Pharma Mirror

APRIL 13, 2021

Sachets are a popular pharmaceutical and nutraceutical packaging format for consumers and manufacturers alike. To ensure accurate dosage and administration, the powders used in these delivery systems require excellent flowability. Consumers appreciate their ease of use and the ability to take them without water.

Dosage 52

Dosage Packaging 52

ISPE

MAY 9, 2023

In addition to the COR, some Latin American markets require approval in the COO, which is defined as the country where the drug is manufactured, packaged, or exported from. Sometimes, COAs for the drug substance, the excipients used in the formulation, and the primary and nonfunctional secondary packaging material are requested.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

MARCH 29, 2023

The TPP defines the indication and patient population, describes usage of the product, provides dosage and administration details, explains dosage form and strengths, and lists packaging and storage requirements. Specification criteria are often established to control CMAs. CPP 3 IPC Film coat weight gain (P.3.4)

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

The TPP defines the indication and patient population, describes usage of the product, provides dosage and administration details, explains dosage form and strengths, and lists packaging and storage requirements. Specification criteria are often established to control CMAs. CPP 3 IPC Film coat weight gain (P.3.4)

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

OCTOBER 27, 2022

Oligos generally have excellent stability in aqueous solutions, and lyophilized oligos are dissolved in aqueous formulation buffers for preparation of the final dosage form anyway. Some regulatory hurdles remain around classification of solution phase oligo as API versus drug product intermediates. Cell & Gene Therapy. Company Name.

Process Improvement 98

Process Improvement Packaging Dosage Compounding 98

ISPE

AUGUST 30, 2022

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. doi:10.1016/j.xphs.2021.09.046

Documentation 52

Documentation FDA Packaging Communication 52