MSF specifications for pharmaceutical products
The manufacturer

Should provide a valid authorization (delivered by its NDRA) to manufacture the products
it intends to sell to MSF

Should provide a valid GMP certificate delivered by the NDRA

Must be compliant with WHO GMP
References
Good manufacturing practices for pharmaceutical products: main principles
(WHO Technical report Series 908, annex 4)
Model certificate of Good Manufacturing Practices
(WHO Technical report Series 908, annex 5)
Good Manufacturing Practices for sterile products
(WHO Technical Report Series 902, annex 6)
Supplementary guidelines on good manufacturing practices for heating, ventilation and airconditioning systems for non sterile pharmaceutical dosage forms
(WHO Technical Report Series 937, annex 2)
Supplementary guidelines on good manufacturing practices: validation
(WHO Technical Report Series 937, annex 4)
The product

Registration/Manufacturer status
A copy of a recent (maximum 24 months) Certificate of Pharmaceutical Product (WHO
type) must be provided.
Reference
Guidelines for implementation of the WHO Certification Scheme on the quality of
Pharmaceutical Products Moving in International Commerce
(WHO Technical Report Series 863, annex 10)
Note: If the NDRA does not issue WHO CPP, another equivalent document must be
provided. This document should clearly mention the status of the product (registered or
non registered) in the country of production

Stability
- The stability of the product must be demonstrated on the basis of stability data generated
in the WHO recommended conditions .
- The recommended shelf life must be coherent with the outcome of the stability studies.
- The storage instructions given on the label must be coherent with the outcome of the
stability studies and should comply with the recommendations of the WHO.
On the label
Means
Do not store over 30°C
Do not store over 25°C
Do not store over 15°C
Do not store over 8°C
Do not store below 8°C
Protect from moisture
From +2°C to +30°C
From +2°C to +25°C
From +2°C to +15°C
From +2°C to +8°C
From +8°C to +25°C
No more than 60% relative humidity in normal storage
conditions; to be provided to the patient in a moisture
resistant container
To be provided to the patient in a light resistant
container
Protect from light
References
Guidelines for stability testing of pharmaceutical products containing established drug
substances in conventional dosage forms
(WHO Technical Report Series 863, annex 5)
Stability testing conditions
(WHO Technical Report Series 937, p12)
Storage instructions
(WHO Technical Report Series 908, p 136)

Active Pharmaceutical Ingredients (API’s)
- The API’s must comply with the monograph requirements of the latest edition of the
British Pharmacopoeia, the European Pharmacopoeia, the US Pharmacopoeia or the WHO
International Pharmacopoeia, whenever applicable.
Note: In house specifications are in principle acceptable as long as they are not less
stringent than the above mentioned pharmacopoeia monographs.
The detailed specifications have to be submitted to and approved by MSF.
In such cases, the detailed analytical methods have to be communicated to MSF.
Those documents ( in house specifications and the analytical methods) must be approved
and signed by the company QA responsible.
- When an API is not described in any of the above mentioned pharmacopoeias alternative
pharmacopoeia references or in house specifications have to be submitted to and approved
by MSF. In such cases, the detailed analytical methods have to be communicated to MSF.
Those documents ( in house specifications and the analytical methods) must be approved
and signed by the company QA responsible.
- The origin of the API’s (Name of the manufacturer and address of the manufacturing
site) must be declared to MSF.
- The API producers must be authorized by their NDRA’s.
- The API’s must be manufactured in compliance with the WHO guidelines. A copy of a
valid GMP certificate must be provided to MSF.
- The manufacturer of the finished product is asked to demonstrate that the quality of its
API (s) sources is properly assured.
Acceptable proofs of quality assurance are by order of preference a Certificate of
Suitability (CEP) delivered by the European Pharmacopoeia or a Drug Master File
registered in an ICH country or, at least, a technical file that summarizes the synthesis
route and the characteristics of the API.
References
The European Pharmacopoeia
The United States Pharmacopoeia
The British Pharmacopoeia
The WHO International Pharmacopoeia
WHO Good Manufacturing Practices: starting materials
(Quality Assurance of Pharmaceuticals. A compendium of guidelines and related materials.
Volume 2, updated edition, WHO Geneva 2004) + WHO Technical Report Series 823

