Standard Operating Procedure for Stability Testing Program

Purpose:-

To confirm the product shelf life under climatic conditions expected during trade, storage and house use.

 Scope:-           This procedure applies to all pharmaceutical products manufactured at Plant

 Responsibility:-

è Quality Control Manager

è Quality Assurance In-charge

è QC Officer

 Procedure:-

A)              Methodology

è Pharmaceutical products manufactured at plant are tested at designated intervals for certain chemical, physical, and microbiological (where applicable) properties, to confirm the stability of the product and compatibility with its immediate container, while stored in accordance with labeled conditions and time, particularly with respect to product degradation.

The number of batches, the condition and time intervals will depend on the type of products involved.

è Stability program.

a)      Stability of New Products

b)      Stability of currently marketed products (on going stability)

c)      Stability of currently marketed products with significant change in formula, process, packaging or material source.

è The stability of the product is determined by validated analytical methods

è When a stability profile illustrates little or no change, the frequency of performing each test may be reduced, but physical inspection must be performed at each testing period.

è Product characteristics during stability may be different than those at the time of release.

è Stability testing programs must ensure that products meet required specifications throughout their shelf life.

è Normally for stability testing, only ambient storage conditions, or conditions consistent with product labeling, are required. Only for special cases accelerated conditions will be required.

B)               Product Stability Sample / Test Frequency

Product Categories	Climatic Condition	Product Shelf Life (Months)	Test Frequency (Months)
New Products & current products with CHANGE in formula, process, packaging or source of material	A) Accelerated condition i)          40 o C & R.H. <  40% ii)        40 o C & 75 % R.H. iii)      Ambient Temp. (15 – 30 o C)		Samples of three batches at 0, 1, 3 months
	B) Ambient Temp (15 – 30 o C)	12 --------- 24 30 --------- 36 48 Months 60 Months	Two batches of each dosage form and one batch significantly different packaging 0,3,6,9,12, Exp. Date 0,3,6,9,12,18,24, Exp Date 0,3,6,9,12,18,24,36, Exp. Date 0,3,6,9,12,18,24,36,48, Exp. Date
Currently marketed products (ongoing stability)	Ambient Temp. (15 – 30 o C)	12 --------- 24 30 --------- 36 48 Months 60 Months	One batch per year as for each product & different dose (250, 500 mg etc) and different packaging (e.g. Blister, Glass, Bottle) 0,6,12, Exp. Date 0,6,12,24, Exp. Date 0,6,12,24,36, Exp Date 0,6,12,24,36,48, Exp Date

C)             A decision to forego testing of the revised formulation, process, package, or use of a new supplier, can be made by QC Manager at the manufacturing plant based on the technical assessment of the significance of the change and historic stability and the profile of the product. QC Manager ensures that the change to forego is indeed a minor change & decision to forego testing be documented and reported.

D)              Data Review and Reporting

The Quality Assurance In-charge is responsible for review of all stability data, data analysis & maintaining all stability records.

Equipment:-

Stability study is conducted in stability chamber equipped with ultrasonic humidifier for relative humidity condition and chamber light.

Precautions:-

—  Ensure humidifier is filled with water before start.

—  Switch off stability chamber after 180 hours continuous run then restart 30 minutes after switch off.

—  Adjust correct Temp / R. humidity from front panel.