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.

Packaging 69

Packaging Documentation Pharmaceutical Companies Pharmaceutical Companies 69

DiversifyRx

NOVEMBER 24, 2023

Exploring the Drug Supply Chain Security Act (DSCSA) The DSCSA, signed into law in 2013, aims to heighten the security of the pharmaceutical supply chain by creating a framework for traceability and accountability. This record-keeping includes detailed documentation of the product’s history and movement through the supply chain.

Independent Pharmacies 52

Independent Pharmacies Packaging Documentation FDA 52

ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

Impact Pharmaceutical Services

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.

FDA 40

FDA Packaging Documentation 40

The People's Pharmacy

MAY 8, 2023

“The FDA said Global Pharma failed to use adequate, tamper-evident packaging and distributed the drugs without proper preservatives.” There have been problems with records in the past: deceit, falsification of documents and even outright fraud. Since the start of 2013, pharmaceutical companies based in the U.S.

FDA 72

FDA Pharmaceutical Companies Pharmaceutical Companies Medical Schools 72

The FDA Law Blog

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 FDA Documentation 45

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 Immunization Labelling 52