European Pharmaceutical Review

NOVEMBER 24, 2022

These include Meditag serialised hologram labels, first introduced in 2005 and found on all registered medicines in Malaysia to help pharmacists and inspectors detect unauthorised and counterfeit product. Elsewhere, holographic labels have been deployed effectively to arrest declining sales of pharmaceuticals.

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Packaging Labelling Documentation Dosage 94

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

AUGUST 30, 2022

The Common Technical Document (CTD) for the Registration of Pharmaceuticals For Human Use: Quality—M4Q guidance covers the minimum requirements for submission of raw materials; however, certain regions have additional requirements. The absence of any of the listed documentation should be scientifically justified.

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Documentation FDA Packaging Communication 52

ISPE

MAY 10, 2023

Although the pharmaceutical industry has consistently improved manufacturing processes 3 in compliance with good manufacturing practices, 4 there are documented deviations from good practices 5 including the continued falsification of medicines. You may unsubscribe from these ISPE communications at any time. Lakerveld, B. Benyahia, P.

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Dosage Chemotherapy Documentation Labelling 52

Pharmaceutical Technology

JUNE 19, 2023

Issues with regulatory requirements and documentation can also cause significant delays, while any inaccuracies in translations on labelling can mean that dosage and storage information is not correctly understood or followed. And accurate labelling and translation are critical for this sector.

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Labelling Packaging Documentation Dosage 52

The Thyroid Pharmacist

FEBRUARY 10, 2023

A few years ago, I had a few clients with documented elevations in prolactin, and I have seen that lowering prolactin levels can help with reducing thyroid antibodies. Studies have, however, documented that bromocriptine, a medication used to lower prolactin levels, can reduce flares in lupus, another autoimmune condition.

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Dosage Documentation FDA Labelling 83