Training personnel under Current Good Manufacturing Practices (cGMP) is crucial for maintaining the quality and compliance of pharmaceutical and other regulated products. Here’s a general Procedure for Training of the Personnel Under cGMP Environment

PURPOSE

The purpose of this SOP is to describe the procedure for training of the Procedure for Training of the Personnel Under cGMP Environment at Pharmaceutical Industries Limited. Based on the identified needs, develop a comprehensive training plan. This plan should outline the training objectives, content, methods, resources, and a timeline for implementation.

SCOPE

The scope of this SOP pertains to all the persons working at Pharmaceutical Industries Limited. Conduct a thorough analysis to identify training needs. This may include assessing the current skills, knowledge, and competencies of employees and identifying areas that require improvement or additional training.

ROLES AND RESPONSIBILITIES

1. It is the responsibility of the department heads to follow this SOP as it is written.
2. It is the responsibility of QA to ensure that all employees have been educated, trained and qualified in their respective job functions, regulatory and compliance regulations and safety procedures/regulations.
3. QA is responsible for reviewing and updating this methodology as required and ensuring compliance.

DEFINITIONS

Orientation training: training of new employees, general company rules, job description, CGMP concepts, safety regulations and an overview of their specific roles and responsibilities.
Document Training – Document training is conducted by QAD. Managers and supervisors or an author also be the conducted documents trainings. Develop documented procedures for conducting training. These procedures should cover the entire training process, including planning, execution, evaluation, and record-keeping.
Task Training – Tasks training refers to particular methodology or process training and applies in laboratory and production areas.
Proficiency training – Training by experience of at least one or more years at any particular discipline.
Equipment training – Equipment training to be operations of equipment’s.

PROCEDURES

Orientation Training (General cGMP Training) for new employ
All the new employees at English Pharmaceutical Industries Limited have to complete orientation training which includes the following, depending on the nature of the job responsibility of the person:

1. General Company Policies
2. GXP requirements
3. Personnel hygiene
4. Procedures for Gowning and De-gowning
5. cGMP documentation
6. General Company Regulations.
7. Job descriptions

Procedure for Training of the Personnel Under cGMP Environment

1. HR department request QA to arrange the orientation training for the newly appointed employees by using the Form (FQA-00).
2. QA executes the training in different stages considering the level of the trainee.
3. At the end of training, trainer gives a questioner to all the participants about the training topic.
4. Name and signature of the trainee are recorded on Training Participants List (FQA-00).
5. Trainee fills the Training Feed Back Form (FQA-004), at the end of training.
6. After one month of the training, Head of Department of trainee evaluates the training and fills the last portion of Training Feed Back Form (FQA-00).
7. Trainer signs the Training Participants List (FQA-005) and forwards it to QA for record keeping.
8. QA maintains the record of the training in Training Record File.
9. Procedure for Training of the Personnel Under cGMP Environment

On-Job Training

1. Department head identifies the training needs of the employees working under their supervision.
2. On-Job training includes both Task training and Equipment training.
3. The trainee observes the trainers during executions of a task or equipment operation and understands it.
4. The trainee performs three times the same task or operation.
5. The trainer must observe the trainee performance during task execution.
6. The trainer evaluates the trainee performance. The evaluation is based on a review of the consistency of the performance.
7. Upon completion of training and approval of trainer, the trainee is qualified to perform that particular task.
8. QA record the information on trainee’s individual training record.
9. Fill the separate training Forms for different equipments and tasks.

Document Training

1. Document training is done either by QA or departmental head, or designee.
2. QA inform trainees about the training venue time and make necessary arrangement for the training.
3. The trainer and trainee discuss the document in detail, addressing all the relevant issues and questions that the trainee may have.
4. At the end of training, trainer gives a questioner to all the participants about the document.
5. QA record the training Form in Training Record File.

NOTE: The trainee’s signature indicates he or she fully understand the content of document on which he or she is trained

Schedule Training

1. Department heads make a schedule for cGMP routine trainings according to the requirements of their working area.
2. The schedule trainings are on at least quarterly basis.
3. The training schedule for all the departments must be approved by QA on bi-annual basis.
4. Trainer request QA to arrange the training at the schedule date and inform the trainees about time and venue.
5. Name and signature of the trainee are recorded.
6. QA maintain the record of the training in Training Record File.

Proficiency Training (job enrichment)

1. When a person is performing the same job or task for more than one year, he or she is considered a trained person for that task.
2. The experienced persons fills the Proficiency Training schedule for his/her skills
3. Head of department signs the Form.
4. QA maintain the record of the training in Training Record File.

Out-Source Training (External Training)

1. EPI arranges out-source training whenever required, for its employees to improve their competency in the job related fields.
2. QA keeps the record of Out-source trainings.

Employee Competence Evaluation and Authorization

1. Head of each department evaluate the competence of his employees.
2. When the competence of the employee is up to acceptable level, department head declare authorization to perform that particular task (machine operation, analysis, documentation etc.)
3. A copy of authorization list must be available in the personnel file and in QA.

QUALITY FORMS AND REORDS

1. Training Schedule
2. Training Record

DISTRIBUTION

1. Head of Operations
2. Quality Assurance Manager
3. Quality Control Manger
4. Production Manager
5. Ware House In-charge
6. Manager Technical Services

Remember that the specific details of the training program may vary based on the organization’s size, industry, and the nature of its operations. Always refer to applicable regulations and guidelines for specific requirements related to cGMP training in your region.