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196 books found — Page 4 of 7
GCP inspections to be nation-based; pharma firms advised to 'get it right first time' for Phase I trials.(EU Clinical trials)(Good Clinical Practices): An article from: Bioresearch Monitoring Alert
GCP inspections to be nation-based; pharma firms advised to…
By: Tamra Sami
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Batch records and water problems crop up at OTC drug maker H2O. (Human Drugs).: An article from: Inspection Monitor
Batch records and water problems crop up at OTC drug maker …
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Revlon OTC drug process, computer, cleaning cited.: An article from: Validation Times
Revlon OTC drug process, computer, cleaning cited.: An arti…
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Nassmith's process validation, lab testing of OTC drugs cited.(over-the-counter)(Brief Article): An article from: Validation Times
Nassmith's process validation, lab testing of OTC drug…
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Uncertified anti-fungus oil, labeling sends OTC firm to clean up act. (Human Drugs).(Salon Sciences Corp.): An article from: Inspection Monitor
Uncertified anti-fungus oil, labeling sends OTC firm to cle…
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Nassmith exits OTC market after validation citations.(over the counter drugs)(Brief Article): An article from: Validation Times
Nassmith exits OTC market after validation citations.(over …
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Nassmith answers citations by recalling its OTC drugs.(Brief Article): An article from: Inspection Monitor
Nassmith answers citations by recalling its OTC drugs.(Brie…
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Cleaning validation noted at Generic Sal, Allscripts; OTC drug/device firm cited.: An article from: Validation Times
Cleaning validation noted at Generic Sal, Allscripts; OTC d…
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Analysis of 483s/EIRs for GMP validation issues : Human Drugs Contract Pharmacal hit for OTC drug validation.: An article from: Validation Times
Analysis of 483s/EIRs for GMP validation issues : Human Dru…
By: Mark McCarty
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Natureplex cited for cleaning, container closure issues for OTC products.(Human drugs): An article from: Validation Times
Natureplex cited for cleaning, container closure issues for…
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Predecessor's ways don't please FDA, Zymed finds.(biotechnology company): An article from: Inspection Monitor
Predecessor's ways don't please FDA, Zymed finds.…
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Agency pulls OTC maker up short for attempted group cleaning validation.(over the counter drug firm Bio-Pharm): An article from: Inspection Monitor
Agency pulls OTC maker up short for attempted group cleanin…
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Questionable OOS handling at American Pharm Partners raises eyebrows at FDA. (Human drugs).: An article from: Validation Times
Questionable OOS handling at American Pharm Partners raises…
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Labeling error paves way for warning to Bio-Pharm. (Human drugs).: An article from: Validation Times
Labeling error paves way for warning to Bio-Pharm. (Human d…
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Measurements - Whether modular or documented, tolerances needed.(calibrating drug- and device-making instruments)(Brief Article): An article from: Validation Times
Measurements - Whether modular or documented, tolerances ne…
By: Mark Karbarz
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BiMo FOIA log.(Freedom of Information Act): An article from: Bioresearch Monitoring Alert
BiMo FOIA log.(Freedom of Information Act): An article from…
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Piedmont Hospital fails to follow procedures, report BPDs.(Biologics): An article from: Validation Times
Piedmont Hospital fails to follow procedures, report BPDs.(…
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2-2-0 updates FDA monthly on validation corrections.(Brief Article): An article from: Validation Times
2-2-0 updates FDA monthly on validation corrections.(Brief …
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Validation issues consume Team Biologics inspection.(Massachusetts Public Health Biologic Laboratories): An article from: Validation Times
Validation issues consume Team Biologics inspection.(Massac…
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Inspection log.: An article from: Inspection Monitor
Inspection log.: An article from: Inspection Monitor
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Wyeth/Lederle audit led to $30 million consent decree.(Brief Article): An article from: Inspection Monitor
Wyeth/Lederle audit led to $30 million consent decree.(Brie…
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FOODS/DIETARY SUPPLEMENTS - HACCP deficiencies cited at Elmira Seafood and The Fish Market; rodent infestation revealed at Hoa Ying Trading; low-acid ... An article from: Warning Letter Bulletin
FOODS/DIETARY SUPPLEMENTS - HACCP deficiencies cited at Elm…
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Elan Pharma, FDA argue stability, solubility issues.(Elan Pharmaceuticals Corp.)(United States Food and Drug Administration)(Brief Article): An article from: Inspection Monitor
Elan Pharma, FDA argue stability, solubility issues.(Elan P…
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Bar codes, handling SOPs trip Florida Blood Service.(Florida Blood Services): An article from: Inspection Monitor
Bar codes, handling SOPs trip Florida Blood Service.(Florid…
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Consultant, MCA official conflict on role of quality unit under Q7A.: An article from: Validation Times
Consultant, MCA official conflict on role of quality unit u…
By: Howard Fields
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PAT seen facilitating quality by design, right-first-time manufacturing.(Manufacturing): An article from: Validation Times
PAT seen facilitating quality by design, right-first-time m…
By: Evelyn Heitman
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FDA not eyeing third party audits of raw materials; stressing C of As.(Excipients): An article from: Validation Times
FDA not eyeing third party audits of raw materials; stressi…
By: Tamra Sami
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Blood bank's reshuffling of paperwork hopes to streamline operation. (Blood & Biologics).(Mississippi Blood Services): An article from: Inspection Monitor
Blood bank's reshuffling of paperwork hopes to streaml…
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Final TV ad guide may see few changes, but release may depend on FDA chief: An article from: Warning Letter Bulletin
Final TV ad guide may see few changes, but release may depe…
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FDA issues final Part 11 guide, draft guides on sterile drugs, disputes, comp. protocols.: An article from: Warning Letter Bulletin
FDA issues final Part 11 guide, draft guides on sterile dru…
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PAT not specifically mentioned in CPG to waive 3-batch validation if firms use 'advanced science,' engineering principles.(Process validation): An article from: Validation Times
PAT not specifically mentioned in CPG to waive 3-batch vali…
By: Ken Reid
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53% say validation doesn't improve instruments, only fits regulatory need, according to informal survey.(Brief Article): An article from: Validation Times
53% say validation doesn't improve instruments, only f…
By: Dan Whipple
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