NPL IS CERTIFIED WITH WHO-GMP CERTIFICATE

Drugs or medicines are those substances that are taken to give relief to a person from his or her ailment. Since medicines are taken by people when they are in a vulnerable physical or mental state it is important that there is no compromise in the quality of medication. A medicine of low quality not only fails to cure the patient but can also aggravate the disease itself. It is therefore very important that there is no compromise in the quality of medicines.

The world Health Organization (WHO) is concerned with the status of health of people all over the world. In an effort to provide good health care and to provide efficacious and safe drugs at economic prices, the WHO has issued strict guidelines for Good Manufacturing Practices (GMP) of medicines.


Like the developed nations around the world, The government of Nepal has also recognized the importance of the WHO GMP guidelines as a method to ensure quality of the drug produced in Nepal for the benefit of its people.. The government of Nepal is keen to implement WHO GMP before Baishakh 2064 in all the National Pharma Industries.
World Health Organization- Good Manufacturing Practices are the methods to be adopted by pharmaceutical manufacturers to produce safe and efficacious medicines at economical prices. It includes Good Laboratory Practices (GLP), Good Storage Practices and Good Documentation Practices. A few of examples GMP methods are as follows.


The medicines must be manufactured in a clean environment by preventing the product from the contamination by environment, men and machines. This is achieved by creating a manufacturing facility with Heating, Ventilation and Air-Conditioning (HVAC) Systems.
Multiple air-locking systems at all men and material entries, providing protective clothing to workmen and sanitizing the entire facility at frequent intervals etc.

The efficacy of product must be assured during the manufacturing process as well as of the finished product. A competent independent body The quality Assurance Department monitors this, by testing at various intervals for assuring the predefined specifications of the products. The quality Control Department monitors the product by performing the stability studies of the products for their entire shelf life and even beyond their shelf life as per the WHO accepted protocols.
Good Storage Practices are defined methods to store all input raw and packing materials and finished products such that they retain their quality for a definite period and prevent cross contamination.

Finally each activity to be performed must follow a standard operating protocol. Each activity performed must be documented and kept for future reference. This is controlled by Good Documentation Practices.

In Nepal the Department of Drug Administration (DDA) issues the WHO GMP certificate to the companies, which comply with the guidelines strictly. Healthcare providers and patients can feel confident regarding the quality and efficacy of the medicinal products made by manufacturers with WHO GMP certification. The WHO GMP is a yardstick by which the quality of a drug can be measured. This will also open the door for the acceptance of Nepalese pharmaceuticals in the international arena. Amongst the manufacturers of medicine of Nepal , five companies have earned the WHO-GMP certification recently; they are Nepal Pharmaceuticals Laboratories Pvt. Ltd (including ß – lactam section), Deurali Janta Pharmaceuticals P. Limited, National Healthcare, Omnica Lab and Quest Pharmaceuticals.

Even in the absence of WHO- GMP certification the quality of pharmaceuticals is taken very seriously by the manufacturers. The WHO- GMP verification is an assurance from an authority of world health that the quality indeed meets the required international standard. Thus, the implementation of WHO GMP ensures an uniform progress of the health industry the world over and in turn the people of the world beneficiaries.


Dr. MSM RAJU 
Msc, BL, Phd (Pharmaceutical Analysis)

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