Month: December 2014

Ensuring Process Stability with Reactor Temperature Control Systems

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New Drug Approvals

Temperature control plays an important role in industrial processes, pilot plants, and chemical and pharmaceutical laboratories. When controlling reactors, both exothermic and endothermic reactions must be offset with high speed and reliability. Therefore, different conditions and effects must be taken into account when specifying an optimum and highly dynamic temperature control system.

Temperature Control of Reactors

Most temperature control systems are used with chemical reactors made of either steel or glass. The former is more rugged and long-lasting, while the latter enables chemists to observe processes inside the reactor.

However, in the case of glass reactors, extensive precautions have to be followed for safe usage. Reactors usually include an inner vessel to hold the samples, which need temperature control. This inner vessel is enclosed by a jacket containing heat-transfer liquid. This reactor jacket is linked to the temperature control system.

In order to control the reactor’s temperature, the temperature control system pumps the heat-transfer…

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Elemental Impurity Analysis in Pharmaceuticals.free download from Butterworth labs

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Elemental Impurity Analysis in Pharmaceuticals

A method to identify the presence of heavy metals in pharmaceuticals was introduced in the United States Pharmacopeia more than 100 years ago.

Pharmaceutical companies are still using essentially the same method, known as the USP Heavy Metals Limit Test.

This paper will provide an overview of current method limitations, considerations for the new methodology and risk-based assessments being carried out by manufacturers.

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  • Elemental Impurity Analysis in Pharmaceuticals 
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FDA issues Guidance for a clear Identification of pharmaceutical Companies

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 FDA issues Guidance for a clear Identification of pharmaceutical Companies
In November the US FDA has issued a Guidance for a clear identification of pharmaceutical companies. The authority now definitely prefers the DUNS system. Get more information.

see………..http://www.gmp-compliance.org/enews_4590_FDA-issues-Guidance-for-a-clear-Identification-of-pharmaceutical-Companies_9187,Z-CAUR_n.html

In our GMP News from September 2013 you learned about a draft of a FDA Guidance for Industry entitled “Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration”. This document’s goal was to clearly identify pharmaceutical sites. The draft comprised (manageable) five pages – including the cover page. And in terms of volume this didn’t change. However, some of the alternatives still mentioned in the draft, are not stated any longer – as one can find out when contacting the authority in these cases. The method now wanted is a registration by a D-U-N-S- (Data Universal Numbering System) number. This number – which is a 9-digit code – is supplied by the company Dun & Bradstreet.

To find out more please see the complete Guidance for Industry “Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration“.

 

 

 

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US FDA issued a Warning Letter to the company Hikma Pharmaceuticals

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Warning Letter: Deficiencies in Visual Inspection
In October 2014, the US FDA issued a Warning Letter to the company Hikma Pharmaceuticals justified by deficiencies in the visual inspection of vials. Read more here.

In October 2014, the US FDA issued a Warning Letter to the company Hikma Pharmaceuticals because of deficiencies in the visual inspection of vials and environmental monitoring.

Already in a Warning Letter issued in 2011, a deficiency in the visual inspection was noted as the detection and evaluation of particulate matter failed to be sufficient. Now, the current complaint in the area of visual control explicitly refers to the qualification of staff for the performance of the manual visual inspection. Here, the FDA inspectors noticed that visible markings were present on the qualifcation test sets which enabled operators for visual inspection to recognize – thanks to these markings – vials with particles. The qualification of staff has been thus completely questioned and therefore also the qualification of the whole visible inspection. According to the FDA, an assessment of the batches reviewed and released to the market by non-qualified personnel was missing in the written reply to this complaint.

Source: Warning Letter issued to the company Hikma Pharmaceuticals.

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm420960.htm

 

 

 

 

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