Monday, June 29, 2015

Who Offers GMP Training?

Who Offers GMP Training?

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

Expertise - We've been delighting clients for more than 20 years. Allan Dewes, President & master trainer, combines his regulatory knowledge and operations experience to meet your needs. He's personable, an active listener, and a trusted partner to 100s of satisfied domestic & international clients. He helps clients succeed.

Live GMP Training - Leadership and course participants rave about our onsite courses. These popular courses are considered interactive, engaging, relevant, and sometimes fun! Students want to be in our classes, instead of trying to find ways to avoid going to class.

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 Allan Dewes, President & master trainer, (415) 948-5220.

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Thursday, June 25, 2015

Wednesday, June 24, 2015

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

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"If a liquid is withdrawn from a vial by means of a syringe, remains of the liquid stay in the vial or on its walls.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."

'via Blog this'

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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