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 Good Manufacturing Practice
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 Current
Planned and systematic activities implemented in a quality system so that quality requirements for a product will be fulfilled Quality Assurance
The FDA applies cGMP regulations on a _______ scale. Sliding
A document issued by QA that confirms that a product meets its specification. Certificate of Analysis
Version controlled templates or instructions for the manufacturing process MBR
A solution meant to reduce or eliminate the cause of a detected nonconformity or other undesirable situation Corrective Action
An action taken to remove or improve a process to prevent potential future occurences of a nonconformance Preventive
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) Batch
All operations involved in the preparation of a product, from receipt of materials, Production
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 Cleanroom
a set of step-by-step instructions compiled by an organization to help workers carry out complex routine operations SOPs
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 IPQA
One of the functions of this group is to accept or reject each batch or lot based on review of the completed manufacturing records Quality Control
A practice that ensures concision, legibility, accuracy, authenticity, and traceability of all development, production, and testing activity records GDP
A hierarchical set of MSK policies and procedures, documented in SOP format, describing institutional cGMP compliance Manufacturing Quality System
An inspection to check for GMP compliance Audit
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 Deviation
The document used for each individual batch of API, based on the master production instruction BPR
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 Change Control
All operations of purchase of materials and products, Production, Quality Control, release, storage, distribution of products and the related controls Manufacture
The non-fulfilment of a specified “material/product” requirement – (usually to a specification) that usually leads to rejection or reworking of the item Nonconformance
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. OOS
The basic cause of a deviation, from which effective actions can be defined to prevent recurrence Root Cause
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
___________ 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 Method
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)) CMC
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 API
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. Quality

Engineering Disciplines Crossword


Plan, perfect, or improve the sound of an architectural space Acoustical
Plan, coordinate, and implement the specifications for a new car, engineering every part Automotive
Design, develop, test, and help manufacture aircraft, missiles, and spacecraft Aerospace
Concerned with the production and processing of agricultural products, which are critical to our ability to feed the ever-expanding world population Agricultural
The application of engineering principles to biological systems Bioengineering
Take what chemists do in a laboratory, apply fundamental engineering, chemistry, and physics principles, and design and develop processes to produce products for use in our society Chemical
Designing and supervising the construction of roads, buildings, airports, tunnels, bridges, and water and sewage systems Civil Engineering
Concerned with the management and operation of construction projects Construction
Responsible for the design, development, testing, and supervision of the manufacturing of electrical equipment, such as household appliances or guidance systems for satellites Electrical Engineering
Apply engineering principles in order to improve and maintain the environment Environmental
Responsible for the design, development, testing, and supervision of the manufacturing of electrical equipment, such as household appliances or guidance systems for satellites Fire Protection
Concerned with providing healthier products to consumers, who increasingly rely on food products Food Process
Use science to research genes found in the cells of plants and animals to develop better products Genetic
Use science to work with land and water Geological
Design, improve, and install integrated systems of people, materials, and energy Industrial
Applies science and math to the design, development, and implementation of manufacturing systems Manufacturing
Concerned with the exploration of oceans, the transportation of products over water, and the utilization of resources in the world’s oceans, lakes, and seas Marine and Ocean
Develop new materials, improve traditional materials, and produce materials that are economical and reliable through synthesis and processing Materials Science
Design, produce, operate, and service machines and mechanical devices Mechanical
Maintain the flow of raw materials by discovering, extracting, and processing minerals for products Mineral and Mining
Study nuclear energy, radiation, and their beneficial uses Nuclear
Concerned with maintaining the safe flow of petroleum, exploring for crude oil deposits, removing and transporting oil, and refining oil Petroleum
Concerned with programming robots and systems to perform tasks autonomously Robotics
Responsible for the coding of computer software that results in a simple and friendly environment for computer users Software
Create safer structures and fit more people and objects per square inch into these structures Structural

GMP Crossword


A roof leak can lead to this type of hazard Biological
When water comes into contact with food it needs to be Potable
Gaps in a building can lead to __________ infestation Pest
Where can you find food safety and quality policies and standards PPL
______________ in place Cleaning
GMP forms an important part of the overall _____________ plan HACCP
A piece of personal protective clothing Hair Net
Where glass and/or hard plastics are used in the manufacturing environment, the risk to product can be managed by a glass __________ Register
Cleaning and ______________ processes shall ensure product quality and integrity is maintained throughout the manufacturing process sanitation
Where lubricants may potentially contact product, the lubricant must be ___________ Approved
Jewellery in hygiene areas are prohibited except for the wearing of a plain wedding band, and ___________bracelets/tags. Medic Alert

