manuf lab

• Validation is the documented act of demonstrating instruments, processes, and activities that are regularly used or done to check if they function according to expectations.
• Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards.
• Detailed written procedures are essential for each process that could affect the quality of the finished product.
• Providing compliance training to staff is the best way to ensure compliance with GMP standards.
• All employees should receive training on recordkeeping, sanitation, proper equipment handling and labeling, and SOPs to minimize errors and maintain compliance.
• 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.
• GMP regulations address issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling.
• Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.
• Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls.
• Utilizing digital tools such as iAuditor by SafetyCulture, a mobile inspection app, and sensors can move your GMP beyond compliance.
• GMP refers to the Good Manufacturing Practice regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act.
• Process validation, cleaning and sanitation validation, computer system validation, and analytical method validation are processes that should be validated according to GMP.
• GMP is also sometimes referred to as "cGMP".
• GMP compliance is crucial and having robust processes and easy-to-use systems that enforce and monitor standards can strengthen GMP compliance in your organization.
• GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors.
• GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff.
• A surprise audit every now and then can help gain more accurate insight on what goes on in the facility.
• These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective.
• Good Manufacturing Practices (GMP) is a system that ensures manufacturing products, such as food, cosmetics, and pharmaceutical goods, are consistently produced and controlled according to set quality standards.
• GMPs examine and cover every aspect of the manufacturing process to guard against any risks that can be catastrophic for products, such as cross-contamination, adulteration, and mislabeling.
• Implementing GMP can help cut down on losses and waste, and protects both the company and consumer from negative food safety events.
• GMP regulations are mandated by manufacturers’ respective national government to regulate production, verification, and validation of manufactured products and ensure that they are effective and safe for market distribution.
• In the United States, GMP is enforced by the US FDA through Current Good Manufacturing Practices (CGMP) which cover a broader range of industries such as cosmetics, food, medical devices, and prescription drugs.
• The FDA conducts facility inspections to assess if a manufacturing company complies with CGMP regulations.
• If any serious violations are found during the inspection, FDA recalls all products, which is problematic for manufacturers in terms of both profit and business operations.
• Quality of manufactured products is highly regulated as it can pose negative health risks to consumers and even the environment.
• Complaints about marketed products are examined, the causes of quality defects investigated and appropriate measures are taken in respect of the defective products and to prevent re-occurrence.
• In the event of defect or malfunction, equipment should be removed or labeled as defective.
• Records are made, manually and/or by recording instruments, during manufacture which demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the product were as expected.
• Quality risk management is a systematic process of assessing risks that can affect the quality of the product.
• Managers should be clear on job descriptions for each worker to avoid misunderstandings and reduce the risk of issues like overlapping responsibilities.
• Sanitation and hygiene covers anything that can cause contamination such as personnel, the premises, equipment, containers, and production materials.
• Equipment should be cleaned and stored according to procedures.
• Any significant deviations are fully recorded and investigated.
• Personnel are qualified and trained to do the job and are aware of the principles of GMP.
• Sanitation and hygiene is vital in every aspect of the manufacturing process.
• The evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient and users.
• All materials used for production should be stored properly according to its appropriate conditions which are set by the manufacturers.
• Operators are trained to carry out procedures correctly.
• Equipment should be designed, located, and maintained to function according to its intended use.