Quiz ICH-Quality Guidelines

Ques 1. What is the aim of Q1C Guideline?

Ans 1. This guideline extends the main stability Guideline for new formulations of already approved
medicines and defines the circumstances under which reduced stability data can be accepted.
Ques 2. Name the types of ICH guidelines?
Ans 2. The guidelines of ICH are broadly categorized into four types.
· Quality guidelines
· Safety guidelines
· Efficacy guidelines
· Multidisciplinary guidelines
Ques 3. The Guideline addresses the ___________and _______ of impurities, including the listing of
impurities in specifications and defines the thresholds for reporting, _________ and ___________.
Ans 3. Chemistry and safety aspects, identification and qualification.
Ques 4. Difference between Q3A(R2): Impurities in new drug substances and Q3B(R2): Impurities
in new drug products
Ans 4.
Q3A(R2): Impurities in new drug substances
The Guideline addresses the chemistry and safety aspects of impurities, including the listing of impurities
in specifications and defines the thresholds for reporting, identification and qualification.
Q3B(R2): Impurities in new drug products
The Guideline specifically deals with those impurities which might arise as degradation products of the
drug substance or arising from interactions between drug substance and excipients or components of
primary packaging materials
Ques 5. Explain Q2 analytical validation guidelines.
Ans 5. There are 2 guidelines under Q2 analytical validation:
Q2(R1): Validation of analytical procedures: Text and methodology
This guideline identifies the validation parameters needed for a variety of analytical methods. It also
discusses the characteristics that must be considered during the validation of the analytical procedures
which are included as part of registration applications.
Q2(R2)/Q14 EWG: Analytical Procedure Development and Revision of Q2(R1) Analytical Validation
This new guideline is proposed to harmonize the scientific approaches of Analytical Procedure
Development, and to provide the principles relating to the description of Analytical Procedure
Development process. This new guideline is intended to improve regulatory communication between
industry and regulators and facilitate more efficient, sound scientific and risk-based approval as well as
post-approval change management of analytical procedures.
Que: 6- Elaborate Pharmacopoeial Harmonisation.
Ans-The pharmacopoeial authorities, working together through the Pharmacopoeial Discussion Group
(PDG), have been closely involved with the work of ICH since the outset and harmonisation between the
major pharmacopoeias, which started before ICH, has proceeded in parallel.
Que-7 Q5A-Q5E guidelines belongs to .............
Answer: Quality of biotechnological products
Que-8- True or False
Statement- Q5C document augments the stability Guideline (Q1A) and deals with the particular aspects
of stability test procedures needed to take
account of the special characteristics of products in which the active components are typically proteins
and/or polypeptides.
Ans- True
Que-9 Specify Q6A and Q6B Guidelines.
Ans. Q6A-Specifications: test procedures and acceptance criteria for new drug substances and new drug
products: chemical substances
Q6B: Specifications: test procedures and acceptance criteria for biotechnological/biological products
Que-10 Define GMP.
Ans-Good Manufacturing Practices or GMP is a system that consists of processes, procedures and
documentation that ensures manufacturing products, such as food, cosmetics, and pharmaceutical goods,
are consistently produced and controlled according to set quality standards
Que-11; Which guideline is used for GMP.
A. Q1 Guidelines
B- Q7 Guidelines
C. Q4 Guidelines
D. Q3 Guidelines
Ans- B. Q7 Guidelines
Ques 12. What are the objective of ICH Guideline?
Ans 12:
· To increase international harmonization of technical requirements to ensure that safe, effective and high-
quality medicines are developed.
· To harmonize technical requirements for registration or marketing approval.
· To develop and register pharmaceuticals in the most efficient and cost-effective manner.
· To promote public health.
· To prevent unnecessary duplication of clinical trials on humans.
· To minimize the use of animal testing without compromising safety and effectiveness of drug.
Ques 13. What is the main aim of Q8 ICH guideline?
Ans 13: The main aim of pharmaceutical development (Q8) is to design a quality product and its
manufacturing process to consistently deliver the intended performance of the product.
Ques 14. What are the two primary principles of QUALITY RISK MANAGEMENT?
Ans: Two primary principles of quality risk management are:
A) The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the
protection of the patient.
B) The level of effort, formality and documentation of the quality risk management process should be
commensurate with the level of risk.
Ques 15. Which category of the ICH quality guidelines concerns Development and manufacture of
drug substances?
Ans : ICH Q11 guidelines.
Ques 16: What are the technical activities followed by Q10 ICH guideline for new and existing
products?
Ans : The following technical activities followed by Q10 ICH guideline for new and existing products
are:
Pharmaceutical development
· Drug substance development;
· Formulation development;
Technology transfer
· New product transfers during Development through Manufacturing;
· Transfers within or between manufacturing and testing sites for marketed products.
Commercial manufacturing
· Provision of facilities, utilities, and equipment;
· Production (including packaging and labeling);
· Quality control and assurance;
· Release, Storage and Distribution (excluding wholesaler activities).
Product discontinuation
· Retention of documentation;
· Sample retention;
Ques 17: Define ICH Q12 guideline?
Ans : This guideline provides a framework to facilitate the management of post-approval CMC changes
in a more predictable and efficient manner. It is also intended to demonstrate how increased product and
process knowledge can contribute to a reduction in the number of regulatory submissions