What Is GMP?
GMP stands for Good Manufacturing Practices & it contains guidelines which are given by US-FDA defined as,
GMP is the set of procedures & documentation which ensures that all the products are manufactured according to the quality standards, are free from contamination, and are fit for human use.
What Is cGMP?
cGMP refers to the Current Good Manufacturing Practices & is defined as,
cGMP is the use of current standards & systems to provide high-quality products.
cGMP gives a system that ensures proper design, control & monitoring of the manufacturing process & facilities.
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Good Manufacturing Practice | GMP VS cGMP
Define Validation
Validation is the documented evidence that gives a high level of assurance that a specific process or method will consistently produce the required level of results with predefined specifications & quality.
Write down Types Of validation.
There are four types of validation given below,
- Prospective Validation
- Concurrent Validation
- Retrospective Validation
- Revalidation
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Validation | Process Validation
What Is RCA?
RCA is the Root Cause Analysis and it is the technique used to find out the main reason for a specific problem.
In RCA we use an investigation & data-driven approach to find out the reason for the problem & provide or find out its solution.
Which Tools Are Used For Root Cause Analysis?
The following are commonly used tools for problem-solving.
- 5 Whys
- Ishikawa Fishbone Diagram (IFD)
- Failure Mode and Effects Analysis (FMEA)
- Fault Tree Analysis (FTA)
- Pareto Chart
- Scatter Diagram
What Is Line Clearance?
Line clearance is the activity or process which ensures that the area, line, or equipment is free from residues, and labels of previous products and is ready for dispensing,manufacturing,printing or packaging activity.
What We Check During Line Clearance?
During line clearance, QA officers check that all the area and equipment are properly cleaned/washed and there is no leftover of the previous product.
The following main points are checked,
- Area/equipment Identification
- Calibration Record
- Temperature
- Humidity
- Differential Pressure
- Log Books Record
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Line Clearance in Pharmaceutical Industries
What Is Documentation?
All types of written material used in pharmaceutical industries including procedures, SOPs, work instructions, etc are known as documentation.
What Is Good Documentation Practice GDP?
Good documentation practice or GDP is the collection of standards or internationally accepted guidelines that are used for creating documents & record keeping and it helps for data integrity.
What Is ALCOA?
ALCOA is used for good documentation practices and stands for,
- Attributable
- Legible
- Contemporaneous
- Original
- Accurate
What Is SOP?
SOP is the standard operating procedure and it is written instruction about how a task or activity will be performed.
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What Is SCP?
SCP is a standard cleaning procedure & is a written document that contains all the instructions regarding the cleaning procedure of equipment, utility, or facility.
What are The Types Of Cleaning?
There are 3 types of cleaning in the pharmaceutical industry which are given as below
- Major Cleaning
- Minor Cleaning
- Shift End Cleaning
What Is Change Control?
Change control is a documented system in pharmaceutical industries to control & regulate any changes in the existing system.
Is Change Control Required For New Area Or Equipment?
Most people in the pharmaceutical industry think that change control is only generated when we change any old procedure or equipment but the reality is that it is also generated whenever we want to add any new equipment or facility.
Types Of Changes
Changes May be of two types
- Planned Changes
- Unplanned Changes
What Are Inprocess Checks?
In-process checks are the tests/activities which are performed during the period when a specific activity i.e manufacturing, filling, printing,labeling or packaging is running and is not finished.
These checks are performed to ensure that all the required standards are met during a specific operation.
Examples Of Inprocess Checks?
Following are some examples of in-process checking for various operations.
For Granulation
LOD
Granule size
For Compression
Hardness
Weight Variation
For Coating
Weight Gain
Color uniformity
For Filling
Volume Checking
Clarity Checking
For Printing
Embossing Pattern
For Blistering
Sealing
Mfg & Expiry
Oral Solid Dosage Forms Are Manufactured In Which ISO Class?
OSD like tablets & capsules are manufactured in an area that maintains ISO class 8 or grade D at rest & during working it is non-classified.
Oral Liquid Dosage Forms Are Manufactured In Which ISO Class?
Oral liquid dosage forms like syrups & suspensions are manufactured in an area that maintains ISO class 7Â or grade C at rest & during working it is ISO class 8 or grade D.
Filling & Sealing Of Sterile Products Take Place in Which ISO Class?
Filling & Sealing Of sterile products take Place In ISO class 5 or grade A.
In Pharmaceutical Industries How We Can Prevent Cross Contamination?
Cross-contamination in various manufacturing areas is prevented by creating a pressure difference using airlock systems.
Write Down Types Of Airlocks?
There are three types of airlocks which are given below,
- Sink Airlock
- Bubble Airlock
- Cascade Airlock
Write Down the Name Of Official Tests or Pharmacopoeial Tests Performed For Tablets.
Official Tests Performed for tablets are given,
- Assay
- Content Uniformity
- Weight Variation
- Disintegration Test
- Dissolution Test
Write the Down Name Of Non-Official Tests or Non-Pharmacopoeial Tests For Tablets.
Non Official Tests Performed for tablets are given,
- Hardness Test
- Friability Test
- Thickness Test
Name Of Dissolution Apparatus?
According to USP 07 types of dissolution apparatus are used which are given below,
- Basket Apparatus
- Paddle Apparatus
- Reciprocating Cylinder
- Flow Through Cell
- Paddle Over Disc
- Rotating Cylinder
- Reciprocating Disc
Which Equipment Is Used For Disintegration Tests?
The equipment which is used for checking Disintegration time is known as Basket Rack Assembly.
How Many Tablets Are Used For Disintegration Tests?
First, we take 6 tablets for the disintegration test & if one or two tablets fail to disintegrate we repeat the test with 12 more tablets. The test is considered pass if 16 out of 18 tablets disintegrate in a specified time.
Define Friability?
Percentage weight loss is known as friability.
Which Equipment Is Used For Friability Tests?
Roche friabilator is used for checking the friability of tablets.
For Which Types Of Tablets Do We Perform Friability Tests?
Friability test is performed for core or uncoated tablets.
It is not performed for coated tablets because polymers in coting formulations give strength to the tablets.
At Which Height Tablets Fall during Friability Test?
Tablets fall at a height of 6 inches during the friability test.
What Is The Acceptance Criteria for Friability Test?
Not more than 1%
What Is The Formula To Calculate Tablet Friability?
Tablet friability is calculated by using the following formula,
Initial Weight(W1) – Final Weight(W2)÷ Initial Weight(W1) × 100
Which Quality Control Tests Are Performed For Suppositories?
Following quality control tests are performed for the suppositories,
- Assay
- Weight Uniformity
- DisintegrationÂ
- Dissolution
- Melting Range Test
- Softening Time Test
- Breaking Test
Which Quality Control Tests Are Performed For Sterile Parenterls?
Following tests are performed for injectables,
- Assay
- pH Checking
- Volume Checking
- Leak Test
- Clarity Test
- Pyrogen Test
- Sterility Test
Write Inprocess Test For Liquid Dosage Form?
Following in-process Tests are performed for the non-sterile liquid dosage forms.
- pH
- VolumeÂ
- Viscosity
- Density
- Clarity Test
- Leakage Test
Which Quality Tests Are Performed For Hard Gelatin Capsules?
- Size & Shape Checking
- Color Verification
- Weight Variation
- Assay
- Disintegration
Which Quality Control Tests Are Performed For Creams & Ointments?
Following quality control tests are performed for creams and ointments.
- Physical Appearance
- Particle Size Determination
- AssayÂ
- Weight Variation Checking
- Solubility Test
- Viscosity Test
- Microbial Growth Test
- Metal Particles Test For Ointments
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