Industrial Revolution Vocabulary Crossword


the era when the use of power-driven machinery was developed Industrial Revolution
a process in Europe from 1700's to the mid 1800's where landowners fenced small fields to create large farms, allowing for more efficient farming enclosure movement
the basic resources for industrialization, such as labor, land and capital factors of production
a usually small-scale industry carried on at home by family members using their own equipment cottage industry
developing industries for the production of goods industrialization
a place where goods are manufactured in mass quantity factory
an organization representing worker's interests labor unions
a work stoppage strike
the system of manufacturing large numbers of identical items mass production
identical machine-made parts that can be substituted for each other in manufacturing interchangeable parts
a mass-production process in which a product is moved fowrd through many work stations where workers perform specific tasks assembly line
a buisness system where companies are allowed to conduct a buisness without interference by the government laissez-faire
a risk taker who starts a buisness system within the economic system of capitalism entrepreneur
a political and economic system in which society, usually in the form of government, owns the means of prodution socialism
economic and political system in which government owns the means of production and controls economic planning communism
a meausure of the quality of living standard of living

chapter 1: The Nature of Science Crossword


facts and statistics collected together for reference or analysis data
a sample that is treated like other experimental groups except that is the independent variable is not applied to it. control
Prediction or statement that can be tested and may be formed by prior knowledge, any previous observations, and new information. hypothesis
facts, information, or ideas for use in creating a book or other work. materials
a judgment or decision reached by reasoning. conclusion
Used to answer scientific questions by testing a hypothesis through the use of a series of carefully controlled steps. experimental research
purpose, planning, or intention that exists or is thought to exist behind an action, fact, or material object. design
a room or building equipped for scientific experiments, research, or teaching, or for the manufacture of drugs or chemicals. laboratories
Factor that is being measured during an experiment. dependent variable
an electronic device for storing and processing data, typically in binary form, according to instructions given to it in a variable program. computer
Process used to investigate what is happening around us in order to solve problems or answer questions; part of everyday life. science
Answers scientific questions through observation. descriptive research
discover or reveal (something) through detailed examination analyze
Ways to solve problems that can include step-by-step plans, making models, and carefully through-out experiments. scientific method
Variable that stays the same during an experiment. constants
the size, length, or amount of something, as established by measuring. measurements
a device or implement, especially one held in the hand, used to carry out a particular function. tools
a test of the performance, qualities, or suitability of someone or something. trials
A variable that can be changed during a experiment. independent variable
A set of controlled steps carried out to discover, test, or demonstrate. experiment

Cyber Security Crossword


any software program in which advertising banners are displayed while the program is running. Adware
designed to detect and destroy computer viruses. Antivirus
an attempt by hackers to damage or destroy a computer network or system. Attack
a method, often secret, of bypassing normal authentication in a product back door
refers to the process of making copies of data or data files to use in the event the original data or data files are lost or destroyed. backup
refers to the process of making copies of data or data files to use in the event the original data or data files are lost or destroyed. Blended threat
are similar to worms and Trojans, but earn their unique name by performing a wide variety of automated tasks on behalf of their master (the cybercriminals) who are often safely located somewhere far across the Internet. bots
are small files that Web sites put on your computer hard disk drive when you first visit cookie
body of technologies, processes and practices designed to protect networks, computers, programs and data from attack, damage or unauthorized access cyber security
made possible by using algorithms to create complex codes out of simple data, effectively making it more difficult for cyberthieves to gain access to the information encryption
a network security system, either hardware- or software-based, that controls incoming and outgoing network traffic based on a set of rules. firewall
someone who seeks and exploits weaknesses in a computer system or computer network. hacker
global system of interconnected computer networks that use the Internet protocol suite internet
a local or restricted communications network, especially a private network created using World Wide Web software. intranet
used to describe any code in any part of a software system or script that is intended to cause undesired effects, security breaches or damage to a system. malicious code
the activity of defrauding an online account holder of financial information by posing as a legitimate company. phishing
software that enables a user to obtain covert information about another's computer activities by transmitting data covertly from their hard drive. spyware
any malicious computer program which is used to hack into a computer by misleading users of its true intent trojan horse
a piece of code that is capable of copying itself and typically has a detrimental effect, such as corrupting the system or destroying data virus
a standalone malware computer program that replicates itself in order to spread to other computers. worm

GMP Training 2018 Crossword


Writing clearly on documents is important when? always
GMP stands for what? goodmanufacturingpractice
Ensure that the products we produce are ______. safe
Branch of Gonvernment which creates and enforces GMP is? foodanddrugadministration
A common source of contamination? pests
Who is responsible in keeping the facility clean? everyone
Facility design should reduce? contamination
Surfaces should be easy to? clean
Equipment should be __________ at defined intervals. calibrated
To verify equipment qualify
_____________ all changes to facilities, equipment, or processes that may have an impact on product quality. document
Procedures should be reviewed ____________ to ensure they are up to date. regularly
Never _______ from a procedure without the approval from a Supervisor or Quality Control. deviate
____ descriptions have been created to define everyone's role. job
Draw a single _____ through any mistakes with an intintial and date. line
Do not _______ any documents. falsify
Keep records for a minimum of ______ years. five
Practice good personal ______ by washing your hand and wearing protective equipment as necessary. hygiene
Maintenance _________ are kept for facilities and equipment. records
Inspect all materials and components when they enter the plant o ensure they meet? specifications
A _______ record or file outlines the specifications and manufacturing procedure. master
A lot number is assigned for? traceability
Controls are in place to prevent contamination, mix-ups, and _______. errors
_______ are conducted to assess weather GMPs are followed. audits

