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Good Manufacturing Practice (GMP)

  Good Manufacturing Practice  ( GMP ) Is a manufacturing and testing process that helps to ensure a product of quality. GMP guidelines are not prescriptive instructions for how to manufacture goods. There is a set of general concepts that have to be followed during production. When a company develops it's a quality system and manufacturing methods, it can be able to satisfy GMP requirements in several ways. It is up to the company to determine the most efficient and effective quality process. For the pharmaceutical industry, GMP is a key term. Good Manufacturing Practice (GMP) is, according to the World Health Organization (WHO), a mechanism to ensure that products are produced and regulated in a safe manner according to quality standards. The main purpose of this is to reduce the risk involved in pharmaceutical production, which by testing the final product is difficult to eliminate. Severe consequences that exist in the absence of provisions such as cancelation of the licen...

Certificate of Pharmaceutical Products (COPP)

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The National Health Authorities grant this CoPP certificate upon request from the consumer, the authorities, or the drug supplier in the importing country. This certificate refers to a particular product whether or not it is sold in the country of origin and also states that the manufacturer of the drug complies with GMP and that they are regularly inspected by the national health authorities A CoPP is issued in the format which is recommended by WHO. It is the importing country which needs the CPP for the pharmaceutical product and a special type of certificate which allows the registration and marketing of a given pharmaceutical product in the exporting country of interest and forms sections of the application for marketing authorization. The CoPP is necessary when the drug is intended by the importing country for registration or renewal (licensing, authorization, or extension) for the scope of the product being sold or marketed in that country. A certificate has been recommended to...

Benefits of getting a Business registered in the USA

  A. Tax Benefits: Although the companies' primary characteristics are similar from state to state, the applicable tax rate is not the same. Some states have tax rates that are as high as 10%. On the other hand, Nevada has no franchise tax and no state income tax. However, income tax considerations generally may not apply to an entity not taxed at the business level, such as an LLC or S Corporation. ➲ A US Based Company can accept credit cards (online and offline) ➲ Nil tax on US and/or internationally-sourced income (subject to certain rules stated below). ➲ Nil tax on exported products / services by a Company registered in the USA. B. Cost Consideration Although retaining an attorney is not required to incorporate your business, the complexities of the process make it advisable to seek legal counsel. Subsequently, if you are considering incorporating out of side the state, working with licensed legal counsel and practicing in the incorporation state can be an extra expe...

BUREAU OF INDIAN STANDARDS (BIS)

  BIS is a national body that ensures the quality, safety, and reliability of Indian goods. BIS is intended to analyze product samples while they are in the preliminary and surveillance stages. India has 8 centers, 4 regional, and 3 BIS branch laboratories in total. The government, therefore, promotes BIS certification for the following purposes: To provide public health protection; To provide quality assurance; To protect consumers against dangerous products; To foster consumer trust. Mandatory product category which requires BIS certification In the public interest, to protect public health and safety government of India has listed products that required mandatory BIS certification: Cement Household electrical goods Batteries Edible food products Cooking stoves Cylinders/valve and regulators Medical equipment Electrical motors Transformers Capacitor Fertilizers and chemicals Different types of BIS certification scheme For domestic manufacturers Normal procedure - The applicant ap...

Steps for Registration of a Patent

  Step 1:     Idea or concept (Invention) must be written down with as many details as possible Step 2:   Drawings, diagrams or sketches explaining the working of the invention must be included while filing the application Step 3:  To check whether the invention is a patentable subject matter or not Step 4:  search for Patentability Step 5:  A patent application needs to be draft by applicant Step 6:  Publication of the application need to be done by the investor Step 7:  Examination request Step 8:  Respond to the objections raised Step 9:  objections must be cleared Step 10:  The final step is the grant of a patent to the inventor  Documents for Patent Registration ➲  Application in Form -1 which includes all the information related to name and address of inventor, name and address of applicant. ➲  Form-2 which describes the provisional or complete specification, as applicable along with the Draw...

Resignation or Removal of Director

  As per section 168 Resignation of Director A director may resign from his or her position by giving written notice to the Company; upon receipt of such notice, the Board shall take note of it; the Company shall notify the Registrar, and the Company shall include the fact of such resignation in the report of directors laid before the Company's next General Meeting. A director's resignation shall take effect on the day the notice is received by the company or if stated by the director in the notice, the date specified by the director in the notice, whichever is later. Even after his resignation, the resigned director is accountable for the offenses committed during his term. Call a Board of Directors meeting [as per section 173 and Secretarial Standard-1 (SS-1)] a. Upon receipt of the resignation letter, the Company shall send a Notice of Board Meeting to all of the Company's Directors at their registered addresses at least 7 days before to the Board Meeting. In the event o...