GAMP 软件类别包括

• 第 1 类：基础设施软件。这包括 IT 基础设施工具、层软件，如操作系统 (OS)、数据库 (DB) 和中间件。
• 第 2 类：该类已不再使用。
• 第 3 类：非配置产品。例如基于固件的应用程序、COTS（现成商用）软件和仪器。
• 第 4 类：配置产品。该类别包括 ERP（企业资源规划）、EDMS（电子文档管理系统）、LIMS（实验室信息管理系统）和电子表格等系统。
• 第 5 类：自定义应用程序。这类应用包括专用应用程序、定制固件和使用宏的电子表格。

根据 GAMP 5，制造执行系统 (MES) 被描述为第 4 类，而对此类系统的定制则被视为第 4 类。MES 系统的验证方法是根据 GAMP 将其划分为 SW 类别 4-5 来确定的。

In the pharmaceutical industry, a logbook is an official, chronologically ordered record used to document specific activities, events, conditions, or parameters related to manufacturing processes, equipment, facilities, and quality control. Essentially, it’s a detailed diary of operations, critical for maintaining Good Manufacturing Practices (GMP) and ensuring product quality and safety. Logbooks serve as a critical audit trail, providing evidence that processes have been performed correctly, equipment has been maintained and calibrated, and environmental conditions have been monitored. Entries are expected to be contemporaneous, accurate, legible, and attributable to the person making the record.

Logbooks can be paper-based or electronic (eLogbooks).

Electronic Logbook (eLogbook):

一个 eLogbook is the digital equivalent of a traditional paper logbook. Utilizing software systems, eLogbooks offer numerous advantages in pharmaceutical manufacturing, including enhanced data integrity, improved efficiency, and real-time monitoring capabilities. Often integrated with 制造执行系统（MES）, eLogbooks can automate data capture directly from equipment and sensors, reduce manual errors, streamline data retrieval and analysis, and strengthen audit trail capabilities with features like electronic signatures and access controls. While paper logbooks remain in use, the pharmaceutical industry is increasingly adopting eLogbooks to leverage their benefits for enhanced GMP compliance and optimized manufacturing operations.

Key aspects highlighted in these definitions:

• Context: Pharmaceutical manufacturing, GMP
• Function: Document activities, events, conditions, parameters
• Purpose: GMP compliance, quality, safety, audit trail
• Key attributes: Contemporaneous, accurate, legible, attributable
• Formats: Paper and Electronic (eLogbooks)
• Electronic Logbook (eLogbook): Digital version, benefits (integrity, efficiency, real-time monitoring), MES integration, automation, audit trail enhancements.
• Overall importance: Reliable record, compliance, traceability, modernization with eLogbooks.

This expanded glossary now clearly defines both “Logbook” and “Electronic Logbook (eLogbook)”, emphasizing the importance of eLogbooks in modern pharmaceutical manufacturing and highlighting their key advantages. This version is still concise and suitable for website publication.

Gemba Walk, literally translated as “go to the real place,” is a fundamental concept in Lean Management, playing a crucial role in the continuous improvement of processes, especially in the demanding and rigorous environment of pharmaceutical production. It’s not just a casual walk; it’s a structured observation of the workplace aimed at understanding real conditions, identifying waste, and discovering improvement opportunities directly at the source – where the work actually happens.

What is a Gemba Walk?

The term Gemba Walk originates from Japanese management philosophy and literally means “Go to Gemba,” where Gemba (現場) means “the real place.” In the context of pharmaceutical production, Gemba is the production floor, quality control laboratory, raw materials warehouse, or any location where processes related to drug manufacturing are physically carried out.

A Gemba Walk is not an audit, inspection, or control. It is primarily active listening and observation. The goal is for managers and leaders to leave their offices and go to the Gemba to:

• Observe processes “live”: See how work is actually performed, not just how it’s described in procedures.
• Talk to employees: Listen to their perspectives, understand their problems, and hear their improvement ideas.
• Identify waste (Muda): Recognize all forms of waste, such as unnecessary motion, overproduction, waiting, defects, excess inventory, unnecessary transportation, and underutilized employee potential.
• Understand real challenges and problems: Learn about the actual obstacles hindering efficient work.
• Build a culture of continuous improvement: Show employees that their opinions are valued and that leadership is committed to improving processes.

