STANDARD OPERATING PROCEDUREPage 1 of 8
Document Number: S-124 Version 1.xx
Training for GMP Compliance

Standard Operating Procedure

Training for GMP Compliance

This is an example of a Standard Operating Procedure. It is a proposal and starting point only. The type and extent of documentation depends on the process environment. The proposed documentation should be adapted accordingly and should be based on individual risk assessments. There is no guarantee that this document will pass a regulatory inspection.

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Company Name: /
Controls:
Superseded Document / N/A, new
Reason for Revision / N/A
Effective Date / April 15, 2012
Signatures:
Author / I indicate that I have authored or updated this SOP according to applicable business requirements and our company procedure: Preparing and Updating Standard Operating Procedures.
Name:______
Signature:______
Date:______
Approver / I indicate that I have reviewed this SOP, and find it meets all applicable business requirements and that it reflects the procedure described. I approve it for use.
Name:______
Signature:______
Date:______
Reviewer / I indicate that I have reviewed this SOP and find that it meets all applicable quality requirements and company standards. I approve it for use.
Name:______
Signature:______
Date:______

1.PURPOSE

Adequate qualification of people is important to meet business and regulatory requirements. Training can close the gap between actual qualifications and requirements of the assigned job. This procedure should ensure that people working in international and FDA regulated GMP environments receive adequate training and that this training is documented.

2.SCOPE

Training assessment, delivery, evaluation and documentation of all employees working in international and FDA regulated GMP environments. The SOP covers initial and ongoing training of new and existing employees. It covers permanent and temporary hires.

3.GLOSSARY/DEFINITIONS

Note: For general definitions, see .

4.REFERENCE DOCUMENTS

N/A

5.RESPONSIBILITIES

5.1.Manager/Supervisor

5.1.1.Defines job description and tasks.

5.1.2.Identifies the employee’s qualification obtained through education, experience and previous training courses.

5.1.3.Determines the gap between the actual qualification and the qualification required to perform the assigned tasks.

5.1.4.Develops a training plan with time schedule.

5.1.5.Allocates enough time to the employee for training.

5.1.6.Ensures that the employee participates in internal or external training courses as described in the training plan.

5.1.7.Evaluates success of trainings through checking certificates or through personal examination.

5.1.8.Retains and maintains training records.

5.1.9.Assures that only qualified persons perform the work.

5.1.10.Reviews and updates the training plan twice a year to ensure ongoing qualification.

5.2.Quality Assurance Department

5.2.1.Develops SOP for training.

5.2.2.Develops forms for the documentation of training.

5.2.3.Reviews the training plan for compliance with FDA and equivalent international GMP regulations.

5.2.4.Approves or rejects the training plan.

5.2.5.Develops training material and delivers training courses on FDA and equivalent international GMP regulations.

5.3.Human Resources

5.3.1.Recruits people with sufficient qualifications so that training can be conducted in a reasonable time frame to close the gap between the actual and desired qualification.

5.3.2.Helps identify external training material and trainers.

5.4.All Employees

5.4.1.Bring gaps between actual and required qualifications to the attention of the supervisor.

5.4.2.Participate in internal and external training courses and other training events as defined in the training plan.

6.PROCEDURE

6.1.Training for New Employees

Independent from any specific job requirements and specific training needs each new permanent and temporary employee gets a basic one day training either by the employee’s supervisor or by his/her delegate. Items to be trained on include:

  • Organization and responsibilities.
  • Basics of Good Manufacturing Practices.
  • Environmental, health and safety issues.
  • Security.
  • General work practices.
  • Documentation of Specific Training Requirements
  • The supervisor documents tasks and job requirements:
  • Job description.
  • Tasks for the next 12 months.
  • Required technical skills.
  • Compliance knowledge.
  • The supervisor, together with the employee, documents actual skills:
  • Education.
  • Experience.
  • Past trainings.
  • The supervisor, together with the employee, documents gaps between requirements and actual skills.
  • Development of a Training Plan
  • The supervisor, together with the employee, develops a training plan to fill the gap between job requirements and actual skills. The plan includes:
  • Items to be included in the training.
  • Type of training (experimental, personnel, classroom, self-study).
  • Verification and documentation of success.
  • Timetable.
  • Type of training.
  • The training plan is reviewed and approved by QA.
  1. Conducting and Documentation of the Training
  2. The employee monitors the training plan and informs the supervisor about upcoming training events.
  3. The employee participates in the trainings and tests.
  4. The employee collects any training certificates, test results and other documentation generated and/or handed out during the training.
  5. The supervisor discusses the training, its effectiveness and results with the employee.
  6. The supervisor evaluates whether the training documentation is complete and sufficient to document the success of the training.
  7. If the documentation in 6.4.5 is insufficient, the supervisor decides on how to further evaluate the employee’s knowledge to assess the success of the training.
  8. The supervisor documents the training event in the employee’s training record file.
  9. Ongoing Evaluation of Training Requirements and Update Trainings
  10. Every six months the supervisor, together with the employee, evaluates the training plan and results.
  11. The supervisor updates the training plan if necessary.
  12. Records

All of the following should be retained:

6.6.1.Job description, tasks and requirements.

6.6.2.Gap analysis and training plan.

6.6.3.Training records.

6.6.4.Training certificates.

7.ATTACHMENTS

7.1.Attachment – Training Requirements

Employee:

Supervisor:

Department:

Date:

Job Description:

Assigned Tasks:

Required Qualification / Education, Previous Experience or Training Courses / (Additional)
Training Required
Yes 0 No 0
Yes 0 No 0
Yes 0 No 0
Yes 0 No 0
Yes 0 No 0
Yes 0 No 0
Yes 0 No 0
Yes 0 No 0

7.2.Attachment – Training Records

Employee:

Supervisor:

Department:

Date:

Training Subject:
Training Objective:
Type of Training: / E.g. classroom
Location:
Date:
Duration (Days):
Qualified Trainer:
Certificate Available:
Training Objective Met: / Yes 0 No 0
Judged by: / E.g. certificate or through personal examination by the supervisor.
If objective not met explain why:
Approval by Supervisor: / ______
Name Date Signature

(Replace with your company’s name) FOR INTERNAL USE