483 A negative report from the FDA after an audit. Something was amiss that needs to be taken care of immediately
Batch Records Detailed, step-by-step sets of instructions with a "fill in the blanks" approach. These are kept on file at the company, and the FDA has the right to inspect them at any time in an audit.
DCS Distributive Control System. The computer systems that hook up a firm's process equipment, such as fermenters, bioreactors, air handling systems, pure water, etc.
GLP Good Laboratory Practices. A set of rules and regulations issued by the FDA that establishes methods for procedures and record keeping. GLPs are to be followed in laboratories involved in the testing and/or preparation of pharmaceuticals.
GMP Good Manufacturing Practices. Sometimes referred to as cGMP (current Good Manufacturing Practices). FDA-mandated general methodologies and procedures that are to be followed in the testing and manufacture of pharmaceuticals.
IQ Installation Qualification. The first step in qualifying or validating a new lab instrument or a piece of process equipment in a regulated environment. If your firm has a new fermenter, for example, this step determines whether the technical requirements necessary to run the tank are available (e.g., the proper utilities, clean water, etc.).
ISO9000 Quality assurance system developed by the International Organization for Standardization. Many companies use ISO9000 processes, or its derivatives (ISO9001, ISO9003) to ensure consistency in manufacturing processes.
OQ Operational Qualification. The next step in the equipment validation process is to plug in the equipment, hook it up, and run tests to see that each switch or user-controllable option does what it is supposed to do. To use our earlier example, fermenters have PLC (programmable logic controller) settings that require significant testing and setup.
PQ Performance Qualification. The final step to ensure that this equipment will be safe and will work properly in the regulated environment. PQs are performed with the fermenter functioning as it would be in a real situation, the objective being to ensure that it operates safely and effectively.
SOP Standard Operating Procedure. A huge number of SOPs make up a process that is used in a regulated environment and under Good Manufacturing Practices (GMP) to produce a product.