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The Indian Pharmaceutical Alliance (IPA) is set to host the ninth edition of the Global Pharmaceutical Quality Summit, on June 27 and 28, 2024 in Mumbai. The theme for this year’s Summit is ‘Advances in Manufacturing and Quality – Patient Centricity’.
The European Commission (EC)’s revised Annex 1 – Manufacture of Sterile Medicinal Products is now effective in the EU. As of 25 August 2023, pharmaceuticalmanufacturers are required to implement the GMP regulation into cleaning and bio-decontamination procedures for these products. What is included in the new revision?
FDA inspections Identification of data integrity deviations Of the 70 Warning Letters issued by the US Food and Drug Administration (FDA) so far in 2024, three have identified data integrity issues at pharmaceuticalmanufacturing sites outside the US. In a letter issued to China-based Sichuan Deebio Pharmaceutical Co.
What are the top 3 trends that defined pharma manufacturing in India and globally in 2024? In 2024, the pharmaceuticalmanufacturing landscape underwent transformative changes, driven by technological innovations, regulatory adaptations, and evolving global demands.
Revised Schedule M: A Complete Guide to Pharma Compliance Introduction Revised Schedule M is a critical update to Indias pharmaceuticalmanufacturing regulations. It aligns Good Manufacturing Practices (GMP) with international standards, ensuring quality, safety, and efficacy in drug production. What is Revised Schedule M?
300 crore, over the next two fiscal years (150 units each in 2024-25 and 2025-26). The intended beneficiaries are now specified as existing pharmaceuticalmanufacturing units with an average turnover of less than Rs. Documentation is an altogether different skill without which compliance is not possible.
Insights from USP’s Medicine Supply Map demonstrate that geographic concentration of pharmaceuticalmanufacturing anywhere in the world – including within the United States – increases the risk for drug shortages. Promoting geographic diversity of the manufacturing base of U.S.
Line clearance ensures the processing line is free of any irrelevant products, components, and documentation that could be left accidentally from an earlier batch. Line opening ensures correct products, components, and documentation are brought into the processing line so the operation can commence without error. .
billion in 340B savings is at risk, due to increasing limitations imposed by pharmaceuticalmanufacturers which could further strain the healthcare safety net and patient care services. Then the manufacturer will approve a rebate and send money back to the CE for the difference in 340B and retail price. Additionally, up to $8.4
Instrument calibration procedure for pharmaceutical industry Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Last Updated on March 20, 2024 Prev PREVIOUS POST Have you ever wondered if the scales at the grocery checkout show the right amount? Additional documents included each month.
He emphasised that India currently holds the third position globally in pharmaceutical production volume and the fourteenth in value, achieving a remarkable $27 billion in pharmaceutical exports in 2024, signifying immense growth potential.
On December 15, 2024, the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy hosted Session 11 of the PULSE (Pharma Upgradation & Learning Series for Excellence) initiative, focusing on Good Practices In Quality Control. Dr Khurana stressed the importance of risk-based testing and the need for proper documentation.
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