1. What is GMP?
Good Manufacturing Practice (GMP) refers to a system of regulations, codes, and guidelines that ensure pharmaceutical products are consistently produced and controlled according to established quality standards. It covers every step involved in manufacturing—from raw materials and equipment to packaging and testing—to guarantee that medicines are safe, effective, and reliable for patient use.
2. Why is GMP important?
GMP is important because it protects consumers by ensuring that products are manufactured under controlled and hygienic conditions. It helps prevent contamination, mix-ups, and manufacturing errors. Ultimately, GMP safeguards public health by ensuring medicines meet their expected quality, safety, and efficacy.
3. What are the key components of GMP?
The major components of GMP include quality management systems, properly designed facilities and equipment, strong documentation practices, production and process controls, quality control testing, personnel training, sanitation and hygiene, and ongoing validation activities. Together, they ensure that every batch of product meets regulatory standards.
4. What is quality assurance in GMP?
Quality Assurance (QA) focuses on preventing defects through well-established systems and processes. It ensures that each product is manufactured to the required quality standards by verifying that all procedures, tests, and controls are properly implemented throughout production.
5. What is the role of personnel in GMP?
Personnel are essential to GMP because human error is one of the biggest risks in manufacturing. Employees must be qualified, well-trained, and follow hygiene, safety, and procedural requirements precisely. Their knowledge and discipline directly impact the quality and consistency of pharmaceutical products.
6. What are GMP guidelines?
GMP guidelines outline the principles and procedures manufacturers must follow to maintain product quality. These guidelines govern every part of the manufacturing cycle—from material handling and equipment maintenance to documentation and quality checks—to minimize the chance of producing defective or contaminated products.
7. How does GMP apply to the pharmaceutical industry?
In pharmaceuticals, GMP governs everything from receiving raw materials to releasing finished products. It ensures that products are manufactured under controlled conditions, tested for compliance, and packed and stored properly. GMP helps companies produce medicines that meet the expectations of regulatory authorities and protect patient safety.
8. What is validation in GMP?
Validation demonstrates, through documented evidence, that a process or system consistently produces results that meet predetermined specifications. It confirms that production processes are reliable and capable of delivering high-quality products batch after batch.
9. How is qualification different from validation?
Qualification ensures that equipment, facilities, and utilities are installed and working correctly (IQ, OQ, PQ). Validation goes a step further by ensuring that the entire manufacturing process consistently produces acceptable results.
10. What are the types of GMP inspections?
Inspections may be routine (regularly scheduled), for-cause (triggered by complaints or concerns), pre-approval (before a product is authorized), or post-approval (after a product is on the market). Each type evaluates a company’s adherence to GMP requirements.
11. What is the purpose of a GMP inspection?
A GMP inspection assesses whether a manufacturing facility complies with regulatory standards. It identifies non-compliances or risks that could affect product safety or quality, helping ensure that only high-quality medicines reach consumers.
12. What is corrective action in GMP?
Corrective actions address problems identified during audits, inspections, or deviations. They focus on correcting the root cause of the issue to ensure it does not occur again, improving the overall reliability of the manufacturing system.
13. What is preventive action in GMP?
Preventive actions aim to identify and eliminate potential problems before they occur. This proactive approach strengthens systems, reduces risks, and supports continuous improvement in manufacturing operations.
14. What are SOPs in GMP?
Standard Operating Procedures (SOPs) are step-by-step written instructions that describe how to perform routine tasks. SOPs ensure consistency, accuracy, safety, and compliance with GMP regulations throughout the production process.
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15. What is a batch record?
A batch record is a detailed document that captures every step, material, and parameter used during the production and testing of a specific batch. It ensures traceability, accountability, and compliance with GMP.
16. Why is documentation critical in GMP?
Documentation provides evidence that processes were followed correctly. Proper records allow traceability, support investigations, and prove compliance to regulators. Without documentation, quality cannot be verified.
17. What is change control in GMP?
Change control is a structured process used to review, assess, approve, and document any changes in materials, equipment, procedures, or systems. It ensures that changes do not negatively affect product quality or compliance.
