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Owing to the importance of the IB in maintaining the safety of human subjects in clinical trials, and as part of their guidance on good clinical practice (GCP), the U.S. Food and Drug Administration (FDA) has written regulatory codes and guidances for authoring the IB, and the International Conference on Harmonisation (ICH) has prepared a ...
The ICH secretariat is located in Geneva, Switzerland. [citation needed] The ICH WGs are established by the assembly when a new technical topic is accepted for harmonisation, and are charged with developing a harmonised guideline that meets the objectives outlined in the concept paper and business plan.
The warning letter detailed that the company failed to monitor changes in the impurity profile of incoming heparin active raw material, to adequately investigate out-of-specification results, to document actual processing steps in batch records, to validate all critical steps in the process, to qualify all suppliers, and to use valid methods to ...
The PIC (Pharmaceutical Inspection Convention) was founded in October 1970 by the European Free Trade Association (EFTA), under the title of the Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products. [1] [2] The initial members comprised the 10 member countries of EFTA at that time.
"EC Safety Phrases" (PDF). ChemBlink.com; Council Directive 2006/102/EC of 20 November 2006 adapting Directive 67/548/EEC on the classification, packaging and labelling of dangerous substances, by reason of the accession of Bulgaria and Romania. No longer in force, Date of end of validity: 31/05/2015; Implicitly repealed by 32008R1272.
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
The header identifies the FDA district office that performed the inspection, the date(s) of inspection, name and address of the facility that was inspected, the name and title of the individual to whom the 483 is issued to (usually the most responsible individual physically present in the facility), a brief description of the type of facility, and the facility's FEI (FDA Establishment ...
The GHS transport pictograms are the same as those recommended in the UN Recommendations on the Transport of Dangerous Goods, widely implemented in national regulations such as the U.S. Federal Hazardous Materials Transportation Act (49 U.S.C. 5101–5128) and D.O.T. regulations at 49 C.F.R. 100–185.