№ lp_1_19192
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Inspection report on compliance with EU GMP guidelines for a pharmaceutical manufacturer or importer, detailing the findings of the inspection, including any deficiencies and required corrective actions.
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
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
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
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
Year:
2009
Region / City:
East Africa
Topic:
Regional integration, East African Community
Institution:
Aalborg University
Author:
Klaas B. J. Overlade
Target Audience:
Researchers, policymakers, academics
Period of Validity:
N/A
Date of Approval:
01-04-2009
Date of Changes:
N/A
Note:
Year
Organization / Institution:
Kennesaw State University
Target Audience:
Students of Kennesaw State University and Georgia Highlands College Marietta
Year:
2021
Region / City:
Castlemilk, Glasgow
Theme:
Credit Union Meeting
Document Type:
Annual General Meeting Agenda
Organization:
Castlemilk Credit Union
Author:
Craig Mathie
Target Audience:
Members of Castlemilk Credit Union
Period of Action:
March 2021
Approval Date:
24th March 2021
Date of Changes:
N/A
Year:
2023
Region / City:
Nevada County, CA
Subject:
Public Health, Recreation, COVID-19 Response
Document Type:
Grant Request
Organization / Institution:
Nevada County Board of Supervisors
Author:
Erika Seward
Target Audience:
Local authorities, nonprofits, businesses, and community members
Duration:
Not specified
Approval Date:
August 8, 2023
Date of Changes:
Not specified
Year:
2024
Region / City:
Serbia
Topic:
Sustainable Development, SMEs, Green Transition, EU Funding
Document Type:
Press Release
Organization / Institution:
European Investment Bank (EIB), Banca Intesa, Intesa Leasing
Author:
European Investment Bank
Target Audience:
Businesses, SMEs, Financial Institutions
Period of Validity:
Not specified
Approval Date:
28 November 2024
Modification Date:
Not specified
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