What is In process checks?
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.
What are the check point during line clearance of granulation area?
- Logbooks
- Floor and walls
- Door and windows
- RMG, Multi-mill, FBD, Blender and Utensils
- All materials
Why granuation is important?
- To improve powder flow.
- To improve compressibility.
- To reduce fines.
- To control the tendency of powders to segregate.
- To control density.
- To capture and fuse small quantities of active Material.
What are the check point during line clearance of comression area?
- Logbooks
- Floor and walls
- Door and windows
- Temperature and humidity
- All parts of compression machine (hopper, turret, dies, ejection plate, punches etc.)
What are the in-process tests of tablet compression?
- Appearance
- Hardness and thickness
- Friability
- DT
- Weight Variation
What are the in-process tests of tablet coating?
- Appearance
- Weight Gain
What is the weight variation limits for tablet?
As per BP
- ± 10% for 80 mg or less
- ± 7.5% for 81 mg to 249 mg
- ± 5% for 250 mg or more
As per USP
- ± 10% for 130 mg or less
- ± 7.5% for 130 mg to 324 mg
- ± 5% for more than 324 mg
What is the weight variation limits for capsule?
- ± 10% for less than 300 mg
- ± 7.5% for more than 300 mg
What are the tablet friability test criteria?
- Rotation: 25 rpm or 100 rotations
- Tab weight: 6.5 g
- Limit: NMT 1.0%
What are the disintegration time (DT) for different types of tablets?
- Uncoated Tablet: NMT 15 min, in water with Disc
- Coated Tablet: NMT 30 min, in water with Disc for Film Coated Tab, and NMT 60 min Other than Film coated tablet
- Dispersible/Soluble Tablet: Within 3 min in water
What are the criteria of DT Apparatus?
- Mesh Size: 2mm (#10)
- Cycles: 28 – 32 cycles/min
- Temperature: 37 °C ± 2 °C
What is the Carr’s Index?
A formula which is calculated compressibility of powder based on true density and bulk density.
Carr’s Index = [(Tapped Density – Bulk Density)/ Tapped Density x 100]
What is hausner ratio?
A simple method to measure powder flow properties.
Hausner ratio = Tapped density/Bulk density.
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What are the common tablet problem during compression?
Capping, Lamination, Sticking, Picking etc.
What is tablet capping?
It is partial or complete separation of the top or bottom of tablet due air entrapment in the granular material.What is tablet lamination?
It is separation of tablet into two or more layers due to air-entrapment in the granular material.
What is tablet sticking?
It is the adhesion of granulation material to the die wall.
What is tablet picking problem?
It is the removal of material from the surface of tablet and its adherence to the face of punch.
How many Tablets shall be taken for checking friability?
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.
What is the formula for calculating weight loss during friability test?
%Weight loss = (Initial Weight - Final Weight)/ Initial Weight X 100.
Why do we check hardness during in process checks?
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.
What are the factors which influence tablet hardness?
1. Compression force
2. Binder quantity(More binder more hardness)
3. Moisture content
Which type of tablets are exempted from Disintegration testing?
Chewable Tablets
What checks shall be carried out, while calibrating DT apparatus?
While calibrating DT apparatus, following checks shall be performed.
1) Number of strokes per minute (Limit:29-32 cycles/min)
2) Temperature by probe & standard thermometer (Limit: 37 ± 1 °C).
3) Distance travelled by basket (Limit:53 -57mm)
What is the difference between disintegration and dissolution?
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).
Where as dissolution is a process by which solid substance enters in the solvent to yield a solution.It is controlled by the affinity between the solid substance and the solvent.
In other word disintegration is a subset of dissolution.
Read also: Pooled Sampling in Dissolution
What is the difference between calibration and validation?
Calibration is a demonstration that, a particular instrument or device produces results with in specified limits by comparisons with those produced by a reference or traceable standard over an appropriate range of measurements.
Where as Validation is a documented program that provides high degree of assurance that a specific process, method or system consistently produces a result meeting pre-determined acceptance criteria.
Why 70% Isopropyl Alcohol is used as Disinfectant in Pharmaceuticals?
70 % isopropyl alcohol kills microorganisms by dissolving plasma membrane of the cell wall. Plasma membrane of gram negative bacteria consist of thin layer of peptidoglycon that easily destroyed by the alcohol.
