This procedure applies to all products manufactured and distributed from this Site. This includes physician samples and commercial product used for market studies

Regulatory basis, reference documents

• FDA: FDA: 21 CFR 211.150
• EMA: EU Directive for GMP’s

Table of Content (just Headers):

1          Purpose

2          Objective

3          Regulatory basis, reference documents

3.1       Company Management

3.2       Quality Management Representative / Quality Assurance / (Recall coordinator)

3.3       Recall Committee

4          Related documents

5          Definitions

6          Procedure

6.1       General

6.2       Preliminary Investigation and Information

6.3       Case Classifications

6.4       Key Factors

6.4.1    Health Hazard

6.4.2    Depth of Recall

6.4.3    Recall Committee Meeting

6.4.4    Recall Documents

6.4.5    Public announcements

6.4.6    Recall Close out

6.4.7    Mock Recall

7          Attachments

7.4       Attachment 1: Recall Decision Flow Chart

8          SOP distribution

9          Health, safety and environmental considerations

Size and Format:

Microsoft Office

Word File

12 pages procedure

The post Product Recall Management appeared first on QMDocs Quality Management System Templates.

This procedure pertains to GMP operations, personnel and areas as well as to raw materials, excipients or components, intermediates, drug products, drug substances and medical devices.

The CAPA system will also be used to track and trend corrective and preventative actions planned to address known issues and actions or to implement quality improvements.

This may include, but is not limited to:

• Deviations/Non-conformance, OOS – Procedure
• Product Complaints – Procedure for Handling Product Complaints
• Returned Products
• External and internal audit observations / assessments
• Annual Product Reviews – Annual Product Review
• Regulatory Issues
• Management Review proposals
• Any issues that require mid-term and long-term corrective or preventative action, with formal tracking and documentation
• Recommendations of executed validations
• Quality Events/Improvements
• Supplier Quality feedbacks and assessments

Regulatory basis, reference documents for this CAPA SOP

FDA: 21 CFR 210, 211, 600, and 820

EMA: ICH Q10 (Pharmaceutical Quality System)

CAPA SOP Table of Content:

1 Purpose

2 Objective

3 Regulatory basis, reference documents

4 Responsibility and accountability

4.1 Company Management

4.2 Quality Management Representative/ Quality Assurance

4.3 Other Departments

5 Related documents

6 Definitions

7 Procedure

7.1 General

7.2 Start of a CAPA

7.3 CAPA Numbering

7.4 CAPA Investigation

7.5 CAPA Route Cause

7.6 Corrective and Preventive Action Plan

7.7 Completion of CAPAs

7.8 Trending of CAPAs

7.9 Reporting of CAPAs

7.10 Archiving

8 Attachments

8.1 Attachment 1: Corrective and Preventive Action Form (2 pages)

8.2 Attachment 2: Request for Extension of CAPA Completion Date (2 pages)

8.3 Attachment 3: Flowchart CAPA (1 page)

9 SOP distribution

10 Health, safety and environmental considerations

Size and Format of SOP:

Microsoft Office

Word File

15 pages procedure

The post CAPA Management SOP appeared first on QMDocs Quality Management System Templates.

Without a robust and effective change control system you will not be able to adjust systems and processes assuring compliance and staying competitive within the industry. Managing changes probably guarantees your company’s future success.

Scope of Change Control SOP:

The purpose of this SOP is to describe in detail the change control process. The Process starts with a request for a change followed by the mandatory assessments and approvals. This standard process ensures that all planned changes related to all aspect of manufacture, testing and distribution are reviewed, assessed and approved by technical and quality competent personnel. One of the main tasks is to evaluate all potential impacts followed by correlative consequences of the requested change on product quality, current Good Manufacturing Practice (cGMP), including qualification and validation and the regulatory file/dossier before approval and implementation of a change control request.

Change Control Objective:

This procedure applies to all new and existing manufacturing/packaging processes, utilities, major equipment, computerized systems, facilities, drug products and drug substances, raw materials, components, testing requirements, specifications and systems for marketed products and clinical trials (clinical, pre-clinical and stability with GMP implications). Documents and systems that may be impacted by a given change in any of these areas include, but are not limited to, all master documents, Marketing Authorization Applications (MAA’s), New Drug Applications (NDA’s), validation, stability protocols and control systems

Regulatory basis, reference documents for Change Control System: 

CFR 314.70 “Supplements and other changes to an approved application”
Commission Regulation EC 541/95 “Variation to the terms of a marketing authorization”
ISO 9004 “08.8 Design Change Control”
ISO 9004 “11.6 Process Change Control”
PIC – PH 1/96
ICH Q7A chapter 13 “Change Control”

SOP Change Control Table of Content:

1     Purpose

2     Objective

3     Regulatory basis, reference documents

4     Responsibility and accountability

4.1       Applicant/Change requester

4.2       Area Experts / Accountable Area Leaders

4.3       Quality Assurance

5     Related documents

6     Definitions

6.1       Like for like replacements / changes

6.2       Temporary and Permanent Changes

7     Procedure

7.1       Raising a Change Control (Form Section 1)

7.2       Assessment of the proposed change (Form Section 2)

7.3       Change implementation / Action Plan (Form Section 3)

7.4       Change Pre Approvals (Form Section 4)

Responsibility of the applicant / change requester

Responsibility of Quality Assurance

7.5       Change Post Approvals (Form Section 5)

Responsibility of the applicant / change requester

Responsibility of Quality Assurance

8     Attachments

Change Control Form

9     SOP distribution

10         Health, safety and environmental considerations

Size and Format of SOP:

• Microsoft Office
• Word File
• 10 pages procedure includes attachment

The post Change Control SOP appeared first on QMDocs Quality Management System Templates.

