№ lp_1_15766
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This document is a template for providing a condensed summary of key information about a finished pharmaceutical product (FPP) approved by a reference stringent regulatory authority (SRA) for use outside the SRA region.
Note: Year
Topic: Pharmaceutical product, regulatory approval, prequalification
Document type: Template
Organization / institution: WHO
Target audience: Regulatory authorities, pharmaceutical manufacturers
Price: 8 / 10 USD
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Quality Information Summary of Finished Pharmaceutical Products Approved by Stringent Regulatory Authorities (SRA)
Year: 2014
Region / City: Global
Topic: Pharmaceutical Product Prequalification
Document Type: Guideline
Organization / Institution: World Health Organization (WHO)
Author: World Health Organization
Target Audience: Pharmaceutical manufacturers, regulatory bodies
Effective Period: Not specified
Approval Date: 2014
Modification Date: Not specified
Quality Information Summary (QIS) of the Biotherapeutic Product Approved by Stringent Regulatory Authority (SRA)(QIS-BTP-SRA)
Year: 2021
Region / city: Worldwide
Topic: Biotherapeutic Product Documentation
Document type: Guidelines
Organization / institution: World Health Organization (WHO)
Author: World Health Organization (WHO)
Target audience: Regulatory authorities, pharmaceutical companies, healthcare professionals
Period of validity: Not specified
Approval date: Not specified
Date of changes: Not specified
Quality Information Summary (QIS) of the Biotherapeutic Product Approved by Stringent Regulatory Authority (SRA)(QIS-BTP-SRA)
Year: 2023
Region / City: Global
Topic: Biotherapeutic Product Prequalification
Document Type: Guidelines
Organization / Institution: World Health Organization (WHO)
Author: WHO
Target Audience: Regulatory Authorities, Pharmaceutical Companies
Validity Period: Ongoing
Approval Date: Not specified
Date of Changes: Not specified
Quality Information Summary (QIS) of the Biotherapeutic Product Approved by Stringent Regulatory Authority (SRA) (QIS-BTP-SRA)
Year: 2021
Region / City: N/A
Topic: Biotherapeutic Product Prequalification
Document Type: Template
Organization / Institution: World Health Organization (WHO)
Author: WHO
Target Audience: Regulatory Authorities, Manufacturers
Effective Period: N/A
Approval Date: N/A
Date of Changes: N/A
Table S1. Demographic, alcohol use, and network characteristics of the Full, Stringent, and Inclusive samples for the simulation study
Year: 2023
Region / city: N/A
Topic: Simulation study of demographic and network characteristics, alcohol use
Document type: Research table
Institution: N/A
Author: N/A
Target audience: Researchers, scholars in social science and network analysis
Period of validity: N/A
Approval date: N/A
Date of changes: N/A
Agriculture, Food, and Natural Resources (AFNR) Frameworks 2021 Section 9 – Food Products and Processing (FPP) Pathway Frameworks
Year: 2021
Region / City: Minnesota
Subject: Food Products and Processing, Agricultural Education
Document Type: Framework, Educational Program
Organization: Minnesota Department of Education
Author: National Council for AFNR Education, Minnesota Department of Education
Target Audience: Students, Educators, Agricultural Professionals
Period of Action: Ongoing
Approval Date: Not specified
Modification Date: Not specified
Variation to a Prequalified Finished Pharmaceutical Product (FPP)
Year: 2023
Region / city: N/A
Theme: Pharmaceutical Product Variation
Document Type: Application Form
Organization / Institution: N/A
Author: N/A
Target Audience: Applicants for pharmaceutical product variations
Period of validity: N/A
Approval Date: N/A
Date of Changes: N/A
Variation to a Registered Finished Pharmaceutical Product (FPP): Major, Minor or Immediate Notification
Note: Year
Instructions for Running Glucose Quality Control on FPP Meter
Organization: POCT Pathology Department
Role: POCT Coordinator
Contact Telephone: 07500050655
Contact Email: [email protected]
Subject: Glucose and Ketone Quality Control Procedure
Device: FPP Meter
Testing Types: Glucose Testing, Ketone Testing
Procedure Type: Quality Control Instruction
Intended Users: Clinical Staff Operating FPP Meter
Document Purpose: Operational Guidance
FPP Blood Glucose/Ketone Monitoring Observations for New to Practice Health Care Assistants
Year: 2026
Location: Not specified
Document Type: Competency Assessment Form
Organization: FPP (Facility/Program unspecified)
Author: Not specified
Target Audience: New to practice health care assistants
Assessment Criteria: Blood glucose and ketone monitoring procedures
Observations Period: During initial training and competency evaluation
Date Completed: To be filled by assessor
Assessor Name: To be filled by assessor
Assessor Initials: To be filled by assessor
Topics: RegionQIS-SRA-MED-crp Stringent FPP