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 results of the risk assessment are used to define experiments. 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. The results of the risk assessment are used to define experiments. CPP 3 IPC Film coat weight gain (P.3.4)

Documentation 52

Documentation Dosage Packaging Communication 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. Cone-bottom reaction vessels can provide the turndown required to process a variety of scales and handle different reactions.

Process Improvement 98

Process Improvement Packaging Compounding Dosage 98

ISPE

SEPTEMBER 11, 2023

Examples include platforms as small as autonomous units placed within a facility and mobile production trailers for compounding to platforms as large as a prefabricated, self-contained GMP facility. POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy. doi:10.1016/j.jbiotec.2015.06.388

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

AUGUST 30, 2022

With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Quality Management Maturity for Finished Dosage Forms Pilot Program for Domestic Drug Product Manufacturers: Program Announcement.” Burke, PhD. 1 September 2022. 5 (May 2022): 1232–1244.

Documentation 52

Documentation FDA Packaging Communication 52