Regulatory aspects and quality control

Owing to the inherent physical and chemical instabilities of thermodynamically less stable forms, the International Committee on Harmonisation has issued a guidance [14] containing a decision tree for investigating the need to set acceptance criteria for polymorphism in dmg substances and drug products (see Figs 

Quality control of solid pharmaceuticals is essential to verify the integrity of the dmg substance and dmg product and such materials require special, yet simple, techniques and methods to analyse these samples. The subsequent sections discuss these methods and techniques and are presented to give an overview of the field but not an in-depth treatise of the subject. 

Drug product - solid dosage form or liquid containing undissolved drug substance 

Undertake the following processes only If technically possible to measure polymorph content In the drug product. 

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