Good Manufacturing Practice (GMP) Crossword

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
The "c" in cGMP stands for "_____," reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation
Planned and systematic activities implemented in a quality system so that quality requirements for a product will be fulfilled
The FDA applies cGMP regulations on a _______ scale.
A document issued by QA that confirms that a product meets its specification.
Version controlled templates or instructions for the manufacturing process
A solution meant to reduce or eliminate the cause of a detected nonconformity or other undesirable situation
An action taken to remove or improve a process to prevent potential future occurences of a nonconformance
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)
All operations involved in the preparation of a product, from receipt of materials,
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
a set of step-by-step instructions compiled by an organization to help workers carry out complex routine operations
This group's mission is to ensure "quality and efficiancy, while supporting regulatory compliance, in the development and manufacture of clinical trial investigational products at MSK
One of the functions of this group is to accept or reject each batch or lot based on review of the completed manufacturing records
A practice that ensures concision, legibility, accuracy, authenticity, and traceability of all development, production, and testing activity records
A hierarchical set of MSK policies and procedures, documented in SOP format, describing institutional cGMP compliance
An inspection to check for GMP compliance
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
The document used for each individual batch of API, based on the master production instruction
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
All operations of purchase of materials and products, Production, Quality Control, release, storage, distribution of products and the related controls
The non-fulfilment of a specified “material/product” requirement – (usually to a specification) that usually leads to rejection or reworking of the item
A finished product or raw material test result that falls outside approved, registered or official specifications or acceptance criteria. If validated it results in a Non-conforming product.
The basic cause of a deviation, from which effective actions can be defined to prevent recurrence
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
___________ validation is the process by which it is established, by laboratory studies, that the performance characteristics of the analytical methods meet the requirements for the intended application
A section in an Investigational New Drug (IND) application describing the composition, production, and controls of the drug substance and product (21 CFR 312.23(a)(7))
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
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.