Pharma Job OpeningsTeva Pharmaceuticals Hiring Clinical Research team for Bangalore/ Mumbai location
Teva Pharmaceuticals Hiring Clinical Research team for Bangalore/ Mumbai location.
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Pharma Job Openings
Pharma Job OpeningsNectar Lifesciences Limited, Walk-In Interview on 09-APR-23
Nectar Lifesciences Limited, Walk-In Interview for Derabassi Plant on 09-APR-23 at HOTEL WINWAY, 164/1, RNT MARG, INDORE
21 CFRChanges in 21 CFR Part 11 Subpart C, Electronic Signatures
Update on recent changes in 21 CFR (Code of Federal Regulations) On 02nd March 2023; The text of § 11.100 General requirements of Subpart C Electronic…
News and UpdatesShutdown of European Pharmacopoeia 10th Edition
European Pharmacopoeia (Ph. Eur.) 10th Edition has been obsolete since 1 January 2023. all previous versions are no longer been accessible.
News and UpdatesICH Q9(R1) Quality Risk Management: Summary & Changes
Intended to provide guidance on the principles & examples of tools for quality risk management that can be applied to different aspects...
Manufacturing and PackagingFDA Dosage & Administration Labeling Guidance — Docket No.
Draft guidance for industry entitled “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products
News and UpdatesNew paragraph on control of N-nitrosamines, Ph. Eur. revised General Monograph 2034 and 2619
Ph. Eur. Commission adopts revised general monographs 2034 and 2619 after inclusion of a new paragraph on control of N-nitrosamines
Manufacturing and PackagingPastes
Pastes are semisolid preparations of stiff consistency and contain a high percentage 20%–50% of finely dispersed solids. Pastes are intended for
Manufacturing and PackagingWHO TRS 1044 (2022): 56th Report Annexes & PDF
WHO Expert Committee on Specifications for Pharmaceutical Preparations has published the Technical Report Series TRS 1044 2022 56th Report
PharmacopoeiaSignal to noise ratio: revision of Ph. Eur. general chapter Chromatographic separation techniques
Ph. Eur. users are advised to continue calculating the S/N ratio on a window “at least 5 x Wh”, instead of “20 x Wh”.
News and UpdatesRevised general chapter on rubber closures published in the Ph. Eur. Supplement 11.1
EDQM revised general chapter on Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders
PharmacopoeiaIMPLANTS
Implants are long-acting dosage forms that provide continuous release of the drug substance often for periods of months to years