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Good Storage Practice Training: Benefits and Importance

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Published - 17.May.2016
Definition and Purpose of effective Data Management Planning

 

Companies that operate within the Pharmaceutical and Pharmacovigilance field and experts involved in the storage of drugs and/or other medicinal products are legally required to be fully aware of the requirements that accompany relevant practices. All professionals engaged in clinical studies of an investigational drug and its efficient preservation are expected to carry out the necessary set of actions and tasks in accordance with Good Storage Practice (GSP) formal guideline. Because of the seriousness of the matter and the importance of well-performed procedures that have to be compliant with regulations and other applicable ethical principles, it is significant for members of staff to complete additional GSP training. But before we go on and outline why such courses matter, let’s first briefly clarify the role GSP has in research.

What makes the GSP training topic more and more relevant for the Clinical Research industry?

Good Storage Practice is valid in all occasions related to storing and distributing pharmaceuticals. There are, of course, many different specifics that need to be taken into account in order to guarantee full regulatory compliance. This includes sufficient knowledge about SOPs, dealing with electronic and paper records, preparing storage areas which allow orderly preservation of different categories of medicinal products, maintaining and monitoring of appropriate storage conditions, working with computerized systems, controlling incoming materials and many more. What’s interesting but not so unusual or unexpected is that in recent years, the significance of GSP is considered to have grown exponentially. Especially when it is more closely linked to the overall clinical research sector. Thus, along with Good Distribution Practice, GSP is part of the management chain of pharmaceuticals. And that management chain, precisely, is key for it makes sure that potency, quality, usability, efficiency and the physical integrity of medicaments are preserved and well kept.

Clinical Data Management

What will our GSP training do for you?

The majority of the Pharmaceutical and Biotech companies as well as CROs request people who are certified in the area, know the nitty-gritty and are more than competent enough to perform the assigned tasks. Astra Nova specializes in the distribution of the most imperative and industry-related training programs that contain the information requested by industry leaders all around the globe. We have prepared a comprehensive GSP course which will help you upgrade your knowledge and prove yourself as a qualified expert in the clinical research.

Good Storage Practice course consists of a wide-ranging agenda that outlines crucial terms, regulations and requirements related to the personnel involved and their responsibilities, essential definitions, premises and facilities, storage conditions etc.

The training also looks at vital documentation and specific storage instructions, complemented by charts and diagrams.

Who is this training suitable for?

  • Distribution staff
  • CRAs
  • Quality Assurance Personnel
  • Quality Control Personnel
  • Suppliers and vendors
  • Operations and Storage Personnel

Finally, in line with our vision and goal to help people in the Pharmaceutical, Clinical and Medical sector extract the most out of our services, we have prepared a whole list of other free training and certification programs relevant to the industry. Learn more about them, get a combination of Astra Nova’s courses or set up your own training package and get a discount of 25% on your purchase.

 

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