Part 4: Validation & Qualification

validation

/ˌvælɪˈdeɪʃən/

Thẩm định.

Example: The process has been validated before commercial production.

qualification

/ˌkwɒlɪfɪˈkeɪʃən/

Thẩm định thiết bị.

Example: Equipment qualification was completed successfully.

validation master plan

/ˌvælɪˈdeɪʃən ˈmæstər plæn/

Kế hoạch tổng thể thẩm định.

Example: Activities were defined in the validation master plan.

VMP

/ˌviː em ˈpiː/

Kế hoạch tổng thể thẩm định.

Example: The VMP is reviewed annually.

user requirement specification

/ˈjuːzər rɪˈkwaɪərmənt ˌspesɪfɪˈkeɪʃən/

Yêu cầu người sử dụng.

Example: URS was approved before procurement.

design qualification

/dɪˈzaɪn ˌkwɒlɪfɪˈkeɪʃən/

Thẩm định thiết kế.

Example: Design qualification confirmed compliance with URS.

installation qualification

/ˌɪnstəˈleɪʃən ˌkwɒlɪfɪˈkeɪʃən/

Thẩm định lắp đặt.

Example: IQ verified correct installation.

operational qualification

/ˌɒpəˈreɪʃənəl ˌkwɒlɪfɪˈkeɪʃən/

Thẩm định vận hành.

Example: OQ verified operating ranges.

performance qualification

/pəˈfɔːrməns ˌkwɒlɪfɪˈkeɪʃən/

Thẩm định hiệu năng.

Example: PQ demonstrated consistent performance.

commissioning

/kəˈmɪʃənɪŋ/

Chạy thử.

Example: Commissioning was completed before qualification.

protocol

/ˈprəʊtəkɒl/

Đề cương.

Example: The protocol was approved before execution.

test script

/test skrɪpt/

Kịch bản kiểm tra.

Example: Test scripts were executed as planned.

acceptance criteria

/əkˈseptəns kraɪˈtɪəriə/

Tiêu chí chấp nhận.

Example: All acceptance criteria were met.

deviation

/ˌdiːviˈeɪʃən/

Sai lệch.

Example: Qualification deviations were investigated.

summary report

/ˈsʌməri rɪˈpɔːrt/

Báo cáo tổng kết.

Example: The summary report concluded successful qualification.

approved state

/əˈpruːvd steɪt/

Trạng thái được phê duyệt.

Example: The equipment remains in an approved state.

process validation

/ˈprəʊses ˌvælɪˈdeɪʃən/

Thẩm định quy trình.

Example: Process validation demonstrated reproducibility.

prospective validation

/prəˈspektɪv ˌvælɪˈdeɪʃən/

Thẩm định tiên lượng

Example: Prospective validation was completed before launch.

concurrent validation

/kənˈkʌrənt ˌvælɪˈdeɪʃən/

Thẩm định đồng thời.

Example: Concurrent validation was justified.

retrospective validation

/ˌretrəˈspektɪv ˌvælɪˈdeɪʃən/

Thẩm định hồi cứu.

Example: Retrospective validation is rarely acceptable today.

continued process verification

/kənˈtɪnjuːd ˈprəʊses ˌverɪfɪˈkeɪʃən/

Xác minh quy trình liên tục.

Example: CPV data are reviewed monthly.

CPV

/ˌsiː piː ˈviː/

Xác minh quy trình liên tục.

Example: CPV supports lifecycle validation.

process performance qualification

/ˈprəʊses pəˈfɔːrməns ˌkwɒlɪfɪˈkeɪʃən/

Thẩm định hiệu năng quy trình.

Example: PPQ batches met all criteria.

PPQ

/ˌpiː piː ˈkjuː/

Thẩm định hiệu năng quy trình.

Example: Three PPQ batches were manufactured.

critical process parameter

/ˈkrɪtɪkəl ˈprəʊses pəˈræmɪtər/

Thông số quy trình trọng yếu.

Example: CPPs were monitored closely.

CPP

/ˌsiː piː ˈpiː/

Thông số quy trình trọng yếu.

