№ files_lp_4_process_2_67027
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Character count: 3478
File size: 166 KB
Structured application form used for regulatory submission detailing the applicant, vaccine specifications, manufacturing and packaging sites, release responsibilities, and lot-specific information for human vaccine approval by SAHPRA.
Year:
2026
Region/Country:
South Africa
Document Type:
Application Form
Regulatory Authority:
South African Health Products Regulatory Authority (SAHPRA)
Subject:
Human Vaccine Lot Release
Applicant/Holder:
Name and contact details provided in form
Responsible Person:
Name and contact details provided in form
Vaccine Details:
Product name, category, pharmacological classification, dosage form, strength, route of administration, country of origin
Manufacturing Sites:
Names, addresses, Site Master File references, licence numbers, dates of submission
Packing Sites:
Primary and secondary packers, addresses, Site Master File references, licence numbers, dates of submission
Finished Product Release:
FPRC and FPRR details, addresses, Site Master File references, licence numbers, dates of submission
Declaration:
Confirmation of fee payment and accuracy of submitted information
Type of Application:
First release, further release, expedited release
Lot Details:
Final container lot number, secondary packaging lot number, container type, doses per container, shipment details, validity period, expiry date, country of lot manufacture
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
Not specified
Jurisdiction:
South Africa
Regulatory authority:
South African Health Products Regulatory Authority (SAHPRA)
Document type:
Regulatory validation checklist
Document format:
eCTD
Subject area:
Medicinal product variations
Product type:
Human medicinal products
Application type:
Variation application
Intended submitter:
Holder of certificate of registration
Submission scope:
Administrative, technical, and business validation
Regulatory modules referenced:
CTD Modules 1–5
Use context:
Initial and follow-up eCTD sequences
Approval status fields:
Included
Language:
English
Year:
2015
Location:
Kiawah Island, SC, USA
Subject:
Asphalt maintenance and parking lot striping
Document Type:
Scope of Work / Contract Specification
Organization:
Charleston County Park and Recreation Commission (CCPRC)
Project Site:
Beachwalker County Park, 8 Beachwalker Drive
Work Hours:
7:00 a.m. – 5:00 p.m., Monday through Friday
Materials:
Coal Tar Pitch Emulsion (CTPE) or equivalent sealcoating products
Standards:
RP 355e, ASTM D5727, ADA Standards for Accessible Design (28 CFR Part 36)
Pre-quote Meeting:
March 6, 2015, 1:00 p.m.
Contractor Responsibilities:
Site preparation, material application, safety, traffic management, cleanup, damage prevention
Year:
2021
Region / City:
West and Central Africa
Topic:
Electricity, Governance, Institutional Strengthening, Africa
Document Type:
Report
Organization:
European Union, African Union Commission
Author:
Dr. Dimitris Papastefanakis, Dr. William Gboney, Dr. George Kyriakarakos, Mr. Jian Bani
Target Audience:
Policy makers, energy sector professionals
Period of Validity:
2021-2040
Approval Date:
August 31, 2021
Date of Revisions:
N/A
Product name:
DQ-DR Combi Tray
Lot number:
2V4
Expiry date:
2029-03-01
Document type:
Laboratory photo document and interpretation reference
Methodology:
HLA-specific PCR with SSP primers
Resolution level:
Low resolution
Genetic targets:
HLA-DQ and HLA-DR loci
Primer sets:
DQ low resolution primer set; DR low resolution primer set
Control elements:
Internal Control Band; negative and positive controls
Amplicon size range:
75–200 base pairs
Reference database:
IMGT/HLA Database release 3.59.0 (2025-01-15)
Related standards:
WHO HLA Nomenclature
Content elements:
Gel image placeholder; interpretation tables; allele amplification notes
Intended use context:
HLA genotyping result documentation
Year:
2025
Region / City:
Greater Cairo
Subject:
Air Pollution Management, Climate Change, Environmental Remediation
