Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -3

Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -3

Question 1:

Why is it important for the design, organization, and documentation of the pharmaceutical quality system to be well structured and clear?

Answer 1:

It is important for the design, organization, and documentation of the pharmaceutical quality system to be well structured and clear to facilitate common understanding and consistent application among stakeholders.

Question 2:

How should the elements of ICH Q10 be applied across different stages of the product lifecycle?

Answer 2:

The elements of ICH Q10 should be applied in a manner that is appropriate and proportionate to each of the product lifecycle stages, recognizing the different goals and knowledge available for each stage.

Question 3:

What factors should be considered when developing or modifying a pharmaceutical quality system, according to the ICH Q10?

Answer 3:

When developing or modifying a pharmaceutical quality system, the size and complexity of the company’s activities should be taken into consideration. Additionally, appropriate risk management principles should be incorporated into the design. While some aspects of the pharmaceutical quality system may be company-wide and others site-specific, the effectiveness of the system is normally demonstrated at the site level.

Question 4:

What assurance should the pharmaceutical quality system provide regarding outsourced activities and purchased materials?

Answer 4:

The pharmaceutical quality system should include appropriate processes, resources, and responsibilities to provide assurance of the quality of outsourced activities and purchased materials.

Question 5:

What are some essential elements that should be included in the pharmaceutical quality system?

Answer 5:

Some essential elements that should be included in the pharmaceutical quality system, include process performance and product quality monitoring, corrective and preventive action, change management, and management review.

Question 6:

How should performance indicators be utilized within the pharmaceutical quality system according to the ICH Q10?

Answer 6:

Performance indicators should be identified and used to monitor the effectiveness of processes within the pharmaceutical quality system.

Question 7:

What documentation approach should be established according to the ICH Q10 and what should it contain?

Answer 7:

According to the ICH Q10, a Quality Manual or equivalent documentation approach should be established. It should contain the description of the pharmaceutical quality system, which includes the quality policy, the scope of the pharmaceutical quality system, identification of the pharmaceutical quality system processes, as well as their sequences, linkages, and interdependencies, and management responsibilities within the pharmaceutical quality system.

Question 8:

What is the purpose of including the quality policy in the Quality Manual?

Answer 8:

The quality policy is included in the Quality Manual to provide a clear statement of the organization’s commitment to quality. It sets the overall direction and objectives for the pharmaceutical quality system.

Question 9:

What information should be provided regarding the scope of the pharmaceutical quality system?

Answer 9:

The scope of the pharmaceutical quality system should be clearly outlined in the Quality Manual. This includes specifying the boundaries and extent of the system’s applicability within the organization.

Question 10:

How should the pharmaceutical quality system processes be described in the Quality Manual?

Answer 10:

The pharmaceutical quality system processes should be identified in the Quality Manual, including their sequences, linkages, and interdependencies. Process maps and flow charts are recommended as useful tools to visually depict these processes.

Question 11:

What aspect of management responsibilities should be detailed within the Quality Manual?

Answer 11:

Management responsibilities within the pharmaceutical quality system should be detailed in the Quality Manual. This includes outlining the roles and responsibilities of management personnel in ensuring the effectiveness and compliance of the quality system.

About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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