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level: Level 1.ppt

Questions and Answers List

level questions: Level 1.ppt

QuestionAnswer
Develop and follows standard operating procedures directed toward assuring the quality, safety, purity and effectiveness of drug productsQuality Assurance and Quality Control
FDA has issued a primary regulation to the industry entitled current __Good Manufacturing Practice (cGMP or GMP)- AO # 220 , s. 1974
(Makes/ Checks Procedure) Establishes systems for ensuring the quality of the product Final authority for product acceptance/ release or rejection Report to chief executive or president Quality monitoring or audit functions (adequate systems, facilities and written procedures)Quality Assurance
- Responsible for the day to day control of quality w/in a company - Staffed w/ scientists and technicians, responsible for sampling and analytical testing for incoming raw materials and inspection of packaging components including labeling - Conduct in- process testing - Inspect operations for compliance - Conduct tests on finished dosage forms - Monitors product quality, testing product complaint samples, evaluating product quality - Perform environmental monitoringQuality Control
In environmental monitoring:Class 100 1.Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones 2. are maintained in areas where parenteral products are filled into clean, sterile container 3. an area that can be controlled to contain fewer than 100 particles, 0.5 µm and larger per cubic foot of air
1 ISO's name 2 In French1 "International Organization for Standardization" 2 "OIN" (Organisation internationale de normalisation)
"ISO", derived from the Greek isos, meaning __"equal".
ensure DESIRABLE CHARACTERISTICS of products and services such as quality, environmental friendliness, safety, reliability, efficiency and interchangeability - and at an economical cost.Standards
ISO standards:1 make the development, manufacturing and supply of products and services more efficient, safer and cleaner 2 facilitate trade between countries and provide governments with a technical base for health, safety and environmental legislation, and conformity assessment 3 share technological advances and good management practice 4 disseminate innovation 5 safeguard consumers, and users in general, of products and services
refers to the process of striving to produce a PERFECT PRODUCT by a series of measures requiring an organized effort by the entire company to prevent or eliminate errors at every stage in production.total quality control
The potential benefits derived from a quality control system are as follows:1. The system minimizes or eliminates the risk of marketing unsafe products 2. It guarantees conformance to regulatory requirements 3. It guarantees product efficacy 4. It reduces operating costs 5. It reduces operating losses 6. It produces higher employee morale 7. It motivates the pharmaceutical/ medical professions to sell or prescribe the product
in recent years, the __ used to describe the overall organizational body designed to assure product quality. __ is limited to that function for on line or in process testing.Quality Assurance, Quality Control