The objective of this SOP is to specify the Human Factors Engineering and Design Validation process to ensure that medical devices are designed according to user requirements and that the use of the device (including labelling, packaging and USER information) is safe, effective, efficient and satisfying. To successfully launch new medical devices this process needs to be in compliance with current regulatory expectations.

Regulatory basis, reference documents

• AAMI/ANSI HE74:2001 Human factors design process for medical devices
• AAMI/ANSI HE75:2009 Human factors engineering – Design of medical devices
• IEC 62366:2007 Medical Devices – Application of human factors engineering to medical devices
• ISO 14971:2007 Medical Devices – Application of risk management to medical devices
• ISO 9241:2010 Ergonomics of human-system interaction – Part 210: Human-centred design for interactive systems
• Food and Drug Administration, CDRH: Do it by design: An introduction to Human Factors in Medical Devices
• Food and Drug Administration, CDRH: Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management, 2000
• ANSI/AAMI/ISO 13485:2016  Medical Devices – Quality Management Systems
• AAMI HE48:1993 Human factors engineering guidelines and preferred practices for the design of medical devices
• Food and Drug Administration, CDRH: Write it right: Recommendations for developing user instruction manuals for medical devices used in home health care
• 21 CFR Part 820: Quality System Regulation

Table of Content (just Headers):

1          Purpose

2          Objective

3          Regulatory basis, reference documents

4          Responsibility and accountability

4.1       Company Management

4.2       Quality Head and Department

4.3       Human Factors Specialist

5          Related documents

6          Definitions

7          Procedure

7.1       General

7.2       Process deliverables

7.2.1    Intended Use / Application Specification

7.2.2    Device Specification

7.2.3    Design Input and Design output

7.3       Task Analysis and Use Error Identification

7.4       Usability Specification

7.5       Testing Activities

7.5.1    Usability Evaluation Study

7.5.1    Usability Evaluation Study

7.5.2    Design Validation Study

8          Attachments

9          SOP distribution

10        Health, safety and environmental considerations

Size and Format:

Microsoft Office 2003

Word File

10 pages procedure

The post Medical Device Human Factor SOP appeared first on QMDocs Quality Management System Templates.

This Standard Operating Procedure (SOP) describes the program developed for performing the Hazard Analysis (HA) during the development of Medical Devices under Device Control in order to identify, understand, control, and prevent potential risks in the use of COMPANY Medical Devices. The Hazard Analysis is conducted throughout product design, development as well as marketing/distribution. This SOP is part of the COMPANY Design Control Program, as outlined in the Design Control SOP and supports the overall Design Control process. This SOP applies to all Medical Devices that are approved for Product Development as well as to the personnel who are responsible for implementing Design Controls for such Medical Devices. This program does not apply to medical devices in very early stage of development such as early concept or feasibility stages.

Regulatory basis, reference documents

• 21 CFR Part 820 – Quality System Regulation, Subpart C – Design Controls, 820.30 Design controls
• HE75:2009 Human factors engineering – Design of medical devices
• ISO 13485:2016: Medical Devices – Quality management systems Requirements for regulatory purposes
• FDA/CDRH – Design Control Guidance for Medical Device Manufacturers, March 11, 1997
• 21 CFR Part 820-Quality System Regulation, Subpart G- Production and Process Controls
• ISO 14971 Medical Devices: Application of Risk Management to Medical Devices

Table of Content

1          Purpose

2          Objective

3          Regulatory basis, reference documents

4          Responsibility and accountability

4.1       Company Management

4.2       Design Review Committee

4.3       Quality Assurance

4.4       Project Leader (PL) / Head of Engineering (HE)

4.5       Function / Area Leaders

5          Related documents

6          Definitions

7          Procedure

7.1       General

7.2       Human Factors Engineering

7.3       Hazard Analysis

7.4       Severity

7.5       Probability

7.6       Risk Index

7.7       Hazard Analysis Project team

7.8       Using the Hazard Analysis Matrix Form “Details”

7.9       Using the Hazard Analysis Matrix Form “Summary”

8          Attachments

Attachment 1: Hazard Analysis Matrix Summary (1 page)

Attachment 2: Hazard Analysis Matrix Details (1 page)

Attachment 3: Generic Risk Management graph (1 page)

9          SOP distribution

10        Health, safety and environmental considerations

Size and Format:

• Microsoft Office 2003
• Word File
• 16 pages procedure

The post Hazard Analysis SOP appeared first on QMDocs Quality Management System Templates.

