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With the new chapter on Contamination Control Strategy (CCS), the USP builds a bridge between the requirements of CFR and the current 1st edition. In its introduction, the USP states that microbiological contamination control is a crucial part of drug manufacturing. In the USA, this is regulated by legal requirements such as CFR §211.113. A contamination control strategy (CCS) is required to minimise the risk of microbial contamination. It includes a holistic view of the entire production facility and is based on quality risk management (QRM). The most important sections are listed below, whereby the USP emphasises that this overview does not represent a 100% list of all relevant aspects.

 

近日，USP發(fā)布了關(guān)于污染控制策略 （CCS） 的新章節(jié)。USP 在其介紹中指出，微生物污染控制是藥物生產(chǎn)的關(guān)鍵部分。需要制定污染控制策略 （CCS） 以最大限度地降低微生物污染的風(fēng)險。它包括整個生產(chǎn)設(shè)施的整體視圖，并基于質(zhì)量風(fēng)險管理 （QRM）。下面列出了最重要的部分，USP 強(qiáng)調(diào)，本概述并不代表所有相關(guān)方面的 100% 列表。

 

 

Planning and operation of the plant

 

廠房設(shè)計(jì)和運(yùn)行

 

Cleanroom design: minimisation of microbial contamination through cascading pressurisation and appropriate cleanroom classifications (ISO standards).

潔凈室設(shè)計(jì)：通過壓差梯度和適當(dāng)?shù)臐崈羰曳诸悾↖SO標(biāo)準(zhǔn)）最大限度地減少微生物污染。

Air control systems: Temperature, ventilation and humidity control, use of HEPA filters.

空氣控制系統(tǒng)：溫度、通風(fēng)和濕度控制，使用 HEPA 過濾器。

Material flow & process flow: Unidirectional processes to avoid      cross-contamination.

物流和工藝流：單向過程以避免交叉污染。

Cleanroom qualification: Regular testing of particles, airflow and filter integrity.

潔凈室確認(rèn)：定期測試顆粒、氣流和過濾器完整性。

Maintenance: Planning of building maintenance taking microbial risks into account.

維護(hù)：廠房維護(hù)計(jì)劃考慮微生物風(fēng)險

 

Equipment and process

 

設(shè)備和工藝

 

Equipment design: Cleanable and sterilisable production equipment with validated cleaning efficiency.

設(shè)備設(shè)計(jì)：可清潔和可消毒的生產(chǎn)設(shè)備，清潔有效性經(jīng)過驗(yàn)證。

Process design: Closed systems are preferred; open processes require ISO 5 environment.

工藝設(shè)計(jì)：首選密閉系統(tǒng);開放式工藝需要 ISO 5 環(huán)境。

Material transfer: Validated methods for transfers to ISO 5 areas.

物料轉(zhuǎn)移：使用經(jīng)過驗(yàn)證的方法轉(zhuǎn)移到 ISO 5 區(qū)域。

Hold times: Must be validated to prevent microbial growth.

保持時間：應(yīng)驗(yàn)證以防止微生物生長。

 

Personnel

 

人員

 

Training: Fundamentals of microbiology, aseptic technique, environmental controls and cleaning.

培訓(xùn)：微生物學(xué)基礎(chǔ)知識、無菌技術(shù)、環(huán)境控制和清潔。

Garbing: ISO 8 areas require protective suits, ISO 5 areas require additional sterile bonnets, masks and gloves.

著裝：ISO 8 區(qū)域需要防護(hù)服，ISO 5 區(qū)域需要額外的無菌頭罩、口罩和手套。

Qualification: Includes training, monitoring and microbiological testing.

確認(rèn)：包括培訓(xùn)、監(jiān)測和微生物測試。

 

Supply facilities

 

公用設(shè)施

 

Water: Must be pharmaceutical grade and regularly tested for microbial contamination.

水：必須是制藥級的，并定期進(jìn)行微生物污染檢測。

Process gases: Direct contact with products requires sterile filters (0.2 µm) and regular testing.

工藝氣體：與產(chǎn)品直接接觸需要除菌過濾器 （0.2 μm） 并定期測試。

 

Raw material controls

 

原輔料控制

 

Risk assessment: Takes into account origin, manufacturing processes and storage.

風(fēng)險評估： 考慮源頭、生產(chǎn)工藝和儲存。

Incoming inspections: Inspection of materials by suppliers and manufacturers required.

入廠檢驗(yàn)： 需要供應(yīng)商和制造商對物料進(jìn)行檢驗(yàn)。

 

Product containers and closures

 

產(chǎn)品容器和密封部件

 

Integrity assurance: Container and closure integrity testing.

完整性保證：容器和密封部件完整性測試

Storage and transport validation: Ensuring microbial barrier function.

儲存和運(yùn)輸驗(yàn)證：確保微生物屏障功能。

 

Management of outsourcing activities

 

外包活動管理

 

Quality assurance of external service providers: audits, quality agreements and regular inspections.

外部服務(wù)提供商的質(zhì)量保證：審計(jì)、質(zhì)量協(xié)議和定期檢查。

Examples: Sterilisation, environmental monitoring and cleaning of outsourced areas.

示例：外包區(qū)域的清潔、消毒和環(huán)境監(jiān)測。

 

Risk management and process validation

 

風(fēng)險管理和工藝驗(yàn)證

 

QRM approach: Identifying, analysing and assessing microbial risks.

QRM

方法：識別、分析和評估微生物風(fēng)險。

Process validation: Continuous evaluation of sterilisation and production processes.

工藝驗(yàn)證：對滅菌和生產(chǎn)過程進(jìn)行持續(xù)評估。

 

Cleaning and disinfection

 

清潔和消毒

 

Regular disinfection: Based on cleanroom classification and microbial trends.

定期消毒：基于潔凈室級別和微生物趨勢。

Validation: Documentation of the effectiveness of cleaning agents and disinfectants used.

驗(yàn)證：記錄所用清潔劑和消毒劑的有效性。

 

Verification of monitoring controls

 

監(jiān)測措施的確認(rèn)

 

Environmental and personnel monitoring: Evaluation of microbial control in production areas.

環(huán)境和人員監(jiān)測：生產(chǎn)區(qū)域微生物控制評估。

Alternative monitoring methods: Faster detection of contamination using new technologies.

替代監(jiān)測方法：使用新技術(shù)更快地檢測污染。

Trend analyses: To identify microbial hotspots and optimise the CCS.

趨勢分析：識別微生物熱點(diǎn)并優(yōu)化 CCS。

 

Aseptic process simulations (APS)

 

無菌工藝模擬（APS）

 

Regular tests: Worst-case scenarios to ensure aseptic conditions.

定期測試： 在最差條件下測試以確保無菌條件

Validation of media fill tests: Proof of the effectiveness of the aseptic process.

培養(yǎng)基灌裝測試驗(yàn)證：無菌工藝有效性的證明。

 

Investigation of deviations

 

偏差調(diào)查

 

Root cause analysis: Determining the cause of microbial contamination.

根本原因分析：確定微生物污染的原因。

Corrective and preventive actions (CAPA): Implementation and effectiveness testing.

糾正和預(yù)防措施 （CAPA）：實(shí)施和有效性測試。