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INTRO

Welcome to "GMP GEEK". This site is intended to create a unique platform to share 21st Century Pharmaceutical Manufacturing related issues with the GEEK professionals, as well as with the NOVICES who are working in a Pharmaceutical GMP Environment.
Categories: Personal Pages, Web Hosting
Topics: 21st century pharmaceutical manufacturing, analytical chemistry, fda, good manufacturing practice, ich, industrial pharmacy, manufacturing, microbiology, process engineering, statistics

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vision28.com

vision28.com vision28.com           
Medical Device Quality Assurance and Regulation Services
Vision28 offers the medical device quality assurance and regulation services you need to ensure compliance with FDA regulations. Contact us today to learn more.


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guerraconsultinggroup.com

guerraconsultinggroup.com guerraconsultinggroup.com           
FDA Regulatory Compliance - Mentoring, Coaching, Consulting and Training
Learn Guerra’s proven method for preventing FDA-483 and Warning Letters. Learn how to document failure investigations and quality events. Prevent data integrity issues in GMP facilities.

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lean2020.com

lean2020.com lean2020.com           
Robbins International
Robbins International LLC, is a consulting firm for Lean and Six Sigma training, process enhancement and organizational consulting, specializing in Healthcare, Manufacturing, and Service environments.


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csueastbay.edu

csueastbay.edu csueastbay.edu           
California State University, East Bay
Cal State East Bay serves the Bay Area as part of the California State University system, providing access to higher education for a diverse student body.

Moz DA: 62 Moz Rank: 5.3 Semrush Rank: 11,552 Facebook ♡: 111
Categories: Education/Reference, Education
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auditing.com

auditing.com auditing.com           
Auditing - The Auditing Group and Validations.com GMP - GLP - GCP Part 11 Audits
Auditing, GMP, Audits, Audit and GMP Auditing Part 11 and Part 820 Auditing and Training services for the Pharmaceutical, Biotechnolgy, Medical Device, Food and Cosmetic Regulated Industry by Industry Professionals. FDA.COM is the next step for professionals seeking compliance information through discussion groups and on-line information sharing. Directed by John Cuspilich, Director Regulatory Affairs and Michael Van Horn, Director Sales and Marketing, companies can get noticed by over 100,000 visitors monthly. GXP Academy is the world's leader in GMP Training and GMP Management Auditing services. GMP Publications is the world's leader in GMP Mini-Regulation Handbooks serving the regulatory community in search of 21 Code of Federal Regulations. Serving the Global Community by assisting global harmonization, and through the International Conference of Harmonization


Categories: Education/Reference, ???
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jgmes.com

jgmes.com jgmes.com           
JG Mechanical Engineering Services
Mechanical Engineer, Senior Vehicle Engineer with 20 years of experience in the transit industry, focusing on passenger transit rail vehicle design; compliance with customer specifications and industry standards.

Semrush Rank: 562,481
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aquamarinegroup.com

aquamarinegroup.com aquamarinegroup.com           
Welcome to The AquaMarine Group, Inc.
Since 1996, The AquaMarine Group, Inc.’s services have been sought and retained by pharmaceutical firms, to furnish expertise in the areas of regulatory review, application writing, cGMP compliance/mock pre-approval audit services, R&D portfolio analysis, contracted management services, and new product/technology evaluation and promotion. Services furnished to clients include not only review and commentary, but have also included project management for a number of significant filings.

Semrush Rank: 6,875,712
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fdaregulatorycomplianceadvisors.com

fdaregulatorycomplianceadvisors.com fdaregulatorycomplianceadvisors.com           
FDA Regulatory Compliance Advisors, Inc. - “Combining science with regulatory knowledge for optimized systemic solutions” ™
We provide technical and FDA regulatory knowledge to lay the foundation for optimized processes and robust systems that are key in the prevention of FDA-483s and FDA Warning Letters.

