Quality Management & GMP
The pharmaceutical industry is one of the most regulated industries. In order to efficiently implement the requirements set out in pharmaceutical regulations, a sound understanding of these regulations is essential.
Phact helps companies to find their way through the “regulatory labyrinth” and to implement the requirements efficiently.
The pharmaceutical business is facing increasing complexity and regulation. The International Council for Harmonisation (ICH) has issued the ICH Q10 Guideline (“Pharmaceutical Quality System – PQS”), which addresses the way forward. Implementation of a PQS requires a change from departmental thinking to an enterprise-wide process orientation.
We can help you get started by
- An assessment of the company’s situation, identifying local and global needs
- A proposal for the design of a PQS
- Implementation of the PQS
- Writing the Quality Manual
- Define the KPIs/Metrics
- Set up the recurring Management Review
Our experienced team can provide an independent external view of a company’s compliance status.
This includes, but is not limited to, the following aspects:
- Assessment of the GMP compliance status according to given standards (EU, FDA, WHO)
- Evaluation of the functioning of the quality system
- Assessment of the documentation system
- Assessment of the data integrity status
- Provide solutions to improve the status quo
Internal and external audits are required by the numerous GMP guidelines. Our experienced auditor can analyse the compliance status of your suppliers on your behalf. Such a contract audit includes the following checks and services, among others
- A meticulous review of the quality system
- Thorough audit of the production plant, warehouses and laboratories
- Analysis of available documentation
- Review of the training records
- Assessment of supply chain activities
- Provision of a detailed audit report to the client
- Discuss improvements and actions with the client
There is no such thing as “no risk”. The International Council for Harmonisation (ICH) has addressed this fact in ICH Q9 (“Quality Risk Management”) and provides industry with a set of tools to control their risks. Phact assists in implementing Quality Risk Management. This can be done for a facility, an organisational unit, a project or a single case.
This includes the activities such as
- Analyse and identify risks to business and manufacturing processes
- Assess the severity, likelihood and detectability of risks
- Determine risk indicators such as Primary Risk Number (PRN) and Risk Priority Number (PRN),
- Identify risk assessment methodology
- Propose measures to reduce and control risks
- Investigate and justify acceptable risks
- Communicate the risks within the organisation
Our experienced team is ready to help. We look forward to hearing from you.
Knowledge Management is described in ICH Q10 as an enabler for a Pharmaceutical Quality System (PQS): by implementing knowledge management a company ensures that the right knowledge is made available to the right people at the right time. Knowledge management transforms data into information, enabling data-driven decisions for the company’s processes.
This includes the activities such as
- Analysis of the company’s knowledge management status
- Identify the knowledge available and match it with the knowledge required
- Implement knowledge tools
- Set knowledge-related goals
- Develop concepts to capture the knowledge and expertise of the company’s employees
Are you looking for advice or support with your implementation? We look forward to hearing from you.