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Pharma companies increasingly to focus on stability studies as norms from US FDA, WHO and D&C Rules mandate product safety information
Pharma Extra, Pharma News

Indian pharma companies now need to increasingly focus on stability studies to prove the safety of formulation till the end of the shelf life. The industry already has three regulations to adhere: Drugs & Cosmetic Rules, US FDA and WHO stability testing guidelines for API, finished drugs and the ICH norms on the same.

The purpose of the stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity and light. It also calls for storage conditions, retest periods and shelf life of the products, said B Kumar, deputy drugs controller, sub-zonal office, CDSCO, Bengaluru.

In order to ensure that the drug formulations marketed in the country are stable till the end of the shelf life, it is necessary that stability studies should be brought under the condition of license for manufacturing drugs especially in Rule 71, 71-B & Rule 76, he added.

Delving on the submission of data for a stability study at the recently concluded seminar organized jointly by the Karnataka drugs control department and the KDPMA, Kumar said these are based on the written and approved stability protocol and not merely based on standard operating procedures. These are generally carried out at quality control laboratories.

With regards to the revised guidance of the D&C Rules, regulatory requirements of stability studies issued on April 10, 2018, mandates the applicants to submit evidence of stability, safety of excipients among others to the State Licensing Authority before grant of product manufacturing license for any product. Schedule M requires the manufacturers to conduct the stability study to ensure stability of the manufactured products too, he said.

The factors affecting stability studies are the storage time, storage conditions, type of storage forms, container and closure system. Here, Kumar went on to state that the longer the storage time, the more potential for degradation of the drug and more deterioration of dosage forms. Even the container closure system may affect the stability of drug. For instance, the plastic containers and rubber closures are reported to absorb antioxidants and preservatives from the solutions in contact leading to destabilization and microbial attack. Some of the stability problems also span from visible to particulate contamination, formation of gas and change in colour, he noted.

The three types of stability testing are accelerated stability studies, intermediate testing studies and long-term stability studies. Further, testing should be done using the containers and closures proposed for storage and distribution. Here the test should also include containers and closures for physician sample, besides promotion and marketing sample and bulk storage sample. The protocol should provide information about type, size and storage of containers and closures. Extensive studies must be done before selection of container-closure system, said Kumar.

Courtesy – Pharmabiz

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