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9 ways pharmacy technician roles are changing

The Checkup by Singlecare

This includes counting, measuring, and packaging medications, as well as labeling and organizing them for distribution. They may also be involved with medication compounding and assisting with clinical trials, depending on the healthcare setting. RELATED: Ways to prevent common pharmacy errors 7.

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FDA guidance highlights E&L considerations for ophthalmic drug products

European Pharmaceutical Review

This document is revised from a version published in October 2023. Firstly, leachables can compromise a products quality and therapeutic effect, by potentially interacting with the formulated drug product, the document reported. Moreover, manufacturers should document information about their safety thresholds, the guidance stated.

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Life-Cycle Approach to Cleaning Topical Drug Products

ISPE

Robbins 1 January 2023 Topical drug products and cosmetics are often manufactured in the same facility under a unified quality standard that supports the topical drug products’ performance and label claims. 1 US Food and Drug Administration. However, some of the products manufactured in a topical drug facility can be difficult to clean.

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Air Quality and Hashimoto’s – Is the Air You’re Breathing Making You Sick?

The Thyroid Pharmacist

I’ve seen a number of airborne toxins showing up as frequent triggers/exacerbating factors for my clients’ autoimmune conditions — mold, volatile organic compounds (VOCs), and artificial/synthetic fragrances, in particular. For sunscreens and other over-the-counter drugs, fragrances must be identified on the label.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” If elements such as these are adopted during the revision of ICH M4Q, this could influence global regulatory agencies to eliminate the requirement for custom Module 2 commitment documents. The authors propose using Module 2.3 Published 15 November 2021.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” If elements such as these are adopted during the revision of ICH M4Q, this could influence global regulatory agencies to eliminate the requirement for custom Module 2 commitment documents. The authors propose using Module 2.3 Published 15 November 2021.

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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). Burke, PhD. 1 September 2022.