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Home - A-Z Listing of Documents

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

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

BCS-based biowaiver applications for RH products
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

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

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 bioequivalence studies for reproductive health medicines
Guidance on collaborative procedure with selected National Medicines Regulatory Authorities (NMRAs) in inspection activities

Annex A - Invitation for expression of interest to participate in the procedure

Annex B - Expression of Interest Form

Annex C - Shared Inspection Schedule Form

Annex D - Nomination of Observer of Co-inspector

Annex E - Inspector Biodata Form

Annex F - Confidentiality Agreement

Annex G - Appointment of Observer or Co-inspector

Annex H - Appointment of Observer or Co-inspector - Template letter to Supervisor

Guidance on collaborative procedure with NMRAs: Questions and Answers
Guidance on Good Manufacturing Practices (GMP): Inspection Report
Guidance on Variations to a Prequalified Product
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
Guidelines on Submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: 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

History of Changes Document - Application of API Prequalification based upon previous SRA assessment

I

Innovators
"Improving Quality for Better Treatment and Greater Access" booklet

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 introduction of a source of non-plant-derived-artemisinin
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&A for submission of applications for prequalification of Zinc Sulfate tablets and Zinc Sulfate oral liquid (solution)
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 Form

Zinc Sulfate Products: Acceptability Study Summary Form