Document Type:
Public Invitation
Institution:
Ministry of Environment – Arab Republic of Egypt
Author:
Ministry of Environment
Target Audience:
Potential Suppliers, Contractors
Duration of Project:
28 months
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2027
Region / City:
Not specified
Topic:
HLA-typing, PCR primers, low resolution
Document Type:
Technical Manual
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
Researchers, laboratory personnel
Validity Period:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2023
Lot Number:
2S1
Expiry Date:
2027-06-01
Document Type:
Laboratory test record
Test Type:
HLA typing by PCR-SSP
Markers:
HLA-A, HLA-B, HLA-DR
Resolution:
Low resolution
Sample Data Fields:
Name, Sample ID, DNA concentration, Test Date, Tested By, Review Date, Reviewed By, Interpretation, Failed lanes, Comments
Controls:
Positive and negative control bands
Data Source:
IMGT/HLA database, April 17, 2023, release 3.53.0
Abbreviations Included:
Yes
Primer Mix Information:
Detailed per HLA locus with amplification notes and potential artifacts
Photo Documentation:
Gel images included
Interpretation Guidance:
Tables with allele grouping and serological specificity references
Lot No:
5R0
Expiry Date:
2026-12-01
Test Date:
______________
Tested By:
______________
Review Date:
______________
Reviewed By:
______________
Interpretation:
___________
Failed lanes:
___________
Comments:
__________________
Note:
HLA-DQ low resolution primer set
ICB:
Internal Control Band
AmpS:
Amplicon Size
The DRB4*01:
03:01:02N allele is amplified by primer mixes 33 and 45.
Date of IMGT/HLA release:
2022-October-12, release 3.50.0
Website for alleles:
www.ebi.ac.uk/imgt/hla
Website for deleted alleles:
http://hla.alleles.org/alleles/deleted.html
Serological reactivity data from Tissue Antigens (2009) 73:
95-170
Target PCR fragments:
75 to 200 base pairs
Year:
2022
Region / City:
Patuxent River, MD
Topic:
Data Requirements for Defense Contracts
Document Type:
Contract Data Requirement List (CDRL)
Agency / Organization:
Department of Defense (DoD)
Author:
NAWCTSD SW ENGR, PMA-205 DAPMTS
Target Audience:
Department of Defense Contractors
Period of Validity:
N/A
Approval Date:
2022-02-14
Date of Changes:
N/A
Year:
[Insert year]
Region / City:
[Insert region or city]
Topic:
Procurement, Bidding Process
Document Type:
Instructional Guide
Organization:
Crown Commercial Service (CCS)
Author:
[Insert author name if available]
Target Audience:
Organizations participating in the bidding process
Period of validity:
[Insert period if applicable]
Approval Date:
[Insert approval date]
Modification Date:
[Insert modification date if applicable]
Location:
Lot 1 SP 750594B, Firewheel Place, Suffolk Park 2481
Region:
Byron Shire
Type of document:
Statutory planning assessment
Proposed development:
Swimming pool and associated fencing
Land use zone:
R2 Low Density Residential
Applicable planning instruments:
Resilience and Hazards State Environmental Planning Policy 2021; Byron Local Environmental Plan 2014
Coastal classification:
Coastal Environment Area; Coastal Use Area
Environmental considerations:
Coastal processes; visual amenity; public access; acid sulphate soils
Acid sulphate soils classification:
Class 3
Contamination status:
Site not contaminated; not listed on EPA Contaminated Land Register
Heritage considerations:
No Aboriginal cultural heritage or built heritage identified
Vegetation impacts:
No native vegetation removal
Earthworks:
Minor ancillary earthworks associated with pool construction
Essential services:
All existing services available; no additional services required
Date:
March 18, 2015
Project:
Asphalt crack sealing, sealcoating, and parking striping
Contractor:
[Contractor Name]
Location:
Beachwalker County Park parking lot
Scope of Work:
Asphalt crack sealing, sealcoating, and parking lot striping
Completion Deadline:
April 29, 2015
Payment Terms:
Net 30
Risk of Loss:
Seller/Contractor assumes all risks until final acceptance
Warranty:
