Question

Role of Good Manufacture Practice, make a short article 500-1000 words

Answer 1

Good Manufacturing practice and is a quality control system which makes every pharmaceutical product is adequately tested and dosed for optimal effectiveness.it also involves in the quality control of food,diagnostics,ingrediants in drugs and other materials like food and pharmaceuticals and devices in the medicine.Thus good manufacturing practice makes sure that a company follows a set of rules and regulations,by producing something that meets all the necessary requirements.it need to be strictly defined and well controlled,ensuring that the product is made with precautions and specifications.if any alteration or danage in product it should go to the quality check again .

the customer has to understand the functioning of the product.and the product should be instructed with the instructable language so this has to meet the high quality and expectations of customer and public.

This GMP involves in the regulation of the quality of drugs,medical devices,blood,food and instruments in medical and healthcare.They are actually different organisation involves in managing all the drugs quality like in us their US Food &Drugs Association is responsible for all this mlike that in india there is ICMR and food corporation of india.by this the promoting and protecting of the public health through under the supervision of the whole process of developing,testing and manufacturingand promotion of foofd and drugs.

it should also takes some prior precautions and maintain the quality and safety.the basic principles and guideliness include

Data history of validated manufacturing steps,used validated equipment distribution serialisation and track&trace support.

process must be controlled

process must follow the good documentation practices

operator must be qualified and trained

conditions in order to prevent cross contamination and protections to adulterants

Manufacturing must be done in clean and hygenic areas

Quality management,quality assurance,Good manufacturing practice for products,Quality control,Quality risk management,Sanatation and hygeine,Building and facilities,eqipment,validation and qualification,inception and quality audits.

sterngthening of GMP in an organisation involves

having robust process and easy-to-use systems that enforce and monitor standards can strengthen the GMP in organisation with technical advancement of equipment we can meet the assurance of the quality and opportunity to transform a reactive company culture,into a proactive, predictive workforce equpipped for continious inspection.

Good Manufacturing Practice (GMP) 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.GMP is Good Manufacturing Practices are systems created and mandated by the government to regulate production, verification and validation of drugs, food and/or medical devices, ensuring that finished products are effective and safe for market distribution.

GMP requires that the manufacturing process is fully defined before being initiated and all the necessary facilities are provided. In practice, personnel must be adequately trained, suitable premises and equipment used, correct materials used, approved procedures adopted, suitable storage and transport facilities available, and appropriate records made

The holder of a manufacturing authentication and authorizationn must manufacture medicinal products so as to ensure that they are fit for their important  use, comply with the requirements of the marketing authorization and do not place patients at risk due to inadequate safety, quality or efficacy of medical equipment.The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment by staff in many different departments and at all levels within the company, by the company’s suppliers and by the distributors