Pharmacy Manufacturing Archives

Reading the Fine Print: Unpacking Plant Verification Standards

Brian RogersJune 4, 20240150 views

When evaluating the quality of pharmaceuticals, it’s crucial to understand the difference between brand names and manufacturing plants. While QP Pharmachem claims to meet cGMP and WHO standards since its construction in 1997, evolving regulations necessitate continuous upgrades and compliance efforts. This article delves into the changing landscape of pharmaceutical standards, highlighting the importance of ongoing adherence to ensure drug safety and quality. The recent contamination scandal involving QP Pharmachem underscores the critical need for stringent quality control and updated certifications in the pharmaceutical industry.

Resistance to Reform: Punjab Pharmaceutical Manufacturers Push Back Against Modi’s Schedule M Mandate

Brian RogersJune 4, 20240131 views

Prime Minister Narendra Modi’s directive for Indian pharmaceutical plants to achieve WHO GMP certification by the end of 2023 faces significant resistance from some manufacturers. The Pundrug Research Foundation, led by several Punjab-based pharmaceutical companies, argues that the financial and logistical burdens of upgrading to meet these standards are too high, particularly for smaller firms. Despite these challenges, the Indian government emphasizes that such upgrades are essential for ensuring the safety, efficacy, and global competitiveness of Indian pharmaceuticals. The debate underscores the critical need for balancing regulatory compliance with economic realities to maintain India’s position as a leading pharmaceutical producer.

The Troubling Case of QP Pharmachem: Indian Manufacturer with a Disturbing Past

Brian RogersMay 29, 20240226 views

Despite significant advancements in the Indian pharmaceutical industry, the case of QP Pharmachem highlights ongoing challenges in manufacturing and export quality control. In 2023, a scandal erupted when a batch of cough syrup produced by QP Pharmachem was found to be substandard and contaminated, causing a global health alert. The World Health Organization (WHO) issued an alert after toxic substances were found in the syrup, leading to serious health risks. This incident underscores the critical need for stringent quality control and regulatory oversight to ensure the safety and efficacy of pharmaceutical products.

Responsibilities of Brands Contracting Pharmaceutical Manufacturing in India

Brian RogersMay 27, 20240157 views

When a pharmaceutical brand, such as Healing Pharma, contracts a manufacturing facility like QP Pharmachem, both parties must adhere to stringent regulatory standards to ensure product quality and compliance. This involves obtaining necessary licenses from CDSCO, following Good Manufacturing Practices (GMP), and conducting regular audits. The brand is responsible for providing detailed product specifications, ensuring thorough testing, and maintaining comprehensive documentation and traceability. Additionally, establishing robust pharmacovigilance and clear contractual agreements are crucial for maintaining high standards and protecting intellectual property. For more detailed guidelines, refer to resources from CDSCO, CliniExperts, and Intertek.