This procedure covers the training program and skills levels required of personnel (including temporary personnel) performing functions that call for skills (i.e. GMP, etc.) where product quality and the quality system itself could be adversely affected by a lack of such skills.

Regulatory basis, reference documents

• 21 CFR Part 211.25 (a)
• 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       Management Team and Supervisory Staff

3.4       Human Resources

3.5       Department Manager

4          Related documents

5          Definitions

6          Procedure

6.1       General

6.2       On-the-Job Training

6.3       Training Need Analysis

6.3.1    GMP Training

6.3.2    Ad hoc GMP Training

6.3.3    Environment Health and Safety Training

6.4       Training schedule

6.5       Registering of names

6.6       Training execution

6.7       Training follow-up

6.8       Non-Attendance of courses

6.9       Training records

6          Attachments

6.1       Attachment 1: On-the-Job training form

6.2       Attachment 2: Training needs analysis form

6.3       Attachment 3: Course evaluation form

6.4       Attachment 4: Attendance register

6.5       Attachment 5: Request to attend training course form        11

7          SOP distribution        11

8          Health, safety and environmental considerations     11

Size and Format:

Microsoft Office

Word File

17 pages procedure

The post Training Program SOP 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.

This SOP is applicable to all GxP manufacturing and quality operations including development processes manufacturing clinical trail materials, toxicity testing and stability studies as well as to the personnel who are responsible for conducting Supplier certification.

This procedure pertains to any supplier that provides raw materials, intermediates, packaging materials and components that are subject to GMP manufacturing, or could have a direct impact upon the quality of a medicinal product or medical device in development, registered or marketed.

Regulatory basis, reference documents

• 21 CFR 211 Section 211.84
• EU GMP Chapter 7

Table of Content: 

1          Purpose

2          Objective

3          Regulatory basis, reference documents

4          Responsibility and accountability

4.1       Company Management

4.2       Quality Assurance

4.3       Quality Control Department

4.4       Procurement Department

5          Related documents

6          Definitions

7          Procedure

7.1       Supplier Qualification and Certification Program (general)

7.2       Supplier Approval (Step I)

7.3       Supplier Qualification (Step II)

7.4       Supplier Certification (Step III)

7.5       Reduced Testing

8          Attachments

8.1       Attachment 1: Supplier Status List

8.2       Attachment 2: Supplier Change Control Sheet

9          SOP distribution

10        Health, safety and environmental considerations

Size and Format:

• Microsoft Office
• Word File
• 11 pages procedure

The post Supplier Approval, Qualification and Certification SOP appeared first on QMDocs Quality Management System Templates.

This SOP is applicable to all GxP manufacturing and quality operations including development processes manufacturing clinical trail materials, toxicity testing and stability studies as well as to the personnel who are responsible for conducting Deviations according to this SOP.
All deviation investigations must be conducted and documented on the attached deviation form.

Regulatory basis, reference documents

• 21 CFR 211.100(b)
• 21 CFR 211.111
• EU GMP Guide Part 1, 1.3 (xii)s

Table of Content: 

1          Purpose

2          Objective

3          Regulatory basis, reference documents

4          Responsibility and accountability

4.1       Company Management

4.2       Manufacturing Department

4.3       Quality Assurance

4.4       Quality Control Department

4.5       Engineering Department

4.6       Information Technology Department

4.7       Other Departments

5          Related documents

6          Definitions

7          Procedure

7.1       Deviation (general)

7.2       Incident (minor deviation)

7.3       Investigation (general)

7.4       Immediate Action

7.5       Corrective Actions

7.6       Preventative Action

7.7       Trending of Deviations

8          Procedure

8.1       Deviation occurred

8.2       Details of Deviation Section I (attached form)

8.3       QA Confirmation Section II (attached form)

8.4       Investigation Section III (attached form)

8.5       Corrective Actions Section IV (attached form)

8.6       Preventive Actions Deviation Section V (attached form)

8.7       Quality Assurance Review Section VI (attached form)

8.8       Deviation close out Section VII (attached form)

9          Attachments

10        SOP distribution

11        Health, safety and environmental considerations

Size and Format:

• Microsoft Office
• Word File
• 17 pages procedure

The post Deviations and Non-Conformances 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.

