RW80洗瓶机PQ洗瓶机性能确认gmp资料

REVISION HISTORY

修订历史

Table of Contents 1.0 Purpose

目的

2.0 Responsibilities

责任

3.0 System Description

系统概述

4.0 Procedure

程序

5.0 Reference

参考

6.0 Signature Identification

签名

7.0 Performance Verification

性能确认

7.1 IOQ Verification

7.2 Instrument and Calibration Verification

仪表和校准确认

7.3 est Instrument Calibration Verification

测试设备校准确认

7.4 Test Materials Verification

测试材料确认

7.5

负载运行性能及实际产量确认

7.6

洗瓶澄明度确认

7.7

洗瓶不溶性微粒检测确认

8.0 Deviations

偏差

9.0 Attachments

附件

1.0 Purpose

This Performance Qualification (PQ) protocol is intended to provide documented verification that the -RW80 洗瓶机performs according to the manufacturer’s specifications. The PQ protocol is limited to the -RW80 洗瓶机and all the associated major components.

本性能确认方案（PQ）是为确定-RW80 洗瓶机按生产商设定的标准运行提供的文件支持。

该方案限定于-RW80 洗瓶机和它的附件。

2.0 Responsibilities

Describes those responsible for the performance of the Performance Qualification (PQ) Protocol and their responsibilities.

本节陈述与性能确认（PQ）的实施有关的部门及其责任。

2.1.1 Quality Control is responsible for the following:

质量控制部门有以下责任：

2.1.1.1 Review and approve PQ Protocol

审核和批准本PQ 方案

2.1.1.2 Review and approve Final Report

审核和批准最终的报告

2.1.1.3 Collect samples and perform assays

收集样品和检测样品

2.1.1.4 Report results

2.1.2 Production is responsible for the following:

生产部的责任：

2.1.2.1 Review and approve the PQ Protocol

审核和批准PQ 方案

2.1.2.2 Assure that the involved equipment is available, clean, and ready for

the PQ Protocol execution

保证相关的设备可以为PQ 方案的执行提供干净的设备。

2.1.2.3 Provide technical assistance and materials necessary to execute the

PQ Protocol

为PQ 的执行提供需要的技术支持和材料

2.1.2.4 Review, and approve the Final Report

审核批准最后的报告

2.1.3 Quality Assurance is responsible for the following:

质量保证部的责任：

2.1.

3.1 Review and approve the PQ Protocol

审核和批准PQ 方案

2.1.

3.2 Review, approve, and archive the Final Report

审核批准和归档最后的报告

2.1.4 Validation is responsible for the following:

验证部门的责任：

2.1.4.1 Generate, review, approve, and execute the PQ Protocol

编写，复核，批准和执行PQ 方案

2.1.4.2 Assemble and write the Final Report

收集数据，写出最后的报告

2.1.4.3 Approve the Final Report

3.0 System Description

本机主要用于对安瓿、抗生素瓶子的洁净清洗，能自动完成从进瓶、超声波清洗、外洗、内洗到出瓶的全部生产过程。利用一对内齿轮回转机构进行传动，喷针往复跟踪式喷淋清洗。玻璃瓶通过输送网带传送进入螺杆，然后由瓶提升架准确地把玻璃瓶送入夹爪机械手；出瓶时由夹爪机械手把玻璃瓶送入出瓶同步带，由出瓶同步带拨瓶块拨出玻璃瓶。清洗后的玻璃瓶洁净度高, 符合 GMP 要求。本机运行稳定可靠, 破损率低, 可无级调速, 操作方便, 既能单机使用, 又能与隧道式灭菌干燥机、灌装封口机组成联动机组使用。广泛应用于制药、生物等行业。

4.0 Procedure

程序

4.1 Follow the procedure section for each verification to be performed (Sections 7).

执行每一部分指定的确认程序。

4.2 Record all data results concurrently with the execution of each verification. All hand

written entries to the PQ protocol are to be made with blue or black indelible ink, and all

corrections made with a single cross through to include initials of the writer and date.

