TRS# Yr.

Annex Annex Title

1 List of available International Chemical Reference Substance
2 List of available International Infrared Reference Spectra
3 Good practices for national pharmaceutical control laboratories
4 Considerations for requesting analysis of drug samples
5 Basic elements of good manufacturing practices in pharmaceutical
production
6 Good manufacturing practices for sterile products
2002

7 Guidelines on pre-approval inspections

902

8 Quality systems requirements for national good manufacturing practice

inspectorates
9 Guidelines on packaging for pharmaceutical products
10 Model certificate of analysis
11 Guidance on the selection of comparator pharmaceutical products for
equivalence assessment of interchangeable multisource (generic)
products
12 Guidelines on the use of International Nonproprietary Names (INNs) for
pharmaceutical substances
1 Recommendations on risk of transmitting animal spongiform
encephalopathy agents via medicinal products
2 The International Pharmacopoeia: revised concepts and future
perspectives
3 Guidelines on Good Manufacturing Practices for radiopharmaceutical
products
4 Good Manufacturing Practices for pharmaceutical products: main
2003

principles
908

5 Model certificate of Good Manufacturing Practices

6 Guidance on Good Manufacturing Practices (GMP): inspection report
7 Application of Hazard Analysis and Critical Control Point (HACCP) method
to pharmaceuticals
8 Procedure for assessing the acceptability, in principle, of pharmaceutical
products for purchase by United Nations agencies
9 Guide to good storage practices for pharmaceuticals

1 International Chemical Reference Substances and International Infrared

Reference Spectra
2 Good manufacturing practices: requirement for the sampling of starting
materials (amendment)
3 WHO Good Manufacturing Practices: water for pharmaceutical use
2005
929

4 WHO guidelines for sampling of pharmaceutical products and related

materials
5 Guidelines for registration of fixed-dose combination medicinal products.

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 TRS# Yr. Annex Annex title
1 List of available International Chemical Reference Substances and
International Infrared Reference Spectra
2 Supplementary guidelines on good manufacturing practices for heating,
ventilation and air-conditioning systems for non-sterile pharmaceutical
dosage forms
3 Supplementary guidelines on good manufacturing practices for the
manufacture of herbal medicines
4 Supplementary guidelines on good manufacturing practices: validation
(Appendix 1: Validation of HVAC,
Appendix 2: Validation of water systems for pharmaceutical use, Appendix 3: Cleaning
validation,
Appendix 4: Analytical method validation,
2006

Appendix 5: Validation of computer system,

937

Appendix 6: Qualification of systems and equipment,

Appendix 7: Non-sterile process validation – revised in TRS 992, 2015, Annex 3)
5 Good distribution practices for pharmaceutical products
6 A model quality assurance system for procurement agencies
(Recommendations for quality assurance systems focusing on pre-
qualification of products and manufacturers, purchasing, storage and
distribution of pharmaceutical products)
7 Multisource (generic) pharmaceutical products: guidelines on registration
requirements to establish interchangeability
8 Proposal to waive in vivo bioequivalence requirements for WHO Model
List of Essential Medicines immediate-release, solid oral dosage forms
9 Additional guidance for organizations performing in vivo bioequivalence
studies
1 List of available International Chemical Reference Substances
and International Infrared Reference Spectra
2 Stability testing of active pharmaceutical ingredients (API) and finished
2009
953

pharmaceutical products (FPP)

3 Procedure for prequalification of pharmaceutical products
4 Procedure for assessing the acceptability, in principle, of active
pharmaceutical ingredients for use in pharmaceutical products
1 WHO good practices for pharmaceutical quality control laboratories.
(QMS, Reagents, Reference materials, Traceability, Sampling, Retained samples, Testing,
OOS, COA, Validation of analytical methods… etc.)
2 WHO good manufacturing practices for active pharmaceutical ingredients
3 good manufacturing practices for pharmaceutical products containing
hazardous substances
4 WHO good manufacturing practices for pharmaceutical products
2010

