№ lp_1_2_61173
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This document provides guidance for TGA licensed manufacturers on the interpretation of GMP principles and compliance requirements for the production of compounded medicines.
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
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Year:
2016
Region / City:
Australia
Topic:
Pharmacy, Medicine Compounding
Document Type:
Consultation Response
Organization:
Pharmaceutical Society of Australia
Author:
Dr Lance Emerson, Chief Executive Officer
Target Audience:
Pharmacists, Pharmacy Regulators
Period of Validity:
Indefinite
Approval Date:
1 February 2016
Date of Amendments:
None
Contextual Description:
Document is a public consultation response discussing terminology issues and proposed updates regarding compounded parenteral medicines, primarily aimed at Australian pharmacists.
Date:
November 17, 2025
Type of document:
Cover letter
Manuscript title:
Effectiveness, Adherence, and Safety of Branded Wegovy™ vs. Compounded Semaglutide + Cyanocobalamin (CSC)
Article type:
Original Article
Journal:
The Journal of Obesity and Metabolism
Author:
Shanmugesh Raja, MS
Affiliation:
University of California, San Francisco
Study design:
Retrospective cohort study
Data source:
De-identified telemedicine cohort
Interventions studied:
FDA-approved semaglutide (Wegovy™) and compounded semaglutide + cyanocobalamin
Outcomes assessed:
Weight-loss magnitude and milestones, treatment adherence and persistence, adverse event reporting
Regulatory context:
FDA-approved semaglutide compared with compounded formulation
Conflict of interest disclosure:
Confirmed disclosed
Prior publication status:
Not previously published and not under consideration elsewhere
Organisation name:
Australian Custom Pharmaceuticals Pty Ltd
Contact name:
Daryll Knowles
E-mail address:
[content redacted]
Date:
1 February 2016
Region:
Australia
Topic:
Pharmacy Guidelines
Document type:
Consultation Paper
Institution:
Pharmacy Board of Australia
Target audience:
Pharmacists, Compounding Professionals
Period of validity:
Indefinite
Approval date:
Not specified
Amendment date:
Not specified
Year:
2019
Region / City:
International
Theme:
Advanced Therapy Medicinal Products, Biological Medicinal Substances
Document Type:
Consultation Notice
Organization:
Pharmaceutical Inspection Co-operation Scheme (PIC/S)
Author:
Pharmaceutical Inspection Co-operation Scheme (PIC/S)
Target Audience:
Stakeholders in the pharmaceutical industry, academia, hospitals, and experts in biotechnology and manufacturing
Period of Validity:
20 September 2019 – 20 December 2019
Approval Date:
20 September 2019
Revision Date:
20 December 2019
Note:
Manufacturer
Version:
1.0
Changes:
Release
Date:
9/1/2021
Year:
2021
Region / city:
Not specified
Topic:
Implementation Conformance
Document Type:
Conformance Statement
Organization / Institution:
Not specified
Author:
Not specified
Target audience:
Manufacturers, suppliers, testing authorities
Period of validity:
From 09/01/2021
Date of approval:
09/01/2021
Date of revisions:
Not specified
Year:
2019
Region / City:
International
Topic:
Consultation on GMP for Advanced Therapy Medicinal Products and Biological Medicinal Substances
Document Type:
Consultation Notice
Organization / Institution:
Pharmaceutical Inspection Co-operation Scheme (PIC/S)
Author:
Pharmaceutical Inspection Co-operation Scheme (PIC/S)
Target Audience:
Academia, hospitals, pharmaceutical industry, subject matter experts
Period of validity:
September 20, 2019 - December 20, 2019
Approval Date:
September 20, 2019
Date of Changes:
None specified
Year:
2022
Region / city:
Not specified
Topic:
COVID-19, PICS, postacute sequelae of SARS-CoV-2 (PASC), outpatient rehabilitation
Document type:
Educational simulation scenario
Organization:
ACAPT (American Council of Academic Physical Therapy)
Author:
Not specified
Target audience:
Physical Therapy (DPT students)
Period of validity:
Not specified
Approval date:
Not specified
Modification date:
Not specified
Year:
2018–2020
Organization type:
International association
Field:
Good Manufacturing Practice (GMP) for medicinal products
Headquarters:
Switzerland
Members:
54 participating authorities, over 2000 inspectors
Key personnel:
Pär Tellner, Sergio Cavalheiro Filho
Associated organizations:
EFPIA, IFPMA
Objectives:
Harmonisation of GMP standards, inspector training, international cooperation
Document type:
Informational overview / strategic roadmap
Target audience:
Regulatory authorities, industry stakeholders
Scope:
Medicinal products, devices, drug-device combinations
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
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