【正文】 ract with, and likely affect the identity, strength, quality, purity, efficacy or safety of the product. If any of these critical subsystems have been previously validated, reference the existing approved Validation Report(s). If not, validation of the subsystem(s) is required.7. Critical Process ParametersOutline the critical process parameters. Process parameters are numerical measures of the equipment operation (. speed in rpm, pressure in psi). Define the anticipated or allowed operating ranges for each parameter and describe briefly the basis for the operating limits.8. StorageWhen intermediate products or in process bulk materials are stored routinely as part of the manufacturing process, a validation of the typical storage time must be carried out. This typically involves three batches of product stored under conditions similar to the environment in which the product will be stored and in containers similar to the actual storage containers to be used. If prolonged storage of intermediate stock is anticipated, a stability study may be required. Where the intermediates or bulk products are shipped to another site for further processing or packaging, the conditions involved in this transportation shall also be considered.E. CLEANING amp。 ., store at a special temperature until tested, test within 5 minutes of taking sample, etc.f. Analyses for Each SampleNote which test(s) must be performed for each sample taken. Be sure to note any special instructions。 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。 ., 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 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 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