Stability Testing Requirements for Products Used In Veterinary

1. Stability Testing Requirements for Products Used In Veterinary As like any other product, manufactured and marketed, veterinary drugs and medicines also have a shelf life. Moreover, the quality of such these drugs can and does deteriorate with time. The manufacturers do add stabilizers in these medicines to enhance their shelf life and quality, however, the quality as time passes is a matter of great concern. Contact No: +91 7672005050 Email: contact@cliniexperts.com

2. To address such concerns and to collect relevant data about quality with passing time, CDSCO has formulated a set of regulations for the stability testing of veterinary drugs. Some important and considerable factors which affect the stability of such drugs include temperature, humidity, moisture, storage conditions, formulation, packaging and light. According to CDSCO, these stability studies of veterinary drugs should include testing of attributes that are susceptible to change over a duration of time and influence quality, safety and efficacy. For testing the formulation of such drugs, the physical, chemical, biological and microbiological attributes, preservative test and functionality test must be conducted. The Medical Device Regulation India outlines the duration and procedures of stability testing, to ensure a comprehensive output in the reports. The testing durations have been categorized into two parts, namely long-term testing and accelerated testing. Long term testing aims at evaluating the quality of a sample over a period of 12 months. Whereas accelerated testing reports can be generated in as quick as 6 months. These tests are further classified into storage conditions, a very main aspect of which is the storage temperature. The samples have to be stored in normal conditions or, inside a refrigerator or /and inside a freezer. Which provide different operating Contact No: +91 7672005050 Email: contact@cliniexperts.com

3. temperatures for the sample, thus, providing a more elaborate report on the behaviour of the sample in different storage conditions. Upon delving further into these regulations, we find that CDSCO has also elaborated upon several more detailed aspects which include: ● Selection of Batches for Testing ● Container Closure System ● Specifications about What Ingredient of the Drug has to be Evaluated ● Analytical Methods to be Adopted While Stability Testing ● Testing Frequency through the Proposed Shelf Life of the Product ● Evaluation of the Stability Information Including Elaborate Results ● In-use Stability to Provide Data for Labelling ● Stability Commitment to Continue Stability Testing Post Approval These stability testing studies can act as an important prerequisite before the introduction of veterinary drugs on the Indian market. Since animals cannot provide reviews like a human can do, it becomes even more crucial to ensure the quality and efficiency of such drugs in treating various medical conditions in animals. Reference: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/ elements/download_file_division.jsp?num_id=NDY5OQ== Contact No: +91 7672005050 Email: contact@cliniexperts.com