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.
The control of hazardous energy.
Title of the employee who locks or tags machines or equipment in order to perform servicing or maintenance.
Source of energy with suspended parts or springs.
Source of energy by oil or water pressure.
Lockout tagout involves the use of a specific lock or locks to ____ equipment from all energy sources.
Locks, tags and isolating devices must not be used for other purposes.
A completed tag should have a _____ and reason why the equipment is down.
____ by themselves, may only be used when locks cannot be used and when the employer can demonstrate that a tagout system will provide full employee protection.
When implementing lockout tagout, ____ all affected employees in the work area.
How do you insure that all the energy and hazard sources are off?
____ authorized employee must affix a personal lockout or tagout device to the machine or equipment when work begins and remove it when work is completed.
The municipality must ensure that the _____ employee knows when their lockout device has been removed before they resume work at the facility.
Never attempt a LOTO procedure unless you have been _____.
____ remove a tagout device unless authorized.
Lockout tagout does not apply when a person has ____ control of the plug while doing the work.
Where staff meet when we have to evacuate the store.
Avoiding injuries at the workplace through proper_____
Sheet used for information on product usage and spillage is known as _____
What do you page in case of a fire?
The practice of following certain rules and procedures to prevent the contamination of food.
It is a comprehensive plan for providing information on the safe use of hazardous materials in the workplace.
______ is an area of concern with the health, safety and welfare of people in the workplace.
_______ refers to protective clothing, helmets, goggles, gloves or other garments and equipment designed to protect the employees body from injury.
What must you wear anytime you do work outside?
This should always be used when cutting product in departments.
This must be done to ensure employee safety when cleaning or repairing a piece of equipment.
This form must always be filled out when there is any injury in the workplace.
Only _____ that limit blade extensions, are to be used to open boxes/strapping.
Under no circumstances should these be blocked.
All _____must be placed on sturdy wooden pallets and stored individually.
All areas of the store are clear and free of _____.
A Foodborne________, commonly referred to as food "poisoning" is a disease carried to people by food or water.
A Foodborne__________, is an incident in which two or more people experience the same illness symptoms after eating a common food.
___________ or other microorganisms that have contaminated food cause most food borne illness.
The temperature ________________ is between 41 degrees F to 140 degrees F.
A foodborne illness can result from a harmful ________ getting into a food that is then eaten by a person.
_________ are another potential source of contamination
___________ contaminated include dirt, hair,nail polish flakes, insects, broken glass, and crockery, nails, staples, metal, or plastic fragments, and buts
To prevent foodborne illness, foodservice personnel must follow procedures for good personal ___________
The temperature danger zone is between _____ degrees to 140 Degrees
___________-temperature relationship problems occur because, food is not stored, prepared, or held at required temperatures
One of the most common causes of foodborne illness is ______ contamination, the transfer of bacteria from hand to hand, food to food, or equipment to food.
the ___________ method is used most often unless a thermometer cannot register a temperature of 32 degrees F (0 degrees C)
______________ method may be less reliable than the ice-point method because of variation due to high altitude
An easy way to determine if hands are rubbed and lathered for 20 seconds is to sing one verse of______________________
cuts, burns, or any kind of break in the skin could harbor harmful__________ that can contaminate food and cause a foodborne illness
________ to food cross contamination happens when harmful microorganisms from one to such as unwashed produce, contaminate other foods.
Bacteria may pass from ___________ to food when the equipment that has touched food has not been properly cleaned and sanitized before being used to prepare another food
Foodservice ___________ are responsible for learning about food safety and following food safety requirements and guidelines
The foodservice __________ is responsible for knowing and implementing the state and local public health department regulations regarding food sanitation and safety
The 3 main________ illnesses are Biological, Physical and Chemical
The harmful microorganisms called ___________ can come from a variety of sources
__________- spreading pest, such as cockroaches, flies or mice which are attracted to food preparation areas, may contaminate food, equipment, or device areas.
