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1.What is Production :
All operations involved in the preparation of a pharmaceutical product, from receipt of raw materials through the completion of a finished product i.e from Raw material Receipt to Finished product dispatch. It also includes the handling of manpower and recording the manufacturing and the packing activity performed.
2. What is Batch Processing or Batch Manufacturing Record :
Documentation that provides the history of a batch from the raw material dispensing stage to completion of the batch or lot which include Dispensing of raw material, Granulation, Blending Compression, Capsule Filling, Coating, Inspection and yield at different stages. It also includes the details of the activity performed by whom, checked by whom, at what time activity was performed, at what date activity was performed and signature of the personnel involved in the batch or activity.
3. What is Batch Packaging Record :
Documentation that provides the history of a batch from packaging material dispensing, Blister packing, Bottle packing, Jar packing, Dry syrup Filling, labeling, Carton packing and shipper packing up to Dispatch of a Batch or Lot.
It also includes the details of the activity performed by whom, checked by whom, at what time activity was performed, at what date activity was performed and signature of the personnel involved in the batch or activity.
4. Active Pharmaceutical Ingredient :
A substance or a bulk pharmaceutical chemical that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of the disease or to effect the structure or any function of the body of man or other animals.
5. What is Standard Operating Procedure (SOP):
It is an authorized written document which describes the step by step instructions requirements for performing operations or any activity and non-specific to any product, process or material. It provides detailed procedure about systems applicable to various operation e.g. Equipment’s / Instrument’s / System’s Operation / Cleaning / Maintenance etc.
Everybody working in organization has to follow the instruction which are written in SOP and perform their activities accordingly.
6. What is GMP and CGMP :
Good manufacturing practices (GMP) are the practices required in order to conform the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, pharmaceutical products, dietary supplements, and medical devices.
These guidelines provide minimum requirements that a manufacturer must meet or follow to assure that their products are consistently high in quality, from batch to batch, for their intended use.
CGMP is Current Good manufacturing practices (GMP) and we have to follow the current practices as there are the changes in regulations so always you have to follow the current practices so it is called current.
7. What are the In processes checks parameters during Tablet compression:
Appearance, Group weight, Individual weight variation, Uniformity of weight, Thickness, Diameter, Hardness, friability, Speed of machine, compaction force, die fill depth and Disintegration time.
8. What are the In processes checks parameters during Capsule Filling:
Appearance, Group weight of filled capsule, Individual weight of filled capsule, Net fill content of the powder, locking length and Disintegration time.
9. What are the In processes checks parameters during Tablet coating:
Appearance, Inlet temperature, out let temperature, pan RPM, Gun distance from tablet bed, spray rate, weight gain, Group weight of Coated tablets, Individual weight of Coated tablets, and Thickness.
10. What are the defects in Compressed tablets :
Picking, sticking, capping, laminating, weight variation, Broken, chipped, Rough Surface, Double compressed, Rough edges, Powdery, Incorrect Description, Black spot, Oil spot, Foreign Product and Debossing/ Embossing.
11. What are the defects in Capsules :
Empty, Cracked, Dented, Telescopic, Unlocked, Partially locked, Improper polishing, Powdery, Long or Short caps, Printing defects, Improper locking length and Weight variation.
12. What is Water For Injection (WFI) :
Water for injection It is the water of extra high quality without significant contamination and Water for injection is generally made by distillation or reverse osmosis.
13. What is Aerosol in Pharmaceuticals :
Aerosol is a pressurized dosage forms containing one or more therapeutic active ingredients which will produce a fine dispersion of liquid and/or solid materials in a gaseous medium during operation.
14. Tell about wet granulation :
It involves Sifting of API & Excipients, Wet mixing, drying, Sifting, Blending and then Blend shall be compressed or Filled in Capsule and then compressed tablets are coated with coating solution.
Sifting of API and Excipients through Sifter, Mixing of API & Excipients then addition of binder solution to form a wet mass in Fluid Bed Processor or Rapid Mixer Granulator, then dried the wet mass in Fluid Bed Processor or Fluid Bed dryer. Dried granules are again screened through a sieve which helps it to break down the granule then it should be lubricated or mixed in Blender. These same size Blend are then compressed or can be filled in capsule.
