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.

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Documentation Pharmaceutical Manufacturing 105

PharmaState Academy

FEBRUARY 10, 2025

Revised Schedule M: A Complete Guide to Pharma Compliance Introduction Revised Schedule M is a critical update to Indias pharmaceutical manufacturing regulations. It aligns Good Manufacturing Practices (GMP) with international standards, ensuring quality, safety, and efficacy in drug production. What is Revised Schedule M?

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Documentation Pharmaceutical Manufacturing 52

Proxsys Rx

APRIL 1, 2025

billion in 340B savings is at risk, due to increasing limitations imposed by pharmaceutical manufacturers 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

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Specialty Pharmacies Hospitals Documentation Drug Pricing 52

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.

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Pharmaceutical Manufacturing Packaging Documentation 78

Putting Patients First Blog

APRIL 7, 2025

12 To this end, the NHC encourages the FDA to establish clear expectations for how sponsors validate and document AI-driven findings that are submitted as part of the regulatory dossier. Finally, to support transparency, reproducibility, and traceability, the FDA should require thorough documentation of AI model validation and verification.

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Documentation Communication Pharmaceutical Manufacturing Labelling 52

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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Labelling Packaging Documentation Pharmaceutical Manufacturing 52

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.

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Express Pharma

JANUARY 27, 2025

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.

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Pharmaceutical Manufacturing Documentation Labelling 99

BioPharma Dive

JUNE 5, 2025

Questions remain The FDA will plan to focus Elsa’s scope on administrative tasks such as summarizing documents and data extraction. The agency provided few other details regarding how Elsa was trained and how much it’s been tested. And for AI life sciences companies, Elsa’s debut may be a source of validation.

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Drug Pricing Drug Development Vaccines Pharmaceutical Manufacturing 52