Articles

Choosing a Suitable Laboratory Equipment Supplier

October 5th 2015

Purchasing new equipment can a big decision for any laboratory. Companies need to weigh up all the options, and think about not only the initial cost but the long term expected return on investment. With so many suppliers out there, you need to make sure you choose the right one.

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5 Design Considerations for New Laboratories

September 29th 2015

While every laboratory is different, there are a few important design principles common to each. Here we take a look at 5 of the most important for a successful working space.

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New Product Development – Do’s & Don’ts

June 2nd 2015

Given that 90% of new product launches fail - it goes without saying that launching a new product carries a significant amount of risk. Here are some points to remember and help put you in the 10% success bracket.

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Elemental Impurity Analysis in Pharmaceuticals

April 3rd 2014

A method to identify the presence of heavy metals in pharmaceuticals was introduced in the United States Pharmacopoeia more than 100 years ago. Today pharmaceutical companies are still using essentially the same method, the USP <231> Heavy Metals Limit Test. This paper will give an overview of the current method limitations, considerations for the new methodology and the risk-based assessments being carried out by manufacturers.

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How Do You Choose the Right Contract Lab?

July 18th 2013

A couple of years ago, I had to choose a new firm of lawyers, as our previous lawyer, a one-man band, was retiring. We don’t use lawyers a lot, but there are times when they are very useful. It was easy enough to make a short list of firms of the right size, offering the kind of legal services that we needed. But how could I choose between the different firms, when what I know about law can fit neatly on to the back of a postage stamp? The same dilemma can face companies when looking for a contract lab. True, most users of contract labs will know more about analysis and stability than I do about law, but most buyers of lab services will know less than the people they are buying from.

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Auditing Pharmaceutical Contract Laboratories

October 4th 2012

Contract laboratories are an extension of a companies own capabilities. Meaning, the quality of the data and results they generate, on which new developments, finished products or stability studies depend, are the responsibility of the contracting company. Regulatory Authorities therefore expect the contracting company to assess the laboratories fulfilment of the relevant regulatory and certified requirements. Assessment should occur prior to any work being conducted and then periodically to ensure continued compliance. The frequency of audits will be determined by the contracting company in accordance with its standard operating procedures (SOPs) on a risk basis, determined by the work being conducted, and should be included as part of the internal audit programme. The auditor must have the appropriate skills and expertise to competently conduct the audit but be sufficiently independent from the operation.

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Selecting A Preclinical Formulation Facility Part Three

September 26th 2012

Inspection of the facilities themselves tells you a lot about the management of the laboratory and how it operates. You can quickly identify a formulation laboratory that has been purpose built as opposed to one that is shoehorned into an existing, potentially inadequate space. It is important to understand if the laboratory is set up to comply with the necessary GLP regulations and in addition operate in a smooth, efficient and seamless way. Considerations should also be given to the laboratory’s ability to maintain separation between studies, both to prevent contamination and also to ensure that there is no risk of confidentiality slips between one customer and another.

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Selecting a Preclinical Formulation Facility Part Two

September 4th 2012

Once you have given the SOPs and organization a review, it is time to look at the laboratory process itself. By far the most structured approach is to follow an imaginary compound through its use in the laboratory. As you do this with the laboratory management, it is important to ask pertinent questions to understand the laboratory way of working and their culture. Is this a laboratory you would feel comfortable working with? It is important they treat your test article with the respect you require.

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Selecting a Preclinical Formulation Laboratory Part One

August 20th 2012

The preclinical formulation laboratory (sometimes called Pharmacy or Dispensary) is an often overlooked but essential piece of the overall toxicology program. Often the laboratory is chosen purely because it supports the toxicology facility of choice. In reality though, the formulation laboratory should be scrutinized in as much detail as the rest of the toxicology functions and be a part of the final decision making process when selecting the toxicology site

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Why Outsource Your Laboratory Testing?

May 31st 2012

Outsourcing is not a new concept. Companies have been outsourcing support services such as IT, training and even sales force activities for many years. But it’s only in the last 10-15 years that laboratory outsourcing has really taken off.

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