Bioladders

Andrew Mickey writes about health care sector in seeking alpha

The market’s main focus is on what the latest government plan will look like when it’s revealed later this week (talk about dramatically shortened time horizons). But hey, this was expected. We knew the stimulus plan wasn’t worth much, and frankly, hopes of a government-orchestrated solution having any impact in a few months time were just irrational. But this is just what we’ve been waiting for.

As you’ll soon see, a very strong pocket of strength is forming in one sector, and it will be safe to jump in soon. It’s shaping up just as we’ve been expecting, but first we should go over a few areas the markets will be forced to “reckon” with over the next few months.

A few months ago, we questioned whether the markets really priced in 9% to 10% unemployment. It looks like the market is starting to get its first glimpse of what it will look like, and it doesn’t like what it sees.

There’s practically no reason to get excited about anything over the short term, and the analyst community (which seems like it’s always the last one to realize how bad things really are) is feeding a very hungry bear.

Over the weekend, Howard Silverblatt, an analyst for Standard & Poor’s, stated:

This is the worst; after the sixth quarter of negative growth, it will be the first quarter ever of negative earnings.

That’s just one realization the market has to go through yet. However, another, potentially bigger problem exists.

An Undeniable Pocket of Strength

There’s no side skirting this one. It’s ugly out there and it’s getting worse, with state budget deficits and a federal stimulus package doomed for failure, slowly but surely, the market is realizing the seriousness of the situation. There is, however, a good side to it all.

Remember a few weeks ago when we talked about how Barometer Capital’s little known, but highly successful David Burrows focuses on finding strength and buying it.

Well, we’re seeing a pocket of strength emerge right now. In the chart below there is a clear separation between the S&P 500 - gold line and iShares Dow Jones Medical Devices (IHI) – black line.

[Read more →]

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Jane Barrett discusses data quality as she addresses the question raised by DIA’s 2nd European Clinical Forum: Is 90% of data rubbish?
Jan 1, 2009
By: Jane Barrett
Applied Clinical Trials

Is 90% of All Data Collected Rubbish?
Is 90% of all data collected rubbish? A provocative keynote debate at the recent DIA 2nd European Clinical Forum explored this question.

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Comprehensive introductory presentation on the business of biotechnology describing legal, commercial, scientific, and regulatory foundations; used in biotech MBA programs.

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A batch processing record is required for each batch of material produced.  The review of this document is a critical part of the batch release process.  A master document should be prepared for each batch size that will be manufactured.  It will be taken from the relevant parts of the master formula as discussed previously.

The first step in this document must be the area clearance check.  This is a record of the previous product and batch processed in the area and a confirmation that all the material and documentation relating to that batch has been removed.  It is also confirmation that all the cleaning has been carried out correctly.  This check must always be documented. [Read more →]

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· All documents should be unambiguous with a title and a clear statement of purpose.

· They should contain clear, numbered references to each activity.

· They should have sufficient space to record relevant data.

· They should be easy to check and all relevant activities should be recorded on them.

· It is possible for some of the documents to be combined, but generally they should be separate. [Read more →]

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There are two classes of labels. There are the finished product labels, which must meet national drug regulatory authority requirements as specified in the marketing authorization. Then there are the labels used within the factory to control processes.

Labels are required for all containers of materials, whether for starting materials, intermediates or finished products; there must be sample labels and labels that are applied to materials that have been sampled; there must also be labels for all process equipment and for premises that are in use for manufacturing. The labels should be clear and unambiguous. Where possible, it is advisable for companies to use colours to indicate status (quarantine, accepted, rejected, cleaned or dirty).

Companies generally have their own systems for internal labelling that define what information is carried, but for finished products, there is a national requirement. Responsibility for labelling varies with company practice, but the process is generally overseen and controlled by the QC department. QC staff are responsible for issuing status labelling when a material has been approved or rejected. The responsible production and/or QC staff should sign labels stating that equipment is clean and available for use.

Reference standards (both primary and secondary) must be appropriately labelled and the issue of these must be controlled.

WHO Training

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The following elements gets often missed during validation.  These are the good ones to start with when auditing any validation related documentation.

At the design qualification (DQ) stage, elements often missed include:

• Adequate description of the equipment’s intended use

• Clear specifications for all critical design parameters

• Setting design parameters that allow future flexibility (for example, the process will likely change, but the equipment may not)

• Specifications that take CGMPs into account. [Read more →]

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Top medical device companies from around the world have established a presence in Finland to develop, manufacture or market their products. This includes setting up their own subsidiaries to penetrate local markets and to build relations with end‐product users.

Philips Medical Systems
Philips Medical Systems MR Technologies Finland Oy develops and manufactures magnetic imaging systems based on Finnish technology for the world’s medical equipment markets. Established in 1993, the company also delivers software, RF‐technology, digital‐ and power electronics, mechanics, imaging methods and methods for image processing for the MRI systems. Over 150 employees are based in Finland and about half of them work in the product development department. Key market: USA.

GE Healthcare
GE Healthcare Finland Oy develops and manufactures imaging diagnostic systems, clinical systems and biopharmaceutical medical diagnostics.

Siemens Medical Solutions
Siemens Medical Solutions, one of the world’s largest suppliers to the healthcare industry, has an active sales representation in Finland through its Swedish subsidiary. Its medical solutions include imaging systems, information systems and technical services. The Siemens Ab Finnish sales office employs over 40 people and the turnover in 2003 was 14 million Euros.

Toshiba Medical Systems
-Toshiba Medical Systems has its own sales, service and support organization in Finland, with a focus on ultrasound systems, x‐ray systems and MRI systems.

Baxter
Baxter International, a global healthcare giant, sells and markets pharmaceuticals and medical devices in Scandinavia in 4 divisions. The Finnnis division employs 30 people out of 200 in Scandinavia. Last reported turnover of Baxter Finland was 26,7 million Euros.

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· Documents should be designed, prepared, reviewed and dated by appropriate authorized persons.  No document should be changed without authorization.

· Any alteration made to a document should be signed and dated; the alternation should permit the reading of the original information.  Where appropriate the reason for the alternation should be recorded.

· Distribution of documents needs to be carefully controlled in order to ensure that the most up-to-date version is always being used.  There should be a distribution list, if appropriate, attached to the document.

· Unauthorized photocopying of original documents should be actively discouraged.  Some companies manage this by having part of the front page printed in colour, or by using an official stamp or other means of identification.

· There should be an SOP for distribution, retrieval and preparation of documentation.  A document register is required.  This ensures that change control over all documents is properly managed.

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Documentation is an essential part of QA and relates to all aspects of GMP.  The pharmaceutical industry must have a good document framework (infrastructure).  It is important for a manufacturer to get the documentation right in order to get the product right.

•They are used to define specifications for materials and for methods of manufacture and control.

•They ensure that everyone concerned with manufacture and QC knows what to do, how and when to do it.

•They allow decisions to be taken on batch release.

•They provide an audit trail, which is particularly important in the case of suspect batches.

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