Term
| purposes of specifications |
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Definition
Communicates exact needs to suppliers
Allows for supplier bids
Basis for judging production
Basis for accepting components
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Term
| specification application to packaging |
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Definition
Aesthetics
Dimensions
Machine requirements / limitations
Marketing / production
Stock policy
Distribution
Regulatory requirements
Supplier
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Term
| Attributes or Variables Inspection |
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Definition
Examine a sample of items, or characteristic of an items
Classify the item as “conforming” or “nonconforming”
Count the number or nonconforming items and compare to the acceptance criteria, for example:
ACCEPT 3
REJECT 4
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Term
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Definition
Super Critical=0.01 (0)
Critical=0.065 (0.1)
Major=0.65 (1.0)
Minor= 4 (2.5)
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Term
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Definition
Inspection whereby either the unit of product is classified as conforming or nonconforming, or the number of nonconformities in the unit of products is counted, with respect to a given requirement or set of requirements.
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Term
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Definition
Pre-Clinical Testing
IND Application
FDA Review IND
Clinical Trials
The NDA
NDA Review Process |
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Term
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Definition
| exemption from statutory requirement to ship drugs in interstate commerce |
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Term
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Definition
| document that contain sufficent info, data, and analyses to permit agency reviewers to make several key decisions |
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Term
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Definition
Standardized Packaging
Standardized filling equipment
Cost effective
Reliable suppliers
Interchangeability
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Term
| Good Package Development 2 |
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Definition
Stability
Meets market requirements
Meets Regulatory requirements
Global considerations
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Term
| Elements of New Product/Package Development |
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Definition
The Mission
Timing
Market Requirements
Product Characterization
Package Characterization
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Term
| Elements of New Product/Package Development |
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Definition
Product/Package Characterization
Registration Stability
Registration Documentation
Launch Preparation
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Term
| purpose of stability testing |
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Definition
The purpose of stability testing is to provide evidence on how the quality of a drug substance or
drug product varies with time under the influence of a variety of environmental factors, such as
temperature, humidity, and light, and to establish a retest period for the drug substance or a shelf
life for the drug product and recommended storage conditions. |
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Term
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Definition
| 1. System of preparing goods for transport distribution storage retailing and use |
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Term
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Definition
| transport and storage purposes to immediate use |
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Term
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Definition
| farm workers to factory workers. Mass goods demands. From agricultural areas to where people. |
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Term
| 3. Present packaging trends |
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Definition
| solid oral dosage forms (less liquids, original pack dispensing), injectable (pre-filled syringes), “targeting of drugs (inhalers-directly to the site of action, transdermal patches) – films, foils and laminates (glass & metals less use). |
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