Semrush Rank: 5,961,466
Categories: Business, Not Rated
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uktopuniversities.com

uktopuniversities.com uktopuniversities.com           

Moz DA: 3 Moz Rank: 2.1 Facebook ♡: 0
Categories: Blogs/Wiki, Business
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tsp-mfg.com

tsp-mfg.com tsp-mfg.com           
TSP Mfg., a WN Global Company
TSP is a Supply Chain Management provider, specializing in engineered fasteners for Oil and Gas Service Manufacturing and other OEMs. We've been in the fastener distribution business for over 80 years and have the knowledge and experience to meet the unique needs of our customers. By combining our vast inventory of specialized, quality products with efficient, cost saving Supply Chain Management programs, TSP is able to provide the right fastener, at the right price, at the right time.

Semrush Rank: 3,473,546
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wn-global.com

wn-global.com wn-global.com           
WN Global
WN Global delivers integrated engineered bolting and supply chain solutions through superior in-house engineering and specialized supply chain strategies. WN Global is your single vendor advantage, becoming your true business partner in production programs.

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jdwilkie.co.uk

jdwilkie.co.uk jdwilkie.co.uk           
J&D Wilkie Ltd - Technical Textile Solutions
Privately owned global textile manufacturing company, with textile manufacturing facilities in China and it's head office based in Scotland. With over 140 years in the textile industry


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adventureinmetals.com

adventureinmetals.com adventureinmetals.com           
Parts Washing Cabinets - Spray Wash Cabinets - Adventure Manufacturing
Adventure Manufacturing Custom Parts Washing Cabinets Made in the USA


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viglya.com

viglya.com viglya.com           
Viglya: promoting science, honoring life - promoting science, honoring life
Viglya provides a broad spectrum of drug safety services tailored to... Included are some links we hope will serve as references and ... Viglya’s commitment to its team and stakeholders includes...

Moz DA: 14 Moz Rank: 2.3 Semrush Rank: 36,840,645 Facebook ♡: 0
Categories: Business, Business
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awengworks.com

awengworks.com awengworks.com           
MedTech System Experts
A&W is a medical device design services company. We are experts at developing the hardware and software "core" of your product while taking a system-level approach. We have deep expertise in analog/digital hardware, DSP, algorithms, and embedded SW

Semrush Rank: 7,561,988
Categories: Marketing/Merchandising, Business
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labormerk.de

labormerk.de labormerk.de           
LaborDr.Merk - Boehringer Ingelheim Therapeutics in Ochsenhausen, Germany
As a CRO and CDMO LaborDr.Merk offers comprehensive know-how for the pharmaceutical industry and for medical device manufacturers in biotechnology.

Facebook ♡: 0
Categories: Health, Health and Wellness
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axys-network.com

axys-network.com axys-network.com           
AXYS-NETWORK-Pharmaceutical consulting firm
Axys-network is a pharmaceutical consulting firm specializing in aseptic processes and in Transition Management - Manufacturing, Quality, Regulatory. Remediation experts for troubleshooting and continuous improvement

Semrush Rank: 11,435,978
Categories: Business, Business
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fda.com

fda.com fda.com           
FDA.COM Information Portal
On-Line Discussion Groups and Information Portal serving the Pharmaceutical, Biotechnolgy, Medical Device, Food and Cosmetic Regulated Industry by Industry Professionals. FDA.COM is the next step for professionals seeking compliance information through discussion groups and on-line information sharing. Directed by John Cuspilich, Director Regulatory Affairs and Michael Van Horn, Director Sales and Marketing, companies can get noticed by over 100,000 visitors monthly. GXP Academy is the world's leader in GMP Training and GMP Management Auditing services. GMP Publications is the world's leader in GMP Mini-Regulation Handbooks serving the regulatory community in search of 21 Code of Federal Regulations. Serving the Global Community by assisting global harmonization, and through the International Conference of Harmonization International sport governing body. The Fédération Internationale de l'Automobile (FIA; English: International Automobile Federation) is an association established on 20 June 1904 to represent the interests of motoring organisations and motor car users. It is the governing body for many auto racing events, including Formula One. The FIA also promotes road safety around the world. Headquartered at 8 Place de la Concorde, Paris, with offices in Geneva and Valleiry, the FIA consists of 246 member organisations in 145 countries worldwide. Its current president is Mohammed bin Sulayem.