_________ spread organisms from their bodies to food by unclean hands, coughing, sneezing.
____________ facilities and equipment may spread harmful organisms to people of food
___________ microorganisms may contaminate food during preparation and serving
The ______ primary ways of preventing foodborne illness are practice good personal hygiene, control time and temperature of foods, and prevent cross contamination
Must be 12 mil thick
Dirty to Clean
Pressure of Decontamination
Spaulding Classification that is defined as Introduced into the sterile body or blood stream
Any medical equipment to be reused from one patient to another
Clean to Dirty
Pressure of Preparation Area
Occurs regularly to ensure everyone knows what to do in case of a fire
Spaulding Classification that is defined as coming into contact with mucous membranes or non-intact skin
Spaulding Classification that is defined as coming into contact with non-intact skin
Acronym for Personal Protective Equipment
Acronym for Safety Data Sheet
RME is considered sterile unless an event occurs deeming it compromised
Wrapping techique frequently used for smaller trays
Wrapping techique frequently used for larger trays
Type of sterilizer used for items that are not heat sensitive
Type of sterilizer that aerates
Pathogen that may be found in dairy plant any grows at refrigerated temperatures
Ensure _______________ are properly attired to avoid any potential foreign material contamination
Immediately inform your Supervisor if you are suffering from a _____________________ disease
Place all ________________ butts in the containers provided to avoid any littering and maintain a clean premises
____________________ is one of our new core values
We must strive to be " _______________ ready every day" to meet our customer, regulatory and corporate requirements
First Time Right _______________
All _____________ from the outside must be kept locked to comply with our Biosecurity Policy
Proper ______________________ is the #1 defense against foodborne illness
We must immediately report any food ________________ deviations to ensure a strong food safety program and culture
A roof leak can lead to this type of hazard
When water comes into contact with food it needs to be
Gaps in a building can lead to __________ infestation
Where can you find food safety and quality policies and standards
______________ in place
GMP forms an important part of the overall _____________ plan
A piece of personal protective clothing
Where glass and/or hard plastics are used in the manufacturing environment, the risk to product can be managed by a glass __________
Cleaning and ______________ processes shall ensure product quality and integrity is maintained throughout the manufacturing process
Where lubricants may potentially contact product, the lubricant must be ___________
Jewellery in hygiene areas are prohibited except for the wearing of a plain wedding band, and ___________bracelets/tags.
Job _______ is a process to identify and determine in detail the particular job duties and requirements and the relative importance of these duties for a given job.
Job _________ is a statement of the essential compotents of a job class including a summary of the work to be performed, primary duties and responsibilities, and the minimum qualifications and requirements necessary to perform the essential functions of the job.
A job _________ will tell you what your employer will expect from you, as well as what you can expect from your employer.
Job Analysis should collect information on the following areas: Duties and Tasks, Tools and Equipment, Relationships, Requirements, and ________________.
In terms of Job Analysis, 'relationships' refer to ____________ given and received and relationships with internal and external people.
The purpose of Job Analysis is to establish and document the 'job relatedness' of employment procedures such as training, selection, ______________, and performance appraisal.
The main purpose of a job description is to collect job-related ______ in order to advertise for a particular job.
Job Specification helps recruiting teams understand what level of _____________, qualities and set of characteristics should be present for a candidate to be eligible for the job opening.
Job Description and Job Specification are two integral parts of ______________.
_______________________ specialists are responsible for recruiting, screening, interviewing and placing workers.
Job Descriptions are based on objective information obtained through job analysis, an understanding of the _______________ and skills required, and the needs of the organization to produce work.
Job Descriptions help an employer cover _____________ bases.
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
Who is responsible to ensure a safe workplace
When to report a work-related injury
Wrist injury associated with computer use
It is imperative to stay ________ during the summer
To prevent slips, trips and _____: take your time, pay attention to where you are going, keep walkways clear of clutter and obstructions.
Never use for egress during an earthquake or fire
These rays cause sunburn
Trips hazards in the workplace
Acronym for using a fire extinguisher
Which is better for the back: pulling or pushing?
HIV and Hepatitis B are considered bloodborne ___________
Necessary accessory when overhead hazards are present
Silicate material regulated by EPA and OSHA
You must take precautions when entering this space
This hazard can be truly shocking
This type of protection is for your lungs
This type of protection is needed when working at height
Spilled liquids create ________ and need to be cleaned up immediately
Reporting unsafe acts and conditions can help prevent ________
_______ refers to protective clothing, helmets, goggles, gloves or other garments and equipment designed to protect employees from injury
Under no circumstances should these be blocked
The practice of following certain rules and procedures to prevent the contamination of food
What must you wear anytime you do work outside?
All areas of the store are clear and free of __________
Avoiding injuries at the workplace through proper_____
This must be done to ensure employee safety when cleaning or repairing a piece of equipment
Creating or controlling a situation rather than just responding to it after it has happened
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.