Pharmaceutical Technology

NOVEMBER 30, 2022

A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceutical products. Encouraged by the regulations, the industry is now mid-transition.

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Containment Manufacturing Production Regulation 130

Pharmaceutical Technology

MARCH 29, 2023

With the new version of EU GMP Annex 1 coming into effect on 25 August this year, big changes to the way the pharmaceutical industry approaches container closure integrity testing (CCIT) are in motion. In addition, 100% testing is now required for fusion-sealed containers such as ampoules and IV bags.

Containment 130

Containment Production Packaging Packaging 130

Pharmaceutical Technology

JULY 4, 2022

Russia is an already insular country and its worldview has tended to be self-contained, but this has hardened in the face of recent sanctions and counter-sanctions imposed during the war with Ukraine. Several global pharma companies have already withdrawn their support following Russia’s invasion of Ukraine, which began on 24 February.

Pharma Production 305

Pharma Production Production Clinical Trials Clinical Trials 305

Advarra

JULY 19, 2022

The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting? The sponsor-initiated IND is conducted by a pharma company seeking commercial approval.

Packaging 52

Packaging Packaging Drugs Containment 52

Drug Discovery World

MARCH 29, 2023

The commission is looking to put more pressure on pharma companies to report such shortages, and to offer a drug’s marketing authorisation to another company before withdrawing it from the market. However, stakeholders should be aware that the leaked review contains no such analysis.

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Clinical Trials Clinical Trials Production Medicine 52

The Pharma Data

MAY 13, 2021

Unfortunately, I learned the hard way that the “Big Pharma” companies don’t care about their patients. Carl was taking ibuprofen and opiates to manage the pain, but knew he had to be careful to regulate it because of the kidney and liver problems it could cause. It’s all about the bottom line, at any cost.

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Pharmacy Production Doctors Doctor 52