执行每项确认之后，及时记录所有数据结果。使用蓝色或黑色不褪色的水笔填写本PQ 方

案的记录。对记录数据的更正应首先在原有数据上划一横线，然后填写更正后的数据，并

签名和日期。

5.0 References

参考

Table 5.1 - Definitions and Abbreviations

表 5.1 –定义和缩写

N/A Not Applicable

该项不应用

N/Av Not Available

数据不可得

N/Spec Not Specified

未指明

性能确认方案Performance Qualification Protocol 方案编号：PQ- -RW80 版本：Protocol No. PQ- -RW80 Rev:第6页，共30页Page 6 of 30 6.0 Signature Identification

签名定义

Any individual that performs or verifies the execution of this protocol must print and sign their full name, initials, and department, or name of contractor firm in the table provided below.

Reviewed By: Date:

审核人日期

7.0 Performance Verification

性能确认

性能确认部分应包括确认系统实际生产能力、机器的运行性能、洗出的瓶子可以满足GMP 的澄明度、不溶性微粒要求。

7.1 IOQ Verification

IOQ 确认

7.1.1 Objective: To verify that the IOQ work has been successfully completed prior

to proceeding with the execution of this PQ protocol.

目标：在开始执行PQ 方案之前确定IOQ 工作已成功结束。

7.1.2 Instruments and materials: None

设备和材料：无

7.1.3 Acceptance Criteria

接受限：

7.1.3.1 The IOQ work has been successfully completed and the Final Report

written and approved.

IOQ 工作已成功结束，最后报告已完成和批准。

7.1.3.2 All deviations must be resolved prior to proceeding with the execution

of this PQ protocol.

所有的偏差在开始执行这个PQ 方案之前已解决。

7.1.4 Procedure:

程序：

7.1.4.1 Verify that the IOQ work has been successfully completed, including

the satisfactory resolution of any deviations.

确认IOQ 工作已成功结束，包括任何的偏差也已得到满意的解决。

7.1.4.2 Record the results in table 7.1.5.1

将结果记录在表7.1.5.1 上

7.1.5 Results

结果

?Table 7.1.5.1 IOQ Verification

7.1.6 Evaluation:

评价：

Was the Acceptance Criteria met?

是否达到标准？

Yes No Initials / Date: /

是否签名／日期

If No, explain: (use reverse side of this page if additional space is required)

Do not proceed further with the execution of this PQ protocol until the

acceptance criteria are met.

如果答案为否，请解释（如果需要额外空间，请使用本页的背面）在符合接受限之前先不要开始执行该PQ 的下一步。

Verified By: Date: 确认人：日期：Reviewed By: Date: 审核人：日期：

7.2 Instrument and Calibration Verification

仪表和校准确认

7.2.1 Objective: To verify that all system instruments continue to be in calibration

during PQ execution.

目的：确认系统仪表在ＰＱ执行期间都在校准有效期内。

7.2.2 Instruments and Materials: None

设备和材料：无

7.2.3 Acceptance Criteria:

接受限：

7.2.3.1 All critical system instruments are in calibration during execution of

this PQ protocol.

所有系统仪表的校准在PQ 执行期间都在有效期内。

7.2.4 Procedure:

程序

8.2.1.1 Verify that all system instruments listed in Table 7.2.5.1 are calibrated.

Record the results in Table 7.2.5.1

确认表7.2.5.1 内的系统仪表都经校准，校准结果记录在表中。

7.2.5 Results:

结果

Table 7.2.5.1: Instruments

表7.2.5.1 仪表

Comments: (use reverse side of this page if additional space is required)

评论（如果需要额外空间，请使用本页的背面）

Verified By: Date:

确认人日期

Reviewed By: Date: _ 复核人日期

7.3 Test Instruments Calibration Verification

测量仪器校准确认

7.3.1 Objective: To identify all test instruments used during the execution of this

protocol and verify that they are calibrated.

目标：确定所有的执行该PQ 方案要用的测量仪器并确认都经过校准。

7.3.2 Instruments and Materials: None

设备和材料：无

7.3.3 Acceptance Criteria:

接受限

7.3.3.1 All test instruments used during the execution of this protocol are

identified and classified according to SOP on calibration management.

根据校准管理程序，定义和分类在执行本方案时使用的所有测量

7.3.3.2 All test instruments have been calibrated according to SOP on

calibration management.

所有测量仪器都已经根据校准管理程序进行校准。

7.3.3.3 Reference standards used in calibration are traceable to national

standards.

校准使用的参考标准可追溯到国家标准。

7.3.4 Procedure:

程序

7.3.4.1 List all test instruments in Table 7.3.5.1. Classify the test instruments

according to SOP on calibration management.

