№ lp_1_2_50198
File format: docx
Character count: 7719
File size: 132 KB
This document is a form used for the application of Good Manufacturing Practice (GMP) inspection for pharmaceutical manufacturing sites, including finished products and active pharmaceutical ingredient facilities in Rwanda.
Year:
2022
Region / City:
Rwanda
Subject:
Pharmaceutical manufacturing, GMP inspection
Document Type:
Form
Organ / Institution:
Rwanda Food and Drugs Authority
Author:
N/A
Target Audience:
Pharmaceutical manufacturers
Period of validity:
20 June 2022 - 10 October 2025
Approval Date:
20 June 2022
Revision Date:
03 October 2022
Effective Date:
11 October 2022
Review Due Date:
10 October 2025
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.
Year:
2024
Region / city:
United Kingdom
Theme:
Organic food certification
Document type:
Form
Organization / institution:
Soil Association
Author:
Soil Association
Target audience:
Companies submitting products for certification
Effective period:
From September 2025
Approval date:
Not specified
Amendment date:
March 2024
Year:
2024
Region / City:
United Kingdom
Subject:
Multi-ingredient product submission form
Document Type:
Form
Organization / Institution:
Soil Association
Author:
Soil Association
Target Audience:
Companies submitting multi-ingredient products
Effective Period:
From September 2025
Approval Date:
Not specified
Amendment Date:
March 2024
Year:
2026
Region / city:
USA, Canada
Topic:
Active substance evaluation
Document Type:
Regulatory document
Organization:
Regulatory Authority (PMRA, EPA)
Author:
Applicant
Target Audience:
Regulatory authorities
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2024
Region / city:
United Kingdom
Topic:
Food & Drink Certification
Document Type:
Form
Institution:
Soil Association
Author:
Soil Association
Target Audience:
Companies sourcing multi-ingredient food products
Period of Validity:
Until September 2025
Approval Date:
March 2024
Date of Changes:
September 2025
Year:
2020
Region / City:
Australia
Topic:
Health software, Active ingredient prescribing
Document Type:
Vendor Resource Document
Organization:
Medical Software Industry Association (MSIA)
Author:
MSIA in collaboration with The Australian Government Department of Health
Target Audience:
Prescribing software developers
Effective Period:
2020
Approval Date:
1 December 2020
Amendment Dates:
23/07/2019, 07/08/2019, 15/08/2019, 22/08/2019, 28/08/2019, 10/09/2019, 24/09/2019, 28/10/2019, 31/10/2019, 7/11/2019, 28/11/2019, 5/12/2019, 29/01/2020, 12/02/2020, 24/02/2020, 27/05/2020, 13/08/2020, 26/08/2020, 5/11/2020, 1/12/2020
Note:
Context Description
Note:
Year
Document Type:
Terms and Conditions
Organization:
Innovative Education Ltd.
Target Audience:
Schools
Context:
Terms and conditions document outlining the subscription, delivery, and service details for Classroom Kitchen Ingredient Delivery Service.
Year:
2026
Document type:
Application form
Subject:
Prequalification of Active Pharmaceutical Ingredient (API)
Organization:
World Health Organization Prequalification Team (PQTm)
Applicant:
[Company name from application]
Contact person:
[Name and position from application]
API manufacturer:
[Name and address from application]
API intermediate manufacturer(s):
[Names and addresses from application]
Site Master File (SMF) included:
Yes / No (depending on submission)
GMP compliance evidence:
Included / Requested inspection
Relevant standards:
ICHQ7, ICHQ3D, Pharmacopoeial standards
Other regulatory agencies involved:
EDQM, US FDA, other authorities if listed
Note:
Year
Theme:
Pharmaceutical
Document Type:
Application form
Organization / institution:
World Health Organization (WHO)
Target audience:
Regulatory authorities, pharmaceutical manufacturers
Context description:
A form for submitting an application to WHO for API prequalification, including details on manufacturing sites, GMP compliance, and nitrosamine risk assessment.
