QMS-095 GMP Training Procedure

Document Owner

Quality Assurance Manager

Affected Parties

All manufacturing colleagues

Purpose

The purpose of this document is to outline the delivery of GMP training.

Scope

The scope of this document covers all permanent, contract and casual staff, whose role has a direct and indirect impact on GMP.

Definition

Related Documents

EHS Statement

Not applicable – there is no EHS impact.

Procedure

All manufacturing employees are required to attend a formal GMP Induction training program at the commencement of employment as an introduction to the principles of Good Manufacturing Practices.

To ensure a continued knowledge of current GMP requirements, Manufacturing staff is required to undertake GMP education on an ongoing basis.  The GMP Maintenance Education Points System is a means of ensuring this.

1.1.           GMP Maintenance Education Points System

1.1.1.       All staff within the Manufacturing Division are required to earn designated GMP points annually or on a pro rata basis, as determined by the GMP Training Officer.  The GMP training calendar operates from January to December and employees are not allowed to carry over points from one year to the next.  The level of points that various job roles and departments need to acquire is depicted in the table below.  This is only a minimum requirement and may be exceeded in any particular year.

1.1.2.       GMP Points can be earned through attendance at internal and external GMP Training courses, meetings, etc.  GMP Points have been allocated based on the GMP content and duration of the courses and are not limited to the courses listed below.  However, suggested courses will require GMP assessment and approval by the GMP Training Officer for the appropriate points allocation.

GMP Maintenance Education Points System

This is considered the minimum requirement and may be exceeded in any particular year.

Points for GMP Education are generally allocated as follows:

Responsibilities for GMP

2.1.          Identifying needs for GMP training

2.1.1.       The GMP Training Officer is responsible for the following:

a. Development and review of GMP training requirements and strategy across the Manufacturing Division and GMP impacting areas.

b. Ensuring policies and plans are documented.

c. Maintaining compliance with in-house and regulatory requirements.

d. Allocation of points for GMP Maintenance Education courses, meetings and presentations.

e. Reviewing and tracking GMP breaches and incidents to assess trends and organizational opportunities for training.

f. Evaluating training programs and materials.

2.1.2.       The Management Responsibilities

Assisting the GMP Training Officer in the development and review of GMP training requirements and strategy across the Manufacturing Division and GMP impacting areas.

Evaluating training programs and materials.

2.2.          Training Design and Delivery

2.2.1.       The GMP Training Officer is responsible for the following:

a. The design of GMP training workshops for staffs.

b. Facilitating GMP awareness and training for staffs (including non Manufacturing Division staff whose activities have GMP impact).

c. Assessing participants against set criteria.

d. Overseeing the design and delivery of programs provided by external organizations and ensuring skills of trainers are appropriate.

2.2.2.       The Management is responsible for the following:

a. Assisting the GMP Training Officer in the design of GMP training workshops for relevant staff.

b. Assessing participants against set criteria.

2.3.          Training Assessment Design

2.3.1.       The GMP Training Officer is responsible for the following:

a. Ensure technical terminology is correct.

b. The level of GMP performance expected from the assessments is appropriate.

c. Working with the management to design appropriate assessments and documentation.

2.3.2.       Management is responsible for the following:

a. Designing assessments and documentation, i.e. ensuring the content and level of assessment is linked to the training conducted; ensuring the assessment questions are appropriately worded.

b. The method of assessment is appropriate.

2.4.          Conducting and recording of assessment

It is the responsibility of the assessor to correctly record the assessment of an employee and return the record to the employees training file located with the relevant Line Manager.

2.5.          Management Reporting

2.5.1.       The GMP Training Officer is responsible for the following:

a. Assess compliance of internal training programs to organizational requirements.

b. Provide reports on current GMP compliance status for training.

c. Maintain training records for QA.

d. Compile performance KPIs (Key Performance Indicator) as required.

e. Facilitate annual review of QA training requirements.

2.6.         Training Coordination and Promotion

It is the responsibility of the management to coordinate the booking of GMP training in consultation with the Area Manager, and the GMP Training Officer if they are facilitating the program.  This includes booking of sessions, notifying employees and their Managers of time, date, location and costs where relevant.

The GMP Training Officer will be responsible for the promotion and awareness of the courses to the business.

2.7.          Recording and Archiving Training Assessment

2.7.1.       It is the responsibility of the training officer and the line manager that, the individual employee’s file is up to date.  These files are stored in the Training Officer’s office.

2.7.2.       Recording of Course attendance and Assessment:

It is the responsibility of the GMP Training  Officer to record all courses booked for GMP training.

Details must include:

a. Title of course and course code

b. Date/s of course

c. Trainer’s name

d. Name of employees who attended

e. Assessment results where appropriate (A copy of the original assessment document including the assessor’s signature should be filed in the employee’s individual training file.

2.7.3.       It is the responsibility of line management to advise the Training Officer, if an employee has attended a GMP training course not centrally coordinated. GMP Training Officer will then record this information in the in the employee’s individual training file.

2.7.4.       It is the responsibility of the Training Officer to record GMP Training Points earned by employees within the Manufacturing division throughout the year.

2.7.5.       Training records for Manufacturing employees should be kept for 15 years after an employee has been terminated.

2.7.6.       If an employee transfers to another department and the Line Manager has kept their training file, this should be transferred to the new Line Manager.

Summary of Changes