Express Pharma

OCTOBER 4, 2023

These workshops are set to continue over the next few months. Another concern for smaller players is that the updated Schedule M will bring in mandatory annual audits of their approved suppliers, including raw material and packaging material suppliers. Will such changes be too exhaustive to implement? These are legitimate concerns.

Packaging 103

Packaging Documentation 103

pharmaphorum

JANUARY 18, 2022

Main Conference: April 25 – 26, 2022 | Workshops: April 27, 2022. Primary Packaging material designers. Secondary packagers. POST CONFERENCE WORKSHOP A: EU MDR 2017/745 Article 117 Requirements. Workshop Leader: Theresa Jeary, Technical Specialist & Scheme Manager, BSi. SMi’s 9th Annual Conference.

Packaging 52

Packaging Documentation Vaccines Drug Development 52

Quality Matters

NOVEMBER 11, 2022

FDA) workshop , my fellow panelist and I addressed the latest developments in the identification and control of nitrosamines in pharmaceutical products. FDA and other global regulatory agencies have issued public health alerts and guidance documents for manufacturers. Earlier this year, at a U.S. Food and Drug Administration (U.S.

Packaging 52

Packaging Documentation Compounding Diabetes 52

GMPSOP

FEBRUARY 10, 2024

GMP/GLP and PPE training are applied to all employees, contractors and casual staff working in a GMP environment, including manufacturing, packaging, labelling, distribution, QA, QC, development, validation, engineering, IT staff and anyone whose activities could affect product quality. Additional documents are included each month.

Health and Personal Care Stores 52

Health and Personal Care Stores Documentation Packaging Compounding 52

GMPSOP

FEBRUARY 15, 2024

They should place all discarded cardboard, paper, and corrugation from the Packaging Dept. Quality assurance inspectors destroy all unused labels and inserts from the Packaging Lines. Additional documents included each month. Labelling and documentation Clearly label all containers, equipment, and production areas.

Documentation 52

Documentation Labelling Compounding Packaging 52

pharmaphorum

FEBRUARY 2, 2022

Through a series of workshops and surveys, which collected the views of research professionals, patients and carers, the group has developed a new guidance document. But how do we package that up?” But we need to evaluate for the gains we hope for, as well as for any unintended consequences.”. A practical consensus.

Documentation 52

Documentation Packaging Communication 52

FDA Law Blog: Biosimilars

DECEMBER 6, 2024

As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance documents now covering CGT product development. CBER will not commit to reviewing packages greater than 250 pages.

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Documentation Packaging Clinical Pharmacology Drug Development 59