Classification and analysis of the GCP inspection …
01 December 2014 . INS/GCP/46309/2012 . Compliance and Inspections . Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP
Download Classification and analysis of the GCP inspection …
Information
Domain:
Source:
Link to this page:
Documents from same domain
Q12 Step 2b Technical and regulatory …
www.ema.europa.euICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management EMA/CHMP/ICH/804273/2017 Page 3/36
Guideline on good pharmacovigilance practices …
www.ema.europa.eu9 December 2013 . EMA/816292/2011 Rev 1* Guideline on good pharmacovigilance practices (GVP) Module VII – Periodic safety update report (Rev 1)
Guideline on good pharmacovigilance practices (GVP)
www.ema.europa.euGuideline on good pharmacovigilance practices (GVP) – Module IX (Rev 1) EMA/827661/2011 Rev 1 Page 2/25
Guideline on good pharmacovigilance practices …
www.ema.europa.euGuideline on good pharmacovigilance practices (GVP) – Module VIII (Rev 3) EMA/813938/2011 Rev 3 Page 2/28
Guideline for good clinical practice E6(R2)
www.ema.europa.euGuideline for good clinical practice E6(R2) EMA/CHMP/ICH/135/1995 Page 2/70 Document History First Codification History Date New Codification
Guideline for good clinical practice E6(R2)
www.ema.europa.euGuideline for good clinical practice E6(R2) EMA/CHMP/ICH/135/1995 Page 2/75 10 Document History 11 First Codification History Date New Codification November
Guideline on good pharmacovigilance practices …
www.ema.europa.euharmful physical or psychological effects [DIR 2001/83/EC Art 1(1 6)]. 74 Adverse event (AE); synonym: Adverse experience 75 Any untoward medical occurrence in a patient or clinical- trial subject administered a medicinal product
European Medicines Agency
www.ema.europa.eu© EMEA 2006 2 SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS ICH Harmonised Tripartite Guideline
products1/traditional herbal medicinal products
www.ema.europa.euThere is no expectation that existing herbal medicinal products on the market will be affected by this guideline, with the exception of traditional herbal medicinal products for human use that were already
Q7 Q&A - good manufacturing practice for active ...
www.ema.europa.euICH guideline Q7 on good manufacturing practice for active pharmaceutical ingredients – questions and answers EMA/CHMP/ICH/468930/2015 Page 2/37
Related documents
Compliance Inspection Report - Aadvanced …
www.aplusinspection.netCompliance Inspection Report Note: Reports of Final and Repair Compliance Inspections left at site always require reviewer's signature to be Official.
PROPERTY INSPECTION REPORT # Sample
www.heritagehomeinspections.usReport Identification: MMDDYYYY-00 - 258 Sample Drive, Your City Page 3 of 23 obtained from these sources is complete or accurate or that this inspection is …
Inspection and reports - Health and Safety Executive
www.hse.gov.ukHSE information sheet Inspection and reports Construction Information Sheet No 47(rev1) Introduction Reports This information sheet sets out the specific The result of an inspection must be recorded and
Wastewater Treatment Plant Compliance …
www.nyc.govNEW YORK CITY DEPARTMENT OF ENVIRONMENTAL PROTECTION. BUREAU OF WATER SUPPLY. Wastewater Treatment Plant Compliance Inspection Reports . Summary – 1st Quarter 2011 . April 26, 2011
Sample BUILDING INSPECTION REPORT - QLD - …
www.reportsdirect.com.aureport no: page 2 standard property inspection report please read the terms and conditions in clause a.1 of this document service requested as agreed with client
INSPECTION REPORTS - Alberta
www.servicealberta.gov.ab.ca31 A landlord can deduct for such things as obvious dirt, soil, etc., as long as the inspection reports were completed according to the RTA. Cleaning up foreign material is not considered a deduction for normal wear
Property Inspection Waiver - Fannie Mae
www.fanniemae.com© 2018 Fannie Mae. Trademarks of Fannie Mae. Updated May 1, 2018 1 of 8 Property Inspection Waiver Frequently Asked Questions May 1, 2018 . Property inspection waiver (PIW) is an offer to waive the appraisal for eligible transactions.