ISPE

OCTOBER 26, 2022

In addition, we took the Board on tours of Vetter’s facilities for sterile products and through all the production steps: compounding to fill-finish to automated visual inspection and secondary packaging. Most Board members were able to attend in person, and we had very productive Board and Executive Committee sessions.

Packaging 52

Packaging Compounding Communication Vaccines 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

OCTOBER 27, 2022

Broad pipelines require facilities to be designed with a large degree of flexibility to support anything from mild reaction conditions to the use of potent or highly biologically active compounds. Large walk-in fume hoods are organized to support a variety of unit operations. Getting More from Facilities. Cell & Gene Therapy. Company Name.

Process Improvement 98

Process Improvement Packaging Compounding Dosage 98

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. The purpose of the QTPP is to link the attributes of the DP back through the TPP to the needs of the intended patient population.

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. The purpose of the QTPP is to link the attributes of the DP back through the TPP to the needs of the intended patient population.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 6, 2023

solvent selection, inhaler propellant replacement, and packaging design) to employee travel and commute policy (e.g., recycled content in packaging, reduction of packaging weights). 16 The second category covers the internal business choices that have an influence on scope 3 emissions.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Compounding 52

ISPE

AUGUST 30, 2022

With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. 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). Burke, PhD. 1 September 2022.

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Documentation FDA Packaging Communication 52