Part 1: GMP Fundanmentals

GMP

/ˌdʒiː em ˈpiː/

Thực hành sản xuất tốt.

Example: GMP ensures product quality and patient safety.

compliance

/kəmˈplaɪəns/

Sự tuân thủ.

Example: The facility is in compliance with GMP requirements.

non-compliance

/ˌnɒn kəmˈplaɪəns/

Sự không tuân thủ.

Example: Any non-compliance must be investigated.

accurate

/ˈækjərət/

Chính xác.

Example: All records must be accurate and complete.

factual

/ˈfæktʃuəl/

Dựa trên sự thật.

Example: Please provide a factual response.

consistent

/kənˈsɪstənt/

Nhất quán.

Example: The process remains consistent across batches.

clear

/klɪr/

Rõ ràng.

Example: The instruction is clear and easy to follow.

document

/ˈdɒkjʊmənt/

Tài liệu.

Example: This document has been approved.

record

/ˈrekɔːrd/

Hồ sơ.

Example: The batch record was reviewed by QA.

procedure

/prəˈsiːdʒər/

Quy trình.

Example: The activity was performed according to the procedure.

instruction

/ɪnˈstrʌkʃən/

Hướng dẫn.

Example: Operators followed the work instruction.

training

/ˈtreɪnɪŋ/

Đào tạo.

Example: All operators received GMP training.

trainer

/ˈtreɪnər/

Người đào tạo.

Example: The trainer explained the procedure.

trainee

/ˌtreɪˈniː/

Người được đào tạo.

Example: The trainee completed the assessment.

qualification

/ˌkwɒlɪfɪˈkeɪʃən/

Thẩm định năng lực.

Example: Personnel qualification was documented.

competency

/ˈkɒmpɪtənsi/

Năng lực.

Example: Competency must be demonstrated before operation.

responsibility

/rɪˌspɒnsəˈbɪləti/

Trách nhiệm.

Example: Responsibilities are clearly defined.

accountability

/əˌkaʊntəˈbɪləti/

Trách nhiệm giải trình.

Example: Accountability is assigned to department heads.

organization

/ˌɔːɡənaɪˈzeɪʃən/

Tổ chức.

Example: The organization supports GMP compliance.

management

/ˈmænɪdʒmənt/

Ban quản lý.

Example: Management reviews quality metrics regularly.

quality

/ˈkwɒləti/

Chất lượng.

Example: Product quality must be maintained.

quality system

/ˈkwɒləti ˈsɪstəm/

Hệ thống chất lượng.

Example: The quality system is effective.

quality culture

/ˈkwɒləti ˈkʌltʃər/

Văn hóa chất lượng.

Example: Quality culture starts with leadership.

standard

/ˈstændərd/

Tiêu chuẩn.

Example: Operations follow established standards.

requirement

/rɪˈkwaɪərmənt/

Yêu cầu.

Example: GMP requirements must be met.

guideline

/ˈɡaɪdlaɪn/

Hướng dẫn.

Example: The guideline provides expectations.

policy

/ˈpɒləsi/

Chính sách.

Example: The company policy supports compliance.

objective

/əbˈdʒektɪv/

Mục tiêu.

Example: Quality objectives are reviewed annually.

performance

/pəˈfɔːməns/

Hiệu suất.

Example: Performance is monitored through KPIs.

assessment

/əˈsesmənt/

Đánh giá.

Example: A risk assessment was completed.

review

/rɪˈvjuː/

Rà soát.

Example: QA performed the final review.

approval

/əˈpruːvəl/

Phê duyệt.

Example: Approval was obtained before execution.

authorized

/ˈɔːθəraɪzd/

Được ủy quyền.

Example: Only authorized personnel may sign records.

signature

/ˈsɪɡnətʃər/

Chữ ký.

Example: Each entry requires a signature.

date

/deɪt/

Ngày tháng.

Example: The date must be recorded accurately.

time

/taɪm/

Thời gian.

Example: Record the time of operation.

traceability

/ˌtreɪsəˈbɪləti/

Khả năng truy xuất.

Example: Traceability is maintained for all materials.

integrity

/ɪnˈteɡrəti/

Tính toàn vẹn.

Example: Data integrity is essential.

data integrity

/ˈdeɪtə ɪnˈteɡrəti/

Toàn vẹn dữ liệu.

Example: Data integrity is a key GMP principle.

attributable

/əˈtrɪbjʊtəbl/

Quy được trách nhiệm.

Example: Records must be attributable.

legible

/ˈledʒəbl/

Dễ đọc.

Example: Entries must remain legible.

contemporaneous

/kənˌtempəˈreɪniəs/

Ghi nhận đồng thời.

Example: Records should be completed contemporaneously.

original

/əˈrɪdʒənəl/

Bản gốc.

Example: Original records must be retained.

deviation

/ˌdiːviˈeɪʃən/

Sai lệch.

