| Term | Definition |
|---|
| Functions That Support Quality Manufacturing | QC, QA, Documentation, Training, & Validation |
| 3 Types of Validation | Process, Equipment, & System |
| SOP | document that contains specifics on a procedure |
| ISO | promotes consistent standards for quality among countries around the world, making international trade easier |
| TQM | an approach to quality based on a total commitment to customer satisfaction ... is reflected in every aspect of the business |
| ISO 9000 | a series of international standards that guide the development of effective quality management systems |
| ISO Certification | Certification tells customers they can count on the company to manufacture a consistent product |
| Quality Improvement Systems | an approach used to satisfy the expectations of the customer; Voluntary & Mandatory systems |
| Voluntary Quality Systems | ISO 9000, TQM, & Continuous Improvement |
| Mandatory Systems | cGMP, and 21 CFR |
| cGMP | a set of minimum standards for manufacturing set by FDA to insure safety & purity of drug products made in the USA. |
| 21 CFR | outlines all cGMP for drug, medical device, and biological industries; includes rules for every aspect of manufacturing |
| BPR | document that provides a traceable record of each batch of product |
| FDA | government agency that sets the standards for the manufacture of food & drugs |
| price of poor quality | damage to company reputation; lost customers; lawsuits; high production costs; company shutdowns & lost jobs |
| Rules of Quality | understand customer needs; say what you do (write procedures); do what you say (follow procedures); prove it (keep records); improve it |
| quality production goal | is to do it right the first time |
| Quality Control (QC) | sampling & checking the product & raw materials that go into the product |
| Quality Assurance (QA) | setting up & checking the systems that assure the quality of the product; examines the process that builds quality into the product, instead of relying only on testing the product itself; more broad than QC |
| documentation | having written specifications & procedures that say what must be done to manufacture a product |
| Validation | proves that the manufacturing processes, equipment, & systems will consistently produce a product to described specifications |
| quality on the job basic activities | monitoring; communicating; following procedures; keeping records; sampling & testing; solving problems & suggesting improvements |
| monitoring the process | understanding; continually observe; notice trends & changes; use all of your senses; respond appropriately; communicate status; keep records |
| effective communication | knowing what, when, how, & with whom to communicate; connects all work activity & keeps the operation orderly & efficient |
| SOP (Standard Operating Procedures) | a document that contains only a procedure; one of the most important documents process techs use |
| SOP include | Effective date, purpose, scope, responsibility, references, materials & equipment, procedures, & approval signatures |
| batch sheet | says what must be done & proves that it was done |
| BPR (Batch Production Record) | includes all documents & records needed to prove hove the batch was made (from start to finish); is critical; if it is not complete or correct, it is worthless; provides proof that product was made to standard |
| Guidelines for keeping records | federal laws enforced by FDA; must be complete, clear, consistent & accurate; use correct format; record data immediately; do not discuss or make unauthorized copies of any company documents |
| military time | 0000hrs=midnight 2300hrs=11:00 PM |
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