Example: CPP limits were established during development.

critical quality attribute

/ˈkrɪtɪkəl ˈkwɒləti ˈætrɪbjuːt/

Thuộc tính chất lượng trọng yếu.

Example: CQAs were defined using risk assessment.

process capability

/ˈprəʊses ˌkeɪpəˈbɪləti/

Năng lực quy trình.

Example: Process capability was evaluated statistically.

reproducibility

/rɪˌprɒdjuˈsɪbɪləti/

Tính tái lặp.

Example: Reproducibility was demonstrated across batches.

consistency /

kənˈsɪstənsi/

Tính nhất quán.

Example: Validation confirmed process consistency.

cleaning validation

/ˈkliːnɪŋ ˌvælɪˈdeɪʃən/

Thẩm định vệ sinh.

Example: Cleaning validation prevented cross-contamination.

cleaning procedure

/ˈkliːnɪŋ prəˈsiːdʒər/

Quy trình vệ sinh.

Example: The cleaning procedure was validated.

cleaning agent

/ˈkliːnɪŋ ˈeɪdʒənt/

Chất tẩy rửa.

Example: The cleaning agent was qualified.

residue

/ˈrezɪdjuː/

Cặn tồn dư.

Example: Residue levels were below limits.

residue limit

/ˈrezɪdjuː ˈlɪmɪt/

Giới hạn tồn dư.

Example: Residue limits were scientifically justified.

swab sampling

/swɒb ˈsɑːmplɪŋ/

Lấy mẫu bằng que lau.

Example: Swab sampling was performed after cleaning.

rinse sampling

/rɪns ˈsɑːmplɪŋ/

Lấy mẫu nước rửa.

Example: Rinse samples met acceptance criteria.

worst case

/wɜːrst keɪs/

Trường hợp xấu nhất.

Example: Worst-case products were selected.

dirty hold time

/ˈdɜːrti həʊld taɪm/

Thời gian lưu bẩn.

Example: Dirty hold time was validated.

clean hold time

/kliːn həʊld taɪm/

Thời gian lưu sạch.

Example: Clean hold time studies were completed.

cross contamination

/krɒs kənˌtæmɪˈneɪʃən/

Nhiễm chéo.

Example: Cleaning validation controls cross contamination.

analytical method validation

/ˌænəˈlɪtɪkəl ˈmeθəd ˌvælɪˈdeɪʃən/

Thẩm định phương pháp phân tích.

Example: The analytical method was validated.

specificity

/ˌspesɪˈfɪsəti/

Độ đặc hiệu.

Example: Specificity was demonstrated successfully.

accuracy

/ˈækjərəsi/

Độ đúng.

Example: Accuracy met validation requirements.

precision

/prɪˈsɪʒən/

Độ chính xác lặp lại.

Example: Precision results were acceptable.

repeatability

/rɪˌpiːtəˈbɪləti/

Độ lặp lại.

Example: Repeatability was confirmed.

linearity

/ˌlɪniˈærəti/

Độ tuyến tính.

Example: Linearity was established across the range.

range

/reɪndʒ/

Khoảng đo.

Example: The analytical range was validated.

robustness

/rəʊˈbʌstnəs/

Độ bền vững.

Example: Robustness testing showed no significant impact.

LOD

/ˌel əʊ ˈdiː/

Giới hạn phát hiện.

Example: LOD was determined during validation.

LOQ

/ˌel əʊ ˈkjuː/

Giới hạn định lượng.

Example: LOQ was suitable for the method.

computer system validation

/kəmˈpjuːtər ˈsɪstəm ˌvælɪˈdeɪʃən/

Thẩm định hệ thống máy tính.

Example: CSV ensured data integrity.

electronic record

/ɪˌlekˈtrɒnɪk ˈrekɔːrd/

Hồ sơ điện tử.

Example: Electronic records were protected.

electronic signature

/ɪˌlekˈtrɒnɪk ˈsɪɡnətʃər/

Chữ ký điện tử.

Example: Electronic signatures were controlled.

audit trail

/ˈɔːdɪt treɪl/

Dấu vết kiểm tra.

Example: Audit trails were reviewed regularly.

user access

/ˈjuːzər ˈækses/

Quyền truy cập người dùng.

