Good manufacturing practice applicable for all healthcare manufactures such as active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP practicesas per GMP guidelines that correspond with their legislation
Department of Health and Human Services, U.S. Food and Drug Administration under title 21 of Code of Federal Regulations part 111/820/210 describes about GMP.
The goal of GMP is to ensure that products have consistent and controlled production according to quality standards. Companies must fulfill several requirements to get GMP certification.
Companies must pass GMP inspections (audit) executed by national regulatory agencies or independent recognized agencies. Passing the assessments and scrutiny are required for certification.
Control of Manufacturing related activities
Manufacturing processes are clearly defined and controlled. Processes involved in manufacturing the product require consistency to meet the quality standards set.
Clear Instructions and standard operating procedures
All procedures are clear and unambiguous; it must be simple and easy to understand. They must be clear, concise and precise for proper execution. Employees and quality specialists must understand all manufacturing procedures they are involved in. Knowledge of these things will help them perform tasks and duties completely and at par with standards set.
Operators of manufacturing equipment perform and document all assigned tasks, must write down and record their observations clearly and completely related to the batch process. Data recorded manually or with the use of modern technology, such as computers, helps operators analyze and evaluate the processes of manufacturing regularly. This is necessary for process and quality improvement.
Review of Complaints
Company management examines complaints about the products in the market and recalls defective batches through an effective method.
GMP Certification Requirements by the World Health Organization (WHO)
A GMP certificate is a document certifying a specific product received an authorization for distribution in the consumer market and has passed quality standards set by the country where a company plans to distribute it. It ensures that the product or service meets standards and specific purposes for its production. WHO issues a COPP when the product in question is under consideration for a product license that will authorize its import and sale. Administrative action is required for renewal, extension, variation or review of such a license. Other documents needed are statement of licensing status, stability data, certificate of analysis, batch records for WHO GMP certification.