The BMS business acronym for communication to management notifying them of the identification of a GxP significant event for evaluation
A document that sets forth the highest overarching regulatory, legal, and/or business requirements that must be adhered to and used in decision-making
Transportation system without active temperature control e.g. insulated container with/without refrigerant (7,9)
Also known as a vendor or provider or contract acceptor
A pharmaceutical product type (e.g. tablet, capsule, solution , cream) that contains a drug substance (6,4)
The systematic application of quality management policies, procedures, and practices to the tasks of assessing, controlling, communicating and reviewing risk. (4, 10)
A filing submitted for regulatory action or approval
Action taken to eliminate the cause of a potential nonconformity or another undesirable situation. It is taken to prevent occurrence (12,6).
Action of proving and documenting that equipment or ancillary systems are properly installed, work correctly and actually lead to expected results.
A cause that if corrected, would prevent recurrence of the problem (4, 5)
An unplanned event or unexpected situation that results in a departure from established GxP procedure, system or process
The process that is the removal or correction of distributed product that may pose a potential health hazard or in which the marketed product does not meet the specifications set forth in the marketing authorization
Any component of the drug substance or drug product that is not the drug substance or an excipient in the drug product.
All operations involved in the preparation of a medicinal product, from receipt of materials through processing and packaging to its completion as a finished product
The uncontrolled temperature of the surrounding environment
The inappropriate or illegal altering of a drug product including its labelling and container without the knowledge of the product’s owner or eventual user.
The acronym for a list of the analytical tests, acceptance criteria and results obtained on a particular batch (1,1,1)