Validated cleaning processes training

The actual FDA inspection process is an opportunity to ask the investigator what he or she has seen across the country. Do not attempt to illicit the investigator s opinion because he or she is prohibited from giving it. Ask the investigator to educate the firm as to the various ways in which the industry might handle, for example cleaning validation or personnel training records. 

Once a cleaning process has been appropriately validated, steps should be taken to help insure that the cleaning process remains consistent and in control. Steps that are taken to help assure this include regular monitoring, a change control system, training, and revalidation. 

Data were collected from a total of 215 sectors of normal line operations. The data collected during these flights were subjected to a formal data cleaning process to ensure validity. Data cleaning involved the analysis of each error event by members, including representatives of the airline s safety, training, standards and operations departments. This process ensured accuracy in the data-set and that the observers interpretation of erroneons crew actions were accurate, especially with reference to the SOPs of the airline involved in the study. 

Obviously, GMP requirements, especially extensive personnel training, calibration, qualification and validation, enhanced documentation, extensive cleaning and sanitation, and sharpened in-process control must considerably influence process organization and output. All these GMP-related activities are costly and time consuming, and will result in decreased productivity and increased production costs. On the other hand, a quality assurance system contributes to consistent production with a lower number of rejected batches and complaints. 

Cleaning validation program Manufacturing SOP and control parameters Process flowchart and description of chemistry Personnel training and safety considerations Quality attributes Assay and yield... 

The garments used by the workers should be made of synthetic fabrics that minimize contamination risks. Operators should be trained for their work and also for the maintenance of clean conditions and hygiene. Cleaning is a key factor in the maintenance of good conditions and reduces or eliminates potential contaminants that can affect the product. Contaminants can have various sources live particles, inert particles (dusts, glass, file dust, lubricants, etc.) or cross-contamination when different processes or products share the same clean area. To avoid problems, the cleaning procedures should be written and approved, validated, and executed by trained operators. 

It is equally important that the sample preparation (extraction and clean-up) of the batch must be done carefully in accordance with the procedmes established by the validated method and any prevailing SOPs. The analysts conducting these tasks must be trained on the applicable SOPs and this training must be documented in their training records. Study samples must be analyzed within known analyte stabihty constraints for the matrix and the processed extracts. When sufficient stability has not been established at the time of sample reporting (e.g. long term freezer stability may be on-going at the time of analysis), this must be clearly documented within the study report. 

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