18. What is the purpose of internal audits in GMP?
Internal audits assess whether operations comply with GMP guidelines and internal procedures. They help identify weaknesses early, enabling the company to correct issues before regulatory inspections.
19. What is risk management in GMP?
Risk management involves identifying risks that could affect product quality, evaluating their impact, and implementing controls to reduce or eliminate them. This systematic approach improves decision-making and product reliability.
20. How are deviations handled in GMP?
Deviations are documented, investigated, and followed by corrective and preventive actions. This ensures any unexpected event is properly understood, controlled, and prevented in the future.
21. What is the purpose of environmental monitoring in GMP?
Environmental monitoring checks the cleanliness and microbial levels in production areas. It ensures that the manufacturing environment remains controlled and suitable for producing safe pharmaceutical products.
22. What is data integrity in GMP?
Data integrity ensures that all data—especially electronic records—are complete, accurate, and consistent. It ensures that decisions about product quality are based on trustworthy information.
23. What is a product recall in GMP?
A product recall removes defective or potentially harmful products from the market. It protects public health and requires immediate communication with customers, regulators, and distribution channels.
24. What is self-inspection in GMP?
Self-inspections are internal evaluations conducted by a company to assess its own GMP compliance. They help identify problems proactively and support continuous improvement.
25. What is supplier qualification in GMP?
Supplier qualification ensures that vendors providing raw materials or components follow quality standards. It involves audits, documentation reviews, and performance monitoring to ensure the reliability of the supply chain.
26. What is calibration in GMP?
Calibration verifies that instruments and measuring devices provide accurate readings. Regular calibration ensures that equipment functions correctly and supports reliable manufacturing and testing.
27. What is an out-of-specification (OOS) result?
An OOS result occurs when a test value falls outside the approved limits. When this happens, a detailed investigation must be conducted to identify causes and implement corrective actions.
28. What is root cause analysis in GMP?
Root cause analysis identifies underlying reasons for deviations or failures. Understanding the root cause ensures that corrective actions are effective and that problems do not repeat.
29. How does GMP ensure traceability?
GMP ensures traceability by maintaining detailed records of raw materials, processes, equipment, and testing. This allows quick investigation and product recall if needed.
30. What is the role of cleanliness in GMP?
Cleanliness prevents contamination and ensures product purity. Proper cleaning procedures, sanitation routines, and personal hygiene practices are essential for maintaining product safety.
31. What is the purpose of media fills in aseptic processing?
Media fills test the sterility of aseptic processes by using growth media instead of actual product. They help confirm that the aseptic environment is properly controlled.
32. How is cross-contamination prevented in GMP?
Cross-contamination is prevented through material segregation, dedicated equipment, robust cleaning procedures, air handling systems, and strict personnel hygiene.
33. What is line clearance in GMP?
Line clearance ensures that no remnants of a previous batch remain before starting a new production run. It prevents mix-ups and maintains batch identity and purity.
34. What is stability testing in GMP?
Stability testing evaluates how a product’s quality changes over time under various conditions. It helps determine shelf life, storage conditions, and expiration dates.
35. What is the significance of expiry dates in GMP?
Expiry dates indicate the time period during which a product is expected to remain safe and effective, based on stability testing. It ensures that patients receive medicines that perform as intended.
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36. What is aseptic processing in GMP?
Aseptic processing involves sterilizing components separately and combining them in a sterile environment to prevent contamination. It is commonly used for injectable and ophthalmic products.
37. What is a CAPA plan in GMP?
A CAPA plan outlines corrective actions to fix existing issues and preventive actions to avoid future problems. It ensures continuous improvement and long-term compliance.
38. What are the requirements for storage conditions in GMP?
Storage conditions must control temperature, humidity, and light exposure as defined by stability data. Proper storage ensures that product quality remains intact throughout its shelf life.
39. How are GMP deviations documented?
Deviations are documented in deviation reports, which describe the event, identify the root cause, and record the corrective and preventive actions taken.
40. What is qualification of equipment in GMP?
Equipment qualification ensures that equipment is installed correctly, operates as intended, and performs consistently under real manufacturing conditions (IQ, OQ, PQ).