15. Tell about Dry granulation :
Dry granulation involves mixing, pre-mixing, milling, compression or Capsule Filling. API and Excipients are sifted, milled in roll compactor to product slugs then slug size is reduced in multi mill or Oscillating granulator. Then these granules are Mixed or lubricated in Blended and then blend shall be compressed in compression machine or can be filled in capsule filling machine to form tablets or capsules.
16. What is tablet :
Tablets is defined as the solid unit dosage form of medicines with suitable Excipients and prepared either by molding or by compression. It comprises a mixture of active substances and excipients, usually in powder form, pressed or compacted from a powder into a solid dose.
17. Name any four tablet processing problems :
Mottling, Capping, lamination, picking and sticking
Mottling– unequal colour distribution of a tablet.
Capping– Partial or complete separation of a tablet top or bottom crowns.
Lamination– Separation of tablets into two or more layers.
Picking– Because of adhesion to the punch faces, Localized portion missing on the surface of the tablet.
Sticking– Adhesion of tablet localized portion to the punch faces resulting in rough and dull appearance.
18. What is Disintegration Test :
It is the time required for the Tablet / Capsule to break into particles, the disintegration test is a measure of the time required under a given set of conditions (Temperature) for a group of tablets/capsules to disintegrate into particles.
Cycle of shaft holding the tube basket limit is 29-32 cycles per minutes and distance covered by shaft basket is 50-60 mm and beaker temperature is 35 to 39 º C. Disintegration is to be Performed to determine whether tablets or capsules disintegrate within the prescribed time when placed in a liquid medium at the experimental conditions.
19. What are the Disintegration Time of tablets :
- Uncoated Tablet 15 min as per BP & 30 min as per USP
- Sugar Coated Tablet 60 min as per BP
- Film Coated Tablet 30 min as per BP
- Plain Coated Tablets DT in specific medium for 30 min as per USP
- Enteric Coated Tablets DT in simulated gastric fluid (0.1 M HCl) for 1 hr and then in simulated intestinal fluid (Phosphate buffer 6.8 pH) until disintegrate as per USP.
- Dispersible Tablets 3 min ( 15- 25º C ) as per BP.
- Effervescent Tablets 1 tablet in 200 mL water for 5 min ( 15- 25º C )
as per BP
- Buccal Tablets 4 hrs as per USP.
- Soluble Tablets 3 min ( 15- 25º C ) as per BP.
- Chewable Tablets are not require to comply with test
20. What is Disintegration Time of capsules :
- Gastro resistant capsule DT 2 hrs without disk in 0.1 M HCl and phosphate buffer pH 6.8 for further 60 min as per BP.
- Hard and Soft gelatin capsule DT 30 min as per BP & USP.
21. What is Friability Test of Tablet & friability Calculation :
Friability is defined as the percentage of weight loss of powder from the surface of the tablets due to mechanical action and the test is performed to measure the weight loss during transportation.
Friability (%) =W1– W2/W1X100
W1 = Weight of Tablets (Initial / Before Tumbling) &
W2 = Weight of Tablets (After Tumbling or friability)
Limit : Friability (%) = Not More Than 1.0 %
Tablets with individual weight equal to or less than 650 mg then take the sample of whole corresponding to as near as 6.5 gram equivalent and tablets with individual weight more than 650 mg then take sample of 10 whole tablets to perform friability test. Tablets must be de-dusted prior to and after use.
22. Weight Variation limit for Tablets and Uniformity of Mass Variation:
23. What is Validation :
Documented program or evidence, that provides a high degree of assurance that a specific process method or system consistently produce a result indicating predetermined accepted criteria.
24. What is Calibration :
The demonstration that a particular instrument or device produces results within specified limits by comparison with those produced by a traceable standard over an appropriate range of measurements.
25. What is Qualification :
The action of proving that any equipment or process work correctly and consistently and produces the expected result. Qualification is part of, but not limited to a validation process, i.e. Installation Qualification (IQ), Operation Qualification(OQ) and Performance Qualification (PQ).
