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Identifying and addressing common deviations in GDP Compliance
Since 2013, all involved parties within the pharmaceutical product supply chain have been mandated to adhere to the Good Distribution Practices outlined in the European Guideline. These regulations are vital because the products must be maintained under controlled conditions. Therefore, transport companies, warehouses, and other partners in the supply chain must strictly adhere to stringent GDP logistics requirements.
Deviations can arise from various circumstances. During daily production inspections, internal irregularities tend to surface near their origin. Moreover, deviations may be flagged through exit or entrance controls, as well as temperature logger readings. Consistent checks are crucial to ensure adherence to specified procedures and accurate task execution.
Furthermore, these internal audits reveal inconsistencies that demand attention. Lastly, consumer and supplier complaints serve as indicators, allowing identification of discrepancies in raw materials or products.
- The GDP Association, an ECA Foundation Interest Group, recently shared examples of deviations documented in GDP Non-Compliance Reports:
- Inadequate storage facilities for cold chain/cool storage medicinal products.
- Failure to control temperature within specified limits.
- Negligence in fulfilling responsibilities by the designated person in charge, with no notification of a change to the competent authority.
- Insufficient verification of suppliers and their wholesalers' authorisation before purchase, lacking approval from the responsible person.
- Lack of proper checks on medicinal products for security measures and falsification, disregarding safety information provided by the securpharm system.
- Inadequate documentation of purchases and sales, both in quantity and batch records, compromising the seamless tracking of all activities.
How Corrective and Preventive Actions (CAPAs) proactively tackle deviations
Calibration management software operates as a vital tool involving various individuals in resolving, analysing, determining CAPAs, and closing loops. Thus, a structured workflow is crucial, outlining responsibilities, establishing a systematic process, and maintaining a complete audit trail with e-signatures.
Now, let's have a look at how Corrective and Preventive Actions (CAPAs) proactively tackle deviations.
Addressing non conformances demands a comprehensive approach involving different stakeholders. It includes assessing potential solutions and conducting a root cause analysis to grasp why deviations occur. The critical questions revolve around identifying triggers and devising strategies to prevent recurrence.
In fields like GDP and pharmaceuticals, continuous monitoring of the long-term effectiveness of these measures is paramount. Once a CAPA is deployed, evaluating its impact becomes pivotal. In cases where a CAPA falls short, it prompts the need for new strategies to mitigate risks promptly.
In fields like GDP and pharmaceuticals, continuous monitoring of the long-term effectiveness of these measures is paramount. Once a CAPA is deployed, evaluating its impact becomes pivotal. In cases where a CAPA falls short, it prompts the need for new strategies to mitigate risks promptly.
The proactive nature of CAPAs plays a significant role in Document Control. Alongside other measures, these actions necessitate modifications to work instructions, ensuring ongoing enhancement and (GDP) compliance within a structured workflow. This structured process not only delineates responsibilities but also provides a complete audit trail with
e-signatures, contributing to a seamless, accountable system.
e-signatures, contributing to a seamless, accountable system.
Navigating a proactive approach: embracing Risk and Change
In Quality Management Systems (QMS), risk management stands out as an essential element, playing a central role in operational success. It represents the key factor in completing the process, transitioning from a reactive approach to a proactive one.
Rather than just concentrating on internal audits, attention now turns to risk-based audits. This change involves anticipating possible risks and putting proactive measures in place to prevent unexpected issues in the future. This foresight aims to stop potential disruptions before they happen.
Risk management is crucial, especially in two critical areas: ensuring strict production control (GMP) and safeguarding the integrity of the supply chain (GDP). Simultaneously, Change Control stands out as significant. Every operational change requires a comprehensive risk assessment. The impact of the change on the organisation becomes the guiding principle for deciding how to implement it.
This risk management journey usually navigates 3 fundamental pathways:
- Complete elimination of risks
- Mitigation of risks to manageable levels
- Acknowledgment and continuous monitoring of unavoidable risks
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Effective Calibration Management
Accuracy measurements heavily rely on the proper calibration of every measuring instrument. Consider temperature loggers as an example — they require structured and periodic calibration to ensure a better monitoring of the precision and trueness.
In this process, instruments fall into distinct categories. Approved devices meet standards for use, operating solely within defined parameters (e.g., a thermomete accurate of half a degree within specific contexts). Some instruments might be rejected outright and decommissioned, no longer deemed fit for use.
Calibration management software serves as a robust solution offering a multitude of advantages. It is a centralised platform, housing all calibration-related data—schedules, reports, and records—facilitating effortless access and seamless organisation.
The beauty lies in its automation capabilities. By automating calibration schedules and sending timely reminders for impending or overdue calibrations, it streamlines processes, slashing manual errors and ensuring tasks are completed promptly.
Empowering Excellence: navigating Pharmaceutical Quality with innovative solutions
In the pursuit of maintaining stringent pharmaceutical quality standards, confronting deviations and complying with Good Distribution Practices (GDP) is a non-negotiable aspect. The complexities unearthed during audits, reported as non-compliances, demand our unwavering attention and strategic handling.
So, how do we tackle these challenges effectively? The answer lies in the empowerment of quality management software—an innovation that doesn't just respond but proactively addresses quality concerns. This tool isn't just a solution; it's a pathway to robust compliance and excellence in pharmaceutical distribution.
So, how do we tackle these challenges effectively? The answer lies in the empowerment of quality management software—an innovation that doesn't just respond but proactively addresses quality concerns. This tool isn't just a solution; it's a pathway to robust compliance and excellence in pharmaceutical distribution.
Would you like to know how Bizzmine's eQMS can help you understand and manage the importance of eQMS for Quality Events Management in GDP logistics? Book a free demo with one of our GDP consultants.
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