA (Warning Letters and Inspection Guides)     back to top

FDA Warning Letters and Responses
(www.fda.gov/foi/warning.htm)

FDA Inspection Guide Index
(www.fda.gov/ora/inspect_ref/igs/iglist.html)

Guide to Inspections of Quality Systems
(www.fda.gov/ora/inspect_ref/igs/qsit/qsitguide.htm)

Guide to Inspections of Bulk Pharmaceutical Chemicals
(www.fda.gov/ora/inspect_ref/igs/bulk.html)

Guide to Inspections of Sterile Drug Substance Manufacturers
(www.fda.gov/ora/inspect_ref/igs/subst.html)

Guide to Inspections of High Purity Water Systems
(www.fda.gov/ora/inspect_ref/igs/high.htm)

Inspectors Technical Guide:  Water for Pharmaceutical Use
(www.fda.gov/ora/inspect_ref/itg/itg46.html)

Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories
(www.fda.gov/ora/inspect_ref/igs/micro.html)

Guide to Inspections of Pharmaceutical Quality Control Laboratories
(www.fda.gov/ora/inspect_ref/igs/pharm.html)

Guide to Inspections Validation of Cleaning Processes
(www.fda.gov/ora/inspect_ref/igs/valid.html)

Guide to Inspections of Foreign Pharmaceutical Manufacturers
(www.fda.gov/ora/inspect_ref/igs/fordrug.html)

Guide to Inspections of Medical Device Manufacturers
(www.fda.gov/ora/inspect_ref/igs/med_dev_mnfct/toc.html)

Guide to Inspections of Foreign Medical Device Manufacturers
(www.fda.gov/ora/inspect_ref/igs/fordev.html)

Guide to Inspections of Viral Clearance Processes
(www.fda.gov/ora/inspect_ref/igs/viralcl.html)

Biotechnology Inspection Guide Reference Materials and Training Aids
(www.fda.gov/ora/inspect_ref/igs/biotech.html)

 

Code of Federal Regulations     back to top

Searchable database of 2004 Code of Federal Regulations Title 21
(www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=200421)

GPO searchable, on-line database - includes Federal Register, Code of Federal Regulations, and Congressional Record
(www.gpoaccess.gov/multidb.html)

21 CFR Part 210
CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL
(www.access.gpo.gov/nara/cfr/waisidx_04/21cfr210_04.html)

21 CFR Part 211
CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
(www.access.gpo.gov/nara/cfr/waisidx_04/21cfr211_04.html)

21 CFR Part 290
CONTROLLED DRUGS
(www.access.gpo.gov/nara/cfr/waisidx_04/21cfr290_04.html)

21 CFR Part 310
NEW DRUGS
(www.access.gpo.gov/nara/cfr/waisidx_03/21cfr310_03.html)

21 CFR Part 312
INVESTIGATIONAL NEW DRUG APPLICATION
(www.access.gpo.gov/nara/cfr/waisidx_03/21cfr312_03.html)

21 CFR Part 314
APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
(www.access.gpo.gov/nara/cfr/waisidx_03/21cfr314_03.html)

21 CFR Part 316
ORPHAN DRUGS
(www.access.gpo.gov/nara/cfr/waisidx_03/21cfr316_03.html)

21 CFR Part 320
BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
(www.access.gpo.gov/nara/cfr/waisidx_03/21cfr320_03.html)

21 CFR Part 330
OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED
(www.access.gpo.gov/nara/cfr/waisidx_03/21cfr330_03.html)

21 CFR Part 500
GENERAL
(www.access.gpo.gov/nara/cfr/waisidx_03/21cfr500_03.html)

21 CFR Part 510
NEW ANIMAL DRUGS
(www.access.gpo.gov/nara/cfr/waisidx_03/21cfr510_03.html)

21 CFR Part 511
NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE
(www.access.gpo.gov/nara/cfr/waisidx_03/21cfr511_03.htm)

21 CFR Part 514
NEW ANIMAL DRUG APPLICATIONS
(www.access.gpo.gov/nara/cfr/waisidx_03/21cfr514_03.html)

21 CFR Part 600
BIOLOGICAL PRODUCTS: GENERAL
(www.access.gpo.gov/nara/cfr/waisidx_04/21cfr600_04.html)

21 CFR Part 601
LICENSING
(www.access.gpo.gov/nara/cfr/waisidx_04/21cfr601_04.html)

21 CFR Part 606
CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS
(www.access.gpo.gov/nara/cfr/waisidx_04/21cfr606_04.html)

21 CFR Part 607
ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS
(www.access.gpo.gov/nara/cfr/waisidx_04/21cfr607_04.html)

21 CFR Part 610
GENERAL BIOLOGICAL PRODUCTS STANDARDS
(www.access.gpo.gov/nara/cfr/waisidx_04/21cfr610_04.html)

21 CFR Part 803
MEDICAL DEVICE REPORTING
(www.access.gpo.gov/nara/cfr/waisidx_03/21cfr803_03.html)

21 CFR Part 807
ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
(www.access.gpo.gov/nara/cfr/waisidx_03/21cfr807_03.html)

21 CFR Part 820
QUALITY SYSTEM REGULATION
(www.access.gpo.gov/nara/cfr/waisidx_03/21cfr820_03.html)

21 CFR Part 1301
REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED UBSTANCES
(www.access.gpo.gov/nara/cfr/waisidx_03/21cfr1301_03.html)

21 CFR Part 1308
SCHEDULES OF CONTROLLED SUBSTANCES
(www.access.gpo.gov/nara/cfr/waisidx_03/21cfr1308_03.html)

40 CFR Part 141
NATIONAL PRIMARY DRINKING WATER REGULATIONS
(www.access.gpo.gov/nara/cfr/waisidx_04/40cfr141_04.html)

 

Compendial and International Regulatory Websites     back to top

United States Pharmacopeia (USP) home page
(www.usp.org)

European Pharmacopoeia (EP or PhEur) home page
(www.pheur.org)

Japanese Pharmacopoeia (JP) home page
(jpdb.nihs.go.jp/jp14e)

EU/EMEA web page - Pharmacos - European Commission - Enterprise DG - The European Agency for the Evaluation of Medicinal Products
(pharmacos.eudra.org)

JPMA web page - Japanese Pharmaceutical Manufacturing Association
(www.jpma.or.jp/12english/index.html)