Clause Standard Repligen Procedure Procedure

4. Context of
Organization

4.1 Understanding the organization and its context

CAP-1004, Quality Manual

Understanding the needs and expectations of

4.2 interested
parties
4.3 Determining the scope of the quality management
system

4.4 Quality management system and its processes

5. Leadership

SOP-1488, Management Review

5.1 Leadership and commitment

SOP-10117, Ensuring and Evaluating Customer Satisfaction

SOP-10047, Recall Procedure

5.2 Policy CAP-1005, Repligen Corporate Quality Policy

Organization roles, responsibilities and authorities SOP-1488, Management Review

5.3

SOP-1490, Internal Audit Procedure

SOP-1496, Supplier Management Program

6. Planning

6.1 Actions to address risks and opportunities SOP-10079, Corrective Action Procedure

SOP-10108, Risk Management

6.2 Quality objectives and planning to achieve them SOP-1488, Management Review
Monthly Operation Meetings

6.3 Planning of changes SOP-1447, Product and Process Change Management

7. Support

SOP-1488, Management Review

7.1 Resources

SOP-1501, Preventive Maintenance Program

SOP-1171, Equipment Control

SOP-MFG-1205, Pest Control

SOP-MFG-1207, Environmental Monitoring of the

Seyon Manufacturing Suites

SOP-MFG-1209, RO/DI Monitoring

SOP-MFG-1264, Manufacturing General Housekeeping

SOP-QC-1264, General Housekeeping Procedure

SOP-MFG-1350, Gowning and Personnel Flow for the

Manufacturing and QC Facilities

SOP-MFG-1330, Equipment Flow within the Waltham

Manufacturing Facility

SOP-MFG-1351, Cleaning Procedure for the Repligen

Manufacturing Facilities

SOP-MFG-10009, Maintenance of the OPUS ISO 7 and ISO 8

cleanrooms

SOP-1181, Calibration Program

Repligen Biosafety Plan

Repligen Chemical Hygiene Plan

Emergency Action Plan

 Incident Reporting

Information Security Program

IT Retention Policy

SOP-10112, HR Job Description and Resume Procedure

7.2 Competence

SOP-QC-1036, Quality Control Training Program

SOP-MFG-1349, Manufacturing Training Program

7.3 Awareness SOP-1489, Training Procedure

7.4 Communication Company Meetings

SOP-1150, Control of Records

7.5 Documented information

SOP-1098, Control of Documents

SOP-1302, Using, Completing and Reviewing Repligen

Documentation

EQ-9000, Installation, Operation, and Maintenance of the

Repligen Electronic Management System

EQ-9001, Training and Development Module Procedure

8. Operation

SOP-1488, Management Review

8.1 Operational planning and control

SOP-1447, Product and Process Change Management

SOP-1449, Quality Systems Oversight of US Biologics (USBL)

Component Specification (CS), Analytical Reagent (AR), Raw

Material (RM), Component Production Record (CPR), Bottling
Production Record (BPR)
SOP-10117, Ensuring and Evaluating Customer Satisfaction
8.2 Requirements for products and services

SOP-10035, Customer Property

SOP-10106, Product Design and Development Procedure

Customer Requirements (CR) documents

SOP-10015, Processing OPUS Custom Orders

SOP-1134, Processing of Customer Complaints

SOP-1496, Supplier Management Program

SOP-1447, Product and Process Change Management

Supply and Quality Agreements

SOP-1378, Repligen Validation Program

8.3 Design and development of products and services

SOP-10110, Design History Files Management

SOP-10108, Risk Management

SOP-10106, Product Design and Development Procedure

SOP-10069, Product Development and

Commercialization Process (PDCP)

SOP-1447, Product and Process Change Management

Control of externally provided processes, products and SOP-1496, Supplier Management Program
8.4 services

SOP-10091, New Supplier Procedure

SOP-10090, Supplier Corrective Action Request

SOP-1495, Receiving Procedure

 SOP-1094, Control of Incoming Raw Materials and Analytical
Reagents

SOP-1488, Management Review

SOP-10042, Control of Incoming Components

SOP-1449, Quality Systems Oversight of US Biologics (USBL)

SOP-1378, Repligen Validation Program

SOP-1501, Preventive Maintenance Program

SOP-1181, Calibration Program

SOP-10079, Corrective Action Procedure

SOP-1097, Identification System

SOP-10035, Customer Property

SOP-MFG-10006, Aseptic Technique

8.5 Production and service provisions

SOP-10093, Shipping Procedure

SOP-MFG-1351, Cleaning Procedure for the Repligen

Manufacturing Facility

SOP-1134, Processing of Customer Complaints

SOP-10047, Recall Procedure

SOP-1447, Product and Process Change Management

SOP-10117, Ensuring and Evaluating Customer Satisfaction

Component Batch Records, Bottling Batch Records

Certificate of Analysis

SOP-10048, Repligen ATF Factory Acceptance Test (FAT)

8.6 Release of products and services

SOP-10093, Shipping Procedure

SOP-10042, Control of Incoming Components

QC Release Testing SOPs

8.7 Control of nonconforming outputs SOP-1188, Nonconforming Material Procedure

SOP-10047, Recall Procedure

9. Performance Evaluation

SOP-10079, Corrective Action Procedure

SOP-10117, Ensuring and Evaluating Customer Satisfaction

SOP-1501, Preventive Maintenance Program

9.1 Monitoring, measurement, analysis and evaluation

SOP-1181, Calibration Program

SOP-1134, Processing Customer Complaints

9.2 Internal audit SOP-1490, Internal Audit Procedure

9.3 Management Review SOP-1488, Management Review

Operation Meetings

10. Improvement

10.1 General SOP-1488, Management Review

Nonconformity and Corrective Action SOP-10078, Root Cause Analysis Procedure

10.2
 Nonconformity and Corrective Action

SOP-1188, Nonconforming Material Procedure

SOP-10079, Corrective Action Procedure

10.2

SOP-1496, Supplier Management Program

SOP-10090, Supplier Corrective Action Request

SOP-1487, Out of Specification (OOS) Results

SOP-1050, Documenting Planned and Unplanned Deviations

SOP-1490, Internal Audit Procedure

SOP-10079, Corrective Action Procedure

10.3 Continual improvement

SOP-1496, Supplier Management Program

SOP-1488, Management Review