One-year warranty for non-conforming work
Delivery and Completion:
Time is of the essence, with specific conditions for rain delays
Compliance:
Adherence to applicable laws, regulations, and safety standards
Insurance:
Contractor must procure general liability insurance
General Terms and Conditions:
Apply to purchase of supplies, construction, or services
Document type:
Statement of Environmental Effects
Address:
Lot 71 DP935196, 32 Shirley Lane, Byron Bay NSW 2481
Prepared by:
All Planning Matters
Date:
May 2023
Development description:
Construction of an in-ground spa pool and adjoining cabana
Planning instruments:
Resilience and Hazards SEPP 2021; Byron Local Environmental Plan; Byron Shire Development Control Plan 2014
Land use:
Residential
Site area:
506 m²
Existing development:
Approved residential dwelling
Locality character:
Low density residential
Environmental considerations:
No removal of native vegetation; no threatened species or ecological communities present
Hazards identified:
Bushfire and flooding prone land; coastal zone
Waste management:
Construction waste to licensed facility
BASIX status:
Not BASIX affected
Lot No:
3V4
Expiry Date:
2029-04-01
Sample ID:
_______________
DNA Conc.(ng/ul):
__________
Test Date:
_______________
Note:
Tested By
Review Date:
_________________
Reviewed By:
_________________
Interpretation:
___________
Failed lanes:
___________
Comments:
_________________
ICB:
Internal Control Band
AmpS:
Amplicon Size
The primers in this kit do not amplify the A*31:
234 allele.
Date:
2025-Januaury-09, release 3.59.0
Year:
2025
Region / city:
Uganda / Kampala
Sector:
Education
Document type:
Procurement notice
Institution:
Ministry of Education and Sports
Target audience:
Eligible bidders
Period of validity:
Until November 20, 2025
Approval date:
Not specified
Amendment date:
Not specified
Context description:
Procurement notice for the supply, delivery, and installation of agricultural mechanization, animal husbandry, and road construction workshop equipment as part of the Business, Technical, and Vocational Education and Training Support Project in Uganda.
Year:
2028
Region / City:
Not specified
Theme:
HLA Typing, PCR Testing
Document Type:
Technical Sheet
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
Researchers, Laboratory Technicians
Period of Validity:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Test Type:
PCR-based HLA Typing
Test Method:
PCR, Low Resolution Typing
Intended Use:
Laboratory analysis of HLA alleles
Description:
This document provides technical details for a DQ-DR Combi Tray, including lot information, test parameters, primer mixes, and interpretation guidelines for PCR-based HLA typing.
Note:
Year
Topic:
Vaccination Consent
Document Type:
Consent Form
Target Audience:
Patients, Healthcare Providers
Year:
2025
Region / city:
England
Topic:
Immunization
Document type:
Patient Group Direction (PGD)
Organization / institution:
UK Health Security Agency (UKHSA)
Author:
Suki Hunjunt, Professor Shamez Ladhani, David Green
Target audience:
Healthcare professionals involved in immunization
Period of validity:
From 5 January 2026 to 5 January 2029
Approval date:
5 January 2026
Amendment date:
2 June 2025, 16 December 2025
Description:
A document detailing the administration guidelines for the pneumococcal polysaccharide conjugate vaccine (PCV13, PCV15) for children under 2 years old in the UK.
Year:
2025
Region / City:
London
Topic:
Neonatal BCG vaccination program
Document Type:
Protocol
Organization / Institution:
NHSE
Author:
Alice Waters
Target Audience:
Healthcare professionals involved in neonatal care and immunization
Period of validity:
Not specified
Approval Date:
Not specified
Date of changes:
September 2025
Year:
2023
Region / City:
N/A
Subject:
Vaccination
Document Type:
Medical Guidelines
Organization / Institution:
Merck
Author:
N/A
Target Audience:
Healthcare professionals
Effective Period:
N/A
Approval Date:
07/13/2015
Revision Dates:
07/13/2015, 11/15/2015, 06/2016, 04/2023, 08/2024