Quality Management System (QMS) MCQ

Quality Management

• The overall intention and direction of an organization regarding quality is formally expressed and authorized by top management, known as the quality policy.
• Planning is the management function that determines and implements the quality policy.

Risk Management

• Quality Risk Management (QRM) is a systematic process for the assessment, control, communication, and review of risks to the quality of the drug product across the product lifecycle.
• Quality Risk Management aims to minimize the risk of harmful effects to patients, customers, and the company.

Pharmaceutical Industry Regulations

• The International Council for Harmonization (ICH) brings together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop guidelines.
• ICH's main mission is to achieve greater harmonization among regulatory requirements and guidelines for pharmaceuticals.

Pharmaceutical Production

• Good Manufacturing Practice (GMP) incorporates Quality Control and Quality Risk Management to achieve quality in pharmaceutical production.
• GMP's primary role is to ensure the production of high-quality drug products that are safe and effective.
• The primary focus of GMP rules is to ensure the quality of drug products.
• Bulk Product refers to an intermediate product that is further processed or packaged into a finished product.

Quality Assurance

• Quality Assurance (Q.A) is primarily concerned with ensuring that quality standards are met during all stages of pharmaceutical production.
• A Quality Management System (QMS) is a set of policies, procedures, and processes that ensure the quality of drug products.
• According to ICH Q9, a QMS is a management system that directs and controls an organization with regard to quality.

Change Management

• Change Management involves a systematic approach to managing changes that affect the quality of drug products.

API and Inactive Ingredients

• Active Pharmaceutical Ingredient (API) refers to the biologically active component of a drug product.
• Inactive Ingredient refers to an ingredient that does not have a therapeutic effect in a drug product.

Regulations and Guidelines

• The United States' Food and Drug Administration's (FDA) version of GMP is considered the general reference worldwide.
• Subpart A: General Provisions Complete Scope Regulations outlines the scope and applicability of GMP regulations.

Intermediate Products

• An Intermediate Product is an incomplete pharmaceutical product that requires further processing or packaging to become a finished product.

ICH Guidelines

• ICH guidelines, such as ICH Q9 and ICH Q10, provide guidance on quality risk management, quality management systems, and pharmaceutical quality systems.