Description

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.

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Frequently Asked Questions

What is a crossword?

Crossword puzzles have been published in newspapers and other publications since 1873. They consist of a grid of squares where the player aims to write words both horizontally and vertically.

Next to the crossword will be a series of questions or clues, which relate to the various rows or lines of boxes in the crossword. The player reads the question or clue, and tries to find a word that answers the question in the same amount of letters as there are boxes in the related crossword row or line.

Some of the words will share letters, so will need to match up with each other. The words can vary in length and complexity, as can the clues.

Who is a crossword suitable for?

The fantastic thing about crosswords is, they are completely flexible for whatever age or reading level you need. You can use many words to create a complex crossword for adults, or just a couple of words for younger children.

Crosswords can use any word you like, big or small, so there are literally countless combinations that you can create for templates. It is easy to customise the template to the age or learning level of your students.

How do I create a crossword template?

For the easiest crossword templates, WordMint is the way to go!

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For a quick and easy pre-made template, simply search through WordMint’s existing 500,000+ templates. With so many to choose from, you’re bound to find the right one for you!

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How do I choose the clues for my crossword?

Once you’ve picked a theme, choose clues that match your students current difficulty level. For younger children, this may be as simple as a question of “What color is the sky?” with an answer of “blue”.

Are crosswords good for students?

Crosswords are a great exercise for students' problem solving and cognitive abilities. Not only do they need to solve a clue and think of the correct answer, but they also have to consider all of the other words in the crossword to make sure the words fit together.

Crosswords are great for building and using vocabulary.

If this is your first time using a crossword with your students, you could create a crossword FAQ template for them to give them the basic instructions.

Can I print my crossword template?

All of our templates can be exported into Microsoft Word to easily print, or you can save your work as a PDF to print for the entire class. Your puzzles get saved into your account for easy access and printing in the future, so you don’t need to worry about saving them at work or at home!

Can I create crosswords in other languages?

Crosswords are a fantastic resource for students learning a foreign language as they test their reading, comprehension and writing all at the same time. When learning a new language, this type of test using multiple different skills is great to solidify students' learning.

We have full support for crossword templates in languages such as Spanish, French and Japanese with diacritics including over 100,000 images, so you can create an entire crossword in your target language including all of the titles, and clues.