Good manufacturing practice (GMP) is a system which ensures that manufacturers produce goods consistently in a very good, controlled and in authentic way. Companies and various organizations must producing their good with compliance to the standard and to the matching standards. GMP also consists of basic guidelines for prevention of factory and facility operations. In other words, it’s a system that mainly aims to take care of high standard of products.
• Good manufacturing practice is in process because it aims to forestall or to reduce risks which is impossible to eliminate within the testing the final goods.
• Good manufacturing practices have certain guidelines which are recommend by the agency to the producers and sellers of drugs, medicine and active pharmaceutical products. The regulations are also recommended to the manufacturers as well as seller
• “Good manufacturing practice (GMP) is system which has made to make sure the production consistency and manufacturing control in accordance with pre-determined quality standards.”
• “It covers all aspects whether it’s about raw materials or about manufacturing process and staff activities.”
• Good manufacturing practice is subjected to the certain changes.
• Responsible employees must make sure GMP. Since methods and regulations changes with time and circumstances, we sometimes refer Goods Manufacturing Practice as Current Good Manufacturing Practice (GMP)
• As GMP regulations and methods are changing, industries required to update their skills and knowledge with the changes. Otherwise, they are going to not be ready to maintain with implementation of the newest techniques.
The environment protection i.e., preventing from contamination.
Control over the manufacturing process.
Methods of Distribution.
The investigation of GMP rules and regulations.
The control over the procedures and keeping records.
Which procedures should be followed when there are defects found in investigation. Regulatory agencies across the world follow many alternative forms of ‘practices.’ For example, they observe good agricultural practices, good clinical practices, and good laboratory practices.
Guidelines made on GMP mainly focuses at ensuring that drugs and food are safe for human consumption.
There has been made some guidelines of GMP for manufacturing, testing, and quality assurance. “Many of the countries have an opinion that manufacturers of food, pharmaceutical and medical device follow GMP procedures. They ought to create some guidelines on GMP of their own so that they will correspond with these guidelines on individual basis.”
The guidelines aims to incorporate safeguard of consumer health. Their objective is to sheild the patients and ensure production of high or top quality medical devices by manufacturers.
In fact, in some countries, a drug must pass all specification test, and if any is violative of GMP guidelines, can be classify as ‘adulterated.’
The production and distribution of the drugs must minimize any risk to their respected quality.
Must maintain a clean and hygienic manufacturing area.
Manufacturing facility design, operating principles and environmental conditions must be controlled so as to forestall any kind of contamination of drug products.
Manufacturing processes must be defined very clearly.
Instructions and procedures must be written in clear and unambiguous language (Good Documentation Practices).
Operators must be trained to hold out the production of the products according to documented procedures.
Records of the document must be maintained.
The process should remain in a state of control throughout the lifecycle of the respected product and improvements should be done if needed.
This shows the ability of management of organization which deals in safety and quality of product.
Help all the employees to grow some good operational habits and increase production.
Reduces the risk involved in safety and quality of product.
It reviews the management and detects all the problems related to production, cost or management.
Helps in reducing the cost.
It complies will all the laws, rules and regulations.
Increases the credibility at international level and enhance the public image
Helps in increasing the confidence of customers to build long term relation.
Step 1 : collection of document by authorized team
Step 2 : a process called gap analysis has been done by authorized team to include all sections of quality standard along with clauses, if any.
Step 3 : to ensure the details of the documents that they are filled with all the necessary requirement, document are being checked.
Step 4 : initial auditing has been done to have a check on company standards and if needed plan to do some corrections for non-conformity of standards.
Step 5 : auditor of authorized team will do final auditing
Step 6 : application which was filed by applicant, submitted to authorities of GMP
Step 7 : authorities will review the application and mandatory requirements which are needed to get GMP Certificate
Step 8 : after the issuance of GMP certificate, renew after three years. As, it is valid for three years.
Step 1 : application has to be filed in proper manner. And applicant must be an authorized person. He must be a person who is responsible just like Production Manager, may be a Quality Assurance Manager, Quality Control Manager or Managing Director.
Step 2 : a process of auditing is necessary for providing certificate, it has been done to have a check on company standards and if needed plan to do some corrections for non-conformity of standards.
Step 3 : after the issuance of GMP certificate, renew after three years. As, it is valid for three years. This certificate is issued on the name of registered company, and it will define the scope.
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