GMP Escape Room Word Search

Word Search

Warning Letter
Work Instructions
Lot Number
Batch Record
Root Cause

Manufacturing Worksheet Crossword


Specific, measurable abilities that you would need to qualify for a job Hard Skill
Amount of a commodity, product, or service available Supply
Stay 3 feet or arm's length away from machines in use. Only operator and instructor are allowed in this zone. Operator Safety Zone
Land, equipment, and money used to start or maintain a business capital
Metal not containing iron. non-ferrous
The use of software to control machine tools in the manufacturing process Computer Aided Manufacturing
Components that are identical so that they will fit into any assembly of the same type. Interchangeable Parts
Shaping pliable raw material using a rigid frame molding
Mobile robot that follows markers or wires in the floor, or uses vision, magnets, or lasers for navigation Automated Guided Vehicles
A joining process that melts the base metal and adds a filler material which then cools and forms a strong joint welding
Example of Additive Manufacturing 3D printing
To shape a material by forcing it through a die extruding
Very specific products that are made to order. Very expensive form of production. Custom Production
Placing flat sheet material into a stamping press where a tool and die presses the material into a new shape Stamping
A tool that moves with a workpiece through a machine in order to provide repeatability and accuracy in the manufacturing of products jig

Entrepreneurship Crossword


What is concerned with the Human resource of an Enterprise ? STAFFING
For effective running of an enterprise, what is essential between the employees and entrepreneur ? COMMUNICATION
Motivation through financial means is called _____ benefits ? MONETARY
What ensures maximum utilization of resources ? SUPERVISION
Controlling begins when establishing standards of what ? PERFORMANCE
What ensures effective performance and planned activities by subordinates ? DIRECTION
Production contain manufacturing, ______ activities and advisory activities ? ANCILLARY
What is continuously needed for running a firm ? FINANCE
Marketing plays an important role in _____ the successful running of a business enterprise ? PROMOTING
Who is appointed in an enterprise on the basis of their performance, skills and service ? PERSONNELS
Entrepreneur carries out the whole set of activities of the business for its _____ SUCCESS
Entrepreneur foresees a potentially _____ opportunity and tries to exploit it ? PROFITABLE
An entrepreneur is a self-confident and highly _____ person and willing to assume the risk involved in his enterprise ? OPTIMISTIC
An entrepreneur is the ____ of his business ? FINAL JUDGE
It is the ability of a good _____ to discover a suitable idea that helps to develop profitable ventures ? ENTREPRENEUR
The entrepreneur will conduct a detailed ________ about the demand for his product in the market ? ANALYSIS
After making sure that the idea is practical and profitable one, the entrepreneur will acquire some _______ , if he has invented something ? PATENT RIGHTS
The entrepreneur decides about the capital structure of the ________ ENTERPRISE
____ helps in determining the course of action to be followed to achieve various entrepreneurial objectives ? PLANNING
Staffing consist of appraisal and determination of employee's _______ ? REMUNERATION
_____ is concerned with carrying out the desired plans with the support of proper instructions ? DIRECTING
Inspiring is the process of inspiring or influencing the ______ by satisfying their needs for the fulfillment of organisational objectives WORKERS
For effective running and accomplishment of organisational goals , proper communication at all ______ is a necessary one ? LEVELS
Supervising ensures maximum utilization of _______, to the proper and timely completion of work, and to correct the workers whenever they go wrong ? RESOURCES
______ involves the process of movement of goods and services from the producer to the consumer ? MARKETING

Vocabulary Words ch1 Supply Chain Logistics (CLA) Worksheet

Matching Worksheet

Farms and Mines Raw Material Providers
Manufacturing or Factories Production Facilities
Airlines/drones/ships/trucks/trains Transportation
network used to deliver products or services from raw materials to customers Supply Chain
world wide supply Global Supply Chain
mines or farms products to production Raw materials Inventory
Inventory currently being processed Work-In-Process (WIP)
inventory ready to ship or package Finished goods Inventory
inventory shipped to customer In-Transit Inventory
what the customer wants/ where../ when…/ why…/ how shipped Customer Interaction
quantity of goods for sale Supply
Most critical/ identify and expecting acquisition of goods Receiving
Assigning product to specific location warehouse Stocking
Activity to administratively process a customer's order Assembly products from various locations for a specific order Order Processing
order process Picking
Materials surrounding an time to protect from damage full case has no packaging requirement Packing
determined by customer Shipping
Just in time process transfer form incoming dock to outgoing dock Goods-In Bay
Just in time Goods-out Bay
process of moving items directly from an incoming trailer or container to an outgoing trailer or container. Cross-docking
A need for a particular item Demand
Warehouse with finished goods Distribution Center
identification SKU (Stock Keeping Unit)
Mathematically measure of efficiency Productivity