Therapeutic equivalence and interchangeability
Upon specific request of the MSF pharmacists, the generic manufacturer can be asked to
submit a proof of therapeutic equivalence against a comparator product.
References
Multisource (generic) pharmaceutical products: guidelines on registration requirements to
establish interchangeability
(WHO Technical Report Series 937, annex 7)
Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential
Medicines immediate-release solid oral dosage forms
(WHO Technical Report Series 937, annex 8)
Additional guidance for organizations performing in vivo bioequivalence studies (WHO
Technical Report Series 937, annex 9)
Packaging
- The packaging materials must conform to the requirements of the latest edition of the British
Pharmacopoeia or the US Pharmacopoeia or the European Pharmacopoeia or the International
Pharmacopoeia, whenever applicable.
In particular, packaging must be suitable for delivery and use in Zone IV countries
- The packaging must comply with the WHO guidelines on packaging for pharmaceutical
products.
- A sample of the product (primary and secondary packaging) submitted for the evaluation
must be provided to MSF together with the product questionnaire.
References
The European Pharmacopoeia
The United States Pharmacopoeia
The British Pharmacopoeia
The WHO International Pharmacopoeia
Guidelines on packaging for pharmaceutical products
(WHO Technical Report Series 902, annex 9)
Stability testing conditions
(WHO Technical Report Series 863, annex 5)
(WHO Technical Report Series 937, page 12)

Labels and leaflets
- All labels must be printed in the following languages: English, French and Spanish
- Self-adhesive labels are preferred.
- Paper labels must be affixed to prevent detachment in tropical climates.
- The pack or container must be affixed with a clear label printed in indelible ink, in black
on white and containing at least the following information:
→ The International Non-proprietary Name (INN)
→ A list of the active ingredients showing the amount of each present in a dosage
unit
→ The manufacturer’s name and address
→ The name and the country of location of the license holder (if different than the
manufacturer)
→ The registration number in the country of origin (when applicable)
→ Any special storage conditions or handling precautions that may be necessary in
English, French and Spanish
→ The directions for use, and any warnings or precautions that may be necessary in
English, French and Spanish
→ The batch Number assigned by the manufacturer
→ The manufacturing date in an uncoded form
→ The expiry date in an uncoded form
→ The labelling instructions should comply with the recommendations of the WHO
The recommended storage conditions should reflect the outcome of the stability
studies performed by the manufacturer in accordance with the WHO guidelines
References
Guidelines for stability testing of pharmaceutical products containing established drug
substances in conventional dosage forms
(WHO Technical Report Series 863, annex 5)
Stability testing conditions
(WHO Technical Report Series 937, p12)
Storage instructions
(WHO Technical Report Series 908, p 136)

Finished Product Specifications
- The finished product must comply with the requirements of the latest edition of the
British Pharmacopoeia, the US Pharmacopoeia or the WHO International Pharmacopoeia
whenever applicable
Note: In house specifications are in principle acceptable as long as they are not less
stringent than the above mentioned pharmacopoeia monographs.
The detailed specifications have to be submitted to and approved by MSF.
In such cases, the detailed analytical methods have to be communicated to MSF.
Those documents ( in house specifications and the analytical methods) must be approved
and signed by the company QA responsible.
- When a monograph of the product is not available in any of the above mentioned
pharmacopoeias, alternative pharmacopoeia references or detailed in house specifications
have to be submitted to and approved by MSF.
In such cases, the detailed analytical methods have to be communicated to MSF.
Those documents ( in house specifications and the analytical methods) must be approved
and signed by the company QA responsible.
- A certificate of analysis (WHO format) must be provided for each batch of a product
that is supplied to MSF
- The certificate must be original or its authenticity must otherwise be assured.
References
The United States Pharmacopoeia
The British Pharmacopoeia
The WHO International Pharmacopoeia
Model of certificate of analysis
(WHO Technical Report Series 902, annex 10)
Variations
- Any intended
change in the manufacturing of a MSF qualified products has to be brought to
the attention of the MSF pharmacists before implementation.
- A written approval by MSF is always necessary before implementation of a change
takes place.