A New Approach to The Pharmaceutical Quality System

Is your quality system keeping pace with the changes in manufacturing technology and new thinking in how manufacturing companies approach the issues of quality?  Many companies have adopted the pharmaceutical quality system outlined in ICH Q10 and experienced the benefits that the change in approach has brought.

What are the benefits of the pharmaceutical quality system?

We outline how it works.

The ICH Q10 Guideline

The ICH Q10 guideline describes a model for an effective quality management system for the pharmaceutical industry or a ‘pharmaceutical quality system’.  It advocates preventative action culture to ensure that actions are taken before problems happen. It also facilitates the use of ICH Q8 and Q9.

It is based on ISO 9000 with an emphasis on management responsibilities, improvement of QS and improvement of product quality over its lifecycle. Its scope is across pharmaceutical drug substances (API) and drug products, including biotechnology and biological products.

The elements of a pharmaceutical quality system (PQS) encourage the use of scientific and risk-based approaches at each lifecycle stage.

Three main objectives to a new pharmaceutical quality system:

1. Achieve Product Realisation– Having a system in place that allows delivery of products with the quality attributes appropriate to meet the needs of the patient.
2. Establish and Maintain a state of Control– To develop and use effective monitoring and control systems for process performance and product quality ie. Use of QRM (Quality risk management).
3. Facilitate Continual Improvement –Identify and implement appropriate product quality improvement, process improvement, variability reduction, innovation and pharmaceutical quality system enhancement.

The PQS covers the entire lifecycle of the product including:

• Pharmaceutical development
• Technology transfer
• Commercial manufacturing
• Product discontinuation

ICH Q10 is used in conjunction with regional GMPs for the technology transfer, commercial manufacturing, product discontinuation and investigational products stages of the process.

Management responsibilities are critical to all stages of the life cycle and the PQS elements which are a very important part of the structure supporting the PQS model.

The PQS elements are used in each lifecycle stage to identify areas for continual improvement, these include:

• Process performance and product Quality monitoring system – ensure that a state of control is maintained, provide assurance of continuous capability of process controls to produce a product of the desired quality.
• Corrective Action/Preventative Action (CAPA) system– this system should result in product and process improvements.
• Change management system– System to evaluate, approve and implement changes identified from innovation, CI, CAPA, Audits. Must be implemented ensuring no unintended consequences from the change.
• Management Review- Product quality review must be carried out at various levels of investigation, deviation, Audit findings and CAPA effectiveness.

The enablers of ICH Q10 are:

• Knowledge management –Product and process knowledge should be managed and developed through the commercial life of the product and up to discontinuation.
• Quality risk management-This is integral to an effective PQS. Applying QRM provides a proactive approach to identifying, scientifically evaluating and controlling potential risks to Quality. (ICH Q9)

These support the PQS goals of achieving product realisation, establishing and maintaining a state of control and facilitating continuous improvement.

Using knowledge management and risk management will allow the company to implement ICH Q10 effectively and successfully.

The system is greatly dependent on senior management commitment to provide leadership, resources, encourage internal communication on quality issues and ensure informed decision-making processes are carried out using process knowledge and risk management tools.

A system should be designed to be well structured and clear with a common understanding, size and complexity of the company’s activities should be taken into account. The system should have the appropriate resources and process to assume the quality of outsourced activities and purchase of materials.

The Importance of the Quality Manual

The company must have an appropriate Quality manual in place, which must include details of the:

• Quality policy
• Scope of the pharmaceutical quality system
• Identification of the PQS processes, sequences, linkages and interdependencies
• Management responsibilities within the pharmaceutical quality system.

Management responsibilities are vital and must include:

• Leadership
• Management commitment
• Establishment of the Quality Policy
• Quality planning
• Resource management
• Internal communications and ensuring that all communications are understood by all levels of staff.
• Management reviews to ensure continuing suitability and effectiveness of the PQS and assessments of the conclusions of periodic reviews of the process and performance and product quality.
• Manage outsourced activities and purchase of materials
• Manage changes in product ownership.

For continuous improvement of the pharmaceutical quality system the below activities must be conducted:

Management review of the pharmaceutical quality system, review must include:

• Measurement of achievement of pharmaceutical quality system objectives, assessment of performance indicators ie: complaints, deviations, CAPA and change management process.
• Feedback on outsources activities
• Self-assessment process including risk assessments, trending, and audits.

Monitoring of internal and external factors impacting the pharmaceutical quality system

• Emerging regulations, guidance and quality issues
• Innovations that enhance PQS
• Changes in business environment and objectives
• Change in product ownership

Outcomes of management review and monitoring

• Improvements to the pharmaceutical quality system and related processes.
• Allocation and reallocation of resources
• Revisions to quality policy and quality objectives
• Documentation and timely and effective communication of the results of management review and actions.

Implementation of ICH Q10 throughout the product lifecycle should facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities.

And Finally….

ICH Q10 is signed up to as the quality system of choice by the regulatory authorities and industry representative for US, Europe and Japan as they are a permanent member of the ICH.  This is the first quality system that is ratified in this way.

ICH Q10 provides a mechanism for having a quality system that covers the entire lifecycle of the product; from R&D to product discontinuation. The appropriate level and rigour being applied dependent on the stage in the lifecycle.

ICH Q10 describes mechanisms with feedback and enablers to facilitate the continuously improve the quality system and increase product knowledge.

We Can Help

Acorn Regulatory provides quality management services to companies worldwide.  If you would like to discuss this issue with us further, then please contact us on 00353 52 61 76 706 or complete your details below and we will get back to you.

Further Reading from Acorn Regulatory

Updated for 2020: Development of the Orphan Drug Sector

Much has been written about orphan drugs in recent times.  These products, developed specifically to treat a rare disease, have become more common in the marketplace.  At the time of writing (May 2020), there are almost 770 orphan drugs commercially available and more than 5600 orphan designated drugs in the biopharmaceutical pipeline.

As the sector continues to grow there has been a tendency for facts about orphan drugs to get lost in the midst of issues concerning specific patients’ needs, pricing and availability.  We look at some facts about orphan designation that companies considering entering the sector should be aware of.

Read more about orphan drugs here.

Medicinal Product Labelling: What You Need To Know

Medicinal products are no exception and must be accompanied by outer and/or immediate packaging information (labelling) and a package leaflet providing information enabling the safe and effective use of the medicinal product. In fact, medicinal products are legally required to have certain information on the labels and package leaflets as defined in Title V of Directive 2001/83/EC on the ‘Community code relating to medicinal products for human use’ (as amended).

Read more about medicinal product labelling here.

Outsourced eCTD Publishing Services: An Overview

More countries are implementing eCTD.  As a result, more companies are being forced to make decisions regarding how they manage their electronic submission and eCTD publishing services.

We typically encounter three scenarios:

1. Companies that maintain control of electronic publishing at the corporate and head office level
2. Others that have retained the day-to-day eCTD maintenance and lifecycle at a local level
3. Companies that have outsourced eCTD entirely

In this article, we will look at the benefits and the limitations presented by the three options presented above.

Find out more about outsourcing eCTD here.