№ lp_1_2_32404
File format: docx
Character count: 3599
File size: 76 KB
This document is a form used to submit an application for the verification of GMP documentary evidence in compliance with Singapore regulations for therapeutic product registration.
Note:
Year
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.
The file will be delivered to the email address provided at checkout within 12 hours.
Don’t have cryptocurrency yet?
You can still complete your purchase in a few minutes:- Buy Crypto in a trusted app (Coinbase, Kraken, Cash App or any similar service).
- In the app, tap Send.
- Select network, paste our wallet address.
- Send the exact amount shown above.
The final amount may vary slightly depending on the payment method.
The file will be sent to the email address provided at checkout within 24 hours.
The product description is provided for reference. Actual content and formatting may differ slightly.
Note:
Year
Topic:
Construction Management
Document Type:
Guaranteed Maximum Price (GMP) Submission
Organization / Institution:
University of Michigan
Year:
2010
Region / City:
European Union
Topic:
Good Manufacturing Practice (GMP) inspection
Document Type:
Inspection report
Organization / Institution:
European Commission, Directorate-General for Health and Food Safety
Author:
European Medicines Agency
Target Audience:
Competent Authorities, Pharmaceutical Manufacturers
Period of Validity:
From 1 August 2010
Date of Adoption:
31 January 2010
Date of Changes:
1 August 2024
Note:
Report Reference no.
Name of Product(s) and Pharmaceutical Form(s):
Essential for inspections requested by the European Medicines Agency
Inspected Site(s):
Name and full address of the inspected site, including exact location/designation of the production facilities
Inspection Date(s):
2010-08-01
Inspector(s) and Expert(s):
Names of inspector(s), expert(s), and Competent Authority(ies)
References:
EMA reference number(s)
Inspection Findings:
Deficiencies found, with classification into critical, major, and other
Document identifier:
GMP 13
Title:
Good Measurement Practice for Ensuring Metrological Traceability
Subject:
Metrological traceability
Type of document:
Good Measurement Practice guideline
Field:
Metrology and measurement science
Issuing organization:
National Institute of Standards and Technology
Referenced standards:
International System of Units (SI)
Referenced publications:
NIST Special Publication 330; NIST Special Publication 811; ILAC P-10:2002
Scope:
Calibration and measurement traceability
Intended users:
Calibration providers and measurement laboratories
Key concepts:
Metrological traceability; calibration hierarchy; measurement uncertainty; measurement assurance
Responsibilities defined:
Calibration provider; user of measurement results
Period of application:
Not specified
Year:
2023
Organization:
IEEE Industry Applications Society (IAS)
Type of Document:
Contest guideline
Target Audience:
IEEE IAS Student Branch Chapters, IEEE Young Professional Affinity Groups
Event Period:
20 February 2023 – 20 June 2023
Submission Format:
Physical report (following Sample Report Template)
Assessment Panel:
IEEE IAS members
Eligibility Criteria:
IEEE IAS SBCs or YP Affinity Groups with active IEEE IAS members
Event Format:
In-person local mentoring events
Evaluation Criteria:
Goals and objectives, number of attendees, mentor experience, topics covered, program structure, lessons learnt
Awards:
Monetary prizes specified in Section 9
Contact Information:
Provided in Section 10
Year:
N/A
Region / City:
N/A
Subject:
Quality Management System Documentation
Document Type:
Standard Operating Procedure (SOP)
Organization / Institution:
N/A
Author:
N/A
Target Audience:
Employees
Period of Validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Note:
Contextual Description
Year:
2020
Region / city:
Australia
Topic:
Pharmaceutical manufacturing, Good Manufacturing Practice (GMP)
Document type:
Guide
Organization / institution:
Therapeutic Goods Administration (TGA)
Author:
Commonwealth of Australia
Target audience:
Licensed pharmaceutical manufacturers, regulatory bodies
Effective period:
Indefinite
Approval date:
September 2020
Amendment date:
N/A
Document type:
Verification and validation protocol
Industry:
GMP-regulated manufacturing
Test type:
Installation Qualification (IQ)
Scope:
Direct impact equipment
Referenced documents:
P&ID; URS; vendor handover documentation
Acceptance criteria:
Specification conformance; correct installation; complete documentation; material certification availability
Prerequisites:
Commissioning completed; punch-list closed; trained testers
Roles involved:
Tester; validation peer reviewer; Quality Assurance
Validation activities:
Installation verification; documentation verification; peer review; QA approval
Standard:
Good Manufacturing Practice (GMP)
Year:
2026
Region / City:
Clayton, Melbourne VIC
Field:
Biotechnology, Biomedical Manufacturing
Document Type:
Job Description
Organization:
CSIRO
Author:
CSIRO
Target Audience:
Australian/New Zealand Citizens, Australian Permanent Residents, and Australian Temporary Residents with full work rights
Period of Validity:
Up to 3 years (till 30, Sept 2026)
Date of Approval:
Not specified
Date of Modifications:
Not specified
Role Overview:
This document provides detailed information on the position of GMP Technician (Downstream) at CSIRO, including job responsibilities, required competencies, and essential criteria for applicants.
