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 2. Stability testing: summary sheet

An example of a form in which the results of stability testing can be presented is shown below. A separate form should be completed for each pharmaceutical preparation tested.

Accelerated/real-time studies

 

Name of drug product ....................................................................................

Manufacturer ..................................................................................................

Address ...........................................................................................................

 

Active ingredient (INN) .................................................................................

Dosage form ....................................................................................................

Packaging .........................................................................................................

 

Batch number

Date of manufacture

Expiry date

1..................................

../../19..

../../19..

2..................................

../../19..

../../19..

3..................................

../../19..

../../19..

Shelf-life

... years (s)

... month(s)

 

Batch size

Type of Batch (experimental, pilot plant, production)

1..................................

.........................................................

2..................................

.........................................................

3..................................

.........................................................

Samples tested (per batch)

..............

 

Storage/test conditions:

 

Temperature

..... °C

Humidity.....%

 

Light

..... cd

 

Results

 

1.

Chemical findings .....................................................................................

 

..................................................................................................................

2.

Microbiological and biological findings ....................................................

 

..................................................................................................................

3.

Physical findings ......................................................................................

 

..................................................................................................................

4.

Conclusions .............................................................................................

 

.................................................................................................................

Responsible officer .......................................................................... Date../../19..

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