GBTU Admit card (UPSEE 2012)

April 18, 2012

Download GBTU Admit Card from here :-  http://upsee.nic.in/upsee/admitCard/authforadmitcard.aspx

 

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WHO Good Manufacturing Practices: water for pharmaceutical use

April 6, 2012

The guidance contained in this document is intended to provide information about the available specifications for water for pharmaceutical use (WPU), guidance about which quality of water to use for specific applications, such as the manufacture of active pharmaceutical ingredients (APIs) and dosage forms, and to provide guidance on the good m anufacturing practice (GMP) regarding the design, installation and
operation of pharmaceutical water systems.

Water is the most widely used substance, raw material or starting material in the production, processing and formulation of pharmaceutical
products. It has unique chemical properties due to its polarity and hydrogen bonds. This means it is able to dissolve, absorb, adsorb
or suspend many different compounds. These include contaminants that may represent hazards in themselves or that may be able to react
with intended product substances, resulting in hazards to health.

Different grades of water quality are required depending on the route of administration of the pharmaceutical products. One source of guidance about different grades of water is the European Medicines Evaluation Agency (EMEA) Note for guidance on quality of water for pharmaceutical use (CPMP/QWP/158/01).

Control of the quality of water throughout the production, storage and distribution processes, including microbiological and chemical quality, is a major concern.

Source: http://apps.who.int/prequal/info_general/documents/TRS929/WHO_TRS_929-Annex3.pdf


INS Chakra: Top 10 must-know facts

April 5, 2012

1) INS Chakra is a Russia-made, nuclear-propelled, hunter-killer submarine. Unlike conventional submarines that India operates which need to surface to charge its battery’s often – sometimes as frequently as 24 hours – INS Chakra can stay under as long as it wants. Its ability to stay underwater is restrained only by human endurance to stay underwater. Also, another problem that the submarine could face is acidity. This is because of a lack of exercise inside due to prolonged deployments.

2) The Akula Class submarine will carry conventional weapons. The vessel is armed with four 533mm torpedo tubes and four 650mm torpedo tubes. It will be used to hunt and kill enemy ships.

3) The INS Chakra displaces about 10,000 tons. It can do over 30 knots – more than twice the speed of conventional submarines. It can go upto a depth of 600 metres.

4) INS Chakra is one of the quietest nuclear submarines around, with noise levels next to zero.

5) It has about 80 crew members on board. The entire crew of INS Chakra has been trained in Russia for over a year. Facilities for the crew on board INS Chakra include a large recreation area, a gymnasium and a sauna as well.

6) INS Chakra has been taken on lease from Russia for 10 years and would provide the Navy the opportunity to train personnel and operate such nuclear-powered vessels. In 2004, India had signed a deal with Russia worth over $900 million for leasing the submarine. INS Chakra was expected to be inducted into Indian Navy a couple of years ago, but after an on-board accident in 2008, in which several Russian sailors died, the delivery schedule was changed.

7) INS Chakra formally joined the Indian Navy on Wednesday.  It was commissioned by Defence Minister AK Antony at the Ship Building Complex in Visakhapatnam in Andhra Pradesh. “INS Chakra will ensure security and sovereignty of the country,” the minister has said. When asked if INS Chakra’s induction will lead to arms race in the region, Defence Minister AK Antony told reporters, “India does not believe in arms race. We are not a confrontationist nation. We are a peaceloving nation….but, at the same time, the armed forces will be strengthened to meet any challenge.”

8) The induction of the nuclear-powered submarine clearly indicates India’s intentions in the Indian Ocean Region and South East Asia which has recently seen increasing assertive Chinese presence in the last few months. It will also a send a strong reassuring message to south east Asian nations like Indonesia, Vietnam and Malaysia who want India to play a more active role in the region to counter the assertiveness of China in the area.

9) The induction of the INS Chakra is likely to be followed by the induction of the indigenous INS Arihant, which will be capable of launching nuclear weapons and therefore complete the nuclear triad. INS Arihant, it is understood, is now undergoing sea trails at Vizag.

10) The only other nations possessing nuclear-powered submarines are – US, Russia, UK, France and China. India is back in this elite club after over a decade. In 1988, the Indian Navy had leased a Charlie Class nuclear-powered submarine for three years till 1991. However, the expertise gathered then was lost as most officers who had trained to operate nuclear submarines have retired.

Source: http://www.ndtv.com/article/india/ins-chakra-top-10-must-know-facts-194179?pfrom=home-otherstories


Guidance for Preparing Standard Operating Procedures (SOPs)

April 5, 2012

The U.S. Environmental Protection (EPA) Agency has developed an Agency-wide program of quality assurance for environmental data. EPA’s Quality System requires documentation of both management and technical activities. This guidance document, Guidance for Preparing Standard Operating Procedures (SOPs) provides a standard working tool that can be used to document routine quality system management and technical activities. It replaces EPA’s March 2001’s Guidance for Preparing Standard Operating Procedures (SOPs) EPA/240/B-01-004 with minimal revisions in text and new examples of both technical and administrative SOPs.

A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity followed by an organization. The development and use of SOPs are an integral part of a successful quality system as it provides individuals with the information to perform a job properly, and facilitates consistency in the quality and integrity of a product or end-result. The term “SOP” may not always be appropriate and terms such as protocols, instructions, worksheets, and laboratory operating procedures may also be used. For this document “SOP” will be used.

Source: http://www.epa.gov/quality/qs-docs/g6-final.pdf