GMP Certification ConsultantsGMP Consultants
GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This in turn, protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.
GMP regulations address issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business.
Clear Instructions and Procedures
Company instructions and procedures are clear and unambiguous. All information provided by management 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.
The Certified Pharmaceutical GMP Professional understands the GMP principles as regulated and guided by national and international agencies for the pharmaceutical industry. This covers finished human and veterinary drugs and biologic, parasitologist, and dietary supplements (alternatively called nutraceuticals where regulated as drug products, as well as their component raw materials (includes active pharmaceutical ingredients (APIs) and excipients), and packaging, and labeling operations.
Good manufacturing practice or GMP is part of a quality system covering the manufacture and testing of 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 procedures, and have created their own 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. In India, Food and drug administration under the ministry of health and family welfare through D & C Act specified in Schedule M, describes the latest GMP requirements for Pharmaceuticals, cosmetics, Medical Devices and APIs.
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.
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