The act of planning, carrying out and recording the results of tests on equipment to confirm its capabilities and to demonstrate that it will perform consistently as intended use and against predefined specification.
26. Design Qualification :
Documented verification that equipment, instrument, facility and system are of suitable design against the URS and all key aspects of design meet user requirements.
27. Installation Qualification (IQ) :
The documented verification that all components of the equipment and associated utilities are properly installed or modified in accordance with the approved design and manufacturer’s recommendations.
28. Operational Qualification :
Operational qualification consists of verification and documentation, of the parameters of the subjected equipment. The documented verification that the equipment, instrument, facility and system as installed or modified, perform as intended throughout the installed operating range.
29. Performance Qualification :
Performance Qualification is designed to prove the process, can consistently produce a product that meets the stated requirements and specifications. It is a documented verification that the equipment, instrument, facility and system as connected together, can perform effectively and reproducibly, based on the approved process method and product specification.
30. Why Three consecutive batches taken for Validation :
Consecutive meaning following closely with no gap or following one after another without interruption.
- The number of batches to be taken under validation depends upon the risk involved in the manufacturing Critical process parameters & critical Quality Attribute so depends upon that manufacturer have to choose the number of batches to be validated.
- If we will consider less than two batches then the data will not be sufficient for evaluation of and to prove reproducibility of data between batch to batch variation & if we consider more than three batches it can increase the time & cost of manufacturer which usually not preferred.
- Generally if we will require quality in the First batch, then it is accidental (co-incidental), Second batch quality is regular & third batch quality is Validation or Confirmation.
Statistical evaluation cannot be done by considering two points, because two points always draw a straight line so minimum three points required for comparison of data.
31. What is Airlock :
An enclosed space with two or more doors, which is interposed
between two or more rooms, e.g. of differing classes of cleanliness, for the purpose
of controlling the airflow between those rooms when they need to be entered.
An airlock is designed for use either by people or for goods and/or equipment.
32. What is Clean Area :
An area with defined environmental control of particulate and microbial
contamination, constructed and used in such a way as to reduce the
introduction, generation, and retention of contaminants within the area
33. What is yield reconciliation :
A comparison between the theoretical quantity of the material and the actual quantity.
Yield Reconciliation can be done in manufacturing and packing stages . i.e Blending, Compression, Capsule filling, Coating, Inspection and packing etc.
34. What is in-process control or checks :
Checks performed during production in order to monitor whether it is meeting the required specification or not and, if necessary, to adjust the process to ensure that the product conforms to its specifications. The control of the environment or equipment may also be regarded as a part of in-process control.
35. What is Finished Products :
A finished dosage form that has undergone all stages of manufacturing
including packaging in its final container with labelling and which is ready for sale or release to market.
36. What is intermediate Product :
Partly or Partially processed product that must undergo further manufacturing steps which includes Blend, Filled capsule, Compressed tablets, coated tablets etc.
37. What are the defects of Coated tablets :
Twins, Cracking, Partially coated, Incomplete drying, Edge broken, Peeling, Print defects, Shade Variation, Weight variation, Debossing/ Embossing fill
38. What is SMF and how it works :
When the product is under drying in FBD, the product loss often occurs due to a puncture or broken filter bag. Solid flow monitor (SFM ) or broken bag detector (BBD) provides good detection of filled filter bag failure or tear in FBD, thus prevent product loss. SFM or BBD located in the exhaust duct of FBD.
39. What is Tolling in compression machine :
In tablet compression machines Punches and dies are used to compressed powder to form table. The dies and punches and their setup on compression machine is called tooling.
40. Tolling are how many Types :
There are four types of tolling in compression machine B Tolling, BB tolling, D tolling and DB tolling. D tolling punch and die diameter is greater than B tolling punch and die diameter. D tolling punch diameter is 25.4 mm and Die diameter is 38.10 mm where as B tolling punch diameter is 19.00 mm and die diameter is 30.15 mm
41. What is Dual time in Compression Machine :
In tablet compression, dwell time is the time that the punch head remains in contact with the compression roller and it is defined as the amount of time that the compression force applied when forming the tablet is above 90% of its peak value.
