Express Pharma

JUNE 12, 2024

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’.

Pharmaceutical Manufacturing 105

Pharmaceutical Manufacturing Documentation 105

Express Pharma

DECEMBER 23, 2024

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.

Documentation 104

Documentation Method Validation Pharmaceutical Manufacturing Packaging 104

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.

Documentation 98

Documentation Pharmaceutical Manufacturing 98

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?

Documentation 98

Documentation Pharmaceutical Manufacturing 98

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.

Documentation 105

Documentation Pharmaceutical Manufacturing 105

Quality Matters

NOVEMBER 5, 2024

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.

Pharmaceutical Manufacturing 78

Pharmaceutical Manufacturing Packaging Documentation 78

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. .

Labelling 52

Labelling Packaging Documentation Pharmaceutical Manufacturing 52