The objective of this SOP is to describe the pre-market clinical evaluation process of medical devices.

This SOP describes how the clinical evaluation is conducted according to MEDDEV 2.7.1, guideline for clinical evaluation.

All activities relevant for the conduct of a clinical investigation according ISO 14155 are not part of this SOP.

Regulatory basis, reference documents

• MEDDEV2.7.1/Rev.3 : Guideline on medical devices: Clinical evaluation – a guide for manufactures and notified bodies
• EN ISO 14155:2011: Clinical investigation of medical devices for human subjects – Good clinical practice
• Directive 93/42/EEC: Council Directive 93/42/EEC and amendments
• EN ISO 14971 Medical devices – application for risk management to medical devices

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       Medical Scientist

5          Related documents

6          Definitions

7          Procedure

7.1       Introduction to Clinical Evaluation

7.2       General

7.3       Process

7.3.1    Definition of Scope

7.3.2    Essential Requirements

7.3.3    Literature Search

7.3.4    Clinical Experience Data

7.3.5    Clinical Investigations

7.3.6    Analysis of Clinical Data

7.3.7    Conclusion and Report

8          Attachments

9          SOP distribution

10        Health, safety and environmental considerations

Size and Format:

Microsoft Office

Word File

10 pages procedure

The post Clinical Evaluation Medical Devices Development appeared first on QMDocs Quality Management System Templates.

This SOP applies to all medical devices under development after concept and feasibility studies are completed and the COMPANY Management approves the initiation of a Product Development. This SOP applies to all personnel involved in the Management Review as well as for marketed Medical Devices.

Regulatory basis, reference documents

• 21 CFR Part 820, Subpart B – Quality System Regulation, 820.20 Management Responsibility
• ISO 13485:2016: Medical Devices – Quality management systems Requirements for regulatory purposes; 5.6 Management Review
• ISO 9001, Section 6: Resource Management

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       Management Committee Members

4.4       Function / Area Leaders / Project Manager

5          Related documents

6          Definitions

7          Procedure

7.1       Frequency of Management Reviews

7.2       Management Review Inputs (Agenda)

7.3       Management Review Participants

7.4       Management Review Outputs

7.5       Management Review Report and Follow up

8          Attachments

Attachment 1: Management Review Flow chart (1 page)

9          SOP distribution

10        Health, safety and environmental considerations

Size and Format:

Microsoft Office 2003

Word File

15 pages procedure

The post Management Review for Medical Devices 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.

Risk Management begins after concept and feasibility studies are completed and Management approves the initiation of a Product Development Project. 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. The SOP describes on how to perform a risk management process, it provides guidance on how to identify hazards, estimate severity and probability of occurrence of harm as well as to evaluate the corresponding risk and on how to mitigate these risks. The SOP describes on how to handle the residual risks after risk mitigations was implemented. This includes hazard identification covering design, manufacturing, labeling/package, maintenance and disposal of the medical device.

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
• 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 Risk Mitigation Priorities (general rules)
7.3 Software Risk Analysis
7.4 Risk Analysis File
7.5 Risk Analysis Plan
7.6 Risk Analysis Process
7.7 Functional Analysis (Grey Box)
7.8 Identification of hazards and estimation of risk
7.9 Probability of Occurrence
7.10 Risk Estimation
7.11 Risk Control
7.12 Residual Risk evaluation and Risk benefit Analysis
7.13 Risk Analysis Report
7.14 Post-Production Activities
8 Attachments
Attachment 1: TOC: Risk Analysis Report (1 pages)
Attachment 2: Schematic representation of the Risk Management principle – ISO 14971 (1 page)
Attachment 3: Generic Risk Management graph (1 page)
Attachment 4: Practical Example Risk Management graph (1 page)
9 SOP distribution
10 Health, safety and environmental considerations

Size and Format:

• Microsoft Office 2003
• Word File
• 19 pages procedure

The post Risk Management Process appeared first on QMDocs Quality Management System Templates.