Example: A deviation was opened for investigation.

investigation

/ɪnˌvestɪˈɡeɪʃən/

Điều tra.

Example: The investigation identified the cause.

root cause

/ruːt kɔːz/

Nguyên nhân gốc.

Example: Root cause analysis was completed.

CAPA

/ˈkæpə/

Hành động khắc phục và phòng ngừa.

Example: CAPA was implemented successfully.

effectiveness

/ɪˈfektɪvnəs/

Tính hiệu quả.

Example: CAPA effectiveness was verified.

verification

/ˌverɪfɪˈkeɪʃən/

Xác minh.

Example: Verification confirmed compliance.

validation

/ˌvælɪˈdeɪʃən/

Thẩm định.

Example: The process has been validated.

change control

/tʃeɪndʒ kənˈtrəʊl/

Kiểm soát thay đổi.

Example: All changes require change control.

risk

/rɪsk/

Rủi ro.

Example: Risks were evaluated before implementation.

risk assessment

/rɪsk əˈsesmənt/

Đánh giá rủi ro.

Example: A formal risk assessment was performed.

mitigation

/ˌmɪtɪˈɡeɪʃən/

Giảm thiểu rủi ro.

Example: Risk mitigation actions were implemented.

impact

/ˈɪmpækt/

Ảnh hưởng.

Example: No impact on product quality was observed.

critical

/ˈkrɪtɪkəl/

Nghiêm trọng.

Example: This is a critical parameter.

major

/ˈmeɪdʒər/

Mức độ lớn.

Example: A major observation was issued.

minor

/ˈmaɪnər/

Mức độ nhỏ.

Example: The issue was classified as minor.

observation

/ˌɒbzəˈveɪʃən/

Nhận xét thanh tra.

Example: The observation was addressed.

finding

/ˈfaɪndɪŋ/

Phát hiện.

Example: No critical findings were identified.

evidence

/ˈevɪdəns/

Bằng chứng.

Example: Supporting evidence was available.

inspection

/ɪnˈspekʃən/

Thanh tra.

Example: The inspection lasted three days.

inspector

/ɪnˈspektər/

Thanh tra viên.

Example: The inspector requested records.

audit

/ˈɔːdɪt/

Đánh giá.

Example: An internal audit was performed.

auditor

/ˈɔːdɪtər/

Đánh giá viên.

Example: The auditor reviewed procedures.

complaint

/kəmˈpleɪnt/

Khiếu nại.

Example: Customer complaints are investigated.

recall

/rɪˈkɔːl/

Thu hồi.

Example: No recall was required.

supplier

/səˈplaɪər/

Nhà cung cấp.

Example: Suppliers are periodically evaluated.

material

/məˈtɪəriəl/

Nguyên liệu.

Example: Materials were released by QC.

raw material

/rɔː məˈtɪəriəl/

Nguyên liệu đầu vào.

Example: Raw materials are sampled upon receipt.

sampling

/ˈsɑːmplɪŋ/

Lấy mẫu.

Example: Sampling followed the approved procedure.

specification

/ˌspesɪfɪˈkeɪʃən/

Tiêu chuẩn kỹ thuật.

Example: The result met specification.

acceptance criteria

/əkˈseptəns kraɪˈtɪəriə/

Tiêu chí chấp nhận.

Example: Acceptance criteria were predefined.

release

/rɪˈliːs/

Phê duyệt xuất xưởng.

Example: The batch was released by QA.

rejection

/rɪˈdʒekʃən/

Loại bỏ.

Example: The material was rejected.

approved

/əˈpruːvd/

Được phê duyệt.

Example: The document is approved.

obsolete

/ˈɒbsəliːt/

Lỗi thời.

Example: Obsolete documents were removed.

retention

/rɪˈtenʃən/

Lưu giữ.

Example: Record retention follows regulations.

archive

/ˈɑːkaɪv/

Lưu trữ.

Example: Documents were moved to the archive.

confidential

/ˌkɒnfɪˈdenʃəl/

Bảo mật.

Example: Confidential records are protected.

access

/ˈækses/

Truy cập.

Example: System access is controlled.

authorization

/ˌɔːθəraɪˈzeɪʃən/

Sự ủy quyền.

Example: Authorization is required before execution.

monitoring

/ˈmɒnɪtərɪŋ/

Giám sát.

Example: Environmental monitoring was completed.

trend

/trend/

Xu hướng.

Example: Trending data showed improvement.

continuous improvement

/kənˈtɪnjuəs ɪmˈpruːvmənt/

Cải tiến liên tục.

Example: Continuous improvement is encouraged.

best practice

/best ˈpræktɪs/

Thực hành tốt nhất.

Example: The procedure reflects best practices.

quality mindset

/ˈkwɒləti ˈmaɪndset/

Tư duy chất lượng.

Example: Employees are trained to develop a quality mindset.