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Added by John Robinson on February 2, 2018 at 5:22am — No Comments
Lyophilization is the clinical term for freeze-drying. In the simplest terms, it can be described as a technical process in which the moisture level of many materials is reduced, most times frozen, for the purpose of creating a new product or an ingredient.
When an injectable drug is freeze-dried -this is the process of lyophilization -its compounds are stabilized. This reconstitution process is…
ContinueAdded by Adam Fleming on January 25, 2018 at 5:13am — No Comments
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Added by John Robinson on December 8, 2017 at 5:40am — No Comments
Medical devices and drugs clinical research have their differences in approach and methodology. It is necessary to have a clear understanding of these differences if one embarks upon a study involving either or both of these.
Some of the major differences between device and drug clinical research include:
Requirement for a study:
One of the important differences between device and…
ContinueAdded by Roger Steven on November 23, 2017 at 6:16am — No Comments
Auditing Quality Management Systems is a core requirement for ensuring that Quality Management Systems – defined as “…a set of policies, processes and procedures required for planning and execution” in the core business area of an organization, meaning those that impact the ability of the organization to meet…
Added by John Robinson on November 21, 2017 at 5:20am — No Comments
The application of DOE and SPC to the development, design and monitoring of manufacturing and testing requires the use of procedures. Why? It is because in a recent guidance document on Process Validation, the FDA has named the Quality Unit as being responsible in the review and interpretation of DOE and SPC studies.
The Quality…
Added by John Robinson on November 2, 2017 at 6:49am — No Comments
The basic reason for which analytical methods and procedures need to be validated is to ensure that analytical data have consistency, accuracy and reliability. This becomes possible when laboratories employ proper scientific methods and procedures and validate analytical methods and procedures. This is the only means to ensure that the analytical data are reliable, consistent and accurate.
The aim of doing so is to substantiate the suitability of…
ContinueAdded by John Robinson on October 4, 2017 at 6:49am — No Comments
The basic reason for which analytical methods and procedures need to be validated is to ensure that analytical data have consistency, accuracy and reliability. This becomes possible when laboratories employ proper scientific methods and procedures and validate analytical methods and procedures. This is the only means to ensure that the analytical data are reliable, consistent and accurate.
The aim of doing so is to substantiate the suitability of…
ContinueAdded by John Robinson on October 4, 2017 at 6:48am — No Comments
Software project management has an important tool in the Agile methodology. The Agile methodology developed as a product of the gradual efforts at arriving at a team…
Added by John Robinson on August 7, 2017 at 6:17am — No Comments
Biosimilars can be described as near-copies of an original pharmaceutical product that another company may have manufactured. These products are versions of an original or innovative product, but are officially approved.
There is a misconception that they are similar to or are the same as generics, but this is not so in…
Added by John Robinson on June 27, 2017 at 6:01am — No Comments
Putting in place a program for calibrating and maintaining test and measurement equipment is a regulatory requirement from both the FDA, under 21 CFR Part 210 and 211, and relevant EU regulations. Both these agencies have regulations that require this program from manufacturers.
The purpose of this equipment validation program is to ensure these…
Added by Adam Fleming on May 26, 2017 at 6:21am — No Comments
Added by John Robinson on May 16, 2017 at 6:22am — No Comments
A perfect hire is a boon to any organization. At the other extreme, a bad hire can bring the inverse result to the organization: It can not only impede productivity; it can even result in drawing the organization into legal issues associated with wrong hiring. Problem employees create employee problems, which is why HR professionals need to be aware of what steps to take and what scenarios to avoid if…
ContinueAdded by John Robinson on May 5, 2017 at 6:21am — No Comments
Professionals in the field of statistical analysis need a clear and perceptive insight into how to understand and interpret statistical concepts used to investigate quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits. Along with these, process and quality controls, as well as ICH Q8 and Q9 also need to be properly and thoroughly understood.
The ICH tripartite-harmonized ICH…
ContinueAdded by John Robinson on May 3, 2017 at 6:18am — No Comments
In the area of GMP regulations, procedures are very vital, for both execution and audits. It is always true that the greater the clarity and comprehensiveness with which these procedures are written; the easier it becomes for users to use them without missing important information for regulators.
Despite the advent of technology into almost all the areas of GMP regulations; there is still the existence of the human factor. It is still the major…
Added by Adam Fleming on April 19, 2017 at 6:44am — No Comments
Considered one of the most significant changes to be introduced into the American healthcare sector since the passage of the Affordable Care Act; the 21st Century Cures Act was one of the last legislative acts of outgoing president Barack Obama. Signed into law in December 2016; the 21st Century Cures Act seeks to strengthen medical research, foster innovation and accelerate the development of innovative treatments for chronic ailments such as cancer.…
Added by Adam Fleming on March 16, 2017 at 6:00am — No Comments
The constant pressure on health services is an age old cliche, we need to constantly look at ways of improving the method of delivery with the growing demand of patients. We believe that everyone in the world should have access to safe, fast, affordable healthcare. Yet our healthcare services are falling short. Technology that connects patients with high quality care is part of the solution and we think we’re uniquely positioned to build it.
This correlates with the latest…
ContinueAdded by Dr Felix on March 13, 2016 at 8:18am — No Comments
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