To achieve a state of inspection readiness, organizations must ensure that they have well established and robust systems including Quality, Production, Facilities and Equipment, Laboratory Controls, Materials, and Packaging and Labeling.
Good Manufacturing Practice (GMP) audits must be routinely performed to ensure pharmaceutical companies have robust controls and systems including Quality, Production, Facilities and Equipment, Laboratory Controls, Materials, and Packaging and Labeling. GMP audits ensure the Safety, Identity, Strength, Purity and Quality of the product. These audits can also help identify deficiencies prior to a regulatory inspection which could result in repercussions such as an FDA Form 483 or Warning Letter. GMP audits are also conducted at Contract Development and Manufacturing Organizations (CDMOs) as regulatory agencies expect companies using CDMOs to ensure that outsourced operations adhere to GMP requirements.
Good Distribution Practice (GDP) regulations describe the minimum standards that a distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the Supply Chain. GDP regulations are required by regulators in most regions of the world. However, the US FDA is different from all other agencies as there are no separate GDP regulations in place. FDA covers violations of storage and distribution under Good Manufacturing Practice (GMP) violations.
Good Tissue Practice (GTP), along with Good Manufacturing Practice (GMP), are core FDA requirements for manufacturing products regulated as Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) and cellular therapies. These regulations are designed to assure high quality cellular and tissue products while maintaining control of potential infections, contaminations and other risk factors with such products. GTP and GMP also define the core elements of operational control and documentation required for manufacturers of such products. Deficiencies in GTP and GMP compliance can lead to FDA Warning Letters, sanctions and other punitive actions on the manufacturers of such products.
Support companies with the development of robust Quality Systems and various programs.