Part 2: Production & Batch record

production

/prəˈdʌkʃən/

Sản xuất.

Example: Production was completed according to the schedule.

manufacturing

/ˌmænjuˈfæktʃərɪŋ/

Quá trình sản xuất.

Example: Manufacturing activities follow GMP requirements.

batch

/bætʃ/

Lô sản xuất.

Example: The batch met all quality specifications.

batch number

/bætʃ ˈnʌmbər/

Số lô.

Example: The batch number ensures traceability.

batch record

/bætʃ ˈrekɔːrd/

Hồ sơ lô.

Example: The batch record was reviewed by QA.

master batch record

/ˈmæstər bætʃ ˈrekɔːrd/

Hồ sơ lô gốc.

Example: Operators followed the master batch record.

batch size

/bætʃ saɪz/

Cỡ lô.

Example: The batch size was approved before production.

yield

/jiːld/

Hiệu suất thu hồi.

Example: The final yield was within the acceptable range.

theoretical yield

/ˌθiːəˈretɪkl jiːld/

Hiệu suất lý thuyết.

Example: The actual yield was compared with the theoretical yield.

actual yield

/ˈæktʃuəl jiːld/

Hiệu suất thực tế.

Example: Actual yield was recorded in the batch record.

reconciliation

/ˌrekənsɪliˈeɪʃən/

Đối chiếu.

Example: Material reconciliation was completed after packaging.

dispensing

/dɪˈspensɪŋ/

Cấp phát nguyên liệu.

Example: Dispensing was performed in a controlled area.

weighing

/ˈweɪɪŋ/

Cân nguyên liệu.

Example: Weighing was verified by a second operator.

raw material

/rɔː məˈtɪəriəl/

Nguyên liệu đầu vào.

Example: Raw materials were released before use.

active ingredient

/ˈæktɪv ɪnˈɡriːdiənt/

Hoạt chất.

Example: The active ingredient met all specifications.

excipient

/ɪkˈsɪpiənt/

Tá dược.

Example: Excipients were dispensed according to the formula.

sampling

/ˈsɑːmplɪŋ/

Lấy mẫu.

Example: Sampling was conducted by trained personnel.

identification

/aɪˌdentɪfɪˈkeɪʃən/

Định danh.

Example: Material identification was confirmed before use.

mixing

/ˈmɪksɪŋ/

Trộn.

Example: Mixing time was recorded in the batch record.

blending

/ˈblendɪŋ/

Phối trộn.

Example: Blending was performed for 15 minutes.

granulation

/ˌɡrænjuˈleɪʃən/

Tạo hạt.

Example: Granulation parameters were within limits.

wet granulation

/wet ˌɡrænjuˈleɪʃən/

Tạo hạt ướt.

Example: Wet granulation improved powder flowability.

dry granulation

/draɪ ˌɡrænjuˈleɪʃən/

Tạo hạt khô.

Example: Dry granulation was selected for moisture-sensitive materials.

binder solution

/ˈbaɪndər səˈluːʃən/

Dung dịch tá dược dính.

Example: Binder solution was prepared according to SOP.

drying

/ˈdraɪɪŋ/

Sấy.

Example: Drying continued until moisture content met specifications.

fluid bed dryer

/ˈfluːɪd bed ˈdraɪər/

Máy sấy tầng sôi.

Example: The fluid bed dryer was cleaned before use.

moisture content

/ˈmɔɪstʃər ˈkɒntent/

Độ ẩm.

Example: Moisture content was measured after drying.

milling

/ˈmɪlɪŋ/

Xay nghiền.

Example: Milling produced the required particle size.

sieving

/ˈsɪvɪŋ/

Rây.

Example: Sieving removed oversized particles.

particle size

/ˈpɑːrtɪkl saɪz/

Kích thước hạt.

Example: Particle size distribution was acceptable.

lubrication

/ˌluːbrɪˈkeɪʃən/

Trộn tá dược trơn.

Example: Lubrication was performed before compression.

compression

/kəmˈpreʃən/

Dập viên.

Example: Compression started after line clearance.

tablet press

/ˈtæblət pres/

Máy dập viên.

Example: The tablet press was qualified.

tablet weight

/ˈtæblət weɪt/

Khối lượng viên.

Example: Tablet weight was checked every 30 minutes.

hardness

/ˈhɑːrdnəs/

Độ cứng viên.

Example: Tablet hardness met specifications.

thickness

/ˈθɪknəs/

Độ dày viên.

Example: Thickness was monitored during compression.

friability

/ˌfraɪəˈbɪləti/

Độ mài mòn viên.

Example: Friability results were acceptable.

disintegration

/dɪsˌɪntɪˈɡreɪʃən/

Độ rã.

Example: Disintegration testing was performed by QC.

coating

/ˈkəʊtɪŋ/

Bao phim.

Example: Coating parameters were recorded.

coating pan

/ˈkəʊtɪŋ pæn/

Nồi bao phim.

Example: The coating pan was inspected before use.

spray rate

/spreɪ reɪt/

Tốc độ phun.

Example: Spray rate was adjusted during coating.

inlet temperature

/ˈɪnlet ˈtemprətʃər/

Nhiệt độ khí vào.

Example: Inlet temperature remained within limits.

exhaust temperature

/ɪɡˈzɔːst ˈtemprətʃər/

Nhiệt độ khí thải.

Example: Exhaust temperature was monitored continuously.

coated tablet

/ˈkəʊtɪd ˈtæblət/

Viên bao phim.

Example: Coated tablets passed visual inspection.

capsule filling

/ˈkæpsjuːl ˈfɪlɪŋ/

Đóng nang.

