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They may be routine interventions like refilling a stopper bowl or non-routine like responding to a power outage. The media fill batch record should capture any stop-start times not just the total duration of the media fill. Media fills must be fully documented. As the integrity of sterile gloves is critical in preventing microbial contamination, the glove integrity testing should be validated to its effectiveness.
Investigations into environmental monitoring EM excursions should trigger a review of environmental controls, batch record review, result in the implementation of corrective actions, and in limited cases revalidation of the aseptic processing. Observation 3 - Environmental Monitoring A,B.
This would include operators who mainly work in the surrounding ISO 7 area but conduct any interventions in the ISO 5 aseptic processing areas such as EM and removing rejected vials. GMP cleanliness classifications, i. EM locations should be risk based and defined in the environmental monitoring procedures. A map of the floor plan showing the sampling location is helpful. Swab sampling conducted in the aseptic filling areas must comply with the procedure found in the SOP. The location of the particle counter when monitoring the filling operation should be based on the risk of product exposure.
Smoke studies may be helpful in determining the location of the particle counter, however, their capacity to distort laminar airflow during routine monitoring should be considered. Companies should be able to establish sampling locations based on practical considerations.
Observation 4 - Aseptic Process Procedures A. The rationale for an in-process bioburden program should be available for regulatory review. This would include sampling after each critical processing step and the bioburden limits adopted.
Conducting disinfectant validations inside a cleanroom, as recommended in the EIR makes no sense, if they involve taking live organisms into critical areas in the facility. Sampling surfaces prior to and after sanitization is unlikely to demonstrate adequate log reductions expected for validation purposes because of the low counts on these surfaces but will demonstrate the overall sanitization effectiveness.
The ability of a disinfectant to eliminate representative microorganisms, including spore-former, from different surfaces found in the facility can be determined in laboratory studies. Observation 4, B is a very questionable observation. Cleanroom garments must be managed to control microbial contamination originating from operators.
Multiple uses of the same garments in an aseptic processing area should be discouraged.
If they are clean, sterilized and reused when they should be inspected for damage prior to cleaning and, if practical, repaired. The use of expiration dating is probably unmanageable with cleanroom garments, but first in, first out inventory control is recommended.
The use of singleuse, disposable garments should be encouraged. Incubation schema validation and growth promotion testing have never required the use of mixed cultures, e. Many microbiologists believe that high- low temperature incubation makes sense because bacteria derived from people are the most common EM isolates. However, there is always the possibility that fungal colonies at lower incubation temperatures and bacteria at higher temperatures will crowd out other colonies on a plate reducing the count and diversity of isolation.
The literature is inconclusive as to the incubation sequence Cundell, Recommendation to use mixed cultures is not a requirement and should not have been included in the Form observations. Major interventions should always be captured in the batch record. It is difficult to comment without the knowledge of the SOP.
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Cleanroom behavior is important in preventing microbial contamination, as people are the major source of microorganisms. Observation 5 — Laboratory Records A. Citing a company for a deficiency that occurred seven years ago and was subsequently corrected is completely misguided.
A company should be judged by current observations made during an inspection and not a long passed cGMP violation. This observation should not have been included in the FDA Form The author believes it was the former. The FDA microbiologists should be aware that only the CFUs reported within the recommended incubation time are considered valid, as colonies will continue to appear and grow in size on the plates with increasing incubation times.
Furthermore plates with numerous colonies had slightly higher counts when reviewed by the FDA investigators beyond the specified incubation time reinforcing this pattern. The EM and PM plates distributed and collected for incubation must be reconciled. Damaged and mishandled plates may be declared invalid, but the number of these plates should be small and their occurrence infrequent.
Audit trails should be comprehensible to an external auditor. The glove inspection and testing procedures need to be tightened up. Raw data generated must be documented and results scored as a pass or fail. Batch records used for routine aseptic filling operations may not be adequate for media fills. Informational sheets may contain statements that a requirement is met, i.
This is a questionable observation. Observation 6 — Cleaning and Disinfection Practices A. The pharmaceutical industry understood that the FDA was going to back off on disinfectant effectiveness validations! Apparently we were wrong. The inclusion of an environmental isolate like Cladosporium oxysporum found in both a media fill and routine monitoring in disinfectant program revalidation is appropriate, especially if the isolation was part of an adverse trend, but the author believes that this mold would not be expected to be more resistant than other representative molds included in the original disinfectant validation.
The log reduction would depend on the choice of disinfectant, application method, contact time, and the nature of the surface. Revalidation of cleaning and disinfection programs are typically conducted annually based on the annual review of the environmental monitoring from the previous year and then scheduled, so this time lag is not unexpected.
Tracking the use of multiple spray bottles is a difficult task. Instead of documenting the number of times a spray bottle is used, assigning an expiration date may work better. Single-use sterile spray bottles would be a suitable, but a more expensive solution. The documentation of the cleaning of all items used in a cleanroom setting may be excessive. Clearly SOPs must be followed. The frequency of changing a disinfectant wipe and the manner of wiping would be important in terms of the disinfectant effectiveness.
Dropping wipes on the floor and retrieving them as reported in the EIR is unacceptable and may suggest insufficient wipes are available to the operators. Representative surfaces in a cleanroom, especially those adjacent to critical aseptic processing activities, should be subject to cleaning and disinfectant validation in laboratory studies.
The extension of the validation to ceiling panels, light features and wall panels outside the critical aseptic filling area is excessive and is not industry practice. Sterile gloves are a critical processing item and the vendor should be subject to qualification that may include a site audit.
The outer packaging is important with respect to items entering a cleanroom and can be inspected for integrity. Double or even triple wrapping is common. AQL-based sampling plans do accommodate the incoming batch size. However, statistical sampling of incoming sterile gloves seems excessive. The EIR documented incoming lots of sterile gloves are subjected to sterility testing, inspection for pinholes and general description and appearance inspection for appearance.
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