zelhealth offers GMP audits across the globe – either for your own facilities or your third party suppliers. We ensure that all audits that you have to conduct as MA holder are getting done appropriately. In addition we support you with all procedures that are required to comply with FDA and EMA regulations. We prepare your management and staff to pass FDA and EMA inspections.
Example of the scope of Audits and Inspections
- Preparation of Internal Audit Agenda
- Conducting an Internal Audit
- Conducting a Gap analysis on-site to check the current compliance status of the relevant topics in Quality Management System, Production System, Facility and the Equipment System, Laboratory Control System, Material System, Packaging & Labelling System, Pharmaceutical Development and Technology Transfers to be in line with FDA or EMA guidelines
- Preparation and Submission of an Audit Report with detailed recommendations of how to achieve FDA or EMA readiness within four weeks after the completion of the audit. This report includes resource requirements, budget and possible timelines to achieve FDA or EMA readiness in phase II.
In phase II we offer to implement our recommendations and to get the desired FDA or EMA approvals for you in cooperation with the relevant authorities.
Preparation
Day 1:
The on-site session should start with a company presentation of the client), followed by a Q&A session with the CEO or COO, Head of R&D/RA, Head of QM and Head of Production. Following the main topics discovered in the preparation work, during the company presentation and the Q&A session we would need to walk through and see all relevant departments and facilities.
Day 2:
After the visits of all departments and facilities the project group needs to meet with the relevant managers and staff in identified departments for deeper understanding of processes, documents, and potential risks. If necessary the zelhealth project group will split up at this time and cover the different areas separately.
Day 3:
Preparation of immediate risk analyses (2-3 hours). The risk associated with each observation will be rated using a three-point scale. The risk ranking will be based on the level of potential risk exposure we feel may have an impact on the achievement of the clients objectives. It will also indicate the priorities Management should give to the recommendations associated with the observation. The following criteria were used in determining the risk exposure level:
Controls are not in place or are inadequate.
Compilance with legislation and regulations is inadequate.
Important ussues are indetified that could negatively impact the achievment of program/operational objectives.
Controls are in place but are not being sufficiently complied with.
Compliance with policies and established procedures is inadequate.
Issues are identified that could negatively impact the efficiency and effectiveness of operations
Controls are in place but the level of compilance varies.
Compilance with policies and established procedures varies.
Issues identfied are less significant but opprtunities that could enhace operations exist.
In a final meeting with CEO or COO, Head of R&D/RA, Head of QM and Head of Production we will present our first risk analyses for discussion and follow up recommendation.
Latest 4 weeks after the on-site-session we will deliver a complete CAPA-Plan along with a project and budget outline for Phase II. This will include resource requirements and timelines. Phase II Based on the results of the Gap analysis in this phase all identified gaps will be closed, followed by conducting a complete FDA Mock Audit. Depending on the client’s preferences, we either offer a full service package with all required external resources coming from zelhealth and its network partners or provide the overall project management by coordinating external and internal resources from the client and its third party providers. Management processes and controls, including governance and accountability, monitoring and reporting, risk management and project management practices will be implemented and effective before starting to deliver on the open findings from the Gap analysis and achieve the Strategic and Operating Review objectives.
