Quality Assurance Articles

The safe use of medicines depends upon the ability of users to read the information on the medicine label carefully and accurately and being able to act accordingly. The label provides important information on the use of the medicines, which helps the users to make correct use of their medicines.

Regulations such as 21 CFR Part 11 have been well understood (and implemented) by the industry for several years. However, for the first time, the life sciences industry is feeling the need to manage regulatory compliance across regulations on a risk-based approach. Often, there is one officer in the company who is charged with regulatory compliance, and this officer is keenly interested in mitigating risk proactively in a unified governance framework for the company.

As biopharmaceutical companies bring new products to market, they generally focus on clinical development, regulatory submissions, and preparation of the target market. Equally as critical is developing the product's commercial supply network. Thoughtful planning and design of the supply chain during product development significantly impacts not only the efficiency of commercial supply, but also the flexibility required to accommodate lifecycle changes. Ultimately, the right supply chain can help ensure the availability of critical and life-saving products to patients who need them. Conversely, an ill-planned supply chain can increase operating costs, restrict a company's flexibility, and constrain the flow of product to patients.

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"I was the new employee and needed some information," says our GMP Agent-in-Place. "Our company makes 300 products, and some products use common ingredients. We had to make a change in one commonly used ingredient and wanted to be sure that we had evaluated the effects for all the necessary products. Because I was new, I didn't know how to figure this out except by looking at all the , and I voiced this frustration to my boss. She told me to use the 'Gazinta Report.'

"So I asked several people for this report, and was given a six-inch thick computer printout. But when I looked at the title, it didn't say Gazinta, and I thought I had the wrong data. When I asked my boss again, she laughed and told me to read the name fast. Apparently, the original request for what is commonly known as 'where used' data was requested as 'what the ingredient goes into,' and the printout was titled 'Goes Into Report.'"

The authors describe how XML-based technology can be used to manage the creation of batch records.



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With the approval of Title 21 Code of Federal Regulations (CFR) Part 111 o­n March 20, 1997, Information Technology (IT) was thrust to the forefront of the Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), (GxP) comp l i a n c earena. Prior to the implementation of Part 11 in August 1997, I T p r i n c i p a l s were usually behind the scenes performing such critical tasks as data backup and archival, setting up access...


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The right person can successfully promote proper management of quality and compliance, leading to desired clinical trial outcomes.The purpose of this article is to propose a role called "quality coach," an independent expert dedicated to system and project quality, as a member of teams implementing software applications to support clinical data management activities. The article presents the issues unique to the regulated environment in which the software project resides, and explains the advantages the quality coach role brings to the team and the accomplishment of its goals. The concept of a quality coach is new and unproven.

Quality assurance units are interwoven throughout the biopharmaceutical enterprise and provide support to sustain operations. Most importantly, they must have the capacity and leadership to adapt to change.

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Have you ever asked or faced any of the following questions regarding Annual Product Reviews (APRs):

Why are APRs required?
We are behind o­n our schedule – how can we get caught up?
Who really is responsible for APRs?
Why is completing APR information always the last priority?
Can we shorten APRs to make them quicker and easier to complete?
Does anything beneficial really result from APRs?

FDA has found several pharmaceutical companies not maintaining Class 100 conditions within transfer carts. The author discusses an approach for designing a transfer cart that will satisfy such conditions.

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