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Addressing US FDA challenges in Indian sterile drug manufacturing – Part 1

Express Pharma

Indian pharmaceutical companies supply more than 60 per cent of global demand for vaccines and over 40 per cent of generic medicines consumed in the United States (2). This growth is further driven by global shortages of sterile products, an expanding biologics pipeline, and the demand for emergency-use therapies including vaccines.

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Effective Control of Microorganisms in Pharmaceutical Manufacturing

GMPSOP

Effective Control of Microorganisms in Pharmaceutical Manufacturing Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Prev PREVIOUS POST The control of microorganisms in pharmaceutical production ensures that they stay at acceptable levels. Additional documents are included each month.

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Supporting the pharmaceutical industry – how a CDMO can help

European Pharmaceutical Review

What is the role of a CDMO during the fill and finish stage in pharmaceutical manufacturing? It represents one of the highest-risk stages in sterile pharmaceutical manufacturing” The importance of fill and finish cannot be overstated. Why is it important?

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The 6-Stage Compounding Framework Every Pharmaceutical Manufacturing Professional Should Know

PharmaTech

3d render, number six glowing in the dark, pink blue neon light | Image Credit: © NeoLeo - stock.adobe.com Pharmaceutical compounding, particularly in 503A and 503B environments, involves complex formulation and regulatory challenges far beyond academic theory. antineoplastics, allergens).

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Continuous manufacturing: Changing the paradigm in the pharmaceutical manufacturing sector

Express Pharma

The world massively relies on the developments that continue to take place in the pharmaceutical industry to experience an improved quality of life. Also, to establish a sense of transparency, especially for audits, and adhere to regulatory standards, manufacturers must have a Quality Management System (QMS) in place.

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How can the pharma industry navigate issues in the global supply chain to minimise drug shortages?

pharmaphorum

The pandemic effectively shut down supply chain paths overnight, and as a result, pharmaceutical manufacturers have faced delays and bottlenecks, which have caused drug shortages in healthcare systems. Companies could benefit from talking to third party experts such as NSF to ensure that they are in compliance.

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GMP rules to keep pharmaceutical warehouse in perfect condition

GMPSOP

A pharmaceutical warehouse is responsible for receiving, storing, and releasing incoming goods (including labeling and packaging) and distributing finished products. Therefore, GMP rules ensure that materials are handled and stored properly and that appropriate documentation is maintained. Additional documents included each month.