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eMDR System Enhancements

The FDA Law Blog

Background FDA first introduced the final rule and guidance on eMDR in 2014 , which we blogged about here. For any major changes, additional time will be granted between the release of the implementation package and production deployment.

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Contamination Trends & Proposed Solutions

ISPE

The cases covered the same types of contaminants and impurities noted in Table 1: microbial contaminants, process-related im-purities, metal contaminants, packaging-related contaminants, drug cross-contamination, and an “unknown” category encompassing other contaminants associated with the manufacturing process, including those from cell culturing.

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Disrupted medical conferences: 2022 and beyond

pharmaphorum

Moreover, no attendee data was available for physical symposia, whereas all virtual symposia packages provided full attendee metrics analyses. Since then, many societies have indeed made discernible progress towards digital transformation of their events and communications practices. www.conferencecompass.com.

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). Nature Communications 12, no. September 2014. 3 (2020):e2970. 3 (2021):457.

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What to Keep in Your Integrative Medicine Cabinet

The Thyroid Pharmacist

Follow package instructions. These signals create communication and function within nerves and muscles, as the electrolytes move in or out of cells. Follow package directions for each supplement. The herb itself can be poisonous if ingested. They’re great for injuries, overuse, or soreness from workouts.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

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. Currently, it takes time and/or communications (e.g.,

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

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. Currently, it takes time and/or communications (e.g.,