This SOP applies to all Medical devices that are approved for Product Development as well as to the personnel who are responsible for implementing Design Controls for such Medical devices. This Design Changes SOP does not apply to Medical devices in very early stage of development such as early concept or feasibility stages.

Regulatory basis, reference documents

• 21 CFR Part 820 – Quality System Regulation, Subpart C – Design Controls, 820.30 Design controls
• ISO 13485:2016: Medical Devices – Quality Management systems ¬Requirements for regulatory purposes
• FDA/CDRH – Design Control Guidance for Medical Device Manufacturers, March 11, 1997

Table of Content: 

1          Purpose

2          Objective

3          Regulatory basis, reference documents

4          Responsibility and accountability

4.1      Company Management

4.2      Design Review Committee

4.3      Quality Assurance

4.4      Project Leader (PL) / Head of Engineering (HE)

4.5      Function / Area Leaders

5          Related documents

6          Definitions

7          Procedure

7.1      Design Changes (general)

7.2      Design Changes Sources

7.3      Design Change Process

7.4      Classes of Change

7.5      Approval of changes

7.6      Changes involving External Organization (EO)

7.7      Design Change Revisions

7.8      Design History File

8          Attachments

Attachment 1: Engineering Change Request Approval and Closure (ECR)

Attachment 2: Engineering Change Request Conduct (ECR) – Sheet 1

Attachment 3: Engineering Change Request Implementation (ECR) – Sheet 2

Attachment 4: Engineering Change Request Cost Estimate (ECR) – Sheet 3

9          SOP distribution

10       Health, safety and environmental considerations

Size and Format:

• Microsoft Office 2003
• Word File
• 21 pages procedure

The post Medical Device Design Changes SOP appeared first on QMDocs Quality Management System Templates.

This SOP applies to all medical devices that are approved for Product Development as well as to the personnel who are responsible for implementing Design Controls for such medical devices. This Design Controls SOP does not apply to medical devices in very early stage of development such as early concept or feasibility stages. Design Controls begin after concept and feasibility studies are completed after the Company Management approves the initiation of a Product Development Project.

This SOP applies to the Product’s labeling including the User Manual. It does not describe the Verification process for Product software.

Regulatory basis, reference documents

• 21 CFR Part 820 – Quality System Regulation, Subpart C – Design Controls, 820.30 Design controls
• ISO 13485:2016: Medical Devices – Quality management systems ¬Requirements for regulatory purposes
• FDA/CDRH – Design Control Guidance for Medical Device Manufacturers, March 11, 1997

Table of Content: 

1          Purpose

2          Objective

3          Regulatory basis, reference documents

4          Responsibility and accountability

4.1      Company Management

4.2      Design Review Committee

4.3      Quality Assurance

4.4      Project Leader (PL) / Head of Engineering (HE)

4.5      Function / Area Leaders

5          Related documents

6          Definitions

7          Procedure

7.1      Design Verification (general)

7.2      Design Verification Deliverable

7.3      Design Output

7.4      Design Verification Matrix (detail)

7.5      Design Verification Equipment Log

7.6      Design Verification Protocol

7.7      Design Verification Report

7.8      Acceptance of deviations and unresolved Non-conformances

7.9      Approval and Design Review

8          Attachment

Attachment 1:            Design Verification Detail Matrix (1Page)

Attachment 2:            DESIGN VERIFICATION EQUIPMENT LOG (1 Page)

Attachment 3:             DESIGN VERIFICATION REPORT (3 Pages)

9          SOP distribution

10       Health, safety and environmental considerations

Size and Format:

• Microsoft Office 2003
• Word File
• 18 pages procedure

The post Medical Device Design Verification SOP appeared first on QMDocs Quality Management System Templates.

Regulatory basis, reference documents 

21 CFR Part 820 – Quality System Regulation, Subpart C – Design Controls, 820.30 Design controls

ISO 13485:2016: Medical Devices – Quality management systems ¬Requirements for regulatory purposes

FDA/CDRH – Design Control Guidance for Medical Device Manufacturers, March 11, 1997

Table of Content:

1     Purpose

2     Objective

3     Regulatory basis, reference documents

4     Responsibility and accountability

4.1       Design Review Committee

4.2       Quality Assurance

4.3       Project Leader (PL) / Head of Engineering (HE)

4.4       Function / Area Leaders

5     Related documents

6     Definitions

7     Procedure

7.1       General Maintenance of Design History File

7.2       Content of the DHF

7.3       Day to day DHF work

7.4       Numbering of the Design History File

7.5       Security of Design History File Information

8     Attachments

9     SOP distribution

10         Health, safety and environmental considerations

Size and Format:

• Microsoft Office 2003
• Word File
• 8 pages procedure

The post Design History File (DHF) SOP appeared first on QMDocs Quality Management System Templates.