Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] View the PDF document
Table of Contents
Open this folder and view contentsIntroduction
Open this folder and view contents1. National drug regulation
Close this folder2. Product assessment and registration
View the documentGuidelines for the assessment of herbal medicines1,2
Open this folder and view contentsStability of drug dosage forms1
Close this folderGuidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms1
View the documentGeneral
View the documentDefinitions
View the document1. Stability testing
View the document2. Intended market
View the document3. Design of stability studies
View the document4. Analytical methods
View the document5. Stability report
View the document6. Shelf-life and recommended storage conditions
View the documentReferences
View the documentOfficial, international and national guidelines
View the documentAppendix 1. Survey on the stability of pharmaceutical preparations included in the WHO Model List of Essential Drugs: answer sheet
View the documentAppendix 2. Stability testing: summary sheet
Open this folder and view contentsMultisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability1
Open this folder and view contents3. Distribution
Open this folder and view contents4. The international pharmacopoeia and related activities
Open this folder and view contents5. Basic tests
Open this folder and view contents6. Laboratory services
Open this folder and view contents7. International trade in pharmaceuticals
Open this folder and view contents8. Counterfeit products
Open this folder and view contents9. Training
View the documentSelected WHO publications of related interest
View the documentBack cover
 

Appendix 1. Survey on the stability of pharmaceutical preparations included in the WHO Model List of Essential Drugs: answer sheet

A checklist similar to that shown here can be used to determine the stability characteristics of a product.

Name of reporting person

Address

Country
Climatic zone

NAME OF ESSENTIAL DRUG:

Description of product

 

Dosage form

 

1. tablet

coated

uncoated

 
 

2. capsule

hard

soft

 
 

3. injection

liquid

powder

 
 

4. oral liquid

solution

suspension

 
 

5. topical semi-solid

cream

ointment

 
 

6. eye preparations

liquid

semi-solid

 
 

7. other (please state)

     
 

Packaging (material and type)

 

1. glass

bottle

vial

ampoule

 

2. plastic

bottle

vial

ampoule

 

3. paper

box

bag

 

4. metal

   
 

5. blister pack

     
 

6. other (please state)

     
         

State of packaging

 

intact

damaged

 

Storage conditions

     
 

according to the manufacturer’s indications?

yes

no

 

Shelf-life (if available)

     
 

claimed by the manufacturer

 

......

years

...... months

 

percentage elapsed when tested

 

......

%

 
 

Source of product tested

     
 

1. manufactured in country of use

 
 

2. imported from neighbouring country/countries

 
 

3. imported from distant country/countries

 
 

Problems encountered

 

Occurrence

 

Pharmacopoeial non-compliance

 
 

1. very frequent

1. identification

 

2. occasional, but important

2. assay

 

3. rare

3. purity tests

 

4. other pharmacopoeial test(s)

 

Organoleptic

 

Microbial

 

1. change of colour

1. Microorganisms visible

2. visible changes, i.e. capping, cracking, foam

2. tests for bacteria positive

3. inhomogeneous appearance

3. tests for fungi positive

4. crystallization

4. tests for pyrogens positive

5. particles, turbidity, precipitation

5. other (please state)

6. sedimentation, caking, agglomeration

   

7. smell, i.e. gas formation

   

8. rancidity

Additional information

 

9. phase separation of emulsion

   

10. other interaction with packaging material

   

11. other (please state)

   
   

Date:

 

Instructions

1. The answer sheet is to be completed for drug products mentioned in the following list of essential drugs for which you have experienced stability problems:

acetylsalicylic acid
aminophylline
ampicillin

benzylpenicillin

chloramphenicol
chloroquine
chlorpromazine

epinephrine
ergometrine
ethinylestradiol

glyceryl trinitrate

ibuprofen
indometacin
isosorbide dinitrate

methyldopa

nifedipine

paracetamol
phenoxymethylpenicillin
propranolol

spironolactone
sulfamethoxazole + trimethoprim
suxamethonium bromide

tetracycline
thiamine

warfarin

2. A separate answer sheet should be completed for each of the above preparations in a specific finished dosage form, e.g. one for tetracycline capsules and another for tetracycline ointment.

Also applicable for other categories such as packaging material, source of drug product, etc.

3. Climatic zones (Schumacher P. Aktuelle Fragen zur Haltbarkeit von Arzneimitteln. [Current questions on drug stability.] Pharmazeutische Zeitung, 1974,119:321-324):

zone I - temperate
zone II - subtropical with possible high humidity
zone III - hot and dry
zone IV - hot and moist.

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