5 WHO good distribution practices for pharmaceutical products

957

6 Guidelines on the re-qualification of pre-qualified dossiers

7 Guidelines for the preparation of a contract research organization master
file

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 TRS# Yr. Annex Annex Title
1 Release procedure of International Chemical Reference Substances
2 WHO good practices for pharmaceutical microbiology laboratories.
(Appendix 1: Zones in which operations could be carried out,
Appendix 2: Examples of maintenance of equipment,
Appendix 3: Calibration of lab. equipment,
Appendix 4: Equipment qualification and monitoring,
Appendix 5: General use of reference cultures)
3 WHO good manufacturing practices: main principles for pharmaceutical
products
4 WHO good manufacturing practices for blood establishments (jointly with
the Expert Committee on Biological Standardization)
5 WHO guidelines on good manufacturing practices for heating, ventilation
and air-conditioning (HVAC) systems for non-sterile pharmaceutical
dosage forms.
6 WHO good manufacturing practices for sterile pharmaceutical products
7 WHO guidelines on transfer of technology in pharmaceutical
manufacturing
2011
961

8 Good pharmacy practice: standards for quality of pharmacy services (joint

FIP/WHO)
9 Model guidance for the storage and transport of time- and temperature-
sensitive pharmaceutical products (jointly with the Expert Committee on
Biological Standardization).. Revised in TRS 992, 2015, Annex 5.
10 Procedure for prequalification of pharmaceutical products
11 Guidelines on submission of documentation for prequalification of
innovator finished pharmaceutical products approved by stringent
regulatory authorities
12 Prequalification of quality control laboratories. Procedure for assessing
the acceptability, in principle, of quality control laboratories for use by
United Nations agencies
13 WHO guidelines for preparing a laboratory information file
14 WHO guidelines for drafting a site master file
15 Guidelines on submission of documentation for a multisource (generic)
finished product: general format: preparation of product dossiers in
common technical document format
1 Development of monographs for The International Pharmacop.
2 WHO GMP: water for pharmaceutical use.
3 Pharmaceutical development of multisource (generic) pharmaceutical
products - point to consider
4 Guidelines on submission of documentation for a multisource (generic)
finished pharmaceutical product for the WHO Prequalification of
Medicines Program
2012
970

5 Development of pediatric medicines: points to consider in formulation

6 Recommendations for quality requirements for artemisinin as a starting
material in the production of antimalarial active pharmaceutical
ingredients.

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 TRS# Yr. Annex Annex Title
1 Release procedure for International Chemical Reference Substances
2 WHO guidelines on quality risk management (QRM).
3 WHO guidelines on variations to a prequalified product
2013
981

4 Collaborative procedure between the World Health Organization

Prequalification of Medicines Program and national medicines regulatory
authorities in the assessment and accelerated national registration of
WHO-prequalified pharmaceutical products
1 The International Pharmacopoeia – Updating mechanism for the section
on radiopharmaceuticals
2 WHO good manufacturing practices for pharmaceutical products: main
principles (Quality risk management, Product quality review, Sanitation and hygiene,
Qualification and validation, complaints, product recalls, Contract manufacturing, self-
inspection and audits, training, documentation...)
Model quality assurance system for procurement agencies
2014

3
986

4 Assessment tool based on the model quality assurance system for

procurement agencies: aide-memoire for inspection
5 Guidelines on submission of documentation for prequalification of
finished pharmaceutical products approved by stringent regulatory
authorities.
6 Guidelines on submission of documentation for a multisource (generic)
finished pharmaceutical product: quality part
1 Procedure for the development of monographs and other texts for The
International Pharmacopoeia
2 Updating mechanism for the section on radiopharmaceuticals in The
International Pharmacopoeia
3 Guidelines on good manufacturing practices: validation, Appendix 7:
non‑sterile process validation (Lifecycle-based process validation).
4 General guidance on hold-time studies
5 Technical supplements to Model guidance for the storage and transport
of time- and temperature-sensitive pharmaceutical products
6 Recommendations for quality requirements when plant‑derived
artemisinin is used as a starting material in the production of antimalarial
active pharmaceutical ingredients
7 Multisource (generic) pharmaceutical products: guidelines on registration
2015
992

requirements to establish interchangeability

8 Guidance on the selection of comparator pharmaceutical products for
equivalence assessment of interchangeable multisource (generic)
products
9 review practices: guidelines for national and regional regulatory auth.

