ISPE

MARCH 29, 2023

Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2. Specification criteria are often established to control CMAs.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2. Specification criteria are often established to control CMAs.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. Accumulus Synergy White Paper. Common Technical Document [CTD] sections). doi:10.1016/j.xphs.2021.09.046.

Documentation 52

Documentation FDA Communication Packaging 52

Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. During the Covid-19 pandemic, large-scale vaccine production placed unprecedented demand on the parenteral packaging industry.

Packaging 52

Packaging Compounding Pharmaceutical Companies Pharmaceutical Companies 52

Pharmaceutical Technology

MARCH 21, 2023

Based on the individual contract, these CMOs manufacture small molecules or biological active pharmaceutical ingredients (APIs), as well as packaging material, and are charged with other related functions. Sharp Packaging Services is producing the solid dose of the drug and packaging it.

Packaging 59

Packaging FDA Vaccines Labelling 59

Pharmaceutical Technology

DECEMBER 8, 2022

Forward-thinking suppliers, including packaging component providers, are also looking at how they can improve their processes through digital technologies. Tom Lenaerts is head of global process engineering for Datwyler, a leading supplier of parenteral packaging components such as stoppers and plungers. Free Whitepaper. By Datwyler.

Packaging 98

Packaging Vaccines Communication 98

Pharmaceutical Technology

FEBRUARY 9, 2023

Container Closure Integrity Testing (CCIT) is used to evaluate the ability of a pharmaceutical’s primary packaging to protect the sterility of its contents. On a regular basis, pharmaceutical manufacturers are performing CCIT during commercial production to ensure that packaging processes are operating as they should.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Communication 52

Pharmaceutical Technology

MARCH 22, 2023

The European Commission plans to launch its revised EU pharmaceutical package in Q1 2023 to ease drug shortages,” she says. Among other things, supply chain optimisation, maintaining access to affordable vaccines, and supporting innovation for unmet clinical needs will be the discussion topics, she adds.

Packaging 105

Packaging FDA Pharmaceutical Companies Pharmaceutical Companies 105

Pharmaceutical Technology

JANUARY 15, 2023

While Catalent Inc and PCI Pharma Services are in charge of the solid dose and packaging of Lupkynis, Lonza is manufacturing the small molecule API. Vetter Pharma-Fertigung GmbH & Co KG is conducting the parenteral manufacture and packaging for Trulicity.

Labelling 52

Labelling Packaging FDA Communication 52

Pharmaceutical Technology

NOVEMBER 28, 2022

We source as much of the materials as we possibly can locally, even packaging,” he notes. When we need new packaging, it is really simple to get and it is quick. “We have the skills. Wherever we can do it locally, we do. It generally does speed up supply; things get to the factory quicker. Printing is done in Glasgow.

Packaging 52

Packaging Hospitals Medical Schools Documentation 52

Pharmaceutical Technology

MARCH 7, 2023

Due to rising healthcare spending, launch of novel treatments, and the rise of chronic diseases in an aging population, the global pharmaceutical packaging equipment market is rapidly expanding. Recent analysis valued the market [i] at USD 8.5 billion in 2021, which is expected to reach $15.77

Dosage 52

Dosage Packaging Communication 52

Pharmaceutical Technology

JANUARY 12, 2023

That would not allow sufficient time to manufacture, package and distribute before half of the content was degraded. Solid state reactions occur much more slowly than liquid interactions. A great example is aspirin. Its half-life is only 50 hours if prepared as a solution. That is the reason aspirin is only sold as a solid.

Packaging 52

Packaging Communication Vaccines 52

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. The evolution of CCIT.

Packaging 52

Packaging FDA Communication 52

Pharmaceutical Technology

FEBRUARY 7, 2023

They can also give their feedback on the design of the clinical trial, if the comparator reflects the standard of care, and if real-world evidence is part of the evidence requirement package.” Overall, it is never too soon to begin market access activities, but it can easily be too late.

Packaging 52

Packaging Insurance Pharmaceutical Companies Pharmaceutical Companies 52

Pharmaceutical Technology

JANUARY 20, 2023

While using high-capacity aircraft and minimal packaging reduces weight and increases capacity for vital products by using fewer flights. To learn more about how Tanner is adapting to changes in the clinical trial supply chain and embracing technological innovations, download this white paper.

Pharmaceutical Companies 142

Pharmaceutical Companies Pharmaceutical Companies Packaging Communication 142

Pharmaceutical Technology

DECEMBER 15, 2022

Kenilworth, NJ, US) is investing $500 million in its Singapore facilities, including setting up a secondary packaging facility and building an inhaler production plant. This year, BioNTech (Mainz, Germany) announced plans to acquire a Singapore facility from Novartis for captive capacity vaccine manufacturing. Additionally, Merck & Co.

Vaccines 105

Vaccines Packaging Pharmaceutical Companies Pharmaceutical Companies 105

Pharmaceutical Technology

FEBRUARY 27, 2023

Contract manufacturing organizations (CMOs) not only produce the active pharmaceutical ingredient (API) at the heart of a therapy, but are also responsible for the sterile manufacturing and packaging of liquid and inhalational drug constituents and packaging, depending on the needs of the particular therapy.

Packaging 52

Packaging Chemotherapy FDA Labelling 52

Pharmaceutical Technology

JANUARY 6, 2023

The preparation of a semi-solid dosage form – from formulation and development, to scale-up, commercial manufacturing, and packaging – should ideally take place under one roof in a contiguous, end-to-end workflow to avoid unnecessary equipment and process changes.

Dosage 52

Dosage Packaging Communication 52

Pharmaceutical Technology

FEBRUARY 23, 2023

Quotient Sciences supported a standalone DCS classification and formulation development package. A recent example of this was for a compound at the candidate selection stage. Permeability was high and solubility at 24 hours in intestinal buffer was less than the expected therapeutic dose, so solubility was classified as “low”.

Compounding 98

Compounding Dosage Packaging Communication 98

Pharmaceutical Technology

FEBRUARY 3, 2023

Compared to other dosage forms, tablets are simpler to manufacture, package, and transport. Tablet manufacturing, which is the most common OSD form, takes an API dry powder ingredient and compresses it to form tablets, which can be coated or uncoated.

Packaging 52

Packaging Dosage Pharmaceutical Companies Pharmaceutical Companies 52