GMP Olympics Cross Word

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Across
  1. 2. Action of proving, in accordance with the principles of GMP, that any procedure, process, equipment, material, activity or system actually leads to the expected results
  2. 5. A document issued by QA that confirms that a product meets its specification.
  3. 8. One of the functions of this group is to accept or reject each batch or lot based on review of the completed manufacturing records
  4. 9. A system for ensuring that products are consistently produced and controlled according to quality standards, designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
  5. 10. The suitability of either a drug substance or drug product for its intended use. This term includes such attributes as the identity, strength, and purity.
  6. 11. Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product
  7. 14. A departure from standard procedures or specifications resulting in non-conforming material &/or processes, or where there have been unusual or unexplained events which have the potential to impact on product quality, system integrity or personal safety
  8. 15. The "c" in GMP stands for "______".
Down
  1. 1. A formal monitoring system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect the validation status of a system or process and cause corrective action, if any, to be taken that will ensure that the system or process retains, or is placed back into a validated state of control
  2. 3. The basic cause of a deviation, from which effective actions can be defined to prevent recurrence
  3. 4. an environment, typically used in manufacturing, that has a controlled level of contamination that is specified by the number of particles per cubic meter at a specified particle size
  4. 6. a set of step-by-step instructions compiled by an organization to help workers carry out complex routine operations
  5. 7. Planned and systematic activities implemented in a quality system so that quality requirements for a product will be fulfilled.
  6. 9. A practice that ensures concision, legibility, accuracy, authenticity, and traceability of all development, production, and testing activity records
  7. 12. An inspection to check for GMP compliance
  8. 13. A specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture. (21 CFR 210.3)