1.0 OBJECTIVE:
1.1 To establish a systematic and documented procedure for planning, conducting, evaluating, recording, and maintaining Good Manufacturing Practice (GMP) training programs to ensure that all employees, contractors, consultants, service providers, and other personnel working within the company possess the knowledge, skills, and awareness necessary to perform their assigned duties in compliance with WHO GMP, applicable regulatory requirements, company procedures, and quality standards.
2.0 SCOPE:
2.1 This SOP applies to all personnel performing activities that may affect product quality, patient safety, data integrity, GMP compliance, and regulatory compliance, including: Permanent employees, Temporary employees, Contract employees, Consultants, Service providers, Contractors
3.0 RESPONSIBILITIES:
3.1 Quality Assurance (QA):
3.1.1 Prepare and maintain Annual Training Plan.
3.1.2 Coordinate GMP training activities.
3.1.3 Maintain training records.
3.1.4 Monitor training compliance.
3.1.5 Conduct periodic review of training effectiveness.
3.1.6 Ensure GMP refresher training is conducted as per schedule.
3.1.7 Verify completion of training before personnel perform GMP activities independently.
3.2 Department Heads:
3.2.1 Identify training needs of personnel.
3.2.2 Ensure personnel attend scheduled training.
3.2.3 Ensure contractors receive required training before work commencement.
3.3 Trainers:
3.3.1 Prepare approved training material.
3.3.2 Conduct training effectively.
3.3.3 Assess trainee understanding.
3.3.4 Maintain attendance records.
3.4 Employees:
3.4.1 Attend scheduled training programs.
3.4.2 Actively participate in training sessions.
3.4.3 Apply training knowledge during routine activities.
3.4.4 Comply with GMP requirements.
3.5 Contractors / Service Providers:
3.5.1 Attend mandatory GMP orientation before entering GMP areas.
3.5.2 Comply with site GMP requirements.
3.5.3 Follow all applicable SOPs and safety requirements.
4.0 DEFINATIONS:
4.1 GMP Training: Training intended to provide knowledge and understanding of Good Manufacturing Practices and applicable regulatory requirements.
4.2 Training Effectiveness: Evaluation performed to determine whether training objectives have been achieved.
4.3 Contractor: Any external individual or organization providing services within the facility.
5.0 PROCEDURE:
5.1 General requirements:
5.1.1 All personnel whose activities may directly or indirectly impact product quality, patient safety, data integrity, contamination control, or GMP compliance shall receive GMP training appropriate to their responsibilities.
5.1.2 GMP training shall be mandatory before personnel are permitted to work independently in GMP areas.
5.1.3 GMP training shall be conducted in a language understood by the trainee.
5.1.4 GMP induction training shall include:
5.1.4.1 Basic principles of GMP.
5.1.4.2 Importance of product quality and patient safety.
5.1.4.3 Personal responsibility under GMP.
5.1.4.4 Personnel hygiene requirements.
5.1.4.5 Gowning procedures.
5.1.4.6 Entry and exit procedures for GMP areas.
5.1.4.7 Cleanroom behavior
5.1.4.8 Contamination control principles.
5.1.4.9 Cross-contamination prevention.
5.1.4.10 Prevention of mix-ups.
5.1.4.11 Material and personnel movement requirements.
5.1.4.12 GMP do’s and don’ts.
5.2 GMP Induction Training for New Employees:
5.2.1 All newly recruited personnel shall undergo GMP induction training before being granted routine access to GMP production, warehouse, laboratory, engineering, utility, or support areas.
5.2.2 Evaluation of trainee shall be performed to determine whether training objectives have been achieved.
5.2.3 If the trainee fails in passing criteria, retraining for the trainee shall be conducted as per the guidance provided in Training SOP.
5.2.4 Training Evaluation and Attendance records of the Trainees shall be maintained in Quality Assurance department.
5.3 Annual GMP Refresher Training:
5.3.1 All personnel working within GMP areas shall undergo GMP refresher training at least once every twelve months.
5.3.2 The purpose of refresher training shall be to reinforce GMP awareness and promote continuous compliance with GMP requirements.
5.3.3 If the trainee fails in passing criteria, retraining for the trainee shall be conducted as per the guidance provided in Training SOP.
5.3.4 Training Evaluation and Attendance records of the Trainees shall be maintained in Quality Assurance department.
5.3.5 Long-term contractors routinely working within GMP areas shall receive annual GMP refresher training.
6.0 REFERENCE:
6.1 WHO Technical Report Series (TRS) – Current GMP Guidelines.
7.0 RECORDS:
Sr No. Title Nature of Document Document No.
NA NA NA NA
8.0 REVISION HISTORY:
Amendment Date: Update Summary Version No.
NA New SOP 01