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Quality Month Crossword 2021

Horizontales
A process that eliminates viable bioburden via the use of sporicidal chemical agents.
The acronym for the area of quality assurance which ensures the quality of the drug product is maintained throughout all stages of the supply chain from the site of manufacture to the pharmacy.
A document that describes a process along with the required steps and responsibilities for the proper execution of that process including “who does what when".
The status of materials expected to be approved but not yet fully tested or approved.
The acronym for the distribution procedure that ensures that the stock with the earliest expiry date is distributed and/or used before an identical stock item with a later expiry date is distributed and/or used.
Any communication that alleges deficiencies related to the product as a result of manufacturing, packaging or distribution and calls into question the identity, strength, quality, potency, purity, tampering, diversion and/or counterfeiting of that marketed product (7, 7, 9)
A systematic examination of an area performed at defined intervals and at sufficient frequency to determine whether the area operates in compliance with procedures, regulations and/or industry standards.
The BMS data management programme utilised for material planning and inventory management
The name of BMS' electronic quality management system
Action taken to eliminate the cause of a detected nonconformity or another undesirable situation. It is taken to prevent recurrence
Any unique combination of letters, numbers, or symbols from which the complete history of the manufacture, processing, packaging, storage and distribution can be determined (5,6)
The set of operations which establish, under specific conditions, the relationship between values indicated by a measuring instrument or measuring system or values represented by a material measure and the corresponding know values of a reference standard
Verticales
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)