Page 13 - Quality control of pharmaceuticals (07-PA 704)
P. 13
Rooms for sample storage
Security and adequate storage conditions (light, ventilation, safety
requirements, and any special requirements) should be ensured for the
rooms in which samples are stored.
Samples should be stored according to the storage conditions as specified
Sampling plans
Starting materials
Finished products
Packaging materials
The following plans are examples
The objective is to ensure that the material comply with predefined
acceptance level if not, should be rejected.
System Suitability Testing (SST) & Qualification of Analytical
Instruments
System Suitability Testing (SST)
SST means continuous monitoring of validation parameters (precision,
accuracy……etc.)