№ lp_1_25378
File format: docx
Character count: 36814
File size: 146 KB
Regulatory source defining the structure and content of quality information required for the assessment of finished pharmaceutical products and their active pharmaceutical ingredients within international and national regulatory frameworks.
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
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:
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)
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:
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
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
Year:
2023
Region / City:
Not specified
Topic:
Storage and distribution of finished products
Document Type:
Standard Operating Procedure (SOP)
Organization:
Not specified
Author:
Not specified
Target Audience:
Production and QC heads, distribution personnel
Effective Period:
Ongoing
Approval Date:
Not specified
Revision Date:
Not specified
Year:
2026
Region / City:
Mecca
Topic:
Religious Rituals
Document Type:
Educational Guide
Organization:
N/A
Author:
N/A
Target Audience:
Muslims
Validity Period:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Note:
Contextual description
Note:
Prologue
Why, Vasher thought, do so many things begin with me getting thrown into prison? The guardsmen laughed to one another outside, slamming the cell door shut with a clang. Vasher stood and duste:
land of Returned Gods, Lifeless servants, BioChromatic research, and--of course--color. The large guard sauntered toward the cell, leaving his friends to their fun with Vasher’s pack. “They say you’re pretty tough,” the man said, sizing up Vasher. Vasher did not respond. “The bartender says you beat down some twenty men in the brawl.” The guard rubbed his chin. “You don’t look that tough to me.” Vasher shrugged. The guard snorted. “You should have known better than to strike a priest. The others, they’ll spend a night locked up. You, though--you’ll hang. Colorless fool.” Vasher turned away, looking over his cell. It was functional, if unoriginal. A thin slit in the top let in light, the stone walls dripped with water and lichen, and a pile of dirty straw decomposed in the corner. “You ignoring me?” the guard asked, stepping closer to the bars. As he did so, the colors of his uniform brightened faintly, like he’d stepped into a stronger light. The change was slight. Vasher didn’t have much Breath remaining. The guard didn’t notice the change in color--just like he hadn’t noticed back in the bar, when he and his buddies had picked Vasher up off the floor and thrown him in their cart. He’d soon wish that he’d been more observant. “Here, now,” one of the men said from behind. “What’s this?” Those two were still looking through Vasher’s pack. Vasher had always found it odd that the men who patrolled dungeons tended to be as bad, or worse, than the men they guarded. Perhaps that was intentional. Society didn’t seem to care if such men were outside the cells or in them--just as long as they were kept away from more honest men. Assuming that such a thing existed. A guard pulled a long object--wrapped in white linen--free from Vasher’s bag. The man frowned at the object, then unwrapped it, revealing a large, thin-bladed sword in a silver sheath. The hilt was pure black. The guard whistled quietly. “Who do you suppose he stole this from?” The lead guard eyed Vasher again, frowning. He was likely wondering if Vasher might be some kind of nobleman. Though such things didn’t really exist in Hallandren, many neighboring kingdoms had their lords and ladies. Yet, what lord would wear a drab brown cloak, ripped in several places? What lord would sport bruises from a bar fight, a half-grown beard, and boots worn from years of walking? Eventually, the guard turned away, apparently convinced that Vasher was no lord. He was right. And he was wrong. “Let me see that,” t
Year:
Not specified
Region / City:
Not specified
Subject:
Quality Control
Document Type:
SOP (Standard Operating Procedure)
Organization / Institution:
Not specified
Author:
Manufacturing Manager
Target Audience:
Quality Control Personnel, Operators
Effective Period:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2022
Location:
Bucharest, Romania
Event:
Plenipotentiary Conference
Type of document:
Meeting transcript
Organizer:
International Telecommunication Union (ITU)
Chair:
Kwame Baah-Acheamfuor
Vice-Chairs:
Almira Gataulina, Leonel Zambia, Inga Rimkeviciene, Alireza Darvishi
Services provided by:
Caption First, Inc.
Duration:
27 September 2022, 9:30–10:50 EEST
Language:
English
Topics discussed:
Agenda approval, Terms of Reference, working methods, committee reports, ad-hoc group procedures, public policy, Internet governance, child online protection, accessibility, IoT, financial inclusion
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:
N/A
Region / City:
N/A
Subject:
Analytical methods for pesticide residue determination
Document Type:
Methodology
Organization / Institution:
N/A
Author:
N/A
Target Audience:
Regulatory authorities, pesticide testing laboratories
Validity Period:
N/A
Approval Date:
N/A
Date of Modifications:
N/A
Note:
Contextual description
Document type:
Supplementary table
Title as given:
S_Table 1 The active ingredients of GXNT and their pharmacokinetic parameters
Subject:
Active ingredients of GXNT and pharmacokinetic parameters
Herb names:
SB; LD
Parameters included:
Mol ID; Molecule Name; OB (%); DL
Abbreviations defined:
OB, Oral bioavailability; DL, Drug-likeness
Note:
* No relevant target was found for this compound
Number of listed compounds:
70+
Language of content:
English
Scientific field:
Pharmacology; Phytochemistry
Format:
Tabular dataset
Year:
2019
Region / City:
Global
Topic:
Sustainable Sourcing, Palm Oil
Document Type:
Corporate Report
Organization / Institution:
NUXE
Author:
NUXE
Target Audience:
Consumers, Industry Partners, Sustainability Advocates
Period of Validity:
Ongoing
Date of Approval:
2019
Date of Changes:
N/A
Note:
Year
Topic:
Culinary Science
Document type:
Educational Instructions
Target audience:
Students