Regulatory authorities are lacking valid data on extractables and leachables, particularly for injectable drugs and medicine products, because of which there is a lot of ambiguity and confusion prevailing among the drug manufacturers and regulatory authorities, says representatives of West Pharma in a recent seminar held in Hyderabad.
Not just the domestic regulators in India, even the international regulators at United States Food and Drugs Administration (US FDA) are also lacking proper documented data on extractables and leachables for the injectable products. The recent cases of drug adverse reactions in government hospitals in Rajasthan, Bihar, and Andhra Pradesh evidently prove that pre filled syringes, vials and bottles are being contaminated either by manual mishandling or because of improper material used for packaging these drugs which get leached and extracted into the actual medicine.
In spite of all precautions taken by the manufacturers, due to lack understanding of the quality of material used for packing, the drugs get contaminated by leaching or extraction of its own packed material. To create more awareness about leachables and extractables, West Pharma conducted a seminar in Hyderabad last week, where about 150 executives from various pharmaceutical and biotechnology companies attended.
Extractables are chemical entities, both organic and inorganic, that will extract from components of a container closure system or device into solvents under controlled conditions. They are used to identify and quantify potential leachables. Leachables are chemical entities, both organic and inorganic, that migrate from components of a container closure system or device into a drug product over the course of its shelf-life. Leachables are usually present in drug product matrices as complex mixtures at trace levels relative to the active pharmaceutical ingredient (API).
According to an executive from Biological E, in most cases, the regulatory authorities are giving approvals just by taking into consideration the data provided by the concerned manufacturing companies, but they themselves do not have valid data or database to cross check the authenticity of packaging products used for injectables.
To overcome the packaging concerns of injectable products, West Pharma, the leading manufacturer of rubber stoppers is doing lot of research and developing authenticate packaging materials and products that does not get extracted or leached in to the packed injectable product. In line to meet the expectations of the GMP and cGMP, West Pharma is moving ahead with predefined objectives with emphasis on the product and understanding the manufacturing process.
“Our approach of designing packaging product is totally different. We follow the concept of quality by design. Every aspect of our design has undergone various analytical and stimulatory procedures before coming to the final product. Our products are proven and highly acceptable across the globe. We also provide valid data to regulators on extractables and leachables and even US FDA relies on our data as there are no proper US FDA regulations available on extractables and leachables in injectable segment,” says, Alagu Subramaniam, Country manager, West Pharma, India.