What is ICH Q10 in the Pharmaceutical Quality System?

In this article, we are going to learn about Scope of ICH Q10 and Objective of ICH Q10 in pharmaceutical.

ICH Q10 In Pharmaceutical Quality System

In 2008, ICH Q10 Pharma Quality System (PQS) was designed to help improve public health around the world by enhancing the quality and availability of medicine. ICH Q10 was designed to facilitate the efficient delivery of high-quality products to people who need them most.

ICH Q10 the goal of this international guidance document is to help pharmaceutical manufacturers by describing standard procedures for setting up and maintaining an effective quality management system in the pharmaceutical industry, commonly referred to as the pharmaceutical quality system.

These guidelines provide a model for developing an effective quality management system. They include a biotechnology approach and a biological perspective, and cover various aspects of product and process development.

Companies that manufacture pharmaceuticals, biotech, and biological products must follow the ICH Q10 guideline.

There are a few comprehensive standards laid out by the International Conference on Harmonization (ICH) Q10, that are required in building an efficient and effective pharmaceutical quality system to support the entire product lifecycle covering development, manufacturing and distribution.

The guidelines meet international quality standards and GMP regulations. The ICH Q10 guideline is one of three guidelines to help pharmaceutical manufacturers improve quality. The other two guidelines are ICH Q8Pharmaceutical Development” and ICH Q9Quality Risk Management.”

Scope of ICH Q10

The guidelines include biotechnology and biological products throughout the lifecycle of the product, as well as pharmaceutical development and manufacturing.

Each of the product lifecycle stages should be subject to elements of ICH Q10 in a manner that is proportional to and appropriate to individual components, as well as to the differences between and different objectives of individual lifecycle stages.

Here we identify the following technical activities that belong to the product lifecycle.

Pharmaceutical Development in ICH Q10: 

  1. Drug substance development; 
  2. Formulation development (including container/closure system); 
  3. Manufacture of investigational products; 
  4. Delivery system development (where relevant); 
  5. Manufacturing process development and scale-up; 
  6. Analytical method development.

Technology Transfer: 

  1. New product transfers during Development through Manufacturing; 
  2. Transfers within or between manufacturing and testing sites for marketed products.

Commercial Manufacturing: 

  1. Acquisition and control of materials; 
  2. Provision of facilities, utilities, and equipment; 
  3. Production (including packaging and labelling); 
  4. Quality control and assurance; 
  5. Release; 
  6. Storage; 
  7. Distribution (excluding wholesaler activities). 

Product Discontinuation: 

  1. Retention of documentation; 
  2. Sample retention; 
  3. Continued product assessment and reporting.

ICH Q10 Objectives:

Three main objectives should be met by the implementation of the Q10 model, which complement or enhance regional GMP requirements.

Achieve product realisation:

A quality-assured system must be established, implemented and maintained to enable products to meet the quality attributes required to meet the needs of customers, including patients, health care professionals, regulatory bodies (including compliance with approved regulatory disclosures) and other internal and external customers.

Establish and maintain a state of control:

The development of effective monitoring and control systems to ensure continual suitability and capacity of processes and provide product quality assurance. Quality risk management can be utilized to identify monitoring and control systems.

Facilitate continual improvement:

Quality Risk Management can be used for identifying and prioritising quality improvement opportunities. Quality risk management could lead to improved product quality, process improvements, variability reduction, innovations and pharmaceutical quality system integration.

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