GAP analyses, optimization of processes and interfaces
The GAP analysis is a management tool to identify strategic and operational gaps. With a comparison between the actual and target state under consideration of the current regulatory requirements PharmSec offers a comprehensive GMP-/GDP-Compliance Check for the analysis of the quality system. From this, concrete solutions or measures for optimisation are developed:
- Analysis of the quality-relevant processes
- Analysis of the complete quality-relevant documentation
- Appraisal of premises and installations
- Creation of an individual action plan
- Monitoring the implementation of the necessary measures
- Ensuring systemic and process-specific compliance
Quality risk management and risk analysis
Quality risk management is a systematic, overarching process for the evaluation, control, communication and review of the risks of a pharmaceutical product. The aim is to identify and minimize patient risks and to improve quality and compliance. For this reason, the risk-based approach is becoming increasingly important in the GMP/GDP environment. Due to the clear regulatory requirements, the topic is now clearly in the focus of inspections and audits.
Quality risk management can be applied both prospectively (for error prevention) and retrospectively (for error elimination). The degree of effort, formality and documentation of the risk management process should be proportional to the risk.
Risk analyses are an important part of pharmaceutical risk management and lead to a comprehensive understanding of the process through a systematic and documented consideration of all potential risks. For most quality assurance systems they are an indispensable basis.
With the focus on goal-oriented moderation and documentation PharmSec offers the complete risk management portfolio (according to ICH Q9/EU-GMP guidelines part 3), consisting of the following process steps:
Process analysis:
- Detailed analysis of the overall process with reasonable delimitation of the individual sub-processes
Risk assessment:
- Identification of all potential risks, systematic consideration of error severity and probability of occurrence (risk analysis) and subsequent risk assessment
Risk management:
- Finding suitable and effective measures to reduce the severity of errors and/or the probability of occurrence, rational decision regarding risk acceptance
Risk monitoring:
- New evaluation of already identified risks within defined intervals, effectiveness check of risk reduction measures
Risk communication:
- Advice on strategic communication within the process participants and the creation of overall transparency of the system
Supply Chain Security
The complex and ever-increasing demands on the pharmaceutical supply chain raise the pressure on the pharmaceutical industry and its partners. The longer supply chains are, the greater the danger that they may become unstable and thus an incalculable risk in terms of product quality and patient safety. With the EU-GDP guidelines (2013) and the Falsified Medicines Directive (2011/62/EC), the regulatory environment has been significantly tightened in recent years with the aim of further increasing the security of the pharmaceutical supply chain.
The PharmSec strategy is based on the core elements of supply chain security: Based on a comprehensive process analysis and risk assessment of the entire supply chain, the transparency of the entire process is increased and critical interfaces are detected. From this, targeted organizational, personnel and technological measures and concepts for process security and risk minimization can be derived.
Qualification and validation
Qualification is understood to be the demonstration that equipment works properly and actually produces the expected results. This is the basis for validation, which proves that procedures, processes or systems actually lead to the expected results.
Controlled environmental conditions in production, laboratory and storage areas ensure product quality. Room qualification is used to prove that an influence of environmental conditions on product quality is avoided or reduced to an acceptable level. The qualification of process plants and supply systems ensures long-term process stability and robustness.
The risk-based qualification and validation is in each case a multi-stage process, which is precisely regulated in Appendix 15 of the EU GMP guidelines. PharmSec supports you in your projects from planning to complete execution:
- Design and consulting for risk-based qualification of cleanrooms and facilities
- Qualification support along all qualification phases
- Implementation of risk analyses
- Creation of the qualification documents
- Conception and consulting for the risk-based qualification of warehouse and distribution areas
- Implementation of climate mapping, temperature distribution studies and stress tests
- Conception and planning of transport validation