Remove Documentation Remove Information Remove Pharmaceutical Manufacturing
article thumbnail

STAT+: FTC says pharmacy benefit managers are stonewalling requests for information

STAT

antitrust regulators into pharmaceutical industry middlemen has been stymied because the companies have failed to provide many of the documents that, in some cases, were requested as far back as June 2022. A much-anticipated inquiry by U.S.

article thumbnail

Revised Annex 1 now effective

European Pharmaceutical Review

The European Commission (EC)’s revised Annex 1 – Manufacture of Sterile Medicinal Products is now effective in the EU. As of 25 August 2023, pharmaceutical manufacturers are required to implement the GMP regulation into cleaning and bio-decontamination procedures for these products. What is included in the new revision?

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

How should cleaning validation sampling locations be chosen?

European Pharmaceutical Review

A recent paper outlines a process that can be used to select and document worst-case sampling locations to validate cleaning processes. To overcome these concerns, Pluta presents the process and documentation activities undertaken by one company.

article thumbnail

Top 5 takeaways from international hybrid and virtual meeting guidance for pharma

pharmaphorum

But the new Joint Guidance on Virtual and Hybrid International Medical Congresses, from the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the Pharmaceutical Research and Manufacturers of America (PhRMA) is here to plug that gap.

article thumbnail

DOP amends PTUAS, expands eligibility criteria to include MSMEs

Express Pharma

A statement from the Department of Pharmaceuticals informed, “The Department of Pharmaceuticals is confident that reform in the PTUAS Scheme will contribute to the pharma industry’s growth and compliance with global manufacturing standards. 500 crore over the last three years.

article thumbnail

Moving to component management & traceability: progress, barriers, and the way forward

pharmaphorum

Component management is fairly new to the regulatory market, with pharmaceutical firms moving from traditional document management systems to more dynamic component content management systems. Most of the information is submitted in the form of unstructured PDF documents, with data embedded into them.

article thumbnail

Leading patient adherence pharmaceutical companies

Pharmaceutical Technology

The download contains detailed information on the providers and their services and solutions, alongside contact details to aid your purchasing decision. Pharmaceutical companies are increasingly integrating data-driven and software-centric medical adherence products to improve patient compliance. Patient adherence.