41. What is Product Quality Review (PQR)?
PQR is an annual assessment of all batches produced. It reviews deviations, trends, stability results, and process performance to ensure consistent quality and identify improvement opportunities.
42. What is out-of-trend (OOT)?
OOT results fall within specifications but differ significantly from historical data. These results require investigation to ensure there are no hidden issues.
43. What is the role of a Quality Control (QC) unit?
QC tests raw materials, in-process samples, and finished products to confirm they meet specifications. QC ensures that only compliant materials move forward in the process.
44. What are the GMP requirements for personnel hygiene?
Personnel must follow strict hygiene rules, including proper handwashing, wearing PPE, and avoiding practices that could introduce contamination, such as eating or wearing jewelry in manufacturing areas.
45. What is the purpose of GMP training?
GMP training ensures employees understand procedures, quality expectations, and safety standards. Regular training helps maintain compliance and reduce operational errors.
46. What is GMP cleanroom classification?
Cleanrooms are classified based on particle concentration levels. Each classification corresponds to the level of environmental control required for the type of product being manufactured.
47. What are Good Documentation Practices (GDP)?
GDP ensures that records are legible, accurate, complete, and created at the time of activity. It supports data integrity and regulatory compliance.
48. What is the GMP requirement for labeling?
Labels must be accurate, clear, and contain essential information such as product name, batch number, expiry date, and storage conditions. Proper labeling prevents mix-ups and ensures traceability.
49. What are the GMP requirements for starting materials?
Starting materials must be tested, approved, and sourced from qualified suppliers. Their quality directly affects the final product, making material control essential.
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50. How can a company demonstrate GMP compliance during an inspection?
A company demonstrates compliance by maintaining complete documentation, following approved procedures, showing validation and calibration records, and presenting clear evidence of training, audits, and product quality consistency.
15 ADDITIONAL QUESTIONS & ANSWERS (Added as Requested)
51. What is an SOP deviation?
An SOP deviation occurs when a task is performed differently from the approved procedure. It must be recorded and investigated to understand the cause and ensure it does not compromise product quality.
52. What is the role of HVAC systems in GMP?
HVAC systems control temperature, humidity, and air cleanliness in production areas. They help prevent contamination and maintain a stable environment for product manufacturing.
53. What is hold time study in GMP?
Hold time studies determine how long intermediate materials can be stored before processing without affecting quality. This ensures that waiting periods do not degrade product integrity.
54. What is reprocessing in GMP?
Reprocessing involves reworking a batch that does not initially meet specifications, using approved procedures. It must be scientifically justified and documented to ensure final product quality.
55. What is re-qualification in GMP?
Re-qualification is the periodic review and testing of equipment to verify that it still performs correctly. It ensures long-term reliability of manufacturing equipment.
56. What is an investigation report in GMP?
An investigation report documents the details of a deviation, OOS result, or problem. It includes root cause analysis and CAPA actions.
57. What is a quarantine area?
A quarantine area is a controlled space where materials are held until they are tested, inspected, and approved for use. It helps prevent mix-ups and contamination.
58. What is equipment cleaning validation?
Cleaning validation confirms that cleaning processes effectively remove residues, ensuring equipment does not contaminate subsequent products.
59. What is in-process control (IPC)?
IPC refers to tests conducted during manufacturing to ensure that the process remains within predefined limits. It helps detect issues early before they affect the final product.
60. What is a Master Formula Record (MFR)?
The MFR provides approved instructions for manufacturing a product, including raw material quantities, equipment, and step-by-step procedures.
61. What is a Certificate of Analysis (COA)?
A COA is a document provided by a supplier that shows test results for a material, confirming it meets quality specifications.
62. What is an audit trail?
An audit trail logs all changes made to electronic data. It ensures transparency, accountability, and compliance with data integrity requirements.
63. What is the role of a Quality Management System (QMS)?
A QMS integrates all quality-related activities, including documentation, audits, change control, and CAPA. It ensures a structured approach to maintaining product quality.
64. What is equipment qualification lifecycle?
It includes design qualification (DQ), installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and periodic re-qualification.
65. What is GMP documentation hierarchy?
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