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 TRS# Yr. Annex Annex Title
1 Good pharmacopeial practices
2 FIP–WHO technical guidelines: Points to consider in the provision by
health-care professionals of children-specific preparations that are not
available as authorized products
3 WHO good manufacturing practices for biological products
4 Guidance on good manufacturing practices: inspection report
5 Guidance on good data and record management practices
6 Good trade and distribution practices for pharmaceutical starting
2016
996

materials
7 Guidelines on the conduct of surveys of the quality of medicines
8 Collaborative procedure between the World Health Organization (WHO)
Prequalification Team and national regulatory authorities in the
assessment and accelerated national registration of WHO-prequalified
pharmaceutical products and vaccines
9 Guidance for organizations performing in vivo bioequivalence studies
10 WHO general guidance on variations to multisource pharmaceutical
products
1 WHO guidelines for selecting marker substances of herbal origin for
quality control of herbal medicines1
2 The International Pharmacopoeia: revised concepts and future
perspectives
3 Prequalification of quality control laboratories: procedure for assessing
the acceptability, in principle, of quality control laboratories for use by
United Nations agencies
1003

2017

4 WHO Global Model Regulatory Framework for Medical Devices including

in vitro diagnostic medical devices
5 General background notes on the list of international comparator
pharmaceutical products
6 Equilibrium solubility experiments for the purpose of classification of APIs
according to the Bio-pharmaceutics Classification System, as an appendix
to the WHO guidelines on Multisource (generic) pharmaceutical products:
guidelines on registration requirements to establish interchangeability
(Annex 7, WHO Technical Report Series, No. 992, 2015)
1 Good herbal processing practices for herbal medicines
2 Guidelines on good manufacturing practices for the manufacture of herbal
medicines
3 Considerations for requesting analysis of medicines samples
4 Model certificate of analysis
5 WHO guidance on testing of “suspect” falsified medicines
1010

2018

6 Good pharmacopeial practices: Chapter on monographs for compounded

preparations
7 Good pharmacopeial practices: Chapter on monographs on herbal medicines
8 Guidelines on heating, ventilation and air-conditioning (HVAC) systems for non-
sterile pharmaceutical products.
9 Guidance on good practices for desk assessment of compliance with good
manufacturing practices, good laboratory practices and good clinical practices
for medical products regulatory decisions

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 10 Stability testing of active pharmaceutical ingredients (API) and finished
pharmaceutical products (FPP).
(Appendix 1: Examples of testing parameter,
Appendix 2: Recommended labeling statements,
Appendix 3: interpretation of storage statement for products approved in climatic Zone2
when products are to be distributed in zone 4)
11 Collaborative procedure in the assessment and accelerated national registration
of pharmaceutical products and vaccines approved by stringent regulatory
authorities.
TRS# Yr. Annex Annex Title
1 Procedure for the development of World Health Organization medicines quality
assurance guidelines
2 Guidelines on heating, ventilation and air-conditioning (HVAC) systems for non-
sterile pharmaceutical products
3 Good manufacturing practices: guidelines on validation
1019

2019

4 Protocol to conduct equilibrium solubility experiments for the purpose of

Biopharmaceutics Classification System-based classification of active
pharmaceutical ingredients for biowaiver
5 Guidelines on import procedures for medical products
6 Good practices of national regulatory authorities in implementing the
collaborative registration procedures for medical products
1 Specifications for pharmaceutical preparations
2 Points to consider when include health-based exposure limits (HBEL) in cleaning
validation
1033

2021

3 Water for pharmaceutical use

4 Guideline on data integrity
8 WHO Biowaiver list
11 Good regulatory practices in the regulation of medicinal products
1 Specifications for pharmaceutical preparations
2 Sterile pharmaceutical products
3 Investigational radiopharmaceutical products
4 Technology transfer in pharmaceutical manufacturing
5 Medicinal gases
1044

2022

6 R&D facilities of pharmaceutical products

7 Investigational products
8 Points to consider for setting remaining shelf-life of medicinal products
9 Natural rubber latex male condom stability studies
10 R&D facilities of pharmaceutical products
11 BE requirements for immediate release SDF

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