【正文】 . Where appropriate, provide a sampling diagram to clearly illustrate the sampling locations.b. Number of Samples Required Typically, at least nine (9) samples are taken for each batch for active assay measurements and for other ingredients or parameters that affect product efficacy. Ideally, these samples would be taken from the top, middle, and bottom of the mixing vessel with left, right, and center of vessel sampled at each level. For true solutions, a lesser number of samples (minimum 3 samples) may be taken. Note: Where the above is not required or followed a technical rationale should be documented in the validation protocol justifying the number of samples. For product parameters not affecting efficacy (flavor, color, etc.), top, middle, and bottom samples (3 samples) for each batch may be used for evaluation. All samples are to be taken in a manner that assures that potential problem spots are sampled. Discharge samples are acceptable provided that the sampling plan is designed to provide representative samples of the entire batch. c. Size of Each SampleFor batch homogeneity, the sample should be the smallest practical size to represent the general geographical location in the mixer. Mixing of the particular sample may be acceptable (., a suspension sample). The aliquot for analysis should be a large enough weight or volume to allow for determination of the concentration of the assayed material(s).d. Disposition of Sample Where will the samples be taken once they are collected.e. Special InstructionsThis would include any special treatment of a sample。 BACKGROUND1. Description of the ProcessBriefly describe the process that is being validated, ., new making process, packaging, etc. If project is an upgrade, briefly describe how new system differs from the current system. A copy of a Master Batch Production Record may be attached to illustrate the process being validated. If this is done, the Master Batch Production Record should be clearly marked “for information only.2. Flow DiagramAttach flow diagram(s) of the entire process or the appropriate individual part(s) of the process or reference appropriate sections of the IQ/OQ, which would contain this information.3. Previous Experimental WorkReference previous plant and/or pilot plant learnings that give confidence in the process, ., ./DOX data covering process ranges, etc. This information can be included as an attachment or referenced.4. Key Equipment ListIdentify in this section all key process equipment, sampling devices, and test equipment that will be used in the performance qualification. Verify that all test equipment calibrations are current.5. Key Analytical Method ListReference all required analytical methods to be used. Verify that all methods have been validated for the formula being produced. Identify any methods that will require plant verification. If a test doesn39。s may be referenced with SOP and Revision instead of attaching.H. PREVENTIVE MAINTENANCE PROCEDURESDetail here the plans for developing preventive maintenance procedures for all new equipment along with plans for adding this equipment to any existing maintenance tracking systems. Specify which lubricants/sealants to use in applications where the potential for product contact exists.I. CALIBRATIONSDevelop a list of instruments that require calibration and discuss plans for initial (prestartup) calibration. Also, discuss plans for assuring that ongoing calibrations are carried out.J. INITIAL CLEANING PROCEDURESDetail what cleaning must be performed to prepare the equipment for initial production. Initial cleaning must remove any residual oil, grease, welding residue, metal shavings, etc. that accumulate during the equipment manufacturing and facility construction. Completion of initial cleaning steps must be clearly documented and included in the IQ/OQ report or referenced appropriately. This section does not apply for qualification or requalification of existing equipment.OPERATIONAL QUALIFICATION (OQ)Operational Qualification involves establishing documented evidence that process equipment and ancillary systems equipment operate as intended throughout anticipated operational ranges. This activity requires evaluation of equipment under dynamic operational conditions, which may include noload or loaded conditions at centerline conditions and may also include operation outside of the normal operating range envisioned for any particular production process. OQ may not need to be repeated for each new product/process, if each new product/process is conducted within originally qualified operational ranges. Major modifications or repairs or use of the equipment in processes where operational parameters are outside those originally investigated will require requalification.K. CRITICAL PARAMETERSList operating parameters that are judged to be critical to the process as a result of pilot plant work, vendor information, or technical judgment. Also include any parameters that are critical to proper functioning of the process or equipment. The critical parameters listed here should be verified via test plans (see Section N).L. TEST INSTRUMENTSDetail which test instruments will be used to execute the verifications in the test plan. Reference the instruments by name and number and either provide proof of calibration or state that the instrument is calibrated and reference the location of the calibration records.M. OPERATIONAL QUALIFICATION TEST PLAN WITH SUCCESS CRITERIADetail here the test plan to verify that the system operates according to the design. The test plan should provide sufficient instruction to assure that the task is carried out correctly. The test plan must specify acceptance criteria for each critical parameter.N. STANDARD OPERATING PROCEDURES FOR PROCESSVerify that appro