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

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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

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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

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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

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For the European market, when a device is placed on the market forming a single integral product together with a medicinal product and it is not reusable, it shall be governed by the Medicinal Products Directive 2001/83/EC (MPD) applying the requirements of Annex I to the Medical Devices Directive 93/42/EEC (MDD), as far as safety and performance-related device features are concerned.

General The objective of this SOP is to specify and describe the all necessary system prerequisites for developing and marketing a combination product following 21 CFR Part 4. Regulatory basis, reference documents

• AAMI/ANSI HE74 Human factors design process for medical devices
• AAMI/ANSI HE75 Human factors engineering – Design of medical devices
• IEC 62366Medical Devices – Application of human factors engineering to medical devices
• ISO 14971: Medical Devices – Application of risk management to medical devices
• ISO 9241Ergonomics 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
• ANSI/AAMI/ISO 13485 Medical Devices – Quality Management Systems
• 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
• 21 CFR Part 4 Current Good Manufacturing Practice Requirements for Combination Products
• 21 CFR Part 3 Product Jurisdiction

Table of content

1 Purpose and Objective
2 Regulatory basis, reference documents
3 Responsibility and accountability
3.1 Company Management
3.2 Quality Head and Department
4 Related documents
5 Definitions
6 Procedure
6.1 Medical Device and combination Product in US
6.1.1 Medical Device US
6.1.2 Combination Product US
6.2 Medical Devices and combination product in EU
6.2.1 Medical devices EU
6.2.2 Combination Product EU
6.3 Process deliverables
6.3.1 Risk Management
6.3.2 Design Control
6.3.3 Design Change Control
6.3.4 Purchasing Control
6.3.5 CAPA
6.3.6 Non-conformance / Deviation during Development and Production of Combination Products
6.3.7 Post Market surveillance
6.3.8 Post-approval Phase
6.3.9 Training
6.3.10 Market complaints
7 Attachments
8 SOP distribution
9 Health, safety and environmental considerations

Size and Format: Microsoft Office 2003
Word File 13 pages procedure

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The purpose of this Compliance Checklist CFR 820 is to verify that a organisation is complainant to 21 CFR 820 Quality System Regulations. This evaluation checklist can be used as part of a supplier evaluation or audit process or as an checklist for internal auditing or to perform a gap analysis as part of any compliance program or inspection readiness initiative.

US Food and Drug Administration (FDA) 21 Code of Federal Regulations (CFR) part 820

Table of Content:

1          Purpose & Objective

2          Regulatory basis, reference documents

3          Responsibility and accountability

4          Definitions

5          Procedure

5.1       820.20 – Management Responsibility

5.2       820.22 – Quality Audits

5.3       820.25 – Personnel

5.4       820.30 – Design Controls

5.5       Design and Development planning

5.6       Design Input

5.7       Design Output

5.8       Design Reviews

5.9       Design Verification

5.10      Design Validation

5.11      Design Transfer

5.12      Design History File

5.13      820.40 – Document Controls

5.14      820.50 – Purchasing Controls

5.15      820.60 – Identification

5.16      820.65 – Traceability

5.17      820.70 – Production and Process Controls

5.18      820.72 – Inspection, Measuring, and Test Equipment

5.19      820.75 – Process Validation

5.20      820.80 – Receiving, in-process, and finished device acceptance

5.21      Receiving acceptance activities

5.22      In-Process acceptance activities

5.23      Final Acceptance Activities

5.24      820.86 – Acceptance Status

5.25      820.90 – Non-Conforming Product

5.26      820.100 – Corrective and Preventive Action

5.27      820.120 – Device Labeling

5.28      820.130 – Device Packaging

5.29      820.140 – Handling

5.30      820.150 – Storage

5.31      820.160 – Distribution

5.32      820.170 – Installation

5.33      820.180 – General Requirements

5.34      820.181 – Device Master Record

5.35      820.184 – Device History Record

5.36      820.186 – Quality System Record

5.37      820.198 – Complaint Files

5.38      820.200 – Servicing

5.39      820.250– Statistical Techniques

6          Attachments

Size and Format of the Compliance Checklist CFR 820:

• Microsoft Office 2003
• Word File
• 24 pages checklist – gap analysis

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