Remove 2024 Remove Documentation Remove Pharmaceutical Manufacturing
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IPA to host 9th Global Pharmaceutical Quality Summit

Express Pharma

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’.

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FDA warning letters highlight data integrity issues

European Pharmaceutical Review

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 pharmaceutical manufacturing sites outside the US. In a letter issued to China-based Sichuan Deebio Pharmaceutical Co.

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Revised Annex 1 now effective

European Pharmaceutical Review

The European Commission (EC)’s revised Annex 1 – Manufacture of Sterile Medicinal Products is now effective in the EU. As of 25 August 2023, pharmaceutical manufacturers are required to implement the GMP regulation into cleaning and bio-decontamination procedures for these products. What is included in the new revision?

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DOP amends PTUAS, expands eligibility criteria to include MSMEs

Express Pharma

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 pharmaceutical manufacturing units with an average turnover of less than Rs. Documentation is an altogether different skill without which compliance is not possible.

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Global manufacturing capacity for active pharmaceutical ingredients remains concentrated

Quality Matters

Insights from USP’s Medicine Supply Map demonstrate that geographic concentration of pharmaceutical manufacturing 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.

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Line clearance procedure and reconciliation in GMP

GMPSOP

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. .

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Instrument calibration procedure for pharmaceutical industry

GMPSOP

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.