将所有的测量仪器在表7.3.5.1 中列出。将测量仪器根据校准管理程序

分类。

7.3.4.2 According to SOP on calibration management, verify all instruments

for type, manufacturer, model number, serial number, Tag ID number,

range, calibration date, and calibration due date. Record the results in

Table 7.3.5.1.

根据校准管理程序的要求，确认仪器类型、生产商、型号、序列号、

标记号、范围、校准日期和下次校准日期。将结果记录在表7.3.5.1。

7.3.4.3 Verify that all instruments have been calibrated according to SOP on

calibration management. Reference standards used in calibration are

traceable to national standards. Attach copy of Calibration Certificates

for all Instruments to this protocol.

确认所有仪器都已经根据校准管理程序进行校准，校准使用的参考标

准可追溯到国家标准。将所有测量仪器的校准证书都附在方案后面。

性能确认方案Performance Qualification Protocol 方案编号：PQ- -RW80 版本：Protocol No. PQ- -RW80 Rev:第13页，共30页Page 13 of 30

7.3.5 Results:

?Table 7.3.5.1: Test Instruments Data

Calibration Certificates for all Instruments have been attached to this protocol. Reference standards used in calibration are traceable to national standards.

所有测量仪器的校准证书都附在该方案后面。校准使用的参考标准可追溯到国家标准。

Verified By: Date:

确认人日期

Reviewed By: Date:

复核人日期

xxxxx 有限公司（中国深圳）

7.4 Test Materials Verification

测试材料的确认（安瓿瓶子）

7.4.1 Objective: To verify that the filling materials meet specifications.

目标：确认安瓿瓶子规格和性能符合质量要求

7.4.2 Instrument and Materials: None

设备和材料：无

7.4.3 Acceptance Criteria

接受限

7.4.3.1 I dentity, quantity and test results of test materials meet requirements as

specified in

测试材料的鉴定，数量和测试结果都符合有关规定。

7.4.3.2 Production or test records of test materials have been reviewed and

approved.

生产或测试材料的测试报告已被审核和批准。

7.4.3.3

任何生产或测试材料测试方面的偏差都在开始执行下一步PQ 前得到解决。

7.4.4 Procedure

程序

7.4.4.1 Verify production or test records of test materials. Record the result in

Table 7.4.5.1.

确认生产或测试材料的测试记录。结果记录于表7.4.5.1 中。

7.4.4.2 Attach production or test records of test materials to section 9.0.

将生产或测试报告附在9.0。

7.4.5 Results

结果

Table 7.4.5.1 Test Materials Verification

7.4.6 Evaluation:

评价：

Was the Acceptance Criteria met?

是否达到标准？

Yes No Initials / Date: /

是否签名／日期

If No, explain: (use reverse side of this page if additional space is required) Do not

proceed further with the execution of this PQ protocol until the acceptance criteria

are met.

如果答案为否，请解释（如果需要额外空间，请使用本页的背面）在符合接受限之

前先不要开始执行该PQ 的下一步。

Verified By: Date:

确认人：日期：

Reviewed By: Date:

审核人：日期：

7.5 负载运行性能和实际产量确认

7.5.1 目的：确认-RW80 洗瓶机负载运行性能符合GMP 要求和客户要求，运行稳定，

实际产量能够满足要求的产量。

7.5.2 Instruments and Materials:

安瓿瓶子

清洗水

压缩空气

秒表

7.5.3 Acceptance Criteria:

接受限

7.5.3.1 Machine operation is stable.

7.5.3.2 Temporary stop and running speed will not influence uniformity.

暂时停止，运行速度调整应不会影响洗瓶效果的一致性

7.5.3.3 Samples shall be collected at intervals as specified in section 7.0.

取样应按照表7.5.5.2 设定的间隔来进行，取样要按顺序做好编号。

7.5.4 Procedure:

7.5.4.1

按照整条生产线正常的负载运行洗瓶，参照各设备说明书进行操作。

7.5.4.2

总共进行三批确认，每批至少20000 瓶。如下表所示。

7.5.5. Results

?Table 7.5.5.1

?表7.5.5.1 机器负载运行操作性能确认（三批可以复印此页）Qualification Batch No.

Table 7.5.5.2 Sampling Verification

表7.5.5.2 取样确认（三批可以复印此页）Qualification Batch No.