FDA Amends Drug Shortage Regulations

Read the full text final rule: Federal Register | Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products:

"The rule requires all applicants of covered approved drugs or biological products—including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application—to notify FDA electronically of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the product in the United States."

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WHO publishes interesting new Guidance for the Storage and Transport of Pharmaceutical Products - GDP Group

• Respected FDA cGMP online training programs and courses taught by SkillsPlus International Inc.

View the article with multiple links:  GMP News: WHO publishes interesting new Guidance for the Storage and Transport of Pharmaceutical Products - GDP Group, an ECA Foundation Interest Group:

"For those working in the area of Good Distribution Practice (GDP) the following paper might be interesting: Technical supplements to Model guidance for the storage and transport of time and temperature-sensitive pharmaceutical products."

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Who Offers GMP Training?

Updated March 10, 2021

Given the COVID-19 pandemic, people also search for:

Current Good Manufacturing Practice Training: A New Generation Series - CGMP Online Courses

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Who Offers GMP Training?

SkillsPlus International Inc. offers highly respected cGMP training. Here's why you need to choose SkillsPlus Intl Inc.:

SkillsPlus Intl Inc. can be your one-stop shop that: meets your needs, wows students, and makes your training delivery easier!

Visit SkillsPlus Intl Inc. training products & services, or call (415) 948-5220.

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FDA slaps U.S. drugmaker over drug testing issues - FiercePharma Manufacturing

• FDA cGMP online training programs and courses offered by SkillsPlus International Inc.

Read the full article: FDA slaps U.S. drugmaker over drug testing issues - FiercePharma Manufacturing:

"Inspectors were particularly troubled with batch testing after inspectors found "multiple incidents of inaccurate batch production records containing erroneous statements, including results that were not derived from analytical testing" or from certificates of analysis (CoAs) of its suppliers."

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You might also be interested in the following GMP training course:

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New FDA Guidance to Avoid Overfill of Vials - ECA GMP News

• FDA cGMP QSR GMP Training - online training courses by SkillsPlus International Inc.

Updated July 2, 2024;

The original link broke.

People are also asking about:

Moderna asks FDA's permission to add 5 more COVID-19 vaccine doses per vial - Becker's Hospital Review

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Read the full article: GMP News: New FDA Guidance to Avoid Overfill of Vials - ECA:

"If a liquid is withdrawn from a vial by means of a syringe, remains of the liquid stay in the vial or on its walls. Since it is nearly impossible to extract 100 % of the liquid but the dosage has to be correct, nevertheless, vials usually are slightly overfilled. A vial with a dosage of 1 ml might for example contain 1.1 ml. The FDA has two points of concern: on the one hand some manufacturers fill up to much or not enough drug products without sufficiently justifying this which may result in medication errors. On the other hand the leftover of several vials with excess volume could be pooled to obtain a further dose which could lead to microbial problems."

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View the guidance:
Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products - FDA Guidance for Industry (PDF)

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Ex-Homeland Security cyber chief warns of threats to outsourcing firms - Outsourcing Pharma

Read the full article: Ex-Homeland Security cyber chief warns of threats to outsourcing firms - Outsourcing Pharma:

. . . "drug companies should consider the weaknesses in all their relationships, from research contracts to materials supply, big data, logistics, cloud solutions such as SalesForce used by sales and marketing companies, and file-sharing services."

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FDA Orange Book 2014 - 34th Edition

The 2014 FDA Orange Book (34th Edition) is hot off the press.

This 34th edition of the FDA Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) is current through December 31, 2013.

View the Orange Book:
FDA Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) - PDF

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