Part 5: Audit & Inspector Communication

inspection

/ɪnˈspekʃən/

Thanh tra.

Example: The inspection started with an opening meeting.

inspector

/ɪnˈspektər/

Thanh tra viên.

Example: The inspector requested additional records.

opening meeting

/ˈəʊpənɪŋ ˈmiːtɪŋ/

Họp khai mạc.

Example: Key personnel attended the opening meeting.

closing meeting

/ˈkləʊzɪŋ ˈmiːtɪŋ/

Họp bế mạc.

Example: Observations were discussed during the closing meeting.

observation

/ˌɒbzəˈveɪʃən/

Nhận xét thanh tra.

Example: We responded to all observations.

finding

/ˈfaɪndɪŋ/

Phát hiện.

Example: No critical findings were identified.

response

/rɪˈspɒns/

Phản hồi.

Example: A written response was submitted.

evidence

/ˈevɪdəns/

Bằng chứng.

Example: Supporting evidence is available.

record

/ˈrekɔːrd/

Hồ sơ.

Example: The record can be retrieved immediately.

document

/ˈdɒkjʊmənt/

Tài liệu.

Example: The document is controlled and approved.

SOP

/ˌes əʊ ˈpiː/

Quy trình thao tác chuẩn.

Example: This activity is governed by an SOP.

explain

/ɪkˈspleɪn/

Giải thích.

Example: I will explain the process step by step.

clarify

/ˈklærɪfaɪ/

Làm rõ.

Example: Let me clarify that point.

describe

/dɪˈskraɪb/

Mô tả.

Example: Please allow me to describe the procedure.

demonstrate

/ˈdemənstreɪt/

Chứng minh.

Example: We can demonstrate compliance with records.

show

/ʃəʊ/

Cho xem.

Example: I can show you the relevant document.

provide

/prəˈvaɪd/

Cung cấp.

Example: We will provide the requested information.

present

/prɪˈzent/

Trình bày.

Example: We presented the investigation results.

review

/rɪˈvjuː/

Rà soát.

Example: The document was reviewed by QA.

verify

/ˈverɪfaɪ/

Xác minh.

Example: We verified the effectiveness of CAPA.

confirm

/kənˈfɜːrm/

Xác nhận.

Example: I can confirm that the procedure was followed.

ensure

/ɪnˈʃʊər/

Đảm bảo.

Example: The controls ensure product quality.

comply with

/kəmˈplaɪ wɪð/

Tuân thủ.

Example: We comply with GMP requirements.

follow

/ˈfɒləʊ/

Tuân theo.

Example: Operators follow the approved SOP.

perform

/pəˈfɔːrm/

Thực hiện.

Example: The activity was performed as instructed.

conduct

/kənˈdʌkt/

Tiến hành.

Example: An investigation was conducted.

maintain

/meɪnˈteɪn/

Duy trì.

Example: We maintain records for traceability.

monitor

/ˈmɒnɪtər/

Theo dõi.

Example: Critical parameters are monitored continuously.

control

/kənˈtrəʊl/

Kiểm soát.

Example: The process is controlled within limits.

assess

/əˈses/

Đánh giá.

Example: Risks are assessed before implementation.

evaluate

/ɪˈvæljueɪt/

Đánh giá.

Example: We evaluate all deviations.

investigate

/ɪnˈvestɪɡeɪt/

Điều tra.

Example: Every deviation is investigated.

documented

/ˈdɒkjʊmentɪd/

Được tài liệu hóa.

Example: The activity is fully documented.

approved

/əˈpruːvd/

Được phê duyệt.

Example: The protocol was approved before execution.

trained

/treɪnd/

Được đào tạo.

Example: All operators are trained.

qualified

/ˈkwɒlɪfaɪd/

Được thẩm định năng lực.

Example: The equipment is qualified.

validated

/ˈvælɪdeɪtɪd/

Được thẩm định.

Example: The process is validated.

effective

/ɪˈfektɪv/

Hiệu quả.

