topic: Risk Management Plan
definition: Risk management system is a set of activities and interventions designed to identify, characterize, prevent or minimize risks relating to medicines, including the assessment of the effectiveness of those activities and interventions.Risk management plans can serve as a safeguard, helping manufacturers prepare for and respond to hazards that could lead to drug supply disruptions and shortages.
topic: Administrative Requirements
definition: Administrative documents (e.g., application forms, such as Form FDA 1571, cover letters, reviewer guides, and cross-reference authorization letters), claims of categorical exclusion, and labeling information should be included in Module 1 of the CTD submissions.
topic: Regulatory Profile
definition: The supporting documentation of the manufacturing process used to produce dosage forms and the accompanying quality control system intended for raw materials, in-process materials, and the finished dosage form suitable for administration of drug.
topic: Submission
definition: Submission is defined as recognition and renewal applications and any documents provided as part of the application process must be submitted electronically, in English. An applicant must provide any translation and interpretation services needed by FDA during the processing of the application, including during onsite assessments of the applicant by FDA.
topic: Certificates
definition: Certificates of pharmaceutical product (CPP) are issued for human drugs exported from the U.S. directly to the requesting country. CPPs conform to the format established by the World Health Organization (WHO) and are intended for use by importing countries when considering whether to license the product in question for sale in that country.
topic: Dossier
definition: Dossier should contain a list of the features, dimensions and performance attributes of the medical device, its variants and accessories, that would typically appear in the product specification made available to the end user, e.g. in brochures, catalogues etc.
topic: Registration Testing
definition: Conformity assessment can be described as the demonstration that specified requirements relating to a product, process, system, person, or body are fulfilled; note that the subject field of conformity assessment may include testing, inspection, and certification, as well as accreditation of conformity assessment bodies.
topic: Samples
definition: Samples should be representative of the batch of materials or products from which they ar