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Is your Environmental Monitoring in line with the new Annex 1?

The 2022 version of the GMP Annex 1 defines some stringent requirements in relation to Environmental Monitoring.

August 2023 is the deadline to comply. Are you ready?

In summary, the following are the most critical aspects of the Annex related to Environmental Monitoring:

  1. A Contamination Control Strategy (CCS) should be implemented across the facility in order to define all critical control points and assess the effectiveness of all the controls (design, procedural, technical and organizational) and monitoring measures employed to manage risks to medicinal product quality and safety. The combined strategy of the CCS should establish robust assurance of contamination prevention. The CCS should be actively reviewed and, where appropriate, updated and should drive continual improvement of the manufacturing and control methods. Its effectiveness should form part of the periodic management review. Where existing control systems are in place and are appropriately managed, these may not require replacement but should be referenced in the CCS and the associated interactions between systems should be understood. Contamination Control Strategy (CCS) has been defined as a main document.
  2. Environmental Monitoring forms part of the CCS and comprises non-viable particles, viable particles for environment and personnel, temperature, relative humidity and other specific characteristics, and Aseptic Product Simulation (APS) for aseptically manufactured products only. For batch release, the information obtained by all these systems should be considered.
  3. Risk assessments should be performed to define the Environmental Monitoring program (i.e., locations, frequencies, methods, incubation, etc.). Risk analysis should be based on knowledge of the process and data from routine monitoring and/or from qualification, as well as knowledge about the microbial flora. Risk analysis should be periodically reviewed.
  4. Any non-conformity in Environmental Monitoring grade A and B should be investigated before the release of a batch.
  5. Additional Environmental Monitoring should be performed after operations performed in the cleanrooms that have not maintained the required standards of cleanliness and/or asepsis (i.e., maintenance interventions).
  6. Any components which are necessary for the aseptic process but that cannot be sterilized should be disinfected, protected, and monitored as they represent routes for contamination.
  7. BFS processes should be viable and monitored during the full duration of the critical processing, including equipment assembly.
  8. Alert and action limits should be defined and periodically reviewed based on real trend data. Alert levels should be defined to detect potential deterioration of the environments.
  9. Trend analysis is required including at least: detection of an increasing numbers of action limits or alert levels, consecutive excursions from alert levels, excursions related to common causes, and changes in microbial flora, with special attention to spore-formers and molds.
  10. If action limits are exceeded, operating procedures should prescribe a root cause investigation, an assessment of the potential impact to products and requirements for CAPA actions. If alert levels are exceeded, operating procedures should prescribe a follow-up, a potential investigation and CAPA.
  11. Viable particle monitoring should be frequent during aseptic operations, but it should also be performed when normal manufacturing is not occurring. In case of incidents, additional locations may be used. Viable air should be continuously monitored in grade A during the full duration of the critical processing as well as the set up. Based on risk, a similar approach should be considered for grade B. Particular consideration should be given to personnel monitoring after critical interventions, and at each exit from grade B.
  12. Microorganisms detected in grades A and B should be identified to species level assessing the potential impact to the product quality. The same consideration should be given to microorganisms detected in grades C and D if they may indicate a loss of control (spore-formers or molds). Microbiota reports should be in place to know which are the common microorganisms are found at your facility.
  13. Environmental Monitoring during APS should be required for regular production and during the entire duration of the simulation.
  14. Media for Environmental Monitoring and APS should be tested by the end user and scientifically justified using a designated group of reference microorganisms.
  15. Personnel: Gowning and gloves control for each staff member should be performed on a regular basis and its results should be trended and traced to confirm correct performance by personnel and disqualify people with incorrect practices or poor results.

If you would like to have more details, and for a description on how the SherpaPharma solution can help you in support the Annex 1, please download this article

 

General Manager at | + posts

Santi studied telecommunications engineering and an MBA. Since 2005 he works at Tiselab, where he has helped to consolidate the current team, achieving sustained growth, and diversifying the company into various divisions. In 2016, he started the SherpaPharma project after realizing that pharmaceutical companies had an opportunity for significant improvement in Environmental Monitoring.

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Santi estudió ingeniería de telecomunicaciones y un MBA. Desde 2005 trabaja en Tiselab, donde ha ayudado a consolidar el equipo actual, consiguiendo un crecimiento sostenido y diversificando la compañía en varias divisiones. En 2016 inició el proyecto SherpaPharma al ver que en las compañías farmacéuticas había una oportunidad de mejora importante en la Monitorización Ambiental.

 


General Manager at | + posts

Santi studied telecommunications engineering and an MBA. Since 2005 he works at Tiselab, where he has helped to consolidate the current team, achieving sustained growth, and diversifying the company into various divisions. In 2016, he started the SherpaPharma project after realizing that pharmaceutical companies had an opportunity for significant improvement in Environmental Monitoring.

--

Santi estudió ingeniería de telecomunicaciones y un MBA. Desde 2005 trabaja en Tiselab, donde ha ayudado a consolidar el equipo actual, consiguiendo un crecimiento sostenido y diversificando la compañía en varias divisiones. En 2016 inició el proyecto SherpaPharma al ver que en las compañías farmacéuticas había una oportunidad de mejora importante en la Monitorización Ambiental.

 

General Manager at | + posts

Santi studied telecommunications engineering and an MBA. Since 2005 he works at Tiselab, where he has helped to consolidate the current team, achieving sustained growth, and diversifying the company into various divisions. In 2016, he started the SherpaPharma project after realizing that pharmaceutical companies had an opportunity for significant improvement in Environmental Monitoring.

--

Santi estudió ingeniería de telecomunicaciones y un MBA. Desde 2005 trabaja en Tiselab, donde ha ayudado a consolidar el equipo actual, consiguiendo un crecimiento sostenido y diversificando la compañía en varias divisiones. En 2016 inició el proyecto SherpaPharma al ver que en las compañías farmacéuticas había una oportunidad de mejora importante en la Monitorización Ambiental.

 

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