Currently, there is a huge industry-academia gap with respect to GMP concepts in academic curriculum and actual industry practice. The recent audit outcomes of various global regulators reflect that building a strong Quality Culture and Data Integrity systems is the need of the hour, especially for the Indian pharmaceutical sector. Both Quality Culture and Data Integrity go hand in hand. We believe that these good practices should be inculcated into young minds from the academic setup so that fresh candidates entering regulated pharma companies are well-versed in GMP practices. Due to inadequate Good Manufacturing Practices, the marketed pharmaceutical products may be defective or have quality issues that go unnoticed at the manufacturers' end or in the medical outlet. Subsequently, the patients will be purchasing a defective product that may have physical or chemical nature complaints or any other complaint on quality attributes. Being a layman, the patient may not notice the defect; the pharmacist may pack the product and hand it over to the ailing patient in a hurry to dispense and prepare the bill. Thus, the ailing patient may consume defective products. Therefore, the proposed Center for current GMP shall also develop a comprehensive procedure and protocol to handle real-life complaints.
The main aim of Center for current GMP is to work towards mitigating these lapses right from academic setup, and this will definitely bring a positive change in the thinking of a fresher joining a regulated company and help to work with commitment from day one until the end of their entire professional career adding value to product quality and patient safety.
