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SOP for Stability/Shelf Life Determination

OBJECTIVE
To lay down a procedure for Stability / Shelf life determination.

SCOPE
This procedure applies to the pharmaceutical manufacturing facilities of XYZ Limited.

RESPONSIBILITY
The Quality Control Chemist is responsible for implementation of the process.
The Quality Control Manager is responsible for the execution of the procedure.


PROCEDURE
  • Until adequate stability study tests have been acquired through long term tests (actual shelf life study) the formulations shall be given two years of expiry date, if the ingredients used for the same have an expiry date equal to or more than the expiry date of the formulation. In case any of the ingredients has an expiry date shorter than the proposed date, the formulation shall be given the expiry date of that ingredient.
  • The stability study shall be carried out on a product in its final package in which its proposed to be sold.
  • At least three batches of the product shall be made and evaluated for stability.
  • Testing schedule:
  1. Long term testing - minimum of 24 months at least 3 batches. Every 3 months over the first year, every 6 months over second year and then annually.
  2. Storage conditions; Long term 30 ± 2 / 65 ± 5% RH
  3. Accelerated 40 ± 2 / 75 ± 5% RH 6 months.
  • The quality parameters to be checked are classified into three groups; physical characteristics, purity and potency.
  • Physical characteristics for
  1. Tablets: Odour, friability, disintegration, dissolution any change in colour, excessive powder formation.
  2. Coated tablets: cracks mottling or tackiness in the coating & clumping of tablets in case of bulk packing, cracks or clips at the face.
  3. Capsules; Condition of shell, aggregation in case of bulk pack, disintegration monthly or tackiness of the contents.
  4. Liquid: Change in odour, taste, colour, clarity, pH, non-homogeneity of suspension, separation of Ingredients, flocculation, caking.
  5. Purity: Moisture content in case of Tablets & Capsules. Possible degradation of active ingredients.
  6. Potency: Assay for active ingredients
  • Stability study of package:
  1. Appearance of the package including the caps and other closures.
  2. Integrity of seals and adhesion of Labels.
  3. Containers: Coercion, migration of container ingredients into the product and reverse.
  • Further stability study should be conducted if there is any major change in product formulation, change of pack or drastic change of material specification.

ABBREVIATION
SOP : Standard Operating Procedure
Q.A : Quality Assurance
No. : Number
Q.C : Quality control

ANNEXURE
Annexure : Stability / Shelf life determination record

REVISION HISTORY
Nil

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