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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

For submission consideration, manufacturers can petition the FDA for ANDA status if the requested change does not require safety or effectiveness studies. It is basically an essential copy, and the pharmaceutical manufacturer has to show bioequivalence to the reference product,” Soefje said. “If

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Building CO2-neutral, defossilised supply chains for chemicals

European Pharmaceutical Review

2 However, most of these efforts relating to catalysis, 3 process waste metrics, 4 lifecycle assessments, 5 pharmaceuticals in the environment 6 and the phase out of substances of concern 7 mainly mitigate the consequences of pharmaceutical manufacturing. However, it is already clear that the investments will be gargantuan.

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

pharmaphorum

Compounding the situation to understand how such an outcome was allowed to occur is the fact that many deals between government and pharmaceutical companies selling the treatments and vaccines were agreed under terms of confidentiality. The discussions over the treaty are set to continue for some time.

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Tracking the Drug Trail

Pharmaceutical Technology

Pharmaceutical companies, regulatory agencies and governments are becoming increasingly concerned about fraud and counterfeiting throughout the pharmaceutical supply chain, especially with the cost of drugs going up. “Europe is favouring 2D data matrix codes to encode information while the US is tending more towards RFID.”

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Validation master plan (VMP) – when and how to create one?

GMPSOP

Regulatory authorities require them to produce evidence that the processes and systems are validated, critical equipment is qualified, and manufactured products are tested for purity. Pharmaceutical companies are accountable for properly warehousing, shipping their products, and guaranteeing their stability until expiry.

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Overview of pharmaceutical quality control steps and implementations

GMPSOP

Certain laboratory reagents are categorized as dangerous commodities, including but not limited to explosives and gases, combustible compounds, peroxides and oxidizing agents, infectious substances and poisons, radioactive materials, and corrosives. Reagents should only be used for the purposes for which they were designed.