№ lp_2_3_20050
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Regulatory application form issued by the Health Sciences Authority detailing company, manufacturing site, quality control, and outsourced activity information required for requesting an overseas GMP inspection for therapeutic product registration.
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
Price: 8 / 10 USD
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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
Note:
Year
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
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
Year:
1991
Region / City:
Overseas
Topic:
Overseas delivery clauses and requirements
Document Type:
Vendor Response
Agency / Institution:
U.S. Government
Author:
Not specified
Target Audience:
Vendors offering overseas delivery
Effective Period:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2021
Region / City:
East Midlands
Subject:
Business Development, International Trade
Document Type:
Invitation to Quote
Organization:
East Midlands Business Limited
Author:
East Midlands Business Limited
Target Audience:
Businesses and Contractors in the Data and Export Sector
Period of Activity:
January 2021 - March 2021
Approval Date:
22nd January 2021
Amendment Date:
N/A
Country:
Pakistan
Issuing authority:
Ministry of National Health Services, Regulations & Coordination
City:
Islamabad
Document type:
Application form with specimen affidavit
Subject area:
Attestation of professional documents
Target professions:
Doctors, paramedics, pharmacists, homeopathics, tabibs, physiotherapists
Purpose:
Attestation of documents for overseas employment
Applicant information required:
Personal, educational, professional, and overseas employment details
Required attachments:
Attested copies of degrees, certificates, CNIC, passport, affidavit
Affidavit requirement:
Stamp paper Rs. 20/-
Applicable employment context:
Overseas job placement
Administrative location:
Pak Secretariat, Kohsar Block
Year:
2014
Region / city:
United Kingdom
Subject:
Overseas Registration of Births and Deaths
Document Type:
Explanatory Document
Organization:
Foreign and Commonwealth Office
Author:
Foreign and Commonwealth Office
Target Audience:
Legislators, Government Officials, Public
Effective Period:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2023
Region / City:
Australia
Theme:
Medical Specialization, Assessment Process
Document Type:
Application Form, Guidelines
Organization:
The Royal Australasian College of Physicians (RACP)
Author:
Royal Australasian College of Physicians (RACP)
Target Audience:
Overseas-trained physicians and paediatricians seeking specialist assessment in Australia
Validity Period:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Document type:
Supporting statement
Form number:
DS-5542
OMB control number:
1405-XXXX
Issuing authority:
U.S. Department of State
Bureau:
Bureau of Consular Affairs
Office:
Office of Records Management
Legal basis:
22 CFR Parts 50 and 71
Subject matter:
Overseas U.S. citizen vital records
Publication notice date:
August 24, 2021
Federal Register reference:
84 FR 18149
Intended respondents:
U.S. citizens and authorized third parties
Submission method:
Mail
Estimated respondent time burden:
40 minutes per response
Estimated annual respondents:
16,846
Estimated annual hour burden:
11,231 hours
Estimated annual cost burden:
$248,815
Geographic scope:
United States and overseas