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昨日，GMP辦公室發(fā)布了APIC《APIC GUIDE FOR AUDITING REGISTERED STARTING MATERIAL MANUFACTURERS（APIC指南：已注冊起始物料生產(chǎn)商審計指南）》的消息，現將該文解讀分享給大家：

QUALITY MANAGEMENT

質(zhì)量管理

There should be a quality unit(s) that can act independently in releasing or rejecting RSM outside the control of the manufacturing company.

應有質(zhì)量部門(mén)獨立自主地放行或拒簽而不受公司的控制。

All quality related activities and responsibilities should be defined and documented.

所有與質(zhì)量相關(guān)的活動(dòng)和責任均應被定義并記錄。

All quality related activities should be recorded at the time they are performed.

所有與質(zhì)量相關(guān)的活動(dòng)應同步記錄。

Quality critical deviations from established procedures should be documented and evaluated prior to release. Where appropriate, the deviations should be investigated and the conclusions documented.

在放行前，應記錄并評估所有偏離既定規程的質(zhì)量重大偏差。適當時(shí)，偏差應被調查并記錄結論。

Internal Audits (Self Inspection)

內部審計

The organization shall conduct internal quality related audits of the relevant departments and systems at planned intervals. These audits should be documented.

應按照計劃時(shí)間對相關(guān)部門(mén)和系統進(jìn)行質(zhì)量相關(guān)的內部審計。這些審計應被記錄。

The audit should be performed by person(s) independent from the area audited.

應由獨立于被審計部門(mén)的人員進(jìn)行審計。

Buildings and facilities

廠(chǎng)房和設施

There should be defined areas/systems for the following activities including but not limited to:

應有確定區域/系統可供下列活動(dòng)，包括但不限于：

- Receipt, identification, quarantine and release of incoming materials;

入庫物料的接收、驗收、和放行

- Rejected materials;

不合格物料

- Sampling of RSM;

起始物料的取樣

- Production Operations; 

生產(chǎn)操作

- Laboratory Operations; 

實(shí)驗室操作

- Storage of final RSM.

最終產(chǎn)品的儲存

Maintenance and cleaning of equipment

設備維護和清潔

There must be written instructions for equipment cleaning. These should contain at least:

應有設備清潔的書(shū)面規程。至少包括：

cleaning agents and minimum volumes

清潔劑和最小量

acceptance criteria

可接受標準

instructions for the dismounting and subsequent mounting of each piece of equipment to ensure correct cleaning, if necessary

如有必要，應有說(shuō)明描述每個(gè)設備如何拆卸和安裝以確保正確清潔

instructions for the protection of cleaned equipment parts against contamination before use inspection of equipment for cleanness before use

應有說(shuō)明描述已清潔的設備部件在使用前如何保護不受污染

Containment

污染

As a general principle production activities of highly toxic materials, herbicides and pesticides should not be conducted in the same equipment and area as used for the production of RSM unless there are circumstances where the RSM manufacturer has appropriate controls in place and the customer agrees.

高毒性物料的生產(chǎn)活動(dòng)的一般原則，用于起始物料生產(chǎn)所用的設備和區域不得使用除草劑和殺蟲(chóng)劑，除非起始物料生產(chǎn)商有適當的控制和用戶(hù)協(xié)議。

Computerised systems

計算機化系統

Computer systems should have sufficient control mechanisms to prevent unauthorised access to or altering of data.

計算機系統應有足夠的控制機制來(lái)防止未經(jīng)授權的訪(fǎng)問(wèn)或更改數據。

Validation

驗證

The complete validation program as required for active pharmaceutical ingredients is not expected. The starting material manufacturer should, however, provide proof of the consistency and stability of his production processes, cleaning procedures, analytical methods, etc.

不期望活性藥物成分所需的完整驗證程序。然而，起始材料制造商應提供生產(chǎn)工藝，清潔程序，分析方法等的一致性和穩定性的證明。

LABORATORY CONTROLS

實(shí)驗室控制

Appropriate specifications including acceptance criteria for impurities (e.g.  residual solvents, elemental impurities, related substances) should be  established for RSM consistent with the Starting Material manufacturing  process.

考慮起始物料的生產(chǎn)過(guò)程，應為起始物料建立適當的標準，包括雜質(zhì)的接受標準（如殘留溶劑，元素雜質(zhì)，有關(guān)物質(zhì)）。

Master production instructions

主生產(chǎn)指令

Master production instructions for the RSM should include but not be limited to:

起始物料的主生產(chǎn)指令應包括但不限于：

• The name of the RSM being manufactured

  所生產(chǎn)起始物料的名稱(chēng)

• A complete list of raw materials and intermediates of the RSM; 

  原料和介質(zhì)的完整清單

• The quantity or ratio of each raw material or intermediate to be used,  including the unit of measure;

  每一個(gè)原料或介質(zhì)的量或比例，包含測量單位

• The production location and major production equipment to be used; 

  生產(chǎn)地點(diǎn)和主要生產(chǎn)設備

  
  

Detailed production instructions, including the: 

詳細的生產(chǎn)指令，包括：

• sequences to be followed,

  所遵循的序列

• ranges of process parameters to be used, 

  所用工藝參數的范圍

• in-process controls with their acceptance criteria, where  appropriate,

  過(guò)程控制及其接受標準，如適用

• sampling.

  取樣

• The instructions for storage of the RSM to assure its suitability for use.

  起始物料的儲存要求以確保其適合使用

Batch Production Records (Batch Production and Control Records)

批生產(chǎn)記錄

Batch Production Records should be prepared and completed for each batch of  RSM and should include complete information relating to the production and  control of each batch. The Batch Production Record may be electronic or paper  and should include at least but not be limited to:

每批起始物料均應有批生產(chǎn)記錄，應包括每批生產(chǎn)和控制相關(guān)的完整信息。批生產(chǎn)記錄可以電子或者紙質(zhì)，并應包括但不限于：

• Dates and when appropriate times, 

  日期，適當時(shí)包括時(shí)間

• Equipment used,

  所用設備

• Record of equipment cleanliness, 

  設備潔凈度的記錄

• batch numbers and quantity of the raw materials, 

  批號和原料的量

• actual values of the process parameters, 

  工藝參數的實(shí)際值

• description of packaging

  包裝的描述

Laboratory Control Records

實(shí)驗室控制記錄

Laboratory control records should include all tests conducted to ensure  compliance with established specifications; the documentation should include  but is not limited to:

實(shí)驗室控制記錄應包括所進(jìn)行以確保符合既定標準的所有測試，記錄應包括但不限于：

• A record of samples received for testing;

  待測樣品接收的記錄

• A statement of or reference to each test method used; 

  所用每一個(gè)測試方法的說(shuō)明或參考

• A record of the actual weight or measure of sample and reference standards, if applicable, used for each test;

  每一個(gè)測試樣品、參考標準的實(shí)際稱(chēng)量或測試記錄，如適用。

• Raw data generated during each test;

  測試期間所產(chǎn)生的原始數據

• A record of all calculations performed in connection with the test; 

  與測試有關(guān)的所有校準記錄

• The signature of the person who performed each test and the date(s) the tests were performed; and

  執行測試人員的簽名和日期，以及

• The date and signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established specifications before release.

  顯示原始記錄已被審核其準確性、完整性和符合既定標準的第二人簽名和日期