This procedure covers all products, which are manufactured and or released by the company. All quality complaints whether verbal or in written must be recorded according to this SOP. Complaints records should be reviewed regularly for any indication of specific or recurring problems requiring attention and possibly the recall of marketed products.

Regulatory basis, reference documents

• 21 CFR Part 211.198, Complaint files
• EudraLex Volume 4, Part 1 Chapter 8 Complaints and Product Recall

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

4          Related documents

5          Definitions

6          Procedure

6.1       Complaint categories

6.1.1    Commercial Complaints

6.1.2    Product Technical Complaints (PTC)

6.1.3    Adverse Drug Event (ADE) Complaints

6.2       Complaint Investigation

6.3       Complaint Investigation details

6.3.1    Complaint information

6.3.2    Complaint registration

6.3.3    Complaint Tracking and follow up

6.3.4    Complaint final decision

6.3.5    Complaint response

6.3.6    Document complaint compiling and retention

6.3.7    Complaint Trending

6.4       Quality control

6.4.1    Testing of complaint samples

6.4.2    Reserve Samples / Retention sample

6.4.3    Report of test results

7          Attachments

7.1       Attachment 1: Complaint Investigation Form (5 pages)

8          SOP distribution

9          Health, safety and environmental considerations

Size and Format:

Microsoft Office

Word File

14 pages procedure

The post Complaint Handling – Customer Complaints SOP appeared first on QMDocs Quality Management System Templates.

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.

The scope of the Internal Audit Program encompasses all current Good Pharmaceutical Manufacturing Practice (cGMP) and Good Distribution Practices (GDP) topics including Information Systems and/or Computerized Systems and related Quality Management System Controls (e.g. compliance with SOPs, the applicable QA system used, change control, etc.). The Internal Audit program also takes into account the need to review any recurrent quality/quality system issues identified through non-conformance reporting.

Regulatory basis, reference documents

• 21 CFR 211 Section 211.84
• EU GMP Chapter 7
• Guide to Good Pharmaceutical Manufacturing Practice 1983.
• Code of Federal Regulations, Food and Drug, 21.211.
• EEC Guide to Good Manufacturing Practice for Medicininal Products, 1989.
• Article 14 of the EU directives on GMP (91/356/EEC and 91/412/EEC).

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       Lead Auditor

3.4       Audit Team

3.5       Auditee / Area Leader

4          Related documents

5          Definitions

6          Procedure

6.1       General

6.2       Internal Audit Preparation

6.3       Perform Internal Audit

6.4       Internal Audit Report

6.5       Internal Audit Follow up

6.6       Issue Categorization

6          Attachments

6.1       Attachment 1: Annual Internal Audit Program

6.2       Attachment 2: Internal Audit Report

6.3       Attachment 2: Internal Audit Report Observations

7          SOP distribution

8          Health, safety and environmental considerations

Size and Format:

Microsoft Office

Word File

15 pages procedure

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

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 SOP applies to all products commercial manufactured on site. It includes all commercial Active Pharmaceutical Ingredients (API), Drug Product and Medical Devices manufactured on site and for third parties used as contract manufacturer.
Where semi-finished product is processed in multiple Sites, all Sites must participate in the Annual Product Review process by supplying information to the facility of release.

Regulatory basis, reference documents

• FDA Code of Federal Regulations 21, Part 211 Subpart I (Laboratory Controls) and J (Records and Reports)
• FDA Human Drug CGMP Notes 1998
• PIC Document PH 2/87, Guideline for the Production of Pharmaceutical Drug Substances
• PIC Document PH 5/92, Guideline to Good Manufacturing Practice for Pharmaceutical Products

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 Management Representative/ Quality Assurance

4.3       Manufacturing

4.4       Quality Control Department (QC)

4.5       Regularly Affairs and Clinical Safety

5          Related documents

6          Definitions

7          Procedure

7.1       General

7.2       Statistic

7.2.1    Trending

7.2.2    Mean Charts

7.2.3    Range Evaluation

7.3       APR Report

7.3.1    Conclusion

7.3.2    Last years Recommendations

7.3.3    Manufactured Batches

7.3.4    Batches rejected

7.3.5    Batches reworked/reprocessed

7.3.6    Deviations, Out of Specification Results (OOS)

7.3.7    Environmental monitoring data

7.3.8    Product Specification/Method Changes

7.3.9    Retain samples (US)

7.3.10  Changes effected (Change Control)

7.3.11  Analytical data

7.3.12  Release Data

7.3.13  Stability data

7.3.14  Validation review

7.3.15  Recalls

7.3.16  Customer Complaints and Returns

7.3.17  Adverse Drug events

7.3.18  Inspections from any official inspectorate

7.3.19  New recommendations

8          Attachments

8.1       Attachment 1: Annual Product Review (APR) Report for Product (7 pages)

9          SOP distribution

10        Health, safety and environmental considerations

Size and Format

Microsoft Office

Word File

19 pages procedure

The post Quality Product Review / Annual Product Review 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 Standard Operating Procedure (SOP) describes the program necessary to ensure suppliers effectiveness of their quality assurance system and to ensure that the requirements of the Good Manufacturing Practice (GM) are being met by independent Audit. It assesses supplier’s reliability as well as continuous quality of products and services.

The purpose of this document is to provide clear guidance for Quality and GMP personnel conducting Audits of suppliers, contract manufacturing, packaging/labeling operations, analytical/microbiological laboratory testing, stability testing and general GMP facilities.

Regulatory basis, reference documents

• 21 CFR 211 Section 211.84
• EU GMP Chapter 7
• Guide to Good Pharmaceutical Manufacturing Practice 1983.
• Code of Federal Regulations, Food and Drug, 21.211.
• EEC Guide to Good Manufacturing Practice for Medicininal Products, 1989.
• Article 14 of the EU directives on GMP (91/356/EEC and 91/412/EEC).

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 Assurance

4.3       Procurement Department

5          Related documents

6          Definitions

7          Procedure

7.1       Different Types of Audit (general)

7.1.1    Audits of new suppliers / Due Diligence

7.1.2    Regular Audit

7.1.3    Re-approval Audit (Time Cycle)

7.1.4    For Cause Audit

7.2       Audit cycle time

7.3       Pre Audit (preparation) activities

7.3.1    Planning of a new supplier Audit

7.3.2    Supplier’s Response to the Audit Questionnaire

7.3.4    Common Pre-Audit Activities

7.3.5    Audit team

7.3.6    Audit Agenda

7.4       Performing the Audit

7.5       Post Audit activities

7.5.1 Audit Report

7.5.2 Conclusion of the Audit

7.5.3 Supplier Approval Categories

7.5.4 Audit closure

7.5.5 Record Retention

8          Attachments

8.1       Attachment 1: FDA Audit Checklist (6 pages)

8.2       Attachment 2: Audit Report Form (3 pages)

9          SOP distribution

10        Health, safety and environmental considerations

Size and Format:

• Microsoft Office
• Word File
• 21 pages procedure

The post Vendor, Supplier and Contractor Audit 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.