Preparation for an inspection

There are several additional critical steps to be taken and techniques to be applied in preparation for an inspection and to assure that the current manufacturing process is both in control and of the highest quality. 

Preparation for an inspection starts when the Inspection Team Leader (ITL) receives a mission warning order , which provides details of type and duration of the inspection mission and the names of the team members. In preparation of this mission, the Inspection Team (IT) selects the necessary equipment from the list of equipment approved by the First... 

Example of a standard operating procedure for preparing for an inspection... 

As the manufacturer will be inspected as part of the prequalification process for specific products to the procurement agency, inspectors should prepare for inspections by studying the product information submitted by the manufacturer. Appendix 10 contains an example of an SOP for preparing for an inspection. 

Inspections are comprehensive audits of manufacturing facilities, and focus on as many areas as are covered in Part 211. In fact, some consider Part 211 as a convenient list of areas for preparation for an inspection. Areas of a plant subject to inspection include not only the product manufacturing area, but also QC laboratories, warehouses, and utility areas. Inspections focus not only on adequacy of the... 

Under the Mine Act, no advance notice of an inspection shall be provided to any person. Prohibiting advance notice of these inspections is intended to give a more accurate picture of mine operator comphance with federal regulations. The miner s representatives are to be notified of the inspection when the MSHA inspector arrives at the property. The Code of Federal Regulations Tide 30 (30 CFR), Part 40, requires that the hst of miners representatives be fQed with MSHA and the mine operator, so that they know who to contact to prepare for an inspection or other necessary business. 

How do you prepare for an audit of the environmental chambers In preparing for an audit, it is necessary that all validation documents be readily available for inspection. If these documents are stored off-site, arrangements should be made to retrieve these documents in time for the inspection. In addition, all chamber deviations should be identified and summarized in an annual report, if necessary. Also, the chamber inventory should be verified against existing records to ensure accuracy. An explanation should be available to explain any inventory discrepancies. 

The traditional audit may still be useful in that it leads one in the direction of identifying a faulty system or process, and if one chooses one can go further. Using the innovative approach offered by the quality assessment has some limitations in that it is not the current approach used during pharmaceutical and biotech inspections. Mock FDA audits should be used on a routine basis to ensure employees communication skills are sharpened and that the facility is inspection-ready. Preparation for an FDA inspection should begin during product development. It is a continuous process of the QAP, which the company should implement as early as phase I. No amount of resources in the last weeks before an inspection can make up for lack of adequate planning and preparation. 

The electronic MS on-site databases are prepared from the certified electronic version of the OCAD (e-OCAD). This version is compiled using the NIST programs (NIST MS Search/Analysis and AMDIS) and is in the form of a NIST MS Database. The e-OCAD does not contain Gas Chromatography retention indices (GC(RI)) that are required for on-site use. To create an electronic MS onsite database, the certified version of e-OCAD, which at the moment contains only MS data, is merged with the certified (GC(RI)), which is in an excel spreadsheet. After merging these data, an AMDIS version of the database is created, which is compatible with the AMDIS software used by the on-site GC/MS equipment (for more details on the software, refer to Chapter 2 and Chapter 4) (5). The MS on-site database can be sent for an inspection as a whole database or as an extract of the whole database. AMDIS is software that is used by the GC/MS on-site equipment... 

The best way to prepare for an FDA PAI is to perform a mock PAI. The mock inspection is usually best performed by an independent auditor who has re-... 

Tetzlaff, R. Preparing for an FDA Pre-approval Inspection Parenteral Drug Association San Diego, CA, 1997 20-21. 

The pilot plant and its staff play a critical role in technology evaluation, scale-up, and transfer activities of new products. These activities begin early in the development cycle and include technical aspects of process development and scale-up, organization and responsibilities of technology-transfer teams, documentation of the transfer process, and often preparation for an FDA pre-approval inspection (PAI). A properly designed and operated pilot plant can enhance the collection of scientific data necessary to support internal transfer activities, as well as regulatory submissions and FDA PAIs.P ... 

Take the time to organize your information with a table of contents—a table listing all experiments and the pages in which they are documented—so that the information can be easily retrieved when the company puts together a submission or prepares for an FDA inspection. 

Manufacturers should be informed of tentative inspection dates, and should be requested to submit information about each manufacturing site to be inspected. This information should normally be provided in a site master file (SMF). An example of a technical questionnaire for pharmaceutical manufacturers is attached as Appendix 8. This information will be used during the preparation for the inspection and during the inspection itself to verify information supplied by the manufacturer to the procurement agency. 

With these seven steps, an organization can cooperatively prepare for an FDA investigation, can appropriately assume the self-regulatory responsibility, and can assure the quality control appropriate to the biomedical industries. A checklist for conducting a self-regulatory GLP inspection is also provided. 

Once testing and final inspection are complete, the unit is prepared for shipment. The specification should have detailed the type of storage anticipated and expected time. It should have specified indoor, warehouse, outside storage, or whatever is planned. An anticipated time point should also have been stated. The contract should have stated the mode of shipment and destination instructions. Upon notice of shipment, the traffic department (if there is one) may wish to monitor the shipment. 

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