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.