Conducting a Mock FDA Audit of Medical Device Manufacturer (Singapore)

A multinational manufacturer of cardiovascular devices recently engaged SeerPharma to conduct a comprehensive mock US FDA audit of their operations in Singapore. The audit was conducted against US FDA 21 CFR Part 820 – Quality System Regulation (21 CFR 820). SeerPharma reviewed relevant documentation remotely and then spent three days on-site reviewing manufacturing operations and activities.

Cardiovascular medical device - pace maker

SeerPharma assessed the following areas of the company’s operations over three days.

Process	21 CFR 820 Reference
Quality System Control of records related to the QMS Quality Manual Quality Policy, Quality Objectives Training Program	Sec. 820.5 Quality System Sec. 820.20 Management Responsibility
Management Responsibility Review of the process in place, planned schedule of meetings, minutes of previous meetings, and follow-up actions Adequacy of management commitment to quality and compliance Implementation and effectiveness of the quality policy Establishment and communication of quality objectives	Sec. 820.20 Management Responsibility
Document Controls Compliance with requirements for the creation, approval, distribution, and maintenance of documents Procedures for document change control and document retrieval	Sec. 820.40 Document Controls
Corrective and Preventive Action Documentation and investigation of nonconformities and customer complaints Implementation and effectiveness of corrective and preventive actions to address root causes of issues Control of nonconforming product Nonconformity review and disposition	Sec 820.90 Nonconforming Product Sec 820.100 Corrective and Preventive Action Sec 820.198 Complaint Files
Design Controls Documentation of design transfer, inputs, outputs, reviews, verification, validation, and design changes Procedures for control of design and development activities	Sec. 820.30 Design Controls (h) Design transfer (i) Design changes Sec 820.181 Device Master Record
Purchasing Controls Verification that purchased components, materials, and services meet specified requirements Establishment and maintenance of procedures for supplier evaluation, selection, and monitoring Control of processes for supplier evaluation and approval Purchasing controls and processes Receipt and release of materials and product	Sec 820.50 Purchasing Controls (a) Evaluation of suppliers, contractors, and consultants (b) Purchasing data
Production and Process Controls Adherence to procedures for production and process control, including cleanliness, maintenance, and calibration of equipment Implementation of process validation activities as required Management of product labelling, packaging, and shipping processes Material Control Identification and Traceability Batch review and release QC testing Automated processes Personnel Manufacturing materials Management of Equipment and Facilities Calibration, maintenance procedures Environmental Controls Contamination Control	Sec 820.70 Production and Process Controls Sec 820.50 Purchasing Controls
Measurement and Analysis Internal Audit Implementation of internal quality audits to ensure compliance with regulatory requirements Documentation and follow-up on audit findings and corrective actions	Sec 820.22 Quality Audit
Records Maintenance and retention of records related to the QMS, including production, quality control, and distribution records	Sec 820.180 General Requirements Sec 820.184 Device History Record

Process

21 CFR 820 Reference

Quality System

Control of records related to the QMS
Quality Manual
Quality Policy, Quality Objectives
Training Program

Sec. 820.5 Quality System

Sec. 820.20 Management Responsibility

Management Responsibility

Review of the process in place, planned schedule of meetings, minutes of previous meetings, and follow-up actions
Adequacy of management commitment to quality and compliance
Implementation and effectiveness of the quality policy
Establishment and communication of quality objectives

Sec. 820.20 Management Responsibility

Document Controls

Compliance with requirements for the creation, approval, distribution, and maintenance of documents
Procedures for document change control and document retrieval

Sec. 820.40 Document Controls

Corrective and Preventive Action

Documentation and investigation of nonconformities and customer complaints
Implementation and effectiveness of corrective and preventive actions to address root causes of issues
Control of nonconforming product
Nonconformity review and disposition

Sec 820.90 Nonconforming Product

Sec 820.100 Corrective and Preventive Action

Sec 820.198 Complaint Files

Design Controls

Documentation of design transfer, inputs, outputs, reviews, verification, validation, and design changes
Procedures for control of design and development activities

Sec. 820.30 Design Controls
(h) Design transfer
(i) Design changes

Sec 820.181 Device Master Record

Purchasing Controls

Verification that purchased components, materials, and services meet specified requirements
Establishment and maintenance of procedures for supplier evaluation, selection, and monitoring
Control of processes for supplier evaluation and approval
Purchasing controls and processes
Receipt and release of materials and product

Sec 820.50 Purchasing Controls
(a) Evaluation of suppliers, contractors, and consultants
(b) Purchasing data

Production and Process Controls

Adherence to procedures for production and process control, including cleanliness, maintenance, and calibration of equipment
Implementation of process validation activities as required
Management of product labelling, packaging, and shipping processes
Material Control
Identification and Traceability
Batch review and release
QC testing
Automated processes
Personnel
Manufacturing materials
Management of Equipment and Facilities
Calibration, maintenance procedures
Environmental Controls
Contamination Control

Sec 820.70 Production and Process Controls

Sec 820.50 Purchasing Controls

Measurement and Analysis

Internal Audit
Implementation of internal quality audits to ensure compliance with regulatory requirements
Documentation and follow-up on audit findings and corrective actions

Sec 820.22 Quality Audit

Records

Maintenance and retention of records related to the QMS, including production, quality control, and distribution records

Sec 820.180 General Requirements

Sec 820.184 Device History Record

Following the mock FDA audit, SeerPharma presented a comprehensive report to the client classifying findings as follows:

Critical

A system that has deficiencies that indicate a significant risk that a product could or would be harmful to the user.
Evidence that the Management Team is/are not exercising their responsibilities.

Major

A system that has deficiencies that indicate a potential risk to product or data integrity.
A finding that is a departure from the standard or procedural requirements, or for which there is no evidence of compliance.
A finding that has a high probability of leading to a Major Finding during a regulatory FDA inspection.

Minor or Other

A system that has deficiencies that may indirectly produce an invalid test result or is a deviation from approved procedure or good manufacturing practices.
A finding that, depending on the circumstances, may lead to a Major Finding during a regulatory FDA inspection.
A system that has deficiencies which cannot be classified as a Major, but which indicates a minor departure from approved procedures.

Recommendation

Feedback or recommendations regarding opportunities for improvement to the quality management system or individual procedures.

The mock inspection and observations by SeerPharma are intended to assist the client in preparing for an impending US FDA inspection.

SeerPharma has over 35 years of industry experience conducting mock GMP regulatory inspections by health authorities such as the US FDA, MHRA, TGA, HSA and other PIC/S member authorities. Our team of seasoned experts can provide a comprehensive independent review of your operations, to help you prepare for regulatory GMP inspections.

Visit https://www.seerpharma.com/services/qa-and-gmp-consulting/auditing to learn more about SeerPharma’s auditing services and contact us if you’d like support with mock GMP regulatory inspections.

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Conducting a Mock FDA Audit of Medical Device Manufacturer (Singapore)

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