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The Role of Good Manufacturing Practice (GMP) in Generic Drug Manufacturing: Ensuring Quality and Safety

Drug Patent Watch

The Unseen Heroes of Generic Drug Manufacturing: Good Manufacturing Practice (GMP) As we navigate the complex world of generic drug manufacturing, it's easy to overlook the unsung heroes that ensure the quality and safety of these life-saving medications. But what exactly does GMP entail?

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The Role of Quality Assurance in Generic Drugs

Drug Patent Watch

The Unsung Heroes of Generic Drugs: The Importance of Quality Assurance As we navigate the complex world of pharmaceuticals, it's easy to overlook the behind-the-scenes efforts that ensure the quality and safety of the medications we rely on. So, what can we learn from the importance of Quality Assurance in generic drugs?

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Indian pharma manufacturing: rising investment in Andhra Pradesh

Pharmaceutical Technology

Indian pharma manufacturing continues to be the backbone of drug supplies worldwide, and GlobalData analysis suggests US overreliance on the country for generic drug supply. Pharma manufacturing facilities in Andhra Pradesh and Telangana accounted for 22.5% © GlobalData. © GlobalData.

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STAT+: Major Indian generic drugmaker closes a U.S. facility after years of manufacturing problems

STAT News

After a decade of manufacturing problems, a U.S. federal court ordered a unit of Wockhardt, one of the largest makers of generic drugs, to refrain from making allegedly adulterated medicines at a facility in Illinois. However, the U.S. Continue to STAT+ to read the full story…

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Quality by design with a focus on biosimilars

Pharmaceutical Technology

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Biosimilars are biologic medical products that almost exactly replicate products already being manufactured by other companies.

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Health Canada’s proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations

Pharma in Brief

Terms and conditions would be imposed after discussions with the manufacturer and would obligate them to take steps to manage risks and resolve uncertainties. An RMP summarizes the risks of a drug and the pharmacovigilance activities and other measures that a manufacturer puts in place to monitor and manage any identified risks.

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Hitting Pause on Criticism of the FDA, Just for Today

Pharmacy Checkers

The FDA’s capacity to evaluate new and generic drug applications and its oversight over drug manufacturing are why we have this degree of assurance. The FDA is also looked to by drug regulatory authorities in other countries for its strengths. The FDA’s Role in Protecting Our Drug Supply. Far from it.