Year:
2026
Region / City:
Not specified
Topic:
Health / Antioxidants
Document Type:
Product Information
Organization / Institution:
E. EXCEL
Author:
Not specified
Target Audience:
Health-conscious individuals
Effective Period:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2021
Country:
Australia
Subject:
Active Ingredient Prescribing (AIP)
Document Type:
Fact Sheet
Related Programs:
Pharmaceutical Benefits Scheme (PBS); Repatriation Pharmaceutical Benefits Scheme (RPBS)
Issuing Authority:
Australian Government Department of Health
Effective Date:
1 February 2021
Target Audience:
Prescribers, pharmacists, consumers
Scope:
Hospital and community settings
Regulatory Context:
Legislative requirements for PBS and RPBS prescriptions
Contact:
[email protected]
Year:
2014
Region / City:
Global
Topic:
Pharmaceutical Product Prequalification
Document Type:
Guideline
Organization / Institution:
World Health Organization (WHO)
Author:
World Health Organization
Target Audience:
Pharmaceutical manufacturers, regulatory bodies
Effective Period:
Not specified
Approval Date:
2014
Modification Date:
Not specified
Note:
Year
Topic:
Pharmaceutical product, regulatory approval, prequalification
Document type:
Template
Organization / institution:
WHO
Target audience:
Regulatory authorities, pharmaceutical manufacturers
Document type:
Regulatory template appendix
Subject:
Quality information summary for finished pharmaceutical products and vaccines
Procedure:
Reference SRA collaborative procedure
Regulatory framework:
WHO Guidelines on submission of documentation for prequalification
Issuing organization:
World Health Organization
Series:
WHO Technical Report Series
Series number:
No. 1010
Year:
2018
Scope:
Pharmaceutical products and vaccines approved by stringent regulatory authorities
Intended use:
National registration under the SRA collaborative procedure
Confidentiality status:
Includes confidential quality information
Approval basis:
Information as approved by the reference SRA
Change management:
Revision required upon approved variations affecting QIS-SRA (crp)
Organization:
World Health Organization; South African Health Products Regulatory Authority
Document type:
Regulatory guideline
Subject area:
Pharmaceutical quality documentation
Scope:
Multisource (generic) finished pharmaceutical products and active pharmaceutical ingredients
Applicable products:
Human medicines; biologics; veterinary medicines
Regulatory references:
WHO TRS 970 Annex 6; VICH guidelines; European Pharmacopoeia; USP; BP
Geographical applicability:
International; South Africa
Related regulatory procedures:
API Prequalification; CEP; APIMF; product dossier submission
Content focus:
Quality data requirements; labelling and product information; drug substance characterization
Intended users:
Marketing authorization applicants; regulatory assessors
Year:
2007
Region / City:
N/A
Theme:
Cosmetics, Quality Control, Manufacturing
Document Type:
Standard Operating Procedure (SOP)
Organization / Institution:
N/A
Author:
N/A
Target Audience:
Employees involved in manufacturing, quality control, and product release
Effective Period:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Year:
2021
Region / city:
Not specified
Topic:
Temperature control, milk storage, dairy products
Document type:
Program Document
Organization / institution:
Company Name
Author:
Kathy Glass, Alex O’Brien
Target audience:
Employees involved in raw material handling and dairy production
Period of validity:
Not specified
Approval date:
Not specified
Amendment date:
Not specified
Year:
2023
Region / city:
N/A
Theme:
Pharmaceutical Product Variation
Document Type:
Application Form
Organization / Institution:
N/A
Author:
N/A
Target Audience:
Applicants for pharmaceutical product variations
Period of validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Year:
2017
Region / City:
Massachusetts
Topic:
Medical Marijuana Sampling and Analysis
Document Type:
Protocol
Organization / Institution:
Massachusetts Cannabis Control Commission
Author:
Department of Public Health (DPH)
Target Audience:
Massachusetts Registered Medical Marijuana Dispensaries (RMDs)
Effective Period:
Ongoing (subject to revisions)
Approval Date:
December 1, 2017
Revision Date:
December 1, 2017