Indian pharma industry sees the significance of the World Health Organization’s update to its guidelines for API and finished drug stability testing. The draft which was released on March 7,2017 reflects how stability testing has evolved since the release of the original in 2009.

Under the updated draft, each product must undergo stability tracking throughout its shelf-life to ensure it remains compliant with the label’s specified storage conditions and the stability programme should include at least one batch of product manufactured in every strength and every container closure system annually, unless otherwise justified.

The WHO also updated the guidance to better reflect stability testing requirements for generics. These guidelines are intended to define the stability data package for active substances and pharmaceutical products that is sufficient for a registration application.

The guidelines seek to exemplify the core stability data package required for registration. Alternative approaches can also be used when they are scientifically justified. Further guidance can be found in guidelines published by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), stated WHO in its release.

The pharma industry has said that the guidelines are current and much wanted going by the changes in the sector. Global regulators like the US FDA have already issued similar norms.

Stability indicating methods are indispensable in drug development. These are adopted primarily to substantiate the variances in drug quality with environment. A drug is sensitive to humidity, temperature and light, said Dr Raghunandan H V, deputy director - academic, JSS University, Mysore.

Dr BR Jagashetty, former National Adviser (Drugs Control) to MoHFW & CDSCO and former Karnataka drugs controller, said for any product to be released in the market stability testing is a must. This is because the drug should be able to retain its strength based on the efficacy and safety studies to ensure its shelf life.

Quoting the FDA guidance which states that a stability method is a validated analytical procedure that can detect the changes with time in the pertinent properties of the drug product, Dr. Raghunandan, said that the method accurately measures the active ingredients, without interference from degradent products, process impurities, excipients, or other potential impurities.

Therefore a stability indicating method should be discriminatory, accurate, precise, robust and reproducible. A stability indicating method can be any analytical method like assay, dissolution, UV or any other chromatographic technique. These studies are essential part of drug development without which the characterization of the product is quite difficult, he added.
 
According to Kaushik Desai, pharma consultant, similar guidelines were issued by ICH but now this rule will be applicable to all WHO countries. This will ensure total global harmonisation. Therefore these guidelines are in line with the stability norms that of other regulators including ICH.