Biophar Life sciences is a Pharma Franchise in Punjab which is a leading manufacturing unit in the pharmaceutical company. The company is known to maintain its quality standards by manufacturing top quality products with an in-house manufacturing unit which is very well equipped with latest machinery. To deliver the same the company focuses on Good manufacturing practice (GMP) which is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
The company is proactively involved in delivering best quality products by following Good Manufacturing Practice complying with all the policies rules and regulations. The PCD Pharma Franchise abandons Poor quality medicines for they are not only a health hazard but a waste of money for both governments and individual consumers. The main risks by following such practices are unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects.
GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made.
The Drug Controller General of India (DCGI) has mandated risk-based inspections for all the Schedule M units in the country following notification for grant of licenses till perpetuity. The Union health ministry had recently notified Drugs and Cosmetics (Tenth Amendment) Rules, 2017 doing away with renewal of licenses for the manufacture, sale and distribution of pharmaceutical products every five years.“These risk-based inspections are meant to ensure that drugmakers comply with GMP notwithstanding the fact that there is now no need to renew a license every five years. Non-compliance to GMP would immediately attract strict penalties under the law and even cancellations based on the severity of the case,”. The manufacturing and sale of licenses, once issued, shall remain valid forever unless suspended or cancelled by the licensing authority. The relevant rules have been amended for this purpose. Risk-based inspections are based on a checklist issued for the state drug regulators aimed at streamlining uniform inspection procedures across the country related to GMP. Central Drug Standard Control Organization recently concluded the checklist and tools which are meant to help them and state drug regulators to understand and collaborate which pharmaceutical and active pharmaceutical ingredient (API) manufacturing sites have been inspected and are found to be compliant. The Union health ministry is also in the final stages to release a draft guideline towards the enhancement of GMP to align India-specific standards with global regulations for better product quality of pharmaceutical products. As per the new notification, an inspection of drug manufacturing plants will be conducted by both central and state inspectors every three years to verify compliance with the conditions of license and provisions of the Drugs and Cosmetics Act, 1940. The manufacturers will have to appraise the regulator and apply for a no-objection certificate in case of any minor or major changes made by them in their unit. Aimed at enhancing ease of doing business in India, the government amended rules for manufacturers to grant licenses that will remain valid as long as they comply with GMP.
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