Loading...
Login/Register
Welcome
Profile
Log Off
text
title
chapter title
keyword
On this page readers can obtain a listing of documents classified by keywords. Click on the bookshelf icon of a keyword to obtain the concerned documents or to return to the main list of keywords.
WHO Home
WHO Health Systems and Services
WHO Medicines
WHO sites
Medicines Documentation home
Search
Titles A-Z
Subjects
Keywords
Series and Periodicals
Publishers
Authors A-Z
Regions
Countries
Index
Sub-collections
Public
sub-collections
WHO Publications
-
Non WHO Publications
-
All
A
-
B
-
C
-
D
-
E
-
F
-
G
-
H
-
I
-
J
-
K
-
L
-
M
-
N
-
O
-
P
-
Q
-
R
-
S
-
T
-
U
-
V
-
W
-
X
-
Y
-
Z
-
All
Expand the sub-collections menu.
Contract the sub-collections menu.
Select all.
Add selected documents to current sub-collection. The default sub-collection
is the one that was last accessed or created.
To change the current subcollection or create a new one
click here
.
To open a subcategory, place your mouse over the respective category and click it once.
If you tick the checkbox in front of a category, all the documents under the respective
category will be selected for addition to the sub-collection. If you tick the checkbox in
front of a main category to add it to the sub-collection, all the corresponding subcategories
will be selected automatically as well.
11 documents on 1 page
Details
Show All
|
Hide All
Subjects
Author
Publishers
Regions
Countries
Add to sub-collection
Create sub-collection
Sub-collections:
...
Title:
Description:
Active Pharmaceutical Ingredient - API
Title:
Exploratory Study on Active Pharmaceutical Ingredient Manufacturing for Essential Medicines
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Author:
Betsch, Ekkehard
;
Bumpas, Janet
Year:
2009
Pages:
52
Publishers:
The World Bank (WB)
Regions:
Global
Title:
Guide to Good Manufacturing Practice for Medicinal Products Part II - PIC/S, PE 009-8 (Part II), 15 January 2009. Developed by the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Year:
2009
Pages:
55
Publishers:
Pharmaceutical Inspection Co-operation Scheme (PIC/S)
Regions:
Global
Title:
Guidelines on Active Pharmaceutical Ingredient Master File Procedure. WHO Technical Report Series, No. 948, 2008, Annex 4
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Prequalification of Medicines
>
WHO-UNICEF-UN Project
Year:
2008
Pages:
10
Publishers:
WHO Headquarters in Geneva
Related documents:
Guidelines on Submission of Documentation for a Multisource (Generic) Finished Pharmaceutical Product for the WHO Prequalification of Medicines Programme: Quality Part. WHO Technical Report Series, No. 970, 2012, Annex 4
Regions:
Global
Title:
Guidelines on Submission of Documentation for a Multisource (Generic) Finished Pharmaceutical Product for the WHO Prequalification of Medicines Programme: Quality Part. WHO Technical Report Series, No. 970, 2012, Annex 4
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Prequalification of Medicines
>
WHO-UNICEF-UN Project
Year:
2012
Pages:
76
Publishers:
WHO Headquarters in Geneva
Related documents:
Pharmaceutical Development of Multisource (Generic) Finished Pharmaceutical Products – Points to Consider. WHO Technical Report Series, No. 970, 2012, Annex 3
Guidelines on Submission of Documentation for a Multisource (Generic) Finished Product. General Format: Preparation of Product Dossiers in Common Technical Document Format. WHO Technical Report Series, No. 961, 2011, Annex 15
Guidelines on Submission of Documentation for Prequalification of Innovator Finished Pharmaceutical Products Approved by Stringent Regulatory Authorities. WHO Technical Report Series, No. 961, 2011, Annex 11
Guidelines on Active Pharmaceutical Ingredient Master File Procedure. WHO Technical Report Series, No. 948, 2008, Annex 4
Regions:
Global
Title:
Inspection of API Manufacturing Sites
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Prequalification of Medicines
>
WHO-UNICEF-UN Project
Year:
2011
Pages:
4
Publishers:
WHO Headquarters in Geneva
Regions:
Global
Title:
MHLW Ministerial Ordinance No. 179, 2004. Ministerial Ordinance on Standards for Manufacuring Control and Quality Control for Drugs and Quasi-drugs.
Subjects:
Medicine Information and Evidence for Policy
>
Information and Publications
Quality and Safety: Medicines
>
Quality Assurance
Quality and Safety: Medicines
>
Regulatory Support
Year:
2004
Pages:
23
Publishers:
Japan - Ministry of Health, Labour and Welfare (MHLW)
Countries:
Japan
Title:
Proposal to Waive in Vivo Bioequivalence Requirements for WHO Model List of Essential Medicines Immediate-release, Solid Oral Dosage Forms. WHO Technical Report Series, No. 937, 2006, Annex 8
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Year:
2006
Pages:
47
Publishers:
WHO Headquarters in Geneva
Related documents:
Additional Guidance for Organizations Performing in Vivo Bioequivalence Studies. WHO Technical Report Series, No. 937, 2006, Annex 9
Related links:
http://www.who.int/medicines/areas/quality_safety/quality_assurance/regulatory_standards/en/index.html
Regions:
Global
Title:
Recommendations for Quality Requirements when Artemisinin is Used as a Starting Material in the Production of Antimalarial Active Pharmaceutical Ingredients. WHO Technical Report Series, No. 970, 2012, Annex 6
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Year:
2012
Pages:
9
Publishers:
WHO Headquarters in Geneva
Regions:
Global
Title:
Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products. WHO Technical Report Series, No. 953, 2009 - Annex 2. (With Table 2 - Updated 1 December 2010)
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Prequalification of Medicines
>
WHO-UNICEF-UN Project
Year:
2009
Pages:
50
Publishers:
WHO Headquarters in Geneva
Regions:
Global
Title:
WHO Good Manufacturing Practices for Active Pharmaceutical Ingredients. WHO Technical Report Series, No. 957, 2010, Annex 2
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Year:
2010
Pages:
62
Publishers:
WHO Headquarters in Geneva
Related documents:
WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 957 - Forty-fourth Report
Related links:
http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
Regions:
Global
Title:
WHO Pharmaceutical Starting Materials Certification Scheme (SMACS): Guidelines on Implementation. WHO Technical Report Series, No. 917, 2003, Annex 3
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Year:
2003
Pages:
24
Publishers:
WHO Headquarters in Geneva
Related documents:
Good Trade and Distribution Practices for Pharmaceutical Starting Materials. WHO Technical Report Series, No. 917, 2003, Annex 2
Regions:
Global
Contacts
|
E-mail scams
|
Employment
|
FAQs
|
Feedback
|
Privacy
|
RSS feeds
© WHO 2013
Last updated: May 3, 2013
Loading...
