European Pharmaceutical Review

JULY 5, 2023

The long-awaited PDA TR 43 report provides an approach to a quality decision-making process and represents best practices for the identification and classification of visual nonconformities for (empty) glass containers as pharmaceutical product packaging.

Pharmaceutical Manufacturing 96

Pharmaceutical Manufacturing Packaging Documentation Pharmaceutical Companies 96

European Pharmaceutical Review

APRIL 8, 2025

Given that multiple work packages may often start or end together, or else take longer than others ( Figure 1 ), the introduction of new PAT requires assessment and planning by multiple departments. Any documentation, such as validation reports then helps with compliance and later regulatory submissions and requests.

Documentation 52

Documentation Packaging Pharmaceutical Manufacturing 52

Express Pharma

MARCH 16, 2025

and Europe held manufacturers accountable for their environmental impact, leading to an increase in partnerships with tech companies focused on sustainable packaging and production solutions. Regulatory bodies in the U.S. Finally, reshoring and localised production emerged as key strategies for improving supply chain resilience.

Biosimilars 98

Biosimilars Insurance Coverage and Processing Pharmaceutical Companies Pharmaceutical Companies 98

FDA Law Blog: Biosimilars

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. The compliance dates were first published in 2013, and subsequently updated in various guidance documents and regulations published by FDA.

Labelling 45

Labelling Packaging Documentation 45

Syner-G

AUGUST 9, 2022

In 2013, the IMPACT (now part of Syner-G BioPharma Group) management team decided that the company needed to build a Regulatory Operations department to support their existing and future client base. Hosted software to publish regulatory submissions in the electronic common technical document (eCTD) format was deployed.

Packaging 40

Packaging Documentation 40

The Thyroid Pharmacist

JULY 29, 2022

Feel free to use my own health timeline as a guideline to document your health journey. Most filter manufacturers have pictures on their filter packaging that indicate what they will and will not filter, along with the MERV rating. Are your symptoms worse in the winter when the house is shut tight, but fine when windows are open?

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunity Immunization 52