№ lp_1_2_46547
File format: docx
Character count: 8707
File size: 59 KB
The document provides a template for applying for variations to prequalified finished pharmaceutical products (FPP), including details on the type of variation, applicant information, proposed changes, and supporting documentation requirements.
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
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Note:
Year
Revised/updated LIF attached:
YES/NO
Contract Number:
T2526.33
Document Type:
General Specification
Subject:
Provision of Polymer Pavement Stabilising Agents
Program:
Register of Prequalified Suppliers (ROPS)
Scope:
Polymer pavement stabilisation works and related contractor obligations
Jurisdiction:
Australia
Referenced Standards:
Relevant Australian Standards
Governing Documents:
General Conditions of Contract
Parties Mentioned:
Principal, Contractor, Superintendent
Key Topics:
Contractor warranties, contract management, approvals and legal compliance, quality management system, reporting and record keeping, payment claims, environmental protection, cultural heritage, traffic management, Heavy Vehicle National Law
Compliance Requirements:
Legislative requirements, Principal’s policies and procedures, industry standards
Associated Materials:
Contractor documents, management plans, reports, procedures, manuals
Note:
Year
Topic:
Pharmaceutical product, regulatory approval, prequalification
Document type:
Template
Organization / institution:
WHO
Target audience:
Regulatory authorities, pharmaceutical manufacturers
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
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
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
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
Note:
Year
Topic:
Pharmaceutical product, regulatory approval, prequalification
Document type:
Template
Organization / institution:
WHO
Target audience:
Regulatory authorities, pharmaceutical manufacturers
Document type:
Regulatory template appendix
Subject:
Quality information summary for finished pharmaceutical products and vaccines
Procedure:
Reference SRA collaborative procedure
Regulatory framework:
WHO Guidelines on submission of documentation for prequalification
Issuing organization:
World Health Organization
Series:
WHO Technical Report Series
Series number:
No. 1010
Year:
2018
Scope:
Pharmaceutical products and vaccines approved by stringent regulatory authorities
Intended use:
National registration under the SRA collaborative procedure
Confidentiality status:
Includes confidential quality information
Approval basis:
Information as approved by the reference SRA
Change management:
Revision required upon approved variations affecting QIS-SRA (crp)
Organization:
World Health Organization; South African Health Products Regulatory Authority
Document type:
Regulatory guideline
Subject area:
Pharmaceutical quality documentation
Scope:
Multisource (generic) finished pharmaceutical products and active pharmaceutical ingredients
Applicable products:
Human medicines; biologics; veterinary medicines
Regulatory references:
WHO TRS 970 Annex 6; VICH guidelines; European Pharmacopoeia; USP; BP
Geographical applicability:
International; South Africa
Related regulatory procedures:
API Prequalification; CEP; APIMF; product dossier submission
Content focus:
Quality data requirements; labelling and product information; drug substance characterization
Intended users:
Marketing authorization applicants; regulatory assessors
Year:
2007
Region / City:
N/A
Theme:
Cosmetics, Quality Control, Manufacturing
Document Type:
Standard Operating Procedure (SOP)
Organization / Institution:
N/A
Author:
N/A
Target Audience:
Employees involved in manufacturing, quality control, and product release
Effective Period:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Year:
2021
Region / city:
Not specified
Topic:
Temperature control, milk storage, dairy products
Document type:
Program Document
Organization / institution:
Company Name
Author:
Kathy Glass, Alex O’Brien
Target audience:
Employees involved in raw material handling and dairy production
Period of validity:
Not specified
Approval date:
Not specified
Amendment date:
Not specified
Year:
2022
Region / City:
Rwanda
Subject:
Pharmaceutical manufacturing, GMP inspection
Document Type:
Form
Organ / Institution:
Rwanda Food and Drugs Authority
Author:
N/A
Target Audience:
Pharmaceutical manufacturers
Period of validity:
20 June 2022 - 10 October 2025
Approval Date:
20 June 2022
Revision Date:
03 October 2022
Effective Date:
11 October 2022
Review Due Date:
10 October 2025
Year:
2017
Region / City:
Massachusetts
Topic:
Medical Marijuana Sampling and Analysis
Document Type:
Protocol
Organization / Institution:
Massachusetts Cannabis Control Commission
Author:
Department of Public Health (DPH)
Target Audience:
Massachusetts Registered Medical Marijuana Dispensaries (RMDs)
Effective Period:
Ongoing (subject to revisions)
Approval Date:
December 1, 2017
Revision Date:
December 1, 2017
Year:
2023
Region / City:
Not specified
Topic:
Storage and distribution of finished products
Document Type:
Standard Operating Procedure (SOP)
Organization:
Not specified
Author:
Not specified
Target Audience:
Production and QC heads, distribution personnel
Effective Period:
Ongoing
Approval Date:
Not specified
Revision Date:
Not specified
Year:
2026
Region / City:
Mecca
Topic:
Religious Rituals
Document Type:
Educational Guide
Organization:
N/A
Author:
N/A
Target Audience:
Muslims
Validity Period:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Note:
Contextual description