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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. Hence, spores require complex treatment to remove them.

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Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

Additionally, ANDA submissions should extrapolate the RLD safety and effectiveness data for drugs with the same active ingredients, dosage forms, strengths, routes, and labeling. For submission consideration, manufacturers can petition the FDA for ANDA status if the requested change does not require safety or effectiveness studies.

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US trade tariffs and the potential impact on pharma supply chains

Pharmaceutical Technology

These ongoing legal challenges highlight the volatility of today’s macroeconomic environment – just one aspect of the complex and volatile world that pharmaceutical manufacturers now find themselves in. Mitigating the challenges Companies are taking actions to minimise the impact on their businesses.

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Leading pharmaceutical wholesalers

Pharmaceutical Technology

Pharmaceutical wholesalers act as intermediaries between pharmaceutical manufacturers and retailers and facilitate the delivery of the right medicines in a timely, efficient, and secure manner. The post Leading pharmaceutical wholesalers appeared first on Pharmaceutical Technology.

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The Pandemic Treaty and the opportunity to end ‘vaccine apartheid’

pharmaphorum

Tendayi Achium, labelled the response by the global community as a form of “vaccine apartheid,” a suggestion echoed by the organisation’s director general. The UN Special Rapporteur on contemporary forms of racism, E. The discussions over the treaty are set to continue for some time.

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Leading commercial packaging companies in contract marketing

Pharmaceutical Technology

The pharmaceutical industry requires specialised and cost-effective commercial packaging solutions to improve efficiency and preserve the integrity of products through the entire supply chain, from primary packaging and labelling to shipping, delivery, storage and distribution to end users.

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Line clearance procedure and reconciliation in GMP

GMPSOP

Proper line segregation involves physically separating different lots of starting materials, labeling components, and printing matters, many of which look similar. Before filling and labeling, you should thoroughly examine the filling line using a standard operating procedure. Please look at the labeling operation in the picture below.