【正文】 For both between batch amp。 within batch, RSD is calculated by the formula Std Deviation of the samples /Average value of samples *100 d. TargetingFor active assay measurements and other ingredients or parameters that affect product efficacy, the overall average of the mean values for all of the validation batches should be within 5% of the intended target. If you specify criterion that is greater than 5%, it must be justified in this section. For instant run or single batch validations, criteria for targeting must be set in advance and should be appropriate for the intended use of the product.2. Critical Process VariablesAny key process variable(s) which is/are likely to affect product quality should have acceptance criteria specified. Process variables are measures of the characteristics of the productinprocess, such as temperature, viscosity, etc. An Acceptance Criteria Matrix for Critical Process Variables should be used to clearly municate this information.I. PRODUCT DISPOSITION amp。 RELEASE CRITERIA State here the end use of the product。 ., to be shipped to the trade, to be scrapped, etc. Explicitly state in this section the product release criteria.If applicable, state in this section the release criteria for shipment of bulk product, ., from a manufacturing site to contract manufacturing site.J. SIGNATURESSee Responsibilities Section for appropriate approval signatures. Submitted by (name/date) for the TeamBy signing below, we indicate that we have reviewed the protocol and have found it to be sufficient to demonstrate the performance of the process against appropriate acceptance criteria.______________________________ ______________________________Name / Title Date Name / Title DatePerformance Qualification ReportThe following sections are to be addressed in the development of a PQ report.PERFORMANCE QUALIFICATION REPORTProjectFormula Number(s)Validation Protocol Number :XXXXDateA. CONCLUSIONSState here the conclusion regarding the validation of the process based on the results of the validation batches. Explain the reasoning that would support a successful or not successful conclusion regarding this validation. B. DISCUSSION1. Compliance with the Performance Qualification ProtocolMake reference to the protocol and indicate whether it was followed pletely or not. Clearly explain and document any deviations made from the protocol. Where there are deviations from the protocol, the Performance Qualification Report should contain a remendation as to the impact of this deviation on the validation. 2. Results versus Success Criteria Use this section to briefly summarize the information and to discuss any result(s) that are not obvious in the table. It is helpful to provide a summary of key data at this point.C. SIGNATURESSee Responsibilities Section for appropriate approval signatures.Submitted by (name/date) for the TeamBy signing below, we indicate that this process is validated because it has met all of the acceptance criteria spelled out in the preapproved protocol.______________________________ ______________________________Name / Title Date Name / Title DateE. APPENDIX1. Performance Qualification Protocol2. Performance Qualification Results Summary Table3. Completed Batch Records (or reference batch record numbers and location)4. Installation /Operational Qualification ReportInstant Run Process Validation (IRPV)IRPV is conducted to support release of a single batch or lot of product. IRPV39。s are used to demonstrate that product manufactured individually or on a onetime basis yields a finished product meeting all of its finished product and inprocess specifications and quality attributes. IRPV can only validate the batch in question, not the process or equipment used to make the product. The use of an IRPV may be acceptable in situations such as the following:? Production of 1 batch of product to produce sales samples well prior to start of mercial production? Production of 1 batch of product for test market, where the decision regarding broadscale mercialization has not been made? Production for onetime studies where the intent is to verify conditions prior to full process validation? Production of very lowvolume products, where only 1 to 2 batches per year are produced.? Production of batch as one time offer typical examples are cosmetic shade change offers or promotion samples in one season where only one batch is required to be produced.IRPV39。s are not intended for test market or national production where 3 or more batches are expected to be required to supply a oneyear test market. IRPV39。s are not intended for meeting shortages in production supply. The decision to use an IRPV will be made by the Plant QA Manager, in consultation with GBU QA and PD, for product intended for mercial distribution.IRPV’s in manufacturing facilities require a protocol and report to support release of product. The protocol and report should follow the format for prospective process validations.In situations where IRPV39。s are used, evaluation of data, testing and sampling are expected to be more extensive than during routine production where more reliance is placed on prospective validation. Instead, data evaluation, testing, and acceptance criteria should be parable to that of the first batch of a full prospective validation. Acceptance criteria must be based on sound technical rational. Consideration must be given to whether the IRPV requires a confirmatory stability study. Establishment of acceptance criteria should consider historical product and pr