Year:
2022
Theme:
Drug Registration, Good Manufacturing Practice (GMP)
Document Type:
Work Procedure
Organization / Institution:
National Medical Products Administration (NMPA), Center for Food and Drug Inspection (CFDI)
Author:
Not specified
Target Audience:
Drug regulatory authorities, manufacturing site inspection teams
Period of Validity:
Starting from January 1, 2022
Approval Date:
Not specified
Date of Changes:
Not specified
Document Type:
Application Form
Subject:
Request for Overseas Good Manufacturing Practice (GMP) Inspection
Regulatory Authority:
Health Sciences Authority
Applicable System:
PRISM
Related Guidance:
GMP Conformity Assessment of Overseas Manufacturers (GUIDE-MQA-020)
Eligible Applicants:
Singapore registered firm/company with valid Accounting and Corporate Regulatory Authority account
Required Account:
CRIS account with client code
Submitting Party:
Responsible Person or Authorised Person with Submitter or CRIS Admin role
Scope:
Overseas manufacturing sites for therapeutic products to be registered
Sections:
Company Particulars; Applicant/Authorised Person; Overseas Manufacturer Site Information; Manufacturing Operations; Responsible Persons; Outsourced Activities
Outsourced Activities Covered:
Storage; QC Testing; Manufacturing
Accreditation Reference:
ISO/IEC 17025
Receiving Unit for QSD:
Therapeutic Product Branch
Language Requirement:
English
Year:
[Date of Agreement]
Note:
Region / City
Subject:
Construction, Contract Management
Document Type:
Amendment
Organization / Institution:
Yale University
Target Audience:
Construction Manager, Owner
Approval Date:
[Date]
Year:
2019
Region / City:
EEA
Subject:
GMP inspection
Document Type:
Inspection checklist
Organ / Institution:
European Medicines Agency (EMA)
Author:
EMA
Target Audience:
GMP inspectors
Effective Period:
Not specified
Approval Date:
19 February 2019
Date of Changes:
Not specified
Document type:
Construction contract agreement
Contract model:
Cost-plus contract with Guaranteed Maximum Price (GMP) ceiling
Parties:
Owner / Developer and General Contractor / Construction Manager
Project reference:
Construction of “[Project]” at [Site]
Currency:
Indian Rupees (INR)
Legal framework reference:
Indian Contract Act, 1872
Key financial structure:
Cost of the Work plus Contractor’s Fee subject to GMP limit
Payment mechanism:
Monthly payment applications with retention
Retention rate:
5 % of each payment until Substantial Completion
Contingency provision:
Contractor-controlled contingency included within GMP
Savings distribution:
Owner 70 % / Contractor 30 % of unused contingency at Final Completion
Bond requirements:
Performance Bond and Labour & Material Payment Bond at 100 % of GMP
Insurance requirements:
CAR, CGL, and Professional Liability insurance
Completion milestone:
Substantial Completion by specified date with liquidated damages for delay
Change management:
Change Orders adjusting scope, schedule, or statutory requirements
Force majeure clause:
Schedule relief and limited cost adjustment for uncontrollable events
Audit rights:
Owner audit of cost records up to 3 years after Final Payment
Dispute resolution:
Negotiation, mediation, then arbitration under SIAC Rules
Termination clause:
Owner termination for convenience with compensation formula
Schedules included:
Scope of Work, Exclusions, Rate Sheet, GMP Breakdown, Schedule of Values, Change Order Form, General Conditions
Year:
2026
Region / City:
Malaysia
Theme:
Pharmaceutical Regulation
Document Type:
Application Form
Organization / Institution:
National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia
Author:
National Pharmaceutical Regulatory Agency (NPRA)
Target Audience:
Pharmaceutical Manufacturers, Product Registration Holders (PRH)
Period of Validity:
N/A
Approval Date:
N/A
Date of Amendments:
N/A
Project name:
Unveiling the Potential of Climate-Smart Agriculture in Restoring Food Security and Livelihoods in Displacement-Affected Communities in Somaliland
Year:
2025
Region / City:
Togdheer Region, Somaliland
Topic:
Climate-Smart Agriculture, Food Security, Livelihood Resilience
Document Type:
Terms of Reference
Organization / Institution:
TAAKULO Somali Community
Author:
TAAKULO Somali Community
Target Audience:
Documentary production teams, humanitarian organizations, government stakeholders
Period of Action:
Until Dec 31st, 2025
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2023
Region / city:
United Kingdom
Subject:
Documentary funding, National Lottery, immersive non-fiction
Document type:
Guidelines
Organization:
BFI Doc Society Fund
Author:
BFI Doc Society
Target audience:
Documentary filmmakers, non-fiction immersive creators
Period of validity:
N/A
Approval date:
4th July 2023
Date of amendments:
N/A
Note:
Year
Note:
Year
Note:
Year
Topic:
Film Studies / Documentary
Document Type:
Worksheet
Organization / Institution:
TeachWithMovies.com
Target Audience:
Teachers in public or non-profit schools, families
Note:
Year
Theme:
Education
Document Type:
Guidance
Organization / Institution:
Kingston University
Target audience:
University faculty and course planners
Context:
Guidance document detailing the specific validation documentation required for Kingston University courses, including standard, collaborative partner, and apprenticeship provision, as well as requirements for blended learning and significant changes to existing courses.