Moz DA: 36 Moz Rank: 3.8 Semrush Rank: 528,634 Facebook ♡: 1,815
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nearsoft.eu

nearsoft.eu nearsoft.eu           
MOM4 - MOM, MES, MRP, Scheduling, Lean Six Sigma
Manufacturing Execution System (MES), Plan and Scheduling (APS, MRP), Operation Management (MOM), Tracking, Maintenance, Lean Six Sigma, ISA 95

Facebook ♡: 0
Categories: Web Mail, Information Technology
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jdq.com

jdq.com jdq.com           
JDQ Systems Inc.
Work Process Automation Custom Software and Robotics Applications Service Robotics Requirements and Prototyping Project Management Quality Improvement Methodologies and System Automation JDQ works with you to discover what your work processes are doing well.

Moz DA: 14 Moz Rank: 2.7 Semrush Rank: 4,892,518
Categories: Business, Business
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tsp-tx.com

tsp-tx.com tsp-tx.com           
TSP Mfg., a WN Global Company
TSP is a Supply Chain Management provider, specializing in engineered fasteners for Oil and Gas Service Manufacturing and other OEMs. We've been in the fastener distribution business for over 80 years and have the knowledge and experience to meet the unique needs of our customers. By combining our vast inventory of specialized, quality products with efficient, cost saving Supply Chain Management programs, TSP is able to provide the right fastener, at the right price, at the right time.

Semrush Rank: 28,104,844
Categories: Business, Business
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bioscience.com.pk

bioscience.com.pk bioscience.com.pk           
BIOSCIENCE. | Read, learn, discover...
BIOSCIENCE's mission is to be your most trusted ally in your pursuit of health and well-being. We’re committed to bringing you authoritative, approachable, and actionable content that inspires and guides you toward the best possible health outcomes for you and your family.

Semrush Rank: 676,761
Categories: Education/Reference, Business
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poka.io

poka.io poka.io           
Connected Worker Platform for Industry 4.0 - Poka
Poka is a web and mobile app designed for manufacturers to support on-the-floor training, knowledge building, and communication.

Facebook ♡: 273
Categories: Business, Information Technology
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gmp-publishing.com

gmp-publishing.com gmp-publishing.com           
GMP-Publishing | Good Manufacturing Practice | GMP Pharma | GMP-Verlag | GMP-Verlag Peither AG
GMP Expertise for Your Safety: up-to-date, practice-oriented and inspection-proven. Regulations | Recommendations | Templates ... Always stay up to...

Semrush Rank: 1,364,844 Facebook ♡: 0
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itamco.com

itamco.com itamco.com           
Integrating Manufacturing, Technology, and Engineering | ITAMCO
ITAMCO is a premier manufacturing and technology provider, leading the way in developing next-generation solutions to current manufacturing problems.

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bestapplicants.com

bestapplicants.com bestapplicants.com           
THE RECRUITING GROUP | NATIONAL RECRUITING COMPANY
How to prepare your resume? How to prepare for a successful interview? Professional way to resign. There are no shortcuts to securing Quality Candidates! It takes time to find the right people. Recruiting must be approached in a systematic, logical method. 80% of the candidates we placed in the past 4 years are still with the same client.


Categories: Job Search, Job Search
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statconsult.de

statconsult.de statconsult.de           
www.statconsult.de | Gesellschaft für klinische und Versorgungsforschung mbH
StatConsult -gegründet 1993- ist als Auftragsinstitut im Umfeld klinischer Forschung und Entwicklung sowie der Versorgungsforschung für nationale und internationale Auftraggeber tätig. Mit erfahrenen Biometrikern und Informatikern fokussieren wir auf unsere Kernkompetenzen Biometrie/Datenmanagement und Medizinische Informatik. Wir bieten Ihnen gemeinsam mit unseren