100% isopropyl alcohol coagulates the protein instantly creating a protein layer that protects the remaining protein from further coagulation. Due to the organism is not killed but remains in dormant stage. While 70% isopropyl alcohol penetrates in the cell wall at slower rate and coagulates the all protein of the cell wall and microorganism dies.
What is deviation?
Deviation is a process that is not mentioned in SOP. It is a process that performs the outside of the process or SOPs.
Read also: Deviation in Pharmaceutical Industry
What is the main difference between deviation and change control?
Deviation is unplanned and not permanent but change control is planned and permanent.
What is the difference between humidity and relative humidity?
- Humidity: Amount of moisture or water present in the air in the form of water vapour
- Relative humidity: Percentage of the moisture in the air at particular specific temperature.
Which factors contribute to quality products?
- Starting materials and packaging materials
- Validated processes
- Personnel
- Procedures
- Equipment
- Design and quality of premises
- Manufacturing environment
What can HVAC do?
- Control airborne particles, dust and micro-organisms
- Maintain room pressure
- Maintain relative humidity and temperature
What are consist of HVAC system?
- Air conditioning
- AHUs
- Dehumidifier/Heater
- Filter (pre/HEPA)
- Dust extractor
- Ducting
- Supply fan
- Smoke detector
- Damper
- Humidity/temperature/pressure sensor.
- Bag filter
- Heating/cooling coil
What is Protocol?
A documented plan, which is reviewed and approved prior to execution, for the test of a process, system, or piece of equipment. Upon completion, the protocol and results serve as the basis for the documentation that the process performs as intended.
What is Qualification?
A documented procedure which demonstrates that a piece of equipment or
process is designed, installed, and operated properly. (Generally equipment is validated by installation qualification, operational qualification, systems by installation, operational and performance qualification. Process validation and Performance Qualification are often synonomously used).
What is Validation plan?
A documented plan (Validation Master Plan) that describes the policy, philosophy, strategy, and methodology for validating a site, process, or product. The plan can be used as an executive summary within a company or to introduce regulatory personnel to a validation project. The plan should identify responsibilities, as well as equipment and processes requiring qualification or validation. It also may include schedules for an overall process.
What is process validation?
A documented evidence that a process is capable of reliablyand repeatedly rendering a product of the required quality.
What are the types of process validation?
- Prospective validation
- Concurrent validation
- Retrospective validation
- Revalidation
What is CAPA (Corrective and preventive action)?
A systematic approach that includes actions needed to correct (“correction”), prevent recurrence (“corrective action”), and eliminate the cause of potential nonconforming product and other quality problems (preventive action) (21CFR 820.100).
What is Quality Policy?
A statement of intentions and direction issued by the highest level of the organization related to satisfying customer needs. It is similar to a strategic direction that communicates quality expectations that the organization is striving to achieve.
What is Risk Assessment?
A systematic process for organizing information to support a risk decision that is made within a risk management process. The process consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards.
What is Cross-contamination?
Contamination of a starting material, intermediate product or finished product with another starting material or product during production.
What is Aseptic Processing Facility?
A building, or segregated segment of it, containing clean rooms in which air supply, materials, and equipment are regulated to control microbial and particle contamination.
What do you mean by LOD and water content?
LOD is the loss during drying of sample as per prescribed conditions which gives loss (presence) of all evaporating solvents along with water. It is the dry base. While water content gives the moisture present in the sample only and determined by KF titration. It is anhydrous base.
What is the difference between drug purity & potency?
- Purity: it is the absence of unwanted substances like impurities & contaminants
- Potency: it is a measure of drug activity measured in terms of amount of drug required to produce an effect
What are the basic requirements of GMP?
a. appropriately qualified and trained personnel;
b. adequate premises and space;
c. suitable equipment and services;
d. correct materials, containers and labels;
e. approved procedures and instructions.
What is Clean Room?
A room in which the concentration of airborne particles is controlled to meet specified airborne particulate cleanliness class.
What do you mean by ALCOA+?
ALCOA+ is an acronym that stands for Attributable, Legible, Contemporaneous, Original, Accurate, and the '+' refers to Complete, Consistent, Enduring, and Available.
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