Example: bankruptcy
European Medicines Agency
manufacturing process, validated test procedure, raw material testing, in-process testing, stability testing, etc. Specifications are chosen to confirm the quality of the drug substance and drug product rather than to establish full characterization, and should focus on those characteristics found to be
Tags:
Information
Domain:
Source:
Link to this page:
Documents from same domain
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
European Medicines Agency
www.ema.europa.eu© EMEA 2006 2 SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS ICH Harmonised Tripartite Guideline
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
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
Related documents
European Medicines Agency
www.ema.europa.euManufacturing Practices, a validated manufacturing process, raw materials testing, in-process testing, stability testing, etc. Specifications are chosen to confirm the quality of the drug substance and drug product rather than to establish full characterisation and should focus on those molecular and biological
Aerospace Supply Chain and Manufacturing
nari.arc.nasa.govOEM –Control design, manufacturing and assembly function, the most critical component of value chain Tier 1 –Support Primes by providing them with equipments and systems like engines, Wings, Fuselage Tier 2 –Manufacture and develop parts as per the specifications provided by primes and Tier 1 suppliers
Ballistic Resistance of Body Armor NIJ Standard-0101
www.ojp.govOffice of Science and Technology to establish and maintain performance standards in accordance with the National Technology Transfer and Advancement Act of 1995 (Public Law 104–113) to test and evaluate law enforcement technologies that may be used by Federal, State, and local law enforcement agencies.