1. What is GMP?
GMP stands for Good Manufacturing Practices and includes guidelines provided by the US-FDA. It ensures that products are manufactured according to quality standards, are free from contamination, and are safe for human use.
2. What is cGMP?
cGMP refers to Current Good Manufacturing Practices. It involves using the latest standards and systems to ensure high-quality production. It focuses on proper design, control, and monitoring of manufacturing processes and facilities.
3. Define Validation.
Validation is documented evidence that ensures a process or method will consistently produce results that meet predefined specifications and quality standards.
4. What are the types of validation?
There are four types of validation:
1. Prospective Validation
2. Concurrent Validation
3. Retrospective Validation
4. Revalidation
5. What is RCA?
RCA (Root Cause Analysis) is a technique used to determine the main reason for a specific problem.
It involves an investigation and data-driven approach to identify the cause and find solutions.
6. Which tools are used for Root Cause Analysis?
Common RCA tools include:
- 5 Whys
- Ishikawa Fishbone Diagram (IFD)
- Failure Mode and Effects Analysis (FMEA)
- Fault Tree Analysis (FTA)
- Pareto Chart
- Scatter Diagram
7. What is Line Clearance?
Line clearance is the process of ensuring that the area, line, or equipment is free from residues or labels from
previous products and is ready for dispensing, manufacturing, printing, or packaging.
8. What do we check during Line Clearance?
QA officers check the following:
- Area/Equipment Identification
- Calibration Record
- Temperature
- Humidity
- Differential Pressure
- Log Books Record
9. What is Documentation?
Documentation includes all written materials used in pharmaceutical industries, such as procedures, SOPs, and work instructions.
10. What is Good Documentation Practice (GDP)?
GDP is a set of internationally accepted guidelines for document creation and record-keeping to ensure data integrity.
11. What is ALCOA++?
ALCOA++ is a principle for good documentation practices:
Attributable,Legible,Contemporaneous,Original,Accurate,Complete,Consistent,Enduring,Available,Traceable
12. What is SOP?
SOP (Standard Operating Procedure) is a written instruction detailing how a specific task or activity should be performed.
13. What is SCP?
SCP (Standard Cleaning Procedure) is a document that contains all the instructions for cleaning equipment, utilities, or facilities.
14. What are the types of cleaning?
There are three types of cleaning in the pharmaceutical industry:
Major Cleaning, Minor Cleaning, Shift End Cleaning
15. What is Change Control?
Change control is a documented system that regulates any changes in the existing system of pharmaceutical industries.
16. Is Change Control required for new areas or equipment?
Yes. Change control is required not only for modifying old procedures or equipment but also for adding new equipment or facilities.
17. What are In-process Checks?
In-process checks are tests/activities performed during manufacturing, filling, printing, labeling, or packaging to ensure that required standards are met.
18. Examples of In-process Checks?
Granulation – LOD, Granule size
Compression – Hardness, Weight variation
Coating – Weight gain, Color uniformity
Filling – Volume checking, Clarity checking
Printing – Embossing pattern
Blistering – Sealing, Mfg & Expiry date
19. What are the official (Pharmacopoeial) tests for tablets?
- Assay
- Content Uniformity
- Weight Variation
- Disintegration Test
- Dissolution Test
Hardness Test
Friability Test
Thickness Test
21. What are the types of Dissolution Apparatus?
According to USP, there are 7 types:
- Basket Apparatus
- Paddle Apparatus
- Reciprocating Cylinder
- Flow Through Cell
- Paddle Over Disc
- Rotating Cylinder
- Reciprocating Disc
22. Which equipment is used for the Disintegration Test?
Basket Rack Assembly is used for the Disintegration Test.
23. How many tablets are used for the Disintegration Test?
Initially, 6 tablets are tested.
If 1-2 fail, the test is repeated with 12 more tablets.
The test is passed if 16 out of 18 tablets disintegrate in the specified time.
24. Define Friability.
Percentage weight loss of tablets during a friability test is called friability.
25. Which equipment is used for the Friability Test?
Roche Friabilator is used.
26. For which types of tablets is the Friability Test performed?
Uncoated (core) tablets. It is not performed for coated tablets as polymer coatings add strength.
27. What is the acceptance criteria for the Friability Test?
Not more than 1% weight loss.