Example: The CAPA was effective.

robust

/rəʊˈbʌst/

Vững chắc.

Example: We have a robust quality system.

consistent

/kənˈsɪstənt/

Nhất quán.

Example: Results are consistent across batches.

accurate

/ˈækjərət/

Chính xác.

Example: Records must be accurate.

factual

/ˈfæktʃuəl/

Dựa trên sự thật.

Example: Our response is factual and evidence-based.

clear

/klɪər/

Rõ ràng.

Example: The procedure is clear and easy to follow.

traceable

/ˈtreɪsəbl/

Có thể truy xuất.

Example: All materials are traceable.

available /əˈveɪləbl/

Sẵn có.

Example: The records are available upon request.

retrievable

/rɪˈtriːvəbl/

Có thể truy xuất được.

Example: Data are readily retrievable.

controlled

/kənˈtrəʊld/

Được kiểm soát.

Example: Documents are controlled.

implemented

/ˈɪmplɪmentɪd/

Đã triển khai.

Example: The CAPA has been implemented.

completed

/kəmˈpliːtɪd/

Đã hoàn thành.

Example: Training has been completed.

ongoing

/ˈɒnɡəʊɪŋ/

Đang tiếp tục.

Example: Monitoring is ongoing.

according to

/əˈkɔːdɪŋ tuː/

Theo.

Example: The task was performed according to SOP.

in accordance with

/ɪn əˈkɔːdəns wɪð/

Phù hợp với.

Example: Activities are conducted in accordance with GMP.

based on

/beɪst ɒn/

Dựa trên.

Example: The conclusion is based on evidence.

supported by

/səˈpɔːtɪd baɪ/

Được hỗ trợ bởi.

Example: The decision is supported by data.

as required

/æz rɪˈkwaɪəd/

Theo yêu cầu.

Example: Records are retained as required.

at this time

/æt ðɪs taɪm/

Tại thời điểm này.

Example: At this time, no impact has been identified.

to my knowledge

/tuː maɪ ˈnɒlɪdʒ/

Theo hiểu biết của tôi.

Example: To my knowledge, the procedure was followed.

let me check

/let miː tʃek/

Để tôi kiểm tra.

Example: Let me check the record.

let me verify

/let miː ˈverɪfaɪ/

Để tôi xác minh.

Example: Let me verify that information.

I don't know

/aɪ dəʊnt nəʊ/

Tôi không biết.

Example: I don't know, but I will find out.

I will confirm

/aɪ wɪl kənˈfɜːrm/

Tôi sẽ xác nhận.

Example: I will confirm and get back to you.

I will provide

/aɪ wɪl prəˈvaɪd/

Tôi sẽ cung cấp.

Example: I will provide the document shortly.

please allow me

/pliːz əˈlaʊ miː/

Xin cho phép tôi.

Example: Please allow me to explain.

could you clarify

/kʊd juː ˈklærɪfaɪ/

Ông/Bà có thể làm rõ không?

Example: Could you clarify your question?

could you repeat

/kʊd juː rɪˈpiːt/

Ông/Bà có thể nhắc lại không?

Example: Could you repeat the question?

if I understand correctly

/ɪf aɪ ˌʌndəˈstænd kəˈrektli/

Nếu tôi hiểu đúng.

Example: If I understand correctly, you are asking about CAPA.

thank you for the question

/θæŋk juː fɔː ðə ˈkwestʃən/

Cảm ơn câu hỏi.

Example: Thank you for the question.

good question

/ɡʊd ˈkwestʃən/

Câu hỏi hay.

Example: That is a good question.

the purpose is

/ðə ˈpɜːpəs ɪz/

Mục đích là.

Example: The purpose is to ensure compliance.

the objective is

/ði əbˈdʒektɪv ɪz/

Mục tiêu là.

Example: The objective is to prevent contamination.

the rationale is

/ðə ˌræʃəˈnɑːl ɪz/

Cơ sở là.