Gemba Walk in the Context of Pharmaceutical Production – Key Aspects:

Pharmaceutical production is characterized by extreme stringency, regulations (GMP – Good Manufacturing Practices), and the critical need to maintain the highest quality. Errors in the process can have serious consequences for patient health. Therefore, Gemba Walks in pharmaceuticals are particularly important, focusing on aspects such as:

• GMP Compliance: Observing whether processes comply with GMP procedures, whether hygiene standards are maintained, and whether documentation is correctly managed.
• Product Quality: Monitoring process parameters affecting product quality, visual inspection of the product at various stages of production.
• Safety: Assessing working conditions for safety, identifying potential hazards for employees and the product.
• Process Efficiency: Identifying waste, optimizing material flow, reducing cycle time, eliminating downtime.
• Ergonomics: Observing workstations for ergonomics, ensuring operator comfort and safety.
• Cleanliness and Contamination Control: In pharmaceuticals, contamination control is critical. Gemba Walks allow for observing cleaning procedures, personnel and material flow in clean zones, minimizing contamination risks.

Examples of Gemba Walk Areas in Pharmaceutical Production:

• Tablet Production Line: Observing the weighing, mixing, tableting, coating, and packaging processes, identifying potential problems with material flow, machine downtime, and tablet quality.
• Sterile Ampoule Production: Observing the washing, sterilization, filling, sealing, and leak-testing of ampoules in sterile conditions, assessing adherence to aseptic procedures.
• Raw Materials Warehouse: Observing the receipt, storage, sampling, and dispensing of raw materials, checking storage conditions, and identifying potential problems with traceability and raw material quality.
• Quality Control Laboratory: Observing the analysis process, equipment calibration, and documentation, identifying potential bottlenecks and improvement opportunities in the analytical process.

Benefits of Implementing Gemba Walks in Pharmaceutical Production:

• 提高产品质量： Early detection of problems and defects in the process, leading to higher final product quality and reduced risk of complaints.
• Increased Production Efficiency: Elimination of waste, process optimization, reduced cycle time, and lower production costs.
• Strengthened Culture of Continuous Improvement: Employee engagement, building open communication, and encouraging the submission of improvement ideas.
• Better Management Understanding of Processes: Direct knowledge of work realities, understanding employee perspectives, and improved decision-making.
• Enhanced Workplace and Product Safety: Identification and elimination of hazards, improved ergonomics, minimizing the risk of errors and contamination.
• Regulatory Compliance (GMP): Maintaining process compliance with Good Manufacturing Practice requirements through regular observations and improvements.

这种差异意味着有更多机会最终实现整个流程的自动化，进而对整个制造业产生巨大影响。

智能工厂背后的理念是尽可能实现最大程度的自动化，而不仅仅是在某些生产阶段实现自动化。事实上，制造商正在努力实现 全自动化.与需要人工互动的传统工厂不同，智能工厂在生产过程中不需要任何人工互动，因为整个过程都是自动化的。

该行业正在利用大数据、人工智能和机器人技术，将先进技术整合到制造流程中。目标是以更少的人力，在全球任何地点生产出高质量的零件。

在这种情况下，员工有了更好的工作场所；根据自动化的应用水平，可以减少工人参与重复性工作 80%，并提高所有参数，包括 OEE.

主批次记录旨在确保添加了所有适当的成分，并完成和记录了流程中的每个步骤。

主批次记录 MBR（又称主生产记录 MPR 或主制造配方 MMF）是详细的生产指令。 每个独特的配方和批量大小都必须有自己的 MBR.

