Are you a graduate in pharmacy? Are you willing to work in Quality Assurance then log on to www.wisdomjobs.com. In Process Quality Assurance includes integrated, interactive software modules that combine inspection, feedback, data collection and critical analysis for additive manufacturing. IPQA is determined by quality proceedings in standards and specifications of manufactured products to prevent mistakes, problems to customer services. The quality assurance specialist conducts quality assurance audits of bottler production facilities assuring company standards are maintained and product integrity is preserved. you have a lot of scope in various pharmaceutical industries as quality assurance inspector, drug inspector etc. So trace yourself as IPQA officer, Executive, Manager, Production Officer in Lab sector, Pharmacy sector by looking into IPQA job interview question and answers given.
For tablets with unit mass equal or less than 650 mg, take sample of whole tablets corresponding to 6.5g.For tablets with unit mass more than 650mg,take a sample of 10 whole tablets.
%Weight loss = Initial Weight - Final Weight X 100Initial Weight.
Generally the test is run for once.If any cracked,cleaved or broken tablets present in the tablet sample after tumbling,the tablets fails the test.If the results are doubtful,or weight loss is grater than the targeted value,the test should be repeated twice and the mean of the three tests determined.A mean weight loss from the three samples of not more than 1.0% is considered acceptable for most of the products.
6 inches.Tablets falls from 6 inches height in each turn within the apparatus.
To determine need for the pressure adjustments on the tableting machine.Hardness can affect the disintegration time.If tablet is too hard,it may not disintegrate in the required period of time. And if tablet is too soft it will not withstand handling and subsequent processing such as coating,packing etc.
25 ±10C (IP) & 15 – 250C (BP)
1.8 -2.2mm (#10)
1.Capping:- ‘Capping’ is the term used, when the upper or lower segment of the tablet separates horizontally, either partially or completely from the main body of a tablet and comes off as a cap, during ejection from the tablet press, or during subsequent handling.
2.Lamination / Laminating:- Definition: ‘Lamination’ is the separation of a tablet into two or more distinct horizontal layers.
3.Sticking/filming: ‘ Sticking’ refers to the tablet material adhering to the die wall. Filming is a slow form of sticking and is largely due to excess moisture in the granulation.
4.Cracking:- Small fine cracks observed on the upper and lower center surface of the tablets, or very rarely on the side wall are referred to as cracks.
5.Chipping:- ‘ Chipping’ is defined as the breaking of tablet edges, while the tablet leaves the press or during subsequent handling and coating operation.
6.Mottling:‘ Mottling’ is the term used to describe an unequal distribution of colour on a tablet.
7.Double Impression: ‘ Double impression’ involves only those punches,which have a monogram or other engraving on them.
If one or two tablets/capsules fails to disintegrate completely, repeat the test on another 12 additional dosage units. The requirement is meet if not fewer than 16 out of 18 tablets/capsules tested are disintegrated completely.
15 - 250C & 35 -55% RH
Weight variation is applicable for following dosage forms;
Hard gelatin capsules,uncoated or film coated tablets,containing 25mg or more of a drug substance comprising 25% or more by weight of dosage unit.
28 – 32 cycles per minute.
Not more than two of the individual weights can deviates from the average weight by more than the percentage given in the pharmacopeia,and none can deviates more than twice that percentage.
Weight Variation limits for Tablets
80 mg or less
130mg or less
More than 80mg or Less than 250mg
130mg to 324mg
250mg or more
More than 324mg
Weight Variation limits for Capsules
Less than 300mg
300mg or More
While collecting inprocess samples, avoid contamination of the product being sampled (Don’t collect samples with bare hands) & avoid contamination of sample taken.
In tablet manufacturing facilities, pressure gradients are maintained to avoid cross contamination of products through air. Usually service corridors are maintained under positive pressure with respect to processing areas.
While calibrating DT apparatus, following checks shall be performed.
In tablet manufacturing facilities, pressure gradients are maintained to avoid cross contamination of products through air. Usually processing areas are maintained under positive pressure with respect to service corridors.
In process checks are checks performed during an activity,In order to monitor and,if necessary,to adjust the process to ensure that product confirms to its specification.
Disintegration is a disaggregation process, in which an oral dosage form falls apart in to smaller aggregates.(Disintegration time is the ‘break up’ time of a solid dosage form).
An equipment or instrument can ‘drift’ out of accuracy between the time of qualification and actual use.So it is recommended to calibrate and recalibrate the measuring devices and instruments on predetermined time intervals, to gain confidence on the accuracy of the data.
The number of batches produced in the validation exercise should be sufficient to allow the normal extent of variation and trends to be established and to provide sufficient data for evaluation and reproducibility.
In 2 batch we cannot assure the reproducibility of data,4 batches can be taken but the time and cost are involved.
Position of oblong tablets should be length wise because the probability of breakage is more in this position.
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Background And History
Why Quality Management?
The Contribution Of Dr. W. Edwards Deming
Standards And Models
Leadership In Quality Management
Strategic Quality Management
Partnerships And Resources
People In Quality Management
Ethics And Corporate Social Responsibility
Learning, Change And Process Improvement
Implementing Quality Management
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