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TOP 10 CHALLENGES IN PHARMACEUTICAL PRODUCT LIFE CYCLE MANAGEMENT

eMediWrite

Understanding a product’s life cycle can assist a company in determining its position in the market relative to rivals and the success or failure of the product. Many pharmaceutical firms find it necessary to put additional quality control systems in place since they were responsible for producing a high-quality products.

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EMA publishes updated Q&A for ICH M10

European Pharmaceutical Review

The European Medicines Agency (EMA) has published an updated Q&A document regarding ICH M10 ‘Bioanalytical Method Validation and Study Sample Analysis’. These concentration measurements are used as part of regulatory decisions regarding the safety and efficacy of medicinal products.

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Bharat Parenterals Limited-Openings for Freshers & Experienced in Regulatory Affairs Dept. -Apply Now

Pharma Pathway

-Apply Now @ Bharat Parenterals Limited Department : Regulatory Affairs Qualification: M.Pharm Designation: Officer/ Officer/ Executive/ Senior Executive Experience: 02 to 05 years (Freshers can also Apply) Job Responsibilities: Responsible for Dossier & Documents preparation. Review of the dossiers, DMF & Technical documents.

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PDA revises report on glass container manufacturing

European Pharmaceutical Review

The long-awaited PDA TR 43 report provides an approach to a quality decision-making process and represents best practices for the identification and classification of visual nonconformities for (empty) glass containers as pharmaceutical product packaging.

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Driving QbD as a quality standard in drug development

European Pharmaceutical Review

While advantages to the Quality by Design approach is clear and practical implementation of Quality by Design is encouraged by publication of public guidance documents ICH Q8(R2) – ICH Q14, the industry has not yet fully embraced the QbD approach in Marketing Authorisation Applications (MAAs) for European market approval, the authors noted.

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Alembic Pharmaceuticals Ltd- Openings for Trainee- IT Helpdesk – Apply Now

Pharma Pathway

Alembic Pharmaceuticals Ltd. is an Indian multinational Pharmaceutical company headquartered in Vadodara city of Gujarat-India. Alembic pharmaceuticals Ltd. is involved in manufacture of pharmaceutical products, pharmaceutical substances and Intermediates. Trainee- IT Helpdesk. Qualification: Any Graduate.

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Leading freeze-drying systems suppliers for the pharmaceutical industry

Pharmaceutical Technology

Freeze drying is a crucial technique to prolong the shelf life of pharmaceutical products. Also known as lyophilisation, the technique stabilises and preserves sensitive products such as biologics, and diagnostic kits, in a permanently storable state.