Semrush Rank: 36,674,518
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regulatory.com.ua

regulatory.com.ua regulatory.com.ua           
Patern Ltd. | Regulatory Affairs Outsourcing ft Pattern of USA Inc. Homepage, FAQ
510(k) – Premarket Notification for Medical Device aka PMN
AADA – Abbreviated antibiotic drug application
ACTD – ASEAN common technical dossier
ADR – Adverse drug reaction
AE – Adverse event
AIM – Active ingredient manufacturer
AIMD – Active implantable medical device
ANDA – Abbreviated new drug application
API – Active pharmaceutical ingredient
AR – Assessment Report (European Union)
ASMF – Active Substance Master File
ATMPs – Advanced therapy medicinal products
BA – Bioavailability
BAP – Biotechnology Action Program
BIND – Biological investigational new drug
BLA - Biologic License Application
BWP – Biotech Working Party (EMA)
C&P – Chemistry and Pharmacy
CA – Competent authority
CANDA – Computer assisted new drug application
CAP – Centrally authorized product
CAPA – Corrective action and preventive action
CAPLA – Computer Assisted Product License Application
CCDS – Company core data sheet
CD – Controlled drug
CDSCO – Central Drug Standard Organization (India)
cGLP – Current good laboratory practice
cGMP – Current good manufacturing practice
Cl – Total body clearance
CLO – Clinical overview
CLS – Clinical summary
CMC – Chemistry – manufacturing – controls
CMP – Certificate of Medicinal Product
COA – Certificate of analysis
CoFS – Certificate of Free Sale
CP – Centralized procedure (European Union)
CP – Comparability protocol (USA)
CPP – Certificate of pharmaceutical product
CQA – Clinical quality assurance
CR – Controlled release
CRO – Clinical Research Organization
CSI – Core safety information
CSP – Core safety profile
CSR – Clinical study report (European Union)
CT – Clinical trial
CTA – Clinical trial application
CTA – Clinical trial authorization
CTD – Clinical Trials Directive
CTD – Common technical document/dossier
CTMS – Clinical trial management system
CTS – Common technical specification
CVM – Center for Veterinary Medicine (US)
DACS – Detailed and critical summary
DAE – Discontinuation due to an a

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world-tree-rpg.com

world-tree-rpg.com world-tree-rpg.com           

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www20.csueastbay.edu

www20.csueastbay.edu www20.csueastbay.edu           
California State University, East Bay
Cal State East Bay serves the Bay Area as part of the California State University system, providing access to higher education for a diverse student body.

Moz DA: 62 Moz Rank: 5.4 Semrush Rank: 11,552 Facebook ♡: 0
Categories: Education/Reference, Education
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f1.hastalosfogones.es

f1.hastalosfogones.es f1.hastalosfogones.es           
Free Web Hosting, Domain Hosting, Reliable Web Hosting Provider, Domain registration, Inexpensive, Low Cost, Affordable, Reseller Program, PHP, MySQL, Linux, Ecommerce
Affordable, reliable web hosting and domain registration provider: low cost, inexpensive plans, reseller program, complete e-commerce solutions, instant customer support, PHP, MySQL, Linux, Perl, CGI.


Categories: Information Technology
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khizar.atwebpages.com

khizar.atwebpages.com khizar.atwebpages.com           
Free Web Hosting, Domain Hosting, Reliable Web Hosting Provider, Domain registration, Inexpensive, Low Cost, Affordable, Reseller Program, PHP, MySQL, Linux, Ecommerce
Affordable, reliable web hosting and domain registration provider: low cost, inexpensive plans, reseller program, complete e-commerce solutions, instant customer support, PHP, MySQL, Linux, Perl, CGI.

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Categories: Personal Pages, Web Hosting
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helpburan.atwebpages.com

helpburan.atwebpages.com helpburan.atwebpages.com           
Stream Free Movies & TV Shows
Browse and Watch all your favorite online movies & series for free!

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alexandrasator.batcave.net

alexandrasator.batcave.net alexandrasator.batcave.net           
Free Web Hosting, Domain Hosting, Reliable Web Hosting Provider, Domain registration, Inexpensive, Low Cost, Affordable, Reseller Program, PHP, MySQL, Linux, Ecommerce
Affordable, reliable web hosting and domain registration provider: low cost, inexpensive plans, reseller program, complete e-commerce solutions, instant customer support, PHP, MySQL, Linux, Perl, CGI.

