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Leading API biologics (cell, gene, vaccine and virus) companies in contract marketing

Pharmaceutical Technology

The list includes providers of development services, biologics management supply chain solutions, clinical trial services, commercial and logistics services, as well as packaging, labelling and distributing services for biologics.

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ICH Q6B for Analytics

PharmTech

A magnifying glass examining a vintage vaccine vial surrounded by four minimalistic chart icons, symbolizing healthcare, medicine, and analytics in the context of global health monitoring. While the document itself is a quarter of a century old at this point, it is laid out in such a way that relevancy is maintained.

Dosage 52
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Cold Chain Packaging – Current Scenario and Future Potential

Roots Analysis

Further, the cold chain storage process involves the cold chain storage, cold chain transportation, and monitoring temperature controlled packaging products. Therefore, the pharmaceutical, biotech, food and chemical industries usually rely on cold chain packaging for the transportation of their products.

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Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g., 16 Health Canada.

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Pharmaceutical Compounding Calculations, Part Two–Bulk Drugs

PharmTech

It builds on drug calculations topics previously described (1), including guidance documents (2–5). FDA guidance documents illustrate labeling salt drugs and associated active moieties. From the Dilantin package insert: “The free acid form of phenytoin is used in DILANTIN-125 Suspension and DILANTIN Infatabs.

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Cell and gene therapy: The vital role of logistics

Pharmaceutical Technology

How will RFK Jr’s American dream for vaccines play out? In addition, documentation of the material is required, along with clearly defined next steps for modification and expansion. Such logistics requires specialists in cold chain logistics, who need to maintain a full chain of custody and ensure traceability.

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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). Finally, the DP is packaged in a suitable container to ensure continued quality. This is followed by DP manufacturing, where the DS is formulated with excipients.