Example: The rationale is based on risk assessment.

the reason is

/ðə ˈriːzən ɪz/

Lý do là.

Example: The reason is documented in the report.

for example

/fɔːr ɪɡˈzɑːmpl/

Ví dụ.

Example: For example, this record shows traceability.

in this case

/ɪn ðɪs keɪs/

Trong trường hợp này.

Example: In this case, no action was required.

as you can see

/æz juː kæn siː/

Như ông/bà có thể thấy.

Example: As you can see, the trend is stable.

this record shows

/ðɪs ˈrekɔːrd ʃəʊz/

Hồ sơ này cho thấy.

Example: This record shows compliance.

this evidence demonstrates

/ðɪs ˈevɪdəns ˈdemənstreɪts/

Bằng chứng này chứng minh.

Example: This evidence demonstrates effectiveness.

we identified

/wi aɪˈdentɪfaɪd/

Chúng tôi đã xác định.

Example: We identified the root cause.

we implemented

/wi ˈɪmplɪmentɪd/

Chúng tôi đã triển khai.

Example: We implemented corrective actions.

we verified

/wi ˈverɪfaɪd/

Chúng tôi đã xác minh.

Example: We verified CAPA effectiveness.

we assessed

/wi əˈsest/

Chúng tôi đã đánh giá.

Example: We assessed the product impact.

we concluded

/wi kənˈkluːdɪd/

Chúng tôi đã kết luận.

Example: We concluded there was no quality impact.

root cause

/ruːt kɔːz/

Nguyên nhân gốc.

Example: The root cause was identified.

corrective action

/kəˈrektɪv ˈækʃən/

Hành động khắc phục.

Example: Corrective actions were implemented.

preventive action

/prɪˈventɪv ˈækʃən/

Hành động phòng ngừa.

Example: Preventive actions reduced recurrence.

effectiveness check

/ɪˈfektɪvnəs tʃek/

Kiểm tra hiệu quả.

Example: An effectiveness check was completed.

change control

/tʃeɪndʒ kənˈtrəʊl/

Kiểm soát thay đổi.

Example: The change was managed through change control.

risk assessment

/rɪsk əˈsesmənt/

Đánh giá rủi ro.

Example: A risk assessment was performed.

impact assessment

/ˈɪmpækt əˈsesmənt/

Đánh giá ảnh hưởng.

Example: Impact assessment showed no risk.

trend analysis

/trend əˈnæləsɪs/

Phân tích xu hướng.

Example: Trend analysis did not identify recurrence.

quality system

/ˈkwɒləti ˈsɪstəm/

Hệ thống chất lượng.

Example: Our quality system is robust.

continuous improvement

/kənˈtɪnjuəs ɪmˈpruːvmənt/

Cải tiến liên tục.

Example: Continuous improvement is encouraged.

best practice

/best ˈpræktɪs/

Thực hành tốt nhất.

Example: The process follows industry best practices.

lessons learned

/ˈlesənz lɜːrnd/

Bài học kinh nghiệm.

Example: Lessons learned were shared across departments.

escalation

/ˌeskəˈleɪʃən/

Báo cáo cấp cao hơn.

Example: The issue was escalated promptly.

ownership

/ˈəʊnərʃɪp/

Tinh thần chịu trách nhiệm.

Example: The team demonstrated ownership.

quality culture

/ˈkwɒləti ˈkʌltʃər/

Văn hóa chất lượng.

Example: Quality culture is promoted at all levels.

speak up culture

/spiːk ʌp ˈkʌltʃər/

Văn hóa lên tiếng.

Example: Employees are encouraged to report concerns.

inspection readiness

/ɪnˈspekʃən ˈredinəs/

Sẵn sàng thanh tra.

Example: Inspection readiness is maintained year-round.

inspection support

/ɪnˈspekʃən səˈpɔːrt/

Hỗ trợ thanh tra.

Example: The team provided inspection support.