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IPEC rolls out GMP auditing program for excipients.(International Pharmaceutical Excipients Council of the Americas, good manufacturing practices)(Brief Article): An article from: Validation Times
🇺🇸 United States
IPEC rolls out GMP auditing program for excipients.(Interna…
By: Dan Whipple
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INSPECTION LOG.(Brief Article)(Statistical Data Included): An article from: Inspection Monitor
🇺🇸 United States
INSPECTION LOG.(Brief Article)(Statistical Data Included): …
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Warning letters.(Case study of Spencer Jones): An article from: Bioresearch Monitoring Alert
🇺🇸 United States
Warning letters.(Case study of Spencer Jones): An article f…
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Initial inspection nets CI six-item 483.(Clinical investigators): An article from: Bioresearch Monitoring Alert
🇺🇸 United States
Initial inspection nets CI six-item 483.(Clinical investiga…
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CRO lands 483 for missing electronic signature, improper password sharing.(CROs (contract research organizations), Perceptive Informatics): An article from: Bioresearch Monitoring Alert
🇺🇸 United States
CRO lands 483 for missing electronic signature, improper pa…
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Firms urged to use ISO 9001 for biz, 13485:200x for FDA.(new medical device quality systems standard)(Brief Article): An article from: Validation Times
🇺🇸 United States
Firms urged to use ISO 9001 for biz, 13485:200x for FDA.(ne…
By: Ellen Beck
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Firm attributes quick 483 turnaround time to contract manufacturing volume. (Biologics).(Brief Article): An article from: Validation Times
🇺🇸 United States
Firm attributes quick 483 turnaround time to contract manuf…
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Two CBL audits focus on endotoxin, microbiology.(Chesapeake Biological Laboratories)(Brief Article): An article from: Inspection Monitor
🇺🇸 United States
Two CBL audits focus on endotoxin, microbiology.(Chesapeake…
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FDA to train inspectors via Internet, allow contractor to sell material to industry.(Food and Drug Administration contracts with EduNeering)(Brief Article): An article from: Inspection Monitor
🇺🇸 United States
FDA to train inspectors via Internet, allow contractor to s…
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Expecting unexpected AEs can reduce IRB reporting burden; FDA not inclined to expand DMCs to help out.(Adverse events)(Institutional Review ... An article from: Bioresearch Monitoring Alert
🇺🇸 United States
Expecting unexpected AEs can reduce IRB reporting burden; F…
By: Tamra Sami
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INSPECTION LOG.: An article from: Inspection Monitor
🇺🇸 United States
INSPECTION LOG.: An article from: Inspection Monitor
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Subpart C on prisoner research should be scrapped, SACHRP told.(United States. Office for Human Research Protections. Secretary's Advisory Committee ... An article from: Bioresearch Monitoring Alert
🇺🇸 United States
Subpart C on prisoner research should be scrapped, SACHRP t…
By: Tamra Sami
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Triage seen key for reporting; regs sketchy.(Adverse event reporting)(clinical trials): An article from: Bioresearch Monitoring Alert
🇺🇸 United States
Triage seen key for reporting; regs sketchy.(Adverse event …
By: Kurt Samson
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OTC manufacturer changes product specs following validation.(Human drugs): An article from: Validation Times
🇺🇸 United States
OTC manufacturer changes product specs following validation…
By: Tamra Sami
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CI/sponsor kept no case report forms or raw data; substitutes study drug without prior approval. (Clinical investigators).: An article from: Bioresearch Monitoring Alert
🇺🇸 United States
CI/sponsor kept no case report forms or raw data; substitut…
By: Tamra Sami, urokinas
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INSPECTION LOG.(United States Food and Drug Administration)(Brief Article): An article from: Inspection Monitor
🇺🇸 United States
INSPECTION LOG.(United States Food and Drug Administration)…
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ALO trips after rebounding in '99 from '98 suspension.(Brief Article): An article from: Inspection Monitor
🇺🇸 United States
ALO trips after rebounding in '99 from '98 suspen…
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Review guidance for all industries before changing systems.(medical equipment industry)(Brief Article): An article from: Validation Times
🇺🇸 United States
Review guidance for all industries before changing systems.…
By: Michael Anello
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Development guide seen adopted by ISO after ANSI.(Association for the Advancement of Medical Instrumentation software standards recognized by American ... Article): An article from: Validation Times
🇺🇸 United States
Development guide seen adopted by ISO after ANSI.(Associati…
By: Ellen Beck
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FDA can find no objections in CI audit. (Clinical investigators).(Metabolic and Atherosclerosis Research Center, Cincinnati, Ohio; clinical investigator, ... article from: Bioresearch Monitoring Alert
🇺🇸 United States
FDA can find no objections in CI audit. (Clinical investiga…
By: Tamra Sami
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Final drug GMPs could mean greater burden for electronic records security - 48% of Part 11 citations cover security.: An article from: Warning Letter Bulletin
🇺🇸 United States
Final drug GMPs could mean greater burden for electronic re…
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FDA, Radionics spar over design controls.(Brief Article): An article from: Inspection Monitor
🇺🇸 United States
FDA, Radionics spar over design controls.(Brief Article): A…
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INSPECTION LOG.(Brief Article)(Directory): An article from: Inspection Monitor
🇺🇸 United States
INSPECTION LOG.(Brief Article)(Directory): An article from:…
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Upgrading HEPA filters suggested for improved HVAC efficiency. (Filters).(high efficiency particulate air): An article from: Validation Times
🇺🇸 United States
Upgrading HEPA filters suggested for improved HVAC efficien…
By: Elisa Ludwig
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Blood bank letter shows FDA still concerned about computer system access, passwords under Part 11.(Blood/Biologics): An article from: Validation Times
🇺🇸 United States
Blood bank letter shows FDA still concerned about computer …
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Electronic 'tagging' for record changes seen as FDA desire.(Brief Article): An article from: Validation Times
🇺🇸 United States
Electronic 'tagging' for record changes seen as F…
By: Dan Whipple, Ellen Beck
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Part 11 Guide Seeks OTS, Internet Validation.(off-the-shelf electronic signature systems)(Brief Article): An article from: Validation Times
🇺🇸 United States
Part 11 Guide Seeks OTS, Internet Validation.(off-the-shelf…
By: Ken Reid
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Mammalian cell technology improving, expert notes; 1-4g/L realized now, 5-10g/L expected soon.(Biotech): An article from: Validation Times
🇺🇸 United States
Mammalian cell technology improving, expert notes; 1-4g/L r…
By: Joseph Pickett
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Training, components lead 17-item Panef 483.(Brief Article): An article from: Inspection Monitor
🇺🇸 United States
Training, components lead 17-item Panef 483.(Brief Article)…
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Inspection log.: An article from: Inspection Monitor
🇺🇸 United States
Inspection log.: An article from: Inspection Monitor
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INSPECTION LOG.(Brief Article): An article from: Inspection Monitor
🇺🇸 United States
INSPECTION LOG.(Brief Article): An article from: Inspection…
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INSPECTION LOG.(FDA, inspection documents available under Freedom of Information Act)(Brief Article): An article from: Inspection Monitor
🇺🇸 United States
INSPECTION LOG.(FDA, inspection documents available under F…
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