1. Define quality assurance
Ans) QA is a broad range of concept contains all the matters that individually or collectively effect the quality of a product. QA mainly concentrated on planning and documenting the procedures to assure the quality of the product.
2. Explain the difference between QC and QA?
Ans) QA provides the confidence that a product will full fill the quality requirements. QC determines and measures the product quality level.
3. Expand cGMP and what is the difference between GMP and cGMP?
Ans) cGMP known as Current Good Manufacturing Practices. It is a USFDA regulations to assure proper design , manufacturing and control of manufacturing processes and services.
GMP-Good Manufacturing Practices. These are the standard guidelines given by Food and Drug administration to make sure that a product is manufactured with safety and quality. c in cGMP means current. It refers to recent and advance updates to these standard guidelines. cGMP is up to date standard reference guidelines.
4) Tell me any five countries with their regulatory authorities?
Ans) India – Central Drugs Standard Control Organisation (CDSCO)
USA – United States Food and Drug Administation (USFDA)
UK – Medicines and Healthcare products Regulatory Agency (MHRA)
Japan- Ministry of Health Labour and Welfare (MHLW)
Australia- Therapeutics Goods Administration (TGA)
Brazil- ANVISA
5) Expand ICH? Tell me about ICH Guidelines?
ICH known as The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. It brings the regulatory authorities and pharmaceutical companies together to discuss the drug registration technical aspects.
The aim of the ICH is to enhance the harmonisation world wide to make sure that safe, high quality and effective drugs are developed and registered in the most efficient manner.
ICH provides guidelines on 4 aspects that is quality , safety , Efficacy and Multidisciplinary guidelines.
6) What is SOP?
SOP known as Standard Operating Procedure.
7)Expand IQ OQ PQ DQ
IQ- Installation Qualification
OQ-Operational Qualification
PQ-Performance Qualification
DQ-Design Qualification
8) Difference between validation and calibration
Validation produces the documented evidence assuring a specific procedure/procedure or activity consistently develops a product with predetermined specifications and quality credits. It is performed according to validation protocol.
Calibration denotes that an equipment produces the values in specified limits by comparing the values produced by a standard. It is done according the calibration standard operating procedure.
9) Expand BMR and BPR?
Ans) BMR – Batch Manufacturing Record , is prepared as a written file during the manufacturing a product by writing. Step by step manufacturing process and details about batch recorded here.
BPR Batch Packaging Record, is kept for every BMR. BPR is depends on packaging operation.
10) What do you know about stability studies?
Ans) These are necessary for developing the pharmaceutical products. It helps to evaluate the effect of environmental factors (e.g Light, Humidity, Temperature etc) on Active Pharmaceutical Ingredient(API) or Pharmaceutical formulation.
11) What is the time period required for long term and accelerated stability studies?
Ans) Long term 12 months, Accelerated studies- 6 months
12) What are types of climatic zones? India belongs to which climatic zone?
Ans) India belongs to Zone III(Hot dry zone) and Zone IVb(Hot/Higher humidity
Qa-What do you know about change control?
Changes which were made to materials or procedures or methods or equipment or software should be documented properly. These changes should approved, validated and able to traceable. Change control deals and makes sure all these changes.
Explain about Bracketing and Matrixing study designs in stability testing/
Ans) These are the study designs for stability testing. In a full study design, you have to test the samples of all the design factors at all time points. Bracketing and Matrixing are reduced study designs.
When multiple design factors involved in a study, these are the best alternatives to full study design. If you use these designs, you need not to test all the samples at all time points. These study designs mostly used when multiple design factors involved.
Bracketing: In this schedule, At all time points only extremes of certain study factor (like container fill & or container size or strength etc) samples tested. Bracketing supposes that tested extremes stability represents the intermediate levels stability of that study factor.
Matrixing: In this schedule, at a specific time point a selected subset of the total number of possible samples for all factor combinations would be tested. At a next or subsequent time point, all the factor combinations for another subset would be tested. Matrixing supposes that at a given time point, tested each subset stability represents the all the samples stability.
Before using this study designs, certain assumptions should be evaluated and justified.
NOEL: No Observed Effect Level
MACO: Maximum Allowable Carry Over
CAPA:
Corrective Action and Preventive action. It’s an important part of QMS (Quality Management System). Corrective actions planned to know the cause of the problems which were happened in the past and correct it. Preventive actions intended to prevent the problems that might happen in the future.
Explain about Out of Specification (OOS) results and Out Of Expectation (OOE) results?
Out Of Specification (OOS) results: Analysed test result falling out side the predefined acceptance range or criteria made by company documentation or official compendia.
Stress Testing:
Also called as Forced degradation study, stress study. Forced degradation study intended to know the degradation products, it will helps us further to know the molecule intrinsic stability, degradation pathways establishment and to validate the molecule stability procedures. Stress testing conducted at the conditions which are more severe than the accelerated study conditions. For a formal stability program, stress testing not considered as a requirement. It is regulatory authority requirement.
What is the purpose/use(s) of stability testing?
Ans) Stability testing gives the confirmation as how the quality of study product changes with time.
It finds out the study product shelf life, recommended storage conditions as well as container closure system suability. Also gives assurance to the patient regarding stability of a drug product. Stability testing is a regulatory requirement also.
What are different types of stability studies along with its conditions?
Ans)
Long-term stability studies: Storage conditions 25+20C, 60+5% RH and Minimum Time period is 12 months
Intermediate stability studies: Storage conditions 30+20C, 60+5% RH and Minimum Time period is 6 months
Accelerated stability studies: Storage conditions40+20C, 75+5% RH and Minimum Time period is 6 months
Dead leg: Dead logs not allowed in water design systems. These are the stagnant areas with no water flow. It allows microbial contamination resulting the surface colonisation by forming biofilms. If a dead log present in any case, it should have particular pipe diameter and velocity. In general agreement in industry, dead log should not be more than the pipe diameter.
For e.g: If the pipe diameter is 5 cm , then dead log should not be more than 10cm.
Cleaning validation: It is a documented evidence involves the approved cleaning procedure for eliminating the process equipment contaminants. It means the process equipment ready and can be used safely for preparing the next product without any previous contaminants.
These contaminants may be chemical (previous product residues), microbial or Physical (Particulate matter) types. Different types of cleaning agents used in the cleaning validation like aqueous solvents (water, surfactants, acids or bases etc) and organic solvents.
Validation master plan (VMP):
It is a document describes the company’s validation strategy and approach for establishing the performance adequacy. VMP includes all the details and time scales regarding the validation work to be performed.
Process validation:
It provides a documented evidence assuring that a particular process produces a product with predetermined specifications and characteristics consistently.
Four types of process validation available.
Prospective validation: Conducted prior to process implementation to assuring that process is performs as intended on the basis of pre-planned plans.
Concurrent validation: Conducted during the product routine production.
Retrospective validation: Conducted on some products , those products which are already on commercial market. The intention is to establish the long term compliance of that product.
Re-validation: This is nothing but repetition of validation. Conducted to assuring that the changes/modifications done in equipment/process in according to the change control procedures. Those changes are not effecting the equipment/process and their produced products adversely.
No comments:
Post a Comment