Interview Question on Quality Assurance
1) Tell me about your self
sir i am ashok kumar son of manoj kumar my present address ram nagar near shiv mandir roorkee distt. Haridwar. I did B. pharma in 2015 . sir I had five year experience in pharma. I working in ABC pharma company.
2) what do you know about Quality assurance
Quality assurance is very important part of pharma manufacturing unit.
In the pharmaceutical company, quality assurance (QA) is important for ensure document management system that pharmaceutical products area unit manufactured to a safe and consistent standard. QA could be a very broad field that refers to any facet which will have an effect on a drug’s quality throughout its analysis, development, manufacturing, and sales phases. insurance and approved all department document.
3) What do you understand by change control
It is to define the procedure for proposed changing, evaluation of change, approval of change in the existing document / system / facility / process etc. related to manufacturing of a product.
4) What do you know about CAPA
Sir Corrective Action and Prevention Action are called CAPA
Corrective Action: The action taken to eliminate the causes of an existing non-conformity, defects or other undesirable situation in order to prevent recurrence, to a degree appropriate to the magnitude of problems and adequate with the risks encountered.
Preventive Action : The action taken to eliminate the causes of a potential non-conformity, defects or other undesirable situation in order to prevent occurrence, to a degree appropriate to the magnitude of problems and adequate with the risks encountered.
5) Explain stability
The stability is to define the procedure for stability study policy for formulated products because quality of a formulated product varies with time under the influence of a variety of environmental factors such as temperature, humidity and light. Stability Study enables recommended storage conditions, retest periods, and shelf life to be established.
Development Phase
This is the phase in which manufacture selects an optimum formulation, manufacturing process and packing for the product. Accelerate studies will be carried out to determine tentative shelf life and storage condition of the product. Real time studies will be started at the same time to substantiate the claimed shelf life.
For Registration Dossier
Various drug authorities require stability data of the drug product. For this purpose both the accelerated (at temperature 400C ± 2° C & %R.H. 75% ± 5%) and real time (at temperature 300C ± 2° C & % R.H. 65% ± 5%) data will be submitted. Stability data of the API and shelf life of similar market products will be given as supportive data.
6) document control system
Only QA department shall retain soft (computer) copy of all documents. QA department shall store the computer copies in document-wise folders. In these folders create another two folders named as ‘Controlled Documents’ and ‘Obsolete Documents’. ‘Controlled Documents’ folder shall store current controlled documents. While ‘Obsolete Documents’ folder shall store all obsolete documents
Whenever required to issue the copy of documents to other department QA personnel shall make photocopies from master copy and put “Controlled Copy” stamp in green colour or “Display Copy” stamp in blue colour near the master copy stamp with sign and date.
7) HANDLING OF DEVIATIONS
The procedure for handling of all deviations observed at any stage either during receipt and handling of RM /PM or during it’s storage, during processing, testing, manufacturing and packaging operations involved during manufacture of pharmaceutical finished products.
Deviation: Any planned or unplanned disappearance from an approved instruction or established standard is a deviation.
Planned Deviation: A planned departure is a proposed change to any approved procedure, document or specification prior to execution.
Unplanned Deviation: An unplanned departure is an unexpected event that requires a change to any approved procedure, document or specification. It is usually discovered after the fact.
Major Deviation (equivalent to critical deviations): Any planned / unplanned deviation from any established standard which may have any impact upon the identity, Quality, purity, stability, safety, physical characteristics, polymorphism and efficacy of the product is a major deviation.
Minor Deviation: Any planned / unplanned deviation from any established standard which may not have any impact upon the identity, Quality, purity, stability, safety, physical characteristics, polymorphism and efficacy of the product is a minor deviation.
8) What do you understand by OOS
out of specification results
the procedure for handling of out of specification results (OOS) generated during the testing of Raw material, packing material, In-process samples, finished product samples and stability samples.
All out-of-specification test results (i.e. suspected test results that fall outside the established specifications or acceptance criteria) of raw material, packing material, In-process samples, finished products and Stability samples shall be investigated. (Except microbiological test results which, when does not comply with the specification, are investigated and actions are taken as per respective SOPs.)
9) Quality risk assessment
Provide the systematic approach to achieve the quality standards by accessing, controlling, communicating and reviewing risks related to product quality, safety and efficacy, System, Process, Facility, Document and Environment.
Risk: The combination of probability of occurrence of harm and severity of harm.
Effects: The results of an action or inaction (that result or could results from cause).
Failure Mode: Different ways that a process or sub process can fail to provide the desired results.
Failure Mode Effect Analysis (FMEA): A “systematic method of identifying and preventing product process problem before they occur”. It is primarily to evaluate a process prior to its implementation.
Risk Priority Number (RPN): The risk priority Number or RPN is a numeric assessment of risk assigned to a process, or steps in a process as part of FMEA. Each failure mode gets a numeric score that quantifies likelihood of occurrence, likelihood of detection and severity of impact.
RPN = severity rating x Occurrence x detection