Good manufacturing practices or cGMP are the practices required in order to conform to the guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products.
Data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and
The principles of Good Laboratory Practice (GLP) define a set of rules and criteria for a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, reported and archived.
The presence of contaminants in pharmaceutical products can reduce or even inactivate the therapeutic activity of the products and can lead to serious health risks to the patients consuming such products. Contamination can be controlled by effective management and by establishing robust control measures.
Computer Software Validation is a formalized, documented process for testing computer software and systems, required by 21 CFR 11.10(a) and Annex 11, Section 4. The FDA and other bodies require validation to demonstrate that computer systems are in compliance with all regulations for all electronic data.
Process validation activities are an integral part of the design and output validation of a product. Process validation guidelines describe the validation steps (protocol, production, and process) needed for regulatory compliance and for confidence in product quality.
Periodically Auditing for Good Manufacturing Practice (GMP) observance is a regulatory requirement. This course gives you detailed information on various aspects of carrying out an audit efficiently and also helps you to improve your skill set to ensure you get the best out of each audit.
21 CFR 11 requires that closed computer systems must have a collection of technological and procedural controls to protect data within the system. Open computer systems must also include controls to ensure that all records are authentic, incorruptible, and (where applicable) confidential.
FDA 21 CFR Part 820, also known as the QSR, outlines Current Good Manufacturing Practice (CGMP) regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.
This program is intended for professionals and others who have roles and responsibilities within organizations who are responsible for making or inspecting test and other documentation within a laboratory of manufacturing environment.
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.