42. What is the work of Pre compression Rollers in Compression Machine :
These are the very first rollers in rotary tablet press. Basically, these rollers apply a small amount of force on the upper and lower punches.
This gives the initial compression force. The aim of this process is to remove air that could be in the die or powder particles.
43. What is the work of Main compression Rollers in Compression Machine :
Main compression rollers exert a predetermined amount of force (final compression force) for the formation of tablets. The compression force at this stage is higher than the pre-compression force.
It is important that the rollers remain stable with no vibration during the entire process. This is to ensure consistency of the tablets’ thickness and size.
44. What are the units of Hardness in tablets :
Kilogram (kg), Newton (N), Pound (lb), Kilopond (kp) and Strong-Cobb (SC)
45. What is Leak test in Packing :
The test which is used to check the integrity of packed strips, blisters, Bottles and small sachets containing tablets, Capsules and Dry Powders is called leak test.
Leak test Apparatus is used to test the quality of the packaging process and to check that the seals enclosing the product are perfectly intact and no water should go inside the pack. It is designed to find the smallest holes or Puncture and imperfections in packed Products .
46. What is FMD in Packing :
The FMD (Falsified Medicines Directive) is a legal framework introduced by the European Commission to improve the protection of Public health within the European Union. The directive applies since 2 January 2013 & the European Commission Delegated Regulation, (EU) 2016/161, supplements Directive 2001/83/EC with rules regarding safety features for the packaging of medicinal products for human use. The regulation was adopted in October 2015 to counteract to fake medicines include stricter record-keeping of wholesale distributors, pharmaceutical producers, an EU-wide quality mark to identify online pharmacies and mandatory safety features on packages.
47. Which indicator is used in Leak test Apparatus :
In order to identify the leakage in Blister or stripes methylene blue colour is used and the solution in the desiccators required to be changed every day or whenever required.
48. What is NFD & how it works :
Non Fill Detection is an system incorporated into the machine which enables the machine to automatically detect and reject those strips or Blisters that have missing tablets or capsules in cavity. This arrangement involves a sensing system, a control system consisting of a Programmable Logic Controller (PLC) and an HMI (Human Machine Interface), and an electro pneumatically activated auto-rejection system. Both – the Strip & blister Packing Machine as well as the NFD system are designed and built by us at our works and are therefore fully integrated with each other.
49. What is Hold time Study:
Hold Time studies establish the time limits for holding the materials at different stages of production to ensure that the quality of the product does not degrade significantly during the hold time at a required temperature and Relative Humidity.
Hold time can be considered as the established time period for which materials (dispensed raw materials, intermediates and bulk dosage form awaiting final packaging) may be held under specified conditions and will remain within the defined specifications. Hold-time studies establish the time limits for holding the materials at different stages of production to ensure that the quality of the product does not produce results outside the acceptance criteria during the hold time.
50. What is Deviation:
Any unwanted event that represents a departure from approved processes or procedures or instruction or specification or established standard or from what is required. Deviations can occur during manufacturing, packing, sampling and testing of drug products.
Examples of Deviations: Temperature and RH of area goes out of limit during manufacturing, Typographical error observed in approved documents, Standard operating procedure not followed, Breakdown of equipment, Spillage of material during unloading, Instrument calibration results goes out of limit etc. Deviations are of three types Minor, Major and Critical.
51. What is Change Control :
It is a Approved Procedure which is taken to change in any documents, Standard operating procedures, Specification, Process parameters and change in batch size etc. Change control is raised by user department as per requirement and finally the change control is approved by Quality assurance. Change control can be raised through software or through manually.
After Final approval of change control the changes can be made in documents and change control can be closed after completion of required action plan which is mentioned in the Change control form. Change controls are of two types i.e Major and Minor.
52. Corrective action and preventive action :
An action taken to eliminate the cause of the existing deviation , incident or problem in order to prevent its recurrence (occurring again).
An action taken to eliminate the cause of potential deviation, incident or problem in order to prevent its occurrence (an incident or event) is called preventive action.
You can also read the Interview Questions and Answers for Quality Assurance https://pharmaceuticalupdates.com/2020/03/06/pharmaceutical-interview-questions-answers/