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Quality Management & GMP

Do it right the first time.
In the past the pharmaceutical industry focused on being compliant with the GMP requirements. Since the pharma quality paradigm shift towards a science and risk based approach additional aspects came into the focus such as thinking in processes, correctly assessing risks and not to constantly reinvent the wheel over the lifecycle of a product (Knowledge Management). This requires a systematic approach where Phact can provide expertise.
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There are numerous examples of disappointments in daily business. The constantly combating of firefighting situations (reactive behavior) cost a lot of energy that could be spend more efficiently within the organization. A change in quality culture and mindset needs to be initiated. A strategy towards quality needs to be designed to continually improve the performance of the organisation. The result will be a high quality, top performing and efficient operating organisation. Finally, proactive behavior and thinking will resolve many of today’s problems.

People working in the pharmaceutical environment are aware of the regulations. Nevertheless, in a world of increasing complexity and increasing workload it is difficult to keep track with all developments. New requirements from outside are perceived as additional burden and often internal processes are not adapted to changes. Documentation is permanently added on top without realising redundancy to existing documents.

In these situations, it is useful to have an independent view, assessing the compliance status. Based on a holistic approach, Phact analyses the company’s quality status and provides effective and sustainable solutions:

  • Assessing the GMP compliance status according to given standards (EU, FDA, WHO)
  • Assessing the functioning of the quality system
  • Assessing the documentation system
  • Assessing completeness of agreed actions and activities
  • Assessing Quality Assurance activities
  • Assessing supply chain activities
  • Monitoring your quality-related projects
  • Interacting with your relevant health authority
  • Coaching of employees and teams

Phact offers GMP assistance on a world-wide basis in the areas of biotechnological production, aseptic/sterile manufacturing, liquids and solids production, API and excipient manufacturing, engineering, logistic and transport and pharmaceutical development.

The implementation of a Management Review is a regulatory expectation and one of the most important instruments of senior management to direct an organisation towards compliance and continual improvement. Phact assists in implementing the Management Review and also provides support in preparing and conducting these meetings. It is the idea to have a true picture of the situation within the company and measure the status of the Quality System. The service comprises:
  • Implementing a formal Management Review process
  • Providing support during Management Review meetings
  • Organising local and global Management Reviews
  • Developing graphical presentation tools
  • Conducting root cause analysis
  • Setting measurable Key Performance Indicators (KPIs) / metrics
  • Monitoring Right First Time (RFT) parameters
  • Assisting in setting priorities
  • Identifying appropriate actions
  • Assessing status of Quality System

It is a GMP requirement to assess the quality and compliance of all parties (internal and external) involved in pharmaceutical manufacturing and supply chain. Conducting a good audit does require more than solid knowledge of the GMP regulations, it also requires the auditor’s empathy towards the auditee.

Lothar Hartmann, Managing Director of Phact, and co-founder of the API Compliance Institute (education and certification of auditors), has gained broad experience in conducting numerous audits around the world. Phact would be pleased to conduct audits within your company, on behalf of your company or train auditors of your company. We assist by:

  • Providing an independent report and view to the customer
  • Creating a constructive environment and atmosphere at the audit
  • Acceptable duration
  • Minimising disruption of auditee
  • Applying recognised questioning techniques
  • Ensuring that audit observations are linked to regulatory requirements (reference)
  • Classifying of observations
  • Ensuring that the auditee is responding to the observations including a target date and responsibility

Pharmaceutical companies are inspected by authorities for compliance with GMP regulations. An inspection and its follow up activities require intensive preparations and absorb a significant portion of energy from the organisation. Preparing for inspections and their follow-up requires an extremely focused approach and the knowledge of the latest inspection trends. During this phase Phact supports organisations with their extensive experience:

  • Meticulous review of the quality system
  • Thorough review of the production plant, warehouses and laboratories
  • Ensuring that all documents (SOPs, organisation charts, P&ID (Piping and Instrumentation Diagram), process flow charts) are available and up-to-date
  • Ensuring that the validation documentation is complete
  • In-depth review of training files
  • Assessment of supply chain activities
  • Compilation of all necessary lists required for an inspection
  • Organisation of the inspection
  • Training of employees for an inspection
  • Establishing the preparation scheme for the inspection
  • Cross-checking of submissions as to daily business practices