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The new APIC Guidance on Handling of Insoluble Matter and Foreign Particles in the Manufacture of Active Pharmaceutical Ingredients
The new APIC Guidance on Handling of Insoluble Matter and Foreign Particles in the Manufacture of Active Pharmaceutical Ingredients
The occurrence of foreign particles in the manufacture of active pharmaceutical ingredients is always undesirable. For the responsible QA departments it involves an increased effort as concerns the search for the root causes and for CAPA measures. A new APIC Guidance offers concrete recommendations for the GMP compliant handling of foreign particles in APIs, intermediates and raw materials.
Foreign particles in APIs or medicinal preparations are undesirable and sometimes lead to a recall of the batches concerned. Depending on the type of particles their presence in active pharmaceutical ingredients may be harmless; in many cases they are inevitable. In any case the manufacturer must find an adequate way how to handle those impurities visible to the human eye. The search for a guideline or another official document in the relevant regulations is in vain. Visible particles or fibres are only mentioned in the USP chapter <790>, in chapter 2.9.20 of the European Pharmacopoeia as well as in the United States Food, Drug and Cosmetic Act (FD&C Act).
In order to remedy this lack of guidance or recommendations a group of experts within APIC has drawn up a guidance on the handling of foreign particles. This “Guidance on Handling of insoluble Matter and Foreign Particles in APIs” describes in detail
- the types of particles which can often occur during the manufacture of APIs, API intermediates and raw materials (including packaging materials),
- suitable measures to minimize the presence of particles or to remove them,
- how to determine them analytically
- how to identify the source and to carry out subsequent CAPA measures and an adequate risk management.
This APIC guidance offers valuable assistance for all API manufacturers that are confronted with the problem of the occurrence of foreign particles in their products, intermediates or raw materials. The implementation of the very concrete and practicable recommendations in this guidance offers also valuable supporting arguments for GMP inspections or audits and can help to avoid unpleasant surprises.
///////APIC Guidance, Handling of Insoluble Matter and Foreign Particles, Manufacture, Active Pharmaceutical Ingredients
Pharmaceuticals; Make in India
PM, MODI
Brand India Pharma aims to make the most of a booming domestic pharma industry
India’s pharma exports stood at 90,000 crore rupees ($15 billion) for the year 2013-2014, and are set to cross the 1 lakh crore rupees ($16.4 billion) mark in the current financial year. The Brand India Pharma campaign aims to tap into this value proposition, under the guidance of the Indian Ministry of Commerce and Industry, aiming to showcase the strengths of the Indian pharma industry.
With more than 10,500 manufacturing units and more than 3,000 pharma companies, India is ranked among the top six producers of pharmaceuticals worldwide, and is well-positioned to take advantage of its place in a global landscape.
READ AT
List of WHO Approved Pharma Plant in India
India’s spacecraft cost $74 million, a fraction of the $671 million spent by NASA’s MAVEN ……….SEPT 24 2014
READ AT
http://www.brandindiapharma.in/infographic-business/
India’s spacecraft reaches Mars orbit … and history
India’s spacecraft cost $74 million, a fraction of the $671 million spent by NASA’s MAVEN
24 sept 2014
India’s Mars Orbiter Mission successfully entered Mars’ orbit Wednesday morning, becoming the first nation to arrive on its first attempt and the first Asian country to reach the Red Planet.
“We have gone beyond the boundaries of human enterprise and human imagination,” declared India’s Prime Minister Narendra Modi, who watched from the space agency’s nerve center in Bangalore. “We have accurately navigated our spacecraft through a route known to a very few.”
The staff at the Indian Space Research Organization erupted into applause and cheers after learning that the Mars Orbiter Mission, also known as Mangalyaan, reached the planet’s orbit and made history.
Before Wednesday, only the United States, Europe and the Soviets have successfully sent spacecraft to Mars.
Photos: India’s first Mars orbiter“The odds were stacked against us,” Modi said. “Of the 51 missions attempted so far, a mere 21 had succeeded. But we have prevailed.”
And India reached Mars with significantly less money.
With a price tag of $74 million, the Mars Orbiter Mission cost a mere fraction of the $671 million NASA spent on its MAVEN spacecraft, which arrived to Mars earlier this week. Some space observers noted that India’s Mars orbiter cost less than the $100 million budget for the space thriller film “Gravity.”
Interactive: Exploring Mars from Viking to MAVEN
“It shows how optimal is the design, that way we’re able to cut cost and we’re not compromising quality,” said S. Satish, a space expert based in Bangalore.
The groundbreaking Mars mission wasn’t without controversy — with some critics who said India should spend the money on other issues.
The spacecraft launched on November 5, and has traveled over 650 million kilometers to enter Mars orbit. Its mission is to orbit the Red Planet, mapping its surface and studying the atmosphere. The Mars Orbiter kicked off its interplanetary debut with its own Twitter account.
The mission has been freighted with patriotic significance for India since its inception and is seen as a symbolic coup over its rival, China, which is also ramping up its space ambitions.
India launches mission to Mars
China’s joint mission with Russia in 2011, which contained the Chinese Mars satellite Yinhuo-1, stalled and eventually fell back to Earth. Japan’s 1998 attempt with the spacecraft Nozomi was also unsuccessful due to fuel problems.
Once nears Mars’ orbit, India’s spacecraft had to execute a series of complicated and critical maneuvers. About half of all spacecraft sent on missions to the planet have veered off course, malfunctioned or crashed.
India’s Mars Orbiter Mission is in the company of NASA’s two Mars rovers on the ground, a European orbiter and NASA orbiters including the MAVEN, which has been there since Sunday.
The United States has expressed interest in cooperating with India as their spacecraft gather data about the planet.
MAKE IN INDIA
http://makeinindia.com/sector/pharmaceuticals/
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