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. Cell & Gene Therapy. Unlock Access to Member-Only Content.

Process Improvement 98

Process Improvement Packaging Dosage Compounding 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 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

MAY 9, 2023

Additionally, quality control testing of these compounds is conducted using standard testing following applicable pharmacopeia—such as United States Pharmacopeia (USP), European Pharmacopeia (EP), and Japanese Pharmacopeia (JP)—that was current at the time of testing. Accessed 6 July 2022.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 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