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‘India’s biotechnology industry is confident of excellent augmentation in the coming years despite global meltdown.

Experts feel that the Indian biotechnology industry, which currently holds only two percent share of the global market, has the potential to grow and emerge as global player in coming years.

Expressing confidence at the prospect of biotech industry attaining the target of five billion dollars by 2010, Kiran Majumdar Shaw, Chairman and Managing Director of Biocon Limited, said agri biotech products and services will contribute a lot towards achieving this target.

“The five billion dollar target that the Biotech industry has is definitely something that is going to be attained in that time frame of 2010. And this five billion dollar market that is forecast is going to comprise largely of pharmaceutical products like vaccines and other therapeutic products. It is going to comprise of agri biotech products, which will almost comprise a billion dollars. Then we are also going to form a billion dollar component of that particular business,” said Shaw. [Read more →]

Tags: Indian Biotech, Interesting News by Plato
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Validation is the establishment of documented evidence that a system does what it is supposed to do.

There are three key points to take from these definitions:

1. The evidence must be documented. (The results of the validation must be recorded).

2. Validation applies to several aspects of manufacturing, including e.g. process development, materials, personnel and equipment).

3. It should demonstrate that the system does what is expected of it.

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The recruitment process for direct operators in particular should include a medical examination. This should be repeated on a regular basis during the employment period. The definition of “regular” will obviously depend on the activities being undertaken and the products being processed.

Induction training for new operators should include basic training in personal hygiene and should state the level of hygiene that is required for working in manufacturing areas. There should be written procedures covering the need to wash hands before entering a manufacturing area. In addition, signs should be posted in the changing rooms to reinforce this.

Staff who have an illness or open lesions that are likely to present a risk to the product, should not be allowed to carry out operations that involve handling of starting materials, intermediates or finished products until the condition has cleared up. Since not all illnesses are going to be obvious, operators must be trained to recognize such risks themselves and be willing to report any illness to the area supervisor.

Tags: GMP, Training by Plato
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The recruitment process for direct operators in particular should include a medical examination. This should be repeated on a regular basis during the employment period. The definition of “regular” will obviously depend on the activities being undertaken and the products being processed.

Induction training for new operators should include basic training in personal hygiene and should state the level of hygiene that is required for working in manufacturing areas. There should be written procedures covering the need to wash hands before entering a manufacturing area. In addition, signs should be posted in the changing rooms to reinforce this.

Staff who have an illness or open lesions that are likely to present a risk to the product, should not be allowed to carry out operations that involve handling of starting materials, intermediates or finished products until the condition has cleared up. Since not all illnesses are going to be obvious, operators must be trained to recognize such risks themselves and be willing to report any illness to the area supervisor.

Tags: GMP, Training by Plato
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Consideration must be given to all personnel, both direct operators and other staff who enter the manufacturing area for whatever purpose. Then there are the premises in which manufacturing takes place. The level of attention to this aspect will vary with the operation that is carried out. All equipment and apparatus used in manufacturing must be controlled, together with production materials and the containers in which they are held.

Production materials (if not handled properly) and the containers (if not properly cleaned) can contribute to dirt and contamination in the factory.Secondary materials, such as cleaning agents and disinfectants, must be controlled to ensure that they do the job for which they are designed but do not cause any contamination to the product. Cleaning tools, such as mops and brushes, must also be controlled.To summarize, the aim of sanitation and hygiene measures is to eliminate all potential sources of contamination and cross-contamination from all areas where the product.

Tags: GMP, Training by Plato
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Each holder of a manufacturing authorization should have a quality control department (except for a holder performing only a fraction of the manufacturing process under a contract).

The independence of quality control from production is considered fundamental. The quality control department should be independent fromother departments and under the authority of a person with appropriate qualifications and experience, who has one or several control laboratories at his disposal.

The quality control department must have adequate resources.

This means:

• Adequate laboratory facilities or access to them e.g. government or contract laboratories

• Appropriately qualified, trained and experienced personnel and approved written procedures

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Rs 10,000 crore Indian medical devices industry has approached the ministry of health and family welfare for a globally harmonised regulatory guidelines and audit through internationally notified quality certification organizations to enable exports.

The Association of Indian Medical Devices Industry (AIMED), representing over 150 medical device manufactuerers, has also demanded that medical devices should not be treated as medicines. “Some of the Indian medical devices, equipments are till date controlled by Drugs Act and treated as similar to medicines, although world over it has been recognised as a separate industry.

There are hardly any similarity in medicines and devices. Henceforth, the industry should be treated as a separate industry from pharmaceuticals, which is regulated by various rules and regulations,” AIMED co-ordinator and Hindustan Syringes & Medical Devices joint managing director Rajiv Nath said. Presently, in India, medical devices such as stents, catheters and orthopaedic implants are treated like drugs and are regulated by state drug regulators under the Drugs and Cosmetics Act (DCA), 1995. [Read more →]

Tags: Indian Biotech, Interesting News by Plato
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This session covers the first half of the quality management systems..

Per ISO 9000, Quality management is defined as the aspect of management function that determines and implements the quality policy.

The quality policy is a statement by the top management of the company of its overall intentions and direction relating to quality, formally expressed as a corporate policy. The top management of a company usually includes the board of directors or general manager of the company, the plant or factory managers together with the senior managers.

A working infrastructure quality system includes:

• Organizational structure

• Procedures

• Processes

• Resources [Read more →]

Tags: GMP, Quality Systems, Training by Plato
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FDA and CDC recommendations for consumers include:

• Do not eat products that have been recalled and throw them away in a manner that prevents others from eating them.
• To determine if commercially-prepared or manufactured peanut butter/peanut paste-containing products (such as cookies, crackers, cereal, candy and ice cream) are subject to recall, consumers are urged first to visit FDA’s website and check the searchable database of recalled products.
• For information on products containing peanut butter from companies not reporting recalls, consumers may wish to consult the company’s website or call the toll-free number listed on most packaging.  Information consumers may receive from the companies has not been verified by the FDA.
• If consumers cannot determine if their peanut butter, peanut butter/peanut paste-containing products or institutionally-served peanut butter contains PCA peanut butter/peanut paste, FDA recommends that they do not consume those products.
• Persons who think they may have become ill from eating peanut butter are advised to consult their health care providers.

MORE INFORMATION http://www.fda.gov/oc/opacom/hottopics/salmonellatyph.html

Search for combined list of peanut butter recalled products

http://www.accessdata.fda.gov/scripts/peanutbutterrecall/index.cfm

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Union Minister of Science and Technology Kapil Sibal recently announced that more biotech parks will be set up throughout the country for promoting research in the field of life sciences. “Setting up of new biotech parks is one of our initiatives for promoting quality research in biotechnology and its applied fields,” he said in his address at the inaugural function of the Biotech Park here. At present, besides Lucknow, there are only three “functional” biotech parks at Hyderabad, Pune and in Punjab.

Sibal also announced that in order to produce “high quality human resource”, an agreement would be signed with the Welcome Trust of Britain. “The Department of Biotechnology (DBT) will form a 10-year pact with the Welcome Trust for ensuring high quality human resource, which is one of the key elements for scientific leadership,” he said. [Read more →]

Tags: Indian Biotech, Interesting News by Plato
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