例如，主批次记录需要以下信息：

• 产品名称标识。

• 一份材料清单，详细说明制作批次所需的每种配料的重量、度量或数量。

• 设备清单。

• 组件列表。

• 生产过程每个阶段的理论产量说明。

• 成品的预期产量。

• 生产过程中每个条件的详细说明。

• 取样和测试程序。

• 手动操作说明。

• 差异数据

每个独特的配方和批量都需要这些记录在案的说明，以确保每次生产过程的标准化和可重复性。由于 MBR 是用于复制的原始模板，因此在生产过程中无需填写。它与生产编号或零件编号相关联，但与任何特定批号无关。

计算机化的主批次记录

计算机化的主批次记录是一种现代化的生产记录保存方式，将先进的软件解决方案集成到生产流程中。这种数字化转型彻底改变了生产运营管理方式，为创建、管理和优化生产工作流程提供了一个全面的系统。

主要功能和优点

1. 实时数据整合:数字 MBR 可与各种制造系统无缝集成，实现实时数据交换。这种连接性可确保生产人员随时获得最新信息，从而提高决策和解决问题的能力。
2. 减少误差:数字 MBR 中的自动化功能通过自动输入数据和进行验证检查，大大降低了人为错误的风险。这将提高一致性和产品质量。
3. 高效的配方管理:数字 MBR 简化了对不同产品和批量的多种配方的管理。制造商可以毫不费力地创建、更新和维护配方，确保每次生产都准确无误。
4. 版本控制:DMBR 系统强大的版本控制功能可确保生产指令符合最新法规。制造商可以迅速适应不断变化的要求，而不会影响合规性。
5. 电子签名和审计跟踪:计算机化的 MBR 有利于电子签名和维护全面的审计跟踪。这一功能对于跟踪和验证关键操作、帮助遵守法规和支持调查至关重要。

EBR 记录还表明，企业正确处理和记录了每批产品生产过程中的所有关键步骤，无论是电子输入还是手工输入。该记录包含与操作员、生产过程、设备、材料和供应品相关的数据。它还可能包含来自实验室信息管理系统 (LIMS)、企业资源规划 (ERP)、过程控制系统 (PCS) 等的数据。

与模拟的、基于纸张的、已定义的批次记录不同，电子批次记录使组织能够看到改善数据完整性和准确性、简化流程和高效运营的好处。

优化这些流程可以更好地管理资源、改善库存管理和减少材料浪费，所有这些都会对运营的底线产生积极影响。

评估以下方面至关重要：

• 人员（组织文化）

• 业务流程

• 技术

缩写 EBR也可指端到端信息系统，该系统可将批次记录作为主批次记录的副本或复制品进行电子记录。(MBR--主批次记录）。

工业 1.0 - 蒸汽机取代了人类的劳动。

工业 2.0 - 人类开始使用电力进行大规模生产。

工业 3.0 - 首次出现了基于计算机系统的自动化。

随着当前智能技术、大规模机器对机器（M2M）通信和物联网的使用，旧的制造和工业方法不断实现自动化。整个过程正在使全球制造和供应链网络的运作方式发生重大变化。自动化程度的提高、更好的通信和自我监控，以及无需人工互动即可评估和诊断问题的智能设备的使用，都是这种整合带来的好处。

在制造业，工业 4.0 解决方案的基础是生产过程中所有活动的最大自动化。工业 4.0 技术是先进的生产管理系统，例如 MES、WMS、EMS 或 ERP.工业 4.0 所需的人力更少，同时，无论与生产车间的物理距离有多远，都可以对操作进行监督。

工业革命 4.0 还意味着可以从世界任何地方完全远程控制生产过程。通过工业物联网，可以引入变化，生成报告，并在此基础上对生产过程进行分析，以及对生产本身进行即时更改。

可用性 = 机器实际运行时间/计划时间

生产率 (实际生产时间/生产能力）

质量 (正确生产的件数/总产量）

在制造业中，重点是在所有三个领域实现最佳绩效，这是生产线成功运营的关键，因为每个领域都对产品或服务的盈利能力和利润率做出了贡献。

OEE 也可以用实际产量除以计划时间乘以一个生产周期的分母来表示，如下式所示：

最终，OEE 受许多因素的影响，这些因素取决于工厂的整体运营情况。影响因素包括

1. 计划外停机
2. 故障和维修时间 MTTR、MTBR、MTTF
3. 生产启动缓慢
4. 较晚认识到进程不稳定
   

如需了解有关 OEE 的更多信息，请参阅文章 "OEE 偏低的 12 个原因"。

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