Example: Capsule filling was performed on a qualified machine.

encapsulation

/ɪnˌkæpsjuˈleɪʃən/

Đóng nang.

Example: Encapsulation parameters were verified.

bulk product

/bʌlk ˈprɒdʌkt/

Bán thành phẩm.

Example: Bulk product was transferred to packaging.

transfer

/trænsˈfɜːr/

Chuyển giao.

Example: Material transfer was documented.

hold time

/həʊld taɪm/

Thời gian lưu giữ.

Example: Hold time limits were not exceeded.

in-process control

/ɪn ˈprəʊses kənˈtrəʊl/

Kiểm tra trong quá trình.

Example: In-process controls were performed as scheduled.

IPC

/ˌaɪ piː ˈsiː/

Kiểm tra trong quá trình.

Example: IPC results were acceptable.

line clearance

/laɪn ˈklɪərəns/

Kiểm tra vệ sinh dây chuyền.

Example: Line clearance was completed before startup.

cleaning

/ˈkliːnɪŋ/

Vệ sinh.

Example: Equipment cleaning was verified.

cleaned status

/kliːnd ˈsteɪtəs/

Tình trạng đã vệ sinh.

Example: The cleaned status label was attached.

equipment

/ɪˈkwɪpmənt/

Thiết bị.

Example: Equipment was inspected before use.

machine setting

/məˈʃiːn ˈsetɪŋ/

Cài đặt máy.

Example: Machine settings were documented.

setup

/ˈsetʌp/

Thiết lập.

Example: Equipment setup followed the SOP.

startup

/ˈstɑːrtʌp/

Khởi động.

Example: Startup checks were completed successfully.

shutdown

/ˈʃʌtdaʊn/

Dừng máy.

Example: Shutdown activities were documented.

downtime

/ˈdaʊntaɪm/

Thời gian ngừng máy.

Example: Downtime was investigated.

operator

/ˈɒpəreɪtər/

Nhân viên vận hành.

Example: The operator signed the batch record.

supervisor

/ˈsuːpərvaɪzər/

Tổ trưởng.

Example: The supervisor reviewed the records.

production manager

/prəˈdʌkʃən ˈmænɪdʒər/

Trưởng bộ phận sản xuất.

Example: The production manager approved the schedule.

cross-contamination

/krɒs kənˌtæmɪˈneɪʃən/

Nhiễm chéo.

Example: Controls were implemented to prevent cross-contamination.

contamination

/kənˌtæmɪˈneɪʃən/

Nhiễm bẩn.

Example: No contamination was detected.

segregation

/ˌseɡrɪˈɡeɪʃən/

Phân khu.

Example: Material segregation was maintained.

status label

/ˈsteɪtəs ˈleɪbəl/

Nhãn trạng thái.

Example: Status labels were clearly displayed.

quarantine

/ˈkwɒrəntiːn/

Biệt trữ.

Example: The material remained in quarantine.

released material

/rɪˈliːst məˈtɪəriəl/

Nguyên liệu đã phê duyệt.

Example: Only released materials were used.

rejected material

/rɪˈdʒektɪd məˈtɪəriəl/

Nguyên liệu bị loại.

Example: Rejected material was segregated.

packaging

/ˈpækɪdʒɪŋ/

Đóng gói.

Example: Packaging was completed without deviations.

primary packaging

/ˈpraɪməri ˈpækɪdʒɪŋ/

Bao bì cấp 1.

Example: Primary packaging materials were verified.

secondary packaging

/ˈsekəndəri ˈpækɪdʒɪŋ/

Bao bì cấp 2.

Example: Secondary packaging was inspected.

packaging material

/ˈpækɪdʒɪŋ məˈtɪəriəl/

Vật liệu đóng gói.

Example: Packaging materials were reconciled.

label

/ˈleɪbəl/

Nhãn.

Example: Labels were verified before use.

label reconciliation

/ˈleɪbəl ˌrekənsɪliˈeɪʃən/

Đối chiếu nhãn.

Example: Label reconciliation was completed.

carton

/ˈkɑːrtn/

Hộp giấy.

Example: Cartons were inspected before use.

leaflet

/ˈliːflət/

Tờ hướng dẫn sử dụng.

Example: Leaflets were checked during packaging.

coding

/ˈkəʊdɪŋ/

In số lô và hạn dùng.

Example: Coding quality was verified.

expiry date

/ɪkˈspaɪəri deɪt/

Hạn dùng.

Example: The expiry date was clearly printed.

manufacturing date

/ˌmænjuˈfæktʃərɪŋ deɪt/

Ngày sản xuất.

Example: The manufacturing date was correct.

finished product

/ˈfɪnɪʃt ˈprɒdʌkt/

Thành phẩm.

Example: The finished product met specifications.

warehouse

/ˈweəhaʊs/

Kho.

Example: Finished products were transferred to the warehouse.

storage condition

/ˈstɔːrɪdʒ kənˈdɪʃən/

Điều kiện bảo quản.

Example: Storage conditions were monitored.

temperature mapping

/ˈtemprətʃər ˈmæpɪŋ/

Đánh giá phân bố nhiệt độ.

Example: Temperature mapping was completed successfully.

distribution

/ˌdɪstrɪˈbjuːʃən/

Phân phối.

Example: Distribution records were maintained.

shipment

/ˈʃɪpmənt/

Lô hàng vận chuyển.

Example: The shipment was released for delivery.

dispatch

/dɪˈspætʃ/

Xuất hàng.

Example: Dispatch was authorized by QA.