European Pharmaceutical Review
MARCH 13, 2024
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.
European Pharmaceutical Review
AUGUST 25, 2023
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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Express Pharma
MARCH 12, 2024
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.
GMPSOP
MARCH 20, 2024
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.
GMPSOP
MARCH 30, 2024
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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