Development and Lifecycle Management of Software as a Medical Device
All Pharmaceutical Quality Systems must operate to a high standard on a daily basis without the requirement for any major preparation activities in advance of an inspection if they are to be considered inspection ready. Pharmaceutical companies in the USA can be inspected regularly and unannounced by the Food and Drug Administration (FDA).
Many US companies have created individual functions within their organisations whose sole duty is to implement inspection readiness. This provides companies with the assurance that they are always ready and prepared to welcome inspectors and accompany them through an inspection at any time.
Although outside the US it is also the goal to establish a consistent and high standard of GMP compliance, FDA inspections are prepared individually as they are typically announced.
It is essential to question and understand the cGMP systems within the company in order to identify potential weak points and compliance risks. Any risks identified should be managed through the internal Quality Management System (QMS) and would typically include escalation and monitoring via the Quality Management Review process. The most common processes to manage the implementation of inspection readiness actions or plans include Change Control, Risk Management and Corrective Action Preventive Action (CAPA) processes.
The 5 most common FDA Inspection Observations are:
- Procedures not in writing or not fully followed
- Laboratory controls not scientifically sound
- Discrepancies and/or failures in investigations
- Absence of written procedures
- Deficient environmental monitoring systems
The following questions may be useful in evaluating how mature your organisation is in terms of inspection readiness:
- Do you examine all your processes critically and without bias – as the FDA would?
- Have you identified, evaluated and tackled all internal and potential compliance risks?
- Are you aware of the current inspection trends and possible focuses specially related to your product?
- Have you involved potential customers, partners and service providers in the information and evaluation?
- Have you informed and prepared all the colleagues involved? Are all the roles clearly assigned?
- Are you sure that all your colleagues are competent enough to answer the inspectors’ questions and provide clear information about the processes and documentation?
- Have you established procedures about how to handle the inspection and answer the inspectors’ questions?
- Do you know how to efficiently put documents at disposal?
- Have you developed strategies to discuss possible compliance weak points during the inspection?
- Do you know what is important after the inspection and how to formulate possible answers?
The above information can be found in detail by visiting the link below:
PharmaLex can support your organisation in many ways. If you would like the PharmaLex team to develop or examine your Inspection Readiness compliance strategy, please connect with us to discuss +353 1 846 4742 or contactirl@pharmalex.com
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