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MANUF LAB
CAPA, ALCOA, AUDIT
| Question | Answer |
|---|---|
| conducted at the implementation stage of most quality concern investigations in GMP environment | CAPA |
| It is identified and implemented as the outcome of investigations | CAPA |
| what are the outcomes of investigations? | deviations, risk assessments, stability failure |
| action to eliminate a detected non-conformity | correction |
| action to eliminate the cause of a detected non-conformity | correction action |
| action to eliminate the cause of a potential non-conformity | preventive action |
| action taken to correct a problem | correction |
| a repair, rework, or adjustment and relates to the disposition of an existing non-conformity | correction |
| fix a defect on hand | corrective action |
| fix the cause of a problem before it can happen | preventive action |
| CAPA initiation is an exercise in risk management | risk- based CAPA |
| it is a combination of a harm and the severity | risk |
| initiated when the problem is systemic | risk-based CAPA |
| unnecessary CAPA can result in additional cost | risk-based CAPA |
| risk-based approach allows assessing risks associated with non-conformity under observation | risk assessment |
| the outcome of the CAPA is treated as a risk with its appropriate severity level | risk assessment |
| severity of consequences | risk criteria |
| severity of risk matrix | risk criteria |
| severity of amount damage | risk criteria |
| likelihood of occurence | risk criteria |
| likelihood on a risk matrix represents | risk criteria |
| likelihood is described as frequency values or with respect | risk criteria |
| risk level | |
| the risk can be acceptable | |
| acceptable risk | |
| not acceptable risk | |
| 7 steps of CAPA | identification evaluation investigation analysis action plan implementation follow up |
| first step and vital role in the success of the ongoing CAPA | identification |
| identifying all the product and quality problems | identification |
| it is evaluated for further decision making | evaluation |
| the problem is analyzed to determine its nature, considers its impact on other process | evaluation |
| the problem is investigated for further planning | investigation |
| typical investigation includes objectives, procedures delivering the intent of the action | investigation |
| identifies and establishes the root cause of the problem by investigating the available data | analysis |
| require information must be accurately depicted and preserved to reflect the actual cause | analysis |
| used RCA tools | analysis |
| what are the RCA tools | fishbone diagrams, 5 whys, fault tree analysis, 8D investigation |
| series of steps required to implement corrective and preventive action | action plan |
| it includes detailed information about the action plan, desired outcomes, setting, steps, observation | implementation |
| final action plan must be thoroughly documented for record purposes | implementation |
| after the execution of CAPA activity | follow-up |
| help to measure the effectiveness of the corrective and preventive action | follow-up |
| 3 reasons for inefficient root cause analysis (RCA) | inability of the CAPA team to identify and categories the problem lack of a tool for CAPA processing like CAPA management software not giving importance to RCA and instead of treating it as a compliance requirements |
| it measures collectively and individually ensure documentation, paper or electronic is secure | GDP |
| a written or printed form which is used to furnish information or instructions | documentation |
| it is defined as generating, transforming, maintaining and assuring the accuracy, completeness and consistency | data integrity |
| the information generated for quality evaluation and decision | data |
| it is a data that defines attributes of other data | metadata |
| the actual information obtained from an observation, test, measurement or activity | raw data |
| it include the raw data that provides evidence of various action taken to demonstrate compliance with instruction | records |
| document that creates the details about the conduct of particular exercises | reports |
| all original records and documentation, including data directly entered into computer through interface | electronic records |
| a concept and process that ensures the accuracy, completeness and consistency | data integrity |
| 2 importance of data integrity | save time, effort, and money protects data like results and all information |
| it is typical part of the QA or regulatory compliance | auditors |
| 5 steps of regulatory audits | risk assessment scope statement audit program audit procedures workpapers |
| identifies relevant risk factors that challenge an organizational area | risk assessment |
| identifies the activities that will be covered during the course of the audit | scope statement |
| refers to the documents that contains listing of audit procedures | audit program |
| specific tasks that the auditor follows to gather, analyze and document | audit procedure |
| detailed documentation from interview and testing the conducted | workpapers |
| 3 types of audit | INTERNAL REGULATORY EXTERNAL |
| become the one of the important key for the success or a pharmaceutical company | auditing |
| play a very important role by assuring the good quality | regulatory agencies |
Created by:
kateperryy