|
A - Z Listing of Documents
Listing in alphabetical order
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
A
Active Pharmaceutical Ingredient Master File (APIMF)
Additional Good Clinical Practice (GCP) Guidance for
Contract Research Organizations (CROs)
Additional Guidance for submission of applications for
prequalification of Zinc Sulfate tablets and Zinc Sulfate
oral liquid (solution)
Advice on the design of bioequivalence studies:
artemether-lumefantrine
Advice on the design of bioequivalence studies:
atazanavir-ritonavir
Alternative procedure for accepting second-line TB product
dossiers for assessment by WHO Prequalification of Medicines
Application of Hazard Analysis and Critical Control Point
(HACCP) Methodology in Pharmaceuticals
B
Bioequivalence Trial Information (BTIF)
Biowaiver Application Form: Additional Strenghts
Biowaiver
Application Form: Biopharmaceutics Classification System
(BCS)
Briefing note: WHO Prequalification of Medicines for
Reproductive Health
C
Comparator for anti-tuberculosis medicines
Comparator for
anti-malarial medicines
Comparator for Influenza-specific antiviral medicines
Comparator for medicines for HIV/AIDS and related diseases
Comparator for Reproductive Health products
Confidentiality
Agreement &
Declaration of No Conflict of Interest
Considerations for Requesting Analyses of Drug Samples
D
Directives relatives à l'établissement d'un dossier
d'information sur les laboratoires
E
Experience
of the Expert Review Panel (ERP)
Expression of Interest (EOI) - APIs -
3rd
Invitation
Expression of Interest (EOI) - HIV/AIDS -
10th
Invitation
Expression of Interest (EOI) - Influenza - 2nd
Invitation
Expression of Interest (EOI) - Malaria -
10th
Invitation
Expression of Interest (EOI) - Neglected Tropical Diseases
- 2nd Invitation
Expression
of Interest (EOI) - Quality
Control Laboratories - 3rd Invitation
Expression of Interest (EOI) - Reproductive Health -
5th
Invitation
Expression of Interest (EOI) - Tuberculosis -
10th
Invitation
Expression of Interest (EOI) - Zinc -
1st
Invitation
F
Facts & Figures 2011
Facts & Figures 2010
Facts & Figures 2009
Facts & Figures 2008
Fixed-dose Combinations (FDCs)
FAQs on the prequalification of medicines for Reproductive
Health
G
General Guidelines for the establishment, maintenance and
distribution of chemical reference substances
General notes on Biopharmaceutics Classification System
(BCS)-based biowaiver applications
Good Clinical Practices (GCP) Handbook
Good Laboratory Practice (GLP)
Good Manufacturing Practices (GMP) for Biological Products
Good Manufacturing Practices (GMP)
for Pharmaceutical Products
Good
Manufacturing Practice (GMP) Guide for Active Pharmaceutical
Ingredients (APIs)
Good Manufacturing Practices (GMP) for Sterile
Pharmaceutical Products
Good Practices for
Pharmaceutical
Quality Control Laboratories
Good Practices for Pharmaceutical Microbiology Laboratories
Guidance
on collaborative procedure with selected National Medicines
Regulatory Authorities (NMRAs) in inspection activities
Guidance on collaborative procedure with NMRAs: Questions
and Answers
Guidance on Good Manufacturing Practices (GMP): Inspection
Report
Guide
to Good Storage Practices for Pharmaceuticals
Guidelines
for Good Clinical Practice (GCP) for Trials on
Pharmaceutical Products
Guidelines for Sampling of Pharmaceutical Products and
Related Materials
Guidelines for the assessment of a Procurement Agency
Guidelines for inspection of drug distribution channels
Guidelines for the preparation of a Procurement Agency
Information File (PAIF)
Guidelines on pre-approval inspections
Guideline on Submission of
Documentation for a Multisource (Generic) Finished
Pharmaceutical Products (FPP): Quality Part
Guidelines on transfer of technology in pharmaceutical
manufacturing
Guidelines for drafting a Site Master File (SMF)
Guidelines for the preparation of a Contract Research
Organisation Master File (CROMF)
H
Heating, ventilation and air-conditioning systems for
non-sterile pharmaceutical dosage form
I
Innovators
J
k
L
Laboratory Information File (LIF)
List of Prequalified Active Pharmaceutical Ingredients
(APIs)
List of Prequalified Medicines
List of
Prequalified Quality Control Laboratories
M
Manufacturers' Survey 2010
Marketing
Authorization of Pharmaceutical Products with
Special Reference to Multisource (Generic) Products
Model
Certificate of Analysis
Model Certificate of Good Manufacturing Practices
Model
Quality Assurance System for Procurement Agencies
Multisource (Generic) pharmaceutical products guidelines on
registration requirements to establish interchangeability
N
Nonclinical Overview for Artemisinin Derivatives
O
P
Pharmaceutical Excipients
Preparation of Product Dossiers (PDS) in Common
Technical Document (CTD) Format
Prequalification of generic products approved by
Stringent Regulatory Authorities (SRAs)
Prequalification
of Quality Control Laboratories
Principles for prioritizing dossiers within WHO
Prequalification of Medicines Programme (PQP)
Procedure for assessing the acceptability, in principle, of
Procurement Agencies for use by United Nations Agencies
Procedure
for Prequalification of Pharmaceutical Products
Provisional guidelines on the
inspection of pharmaceutical manufacturers
Q
Quality Assurance of Pharmaceuticals. A Compendium of
Guidelines and related materials. Volume 2
Quality Information Summary (QIS)
Quality Overall Summary - Product Dossier (QOS-PD)
Quality system requirements for national GMP inspectorates
Questions and Answers (Q&A)
R
Recommendations on the content of a quality survey protocol
for antimalarial medicines
Régles de bonne pratique applicables par les laboratoires
nationaux de contrôle pharmaceutique
Report on the Meeting on the Survey of the Quality of
Antimalarials in sub-Saharan Africa (QAMSA)
Requalification of
Prequalified Dossiers
Requalification model letter to the applicant
S
Supplementary Guidelines for the manufacture of
investigational pharmaceutical products for clinical trials
in humans
Survey of the quality of antiretroviral medicines
circulating in selected African countries
Survey of the quality of selected antimalarial medicines
circulating in six countries of sub-Saharan Africa
Survey of the quality of anti-tuberculosis medicines
circulating in selected newly independent states of the
former Soviet Union
T
U
V
Validation
Variations
W
Water for Pharmaceutical Use
World Health Organization Public Assessment Reports (WHOPARs)
Guidance - includes all mentioned Appendixes
X
Y
Z
Zinc Sulfate Products: Biowaiver Application & Acceptability
Study Summary Form
|
Home -
A-Z Listing of Documents