The European Commission (EC) has updated stability testing guidance to cover procedures for variations, such as change in batch size to marketing authorisations. This is expected to benefit several Indian companies including Stabicon Life Sciences, Rubicon, Vimta Labs and Sipra Labs.
Under the new guidelines, EC has expanded on its 2005 document with the addition of required submissions. For instance, if a change in batch size alters ingredient characteristics such as impurity, comparative stability data in accelerated and long-term testing, details of the same need to be submitted. In the earlier version, three type II variations were detailed whereas the new document lists nine.
Under the category of packaging priorities, EC has detailed a set of norms for Active Pharmaceutical Ingredients (APIs) and finished products.
According to Kaushik Desai, chairman, Industrial Pharmaceutical Division, Indian Pharmaceutical Association, the new guidelines are ideal for India.
Among Indian companies that stand to benefit from the new guidelines is Bangalore-based Stabicon which is a dedicated stability management company and the only one in Karnataka. The company has expertise on associated analytical method development and validations. It has a laboratory equipped with modern analytical equipment, ICH compliant stability chambers and quality systems meeting EU, US FDA, WHO and Indian regulations. Its customers include leading national and multinational companies.
According to Suresh Khanna, chairman, Stabicon Life Sciences, the European Medicines Agency’s draft guideline clarifies that stability data is required from variations to active substances and finished products. The guideline provides a general indication on the requirement for stability testing but leaves sufficient flexibility to encompass a variety of different practical situations required for specific scientific situations and characteristics of the material being evaluated.
“The guideline will help companies to efficiently plan their stability study programme,” informed Khanna. Viewing the guidelines as an extension of the CHMP and CVMP standards on Stability Testing, Dr Uday Shetty, managing director, Stabicon Life Sciences stated that the norms are intended to be applied in the European Union and is applicable to chemical active substances and related finished products, herbal drugs, herbal drug preparations and related herbal medicinal products, but not to radiopharmaceuticals, biologicals and products derived from biotechnology.
Variations for active substances and finished products encompass a wide range of situations. The guideline provides general guidance on stability testing in case of type I (A and B) variations. Furthermore, it addresses the information required for active substances and finished products in widely encountered cases of type II variations. These include introduction of a new manufacturer for the active ingredients. Change in the manufacturer for a reagent, intermediate or the active substance that uses a substantially different route of synthesis or manufacturing conditions. There are also rules not just for modification in the manufacturing process of the active substance, but guidance on immediate packaging of the sterile active pharmaceutical ingredients.
The regulations also address composition of the finished product; coating weight of oral dosage forms; manufacturing process of the finished product; batch size of the finished product. Therefore this guideline will definitely help the industry, added Dr Shetty.