Semrush Rank: 5,190,353
Categories: Education/Reference, Web Hosting
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wizmed.com

wizmed.com wizmed.com           
WIZMED: Consolidated Pharma Data
Better than the orange book, Easy to use pharma industry information - Approvals, Labels, 483s, Warning Letters, jobs and more.

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redica.com

redica.com redica.com           
Regulatory Compliance Software | Redica
Improve compliance, product quality, and team efficiency with the data in our regulatory compliance software. Learn more here!

Semrush Rank: 1,652,057 Facebook ♡: 0
Categories: Computers/Internet/Web Design and Development, Society/Law, Health/Conditions and Diseases, Business, Medicine
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eglifesciences.com

eglifesciences.com eglifesciences.com           
Home | EG Life Sciences
EG Life Sciences, a company of Eliassen Group, delivers strategic consulting and innovative solutions for multiple industries. Learn more.

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pharmaceuticalupdates.com

pharmaceuticalupdates.com pharmaceuticalupdates.com           
Pharmaceutical Updates - Pharmaceutical Updates was started to share knowledge among the pharma professionals & it will become helpful to the pharma Professionals. The author of pharmaceutical updates is Chandrasekhar panda who is having more than 13 years of Experience in Pharmaceutical Quality Assurance department and he has worked in Pharma Companies like Cipla, USV & Aurobindo Pharma Limited.
Pharmaceutical Updates was started to share knowledge among the pharma professionals & it will become helpful to the pharma Professionals. The author of pharmaceutical updates is Chandrasekhar panda who is having more than 13 years of Experience in Pharmaceutical Quality Assurance department and he has worked in Pharma Companies like Cipla, USV & Aurobindo Pharma Limited.

Moz DA: 4 Moz Rank: 0.8 Semrush Rank: 4,366,156 Facebook ♡: 36
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fmdic.org

fmdic.org fmdic.org           
FDA Medical Device Industry Coalition (FMDIC)
The FDA Medical Device Industry Coalition (FMDIC), composed of members of the Dallas District FDA Staff and individuals from associations representing the medical device industry, was formed to promote communication, education and cooperation between the regulators and the regulated industry.

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Categories: Education/Reference, Government and Legal Organizations
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eduquest.net

eduquest.net eduquest.net           
FDA Compliance Training, Consulting and Regulatory Advice
EduQuest, a global team of FDA compliance experts, including former FDA inspectors and rule-makers. Provides FDA training, consulting and advice.


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fda483s.com

fda483s.com fda483s.com           
FDA 483s Resource Center - FDA 483s
FDA 483s Resource Center Resources to Avoid & Respond to FDA 483s Form FDA 483s.  If you're part of the very small fraternity of people who have "FDA 483s" in your vocabulary, this website is for you.  Please see our list of most helpful resources

Semrush Rank: 4,421,806
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emmainternational.com

emmainternational.com emmainternational.com           
Quality and Regulatory Consulting - EMMA International
EMMA International specializes in FDA regulatory affairs, compliance services, and submissions in the Life Sciences industry.

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alliancecalibration.com

alliancecalibration.com alliancecalibration.com           
(Alliance Calibration) Cincinnati Calibration Lab | Transcat
ISO-accredited Alliance Calibration, part of Transcat since 2022, offers expert on-site calibrations with quick turnaround.

Moz DA: 27 Moz Rank: 3.6 Semrush Rank: 6,237,127 Facebook ♡: 527
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pharmalex.com

pharmalex.com pharmalex.com           
Specialized services for the pharmaceutical industry - PharmaLex
Pharma consulting of specialized services for the pharmaceutical, biotech and medical device industries, compliance is our top priority.

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operonstrategist.com

operonstrategist.com operonstrategist.com           
Medical Device Consulting Company in India | Operon Strategist
Operon strategist medical device consulting firm, provides turnkey solutions to the medical device manufacturer who wants to set up world class manufacturing unit

Moz DA: 20 Moz Rank: 3.9 Semrush Rank: 3,755,334 Facebook ♡: 398
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