Example: User access was periodically reviewed.

backup

/ˈbækʌp/

Sao lưu dữ liệu.

Example: System backups were performed daily.

restore

rɪˈstɔːr/

Khôi phục dữ liệu.

Example: Restore testing was successful.

data integrity

/ˈdeɪtə ɪnˈteɡrəti/

Toàn vẹn dữ liệu.

Example: Data integrity is critical for compliance.

temperature mapping

/ˈtemprətʃər ˈmæpɪŋ/

Đánh giá phân bố nhiệt độ.

Example: Temperature mapping was completed.

humidity mapping

/hjuːˈmɪdəti ˈmæpɪŋ/

Đánh giá phân bố độ ẩm.

Example: Humidity mapping met requirements.

HVAC qualification

/eɪtʃ viː eɪ ˈsiː ˌkwɒlɪfɪˈkeɪʃən/

Thẩm định hệ thống HVAC.

Example: HVAC qualification was completed.

water system qualification

/ˈwɔːtər ˈsɪstəm ˌkwɒlɪfɪˈkeɪʃən/

Thẩm định hệ thống nước.

Example: The water system was qualified.

purified water

/ˈpjʊərɪfaɪd ˈwɔːtər/

Nước tinh khiết.

Example: Purified water met specifications.

WFI

/ˌdʌbljuː ef ˈaɪ/

Nước pha tiêm.

Example: WFI quality was monitored routinely.

compressed air qualification

/kəmˈprest eər ˌkwɒlɪfɪˈkeɪʃən/

Thẩm định khí nén.

Example: Compressed air was qualified.

environmental monitoring

/ɪnˌvaɪrənˈmentl ˈmɒnɪtərɪŋ/

Giám sát môi trường.

Example: Environmental monitoring data were trended.

requalification

/ˌriːˌkwɒlɪfɪˈkeɪʃən/

Tái thẩm định.

Example: Requalification was performed every two years.

periodic review

/ˌpɪəriˈɒdɪk rɪˈvjuː/

Rà soát định kỳ.

Example: Periodic review confirmed validated status.

change control

/tʃeɪndʒ kənˈtrəʊl/

Kiểm soát thay đổi.

Example: Changes were assessed before implementation.

validation lifecycle

/ˌvælɪˈdeɪʃən ˈlaɪfsaɪkl/

Vòng đời thẩm định.

Example: Validation follows a lifecycle approach.

risk assessment

/rɪsk əˈsesmənt/

Đánh giá rủi ro.

Example: Risk assessment supported validation scope.

risk-based approach

/rɪsk beɪst əˈprəʊtʃ/

Cách tiếp cận dựa trên rủi ro.

Example: A risk-based approach was applied.

scientific rationale

/ˌsaɪənˈtɪfɪk ˌræʃəˈnɑːl/

Cơ sở khoa học.

Example: Scientific rationale was documented.

worst-case challenge

/wɜːrst keɪs ˈtʃælɪndʒ/

Thử thách điều kiện xấu nhất.

Example: Worst-case challenges were included.

acceptance limit

/əkˈseptəns ˈlɪmɪt/

Giới hạn chấp nhận.

Example: Results met acceptance limits.

outlier

/ˈaʊtlaɪər/

Giá trị ngoại lai.

Example: The outlier was investigated.

statistical analysis

/stəˈtɪstɪkəl əˈnæləsɪs/

Phân tích thống kê.

Example: Statistical analysis supported conclusions.

trend review

/trend rɪˈvjuː/

Rà soát xu hướng.

Example: Trend review identified no concerns.

validated state

/ˈvælɪdeɪtɪd steɪt/

Trạng thái đã thẩm định.

Example: The system remains in a validated state.

lifecycle management

/ˈlaɪfsaɪkl ˈmænɪdʒmənt/

Quản lý vòng đời.

Example: Lifecycle management maintains compliance.

ongoing verification

/ˈɒnɡəʊɪŋ ˌverɪfɪˈkeɪʃən/

Xác minh liên tục.

Example: Ongoing verification supports process control.

validation package

/ˌvælɪˈdeɪʃən ˈpækɪdʒ/

Hồ sơ thẩm định.

Example: The validation package was approved by QA.