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.
Writing clearly on documents is important when?
GMP stands for what?
Ensure that the products we produce are ______.
Branch of Gonvernment which creates and enforces GMP is?
A common source of contamination?
Who is responsible in keeping the facility clean?
Facility design should reduce?
Surfaces should be easy to?
Equipment should be __________ at defined intervals.
To verify equipment
_____________ all changes to facilities, equipment, or processes that may have an impact on product quality.
Procedures should be reviewed ____________ to ensure they are up to date.
Never _______ from a procedure without the approval from a Supervisor or Quality Control.
____ descriptions have been created to define everyone's role.
Draw a single _____ through any mistakes with an intintial and date.
Do not _______ any documents.
Keep records for a minimum of ______ years.
Practice good personal ______ by washing your hand and wearing protective equipment as necessary.
Maintenance _________ are kept for facilities and equipment.
Inspect all materials and components when they enter the plant o ensure they meet?
A _______ record or file outlines the specifications and manufacturing procedure.
A lot number is assigned for?
Controls are in place to prevent contamination, mix-ups, and _______.
_______ are conducted to assess weather GMPs are followed.
representation of facts
secure, computer-generated, time stamped electronic record
set of related data items treated as unit
an exact verified copy of an original record
clear and readable
agency of the U.S federal government
systematic and independent examination of records
term used to define manipulation of data
system of moral principles
system for ensuring products are consistently produced & controlled according to standards
step by step instructions to carry out the operations
This is needed to ensure data integrity
European Medicines Agency
procedure of preparing, reviewing, approving, issuing, recording, storing & archival of any document
data about data
acronym used to describe data integrity
extent to which all data are complete, consistent & accurate throughout data life cycle
act of following regulations
record or report
data able to track all changes
this is divided into 50 titles
a set of specification for application dossier for the registration of Medicines and designed to be used across Europe
Equivalent of the FDA in UK
Occupational Safety and _________ Administration
FERC Order 706 governs these Standards
Generally ________________ Accounting Principles
ATC’s FERC formula rates are housed within this
An ATC ___________ has a $50,000 expenditure authorization limit
Escheatment is the process of turning over ___________ property to a state authority
The frequency of completing ATC’s Business Ethics Questionnaire
Regulation (acronym) enacted in 1996 aimed at ensuring medical records, medical billing, and patient accounts meet certain consistent standards with regard to documentation, handling, and privacy
An employee may take maternity leave under the ________ and Medical Leave Act
The heading on Page 3 of ATC’s Code of Conduct: Doing What’s _________
Tax (acronym) imposed on both employees and employers to fund Social Security and Medicare
The Federal _____________ Guidelines outline the seven elements of an effective compliance program
Tone at the ________
An anonymous way to report an ethics or compliance concern
The number of members on ATC’s Policy & Ethics Committee
________________ Reliability Organization
Juanita Banks is ATC’s Designated ___________ Officer
Substantiated ethics and/or compliance violations are reported to ATC’s ____________ Committee
Enterprise ____________ Management
Regulatory entity (acronym) that assists in the protection of employment discrimination on the basis of race, sex, religion, national origin, and a variety of other characteristics
Information should be classified as ATC __________ Information when the unauthorized disclosure, alteration, or destruction of that information could expose the Company to a significant level of risk
Controls for providing Users the means to verify or validate a claimed identity through the presentation of something they know (e.g., passwords), something they own (e.g., hardware token), or something they are (e.g., fingerprint, biometrics, etc.).
Per the Acceptable Use of Electronic Resources Policy, data moved to removable media sources (e.g. USB, CD, etc.) must be ___________.
Ways to report potential issues or concerns are outlined in ATC’s Open ______ Policy
Employment ______________ and Professional References Policy
Accepting a gift card from a supplier vying for business at ATC represents a Conflict of ________
Per the External Communications & Social Media Policy, do not represent yourself as a ____________ for ATC
Per the Gifts & Entertianment Policy, all tangible gifts given to an ATC employee, regardless of dollar amount, must be reported to _________
Environmental ____________ Agency
A competitive _________ is required to procure services over $100,000
___________ Oxley Act was instituted in 2002, as a result of a series of high-profile financial scandals
Per NERC, Critical __________ are facilities, systems, and equipment which, if destroyed, degraded, or otherwise rendered unavailable, would affect the reliability or operability of the bulk electric system
Personnel Risk ____________ Policy
The Travel & Expense Policy governs transactions inputted into this system
___________ employees who do not charge time to project work orders only need to report their exception time (e.g. vacation, sick, personal, or floating holiday hours) each pay period
Per ATC’s Code of Conduct, each ATC employee has a responsibility to promptly _________ any known violation or dishonest, unethical, or illegal conduct
_______ % of ATC’s corporate goal attainment ties to Reliability Compliance
Behavior Based _________ Observations
Certificate of Analysis