Standard Operating Procedure (SOP) on Batch Record Training

1. Purpose

The purpose of this SOP is to provide a standardized approach to training personnel on the proper handling, completion, and review of batch records. This training ensures compliance with regulatory and company standards, minimizes errors, and promotes accurate documentation for quality assurance in manufacturing processes.

2. Scope

This SOP applies to all personnel involved in the creation, completion, and review of batch records within the manufacturing and quality control departments.

. Responsibilities

3.1 Training Department

1. Designing the Training Program

The Training Department is responsible for creating a structured, comprehensive batch record training program tailored to the company’s specific processes, regulatory requirements, and industry standards. This involves:

• Understanding Regulatory Requirements: The department must ensure the training aligns with FDA, GMP, and other applicable guidelines to meet industry compliance standards.
• Developing Training Content: Training materials should cover all aspects of batch record documentation, from data entry requirements to error prevention strategies and regulatory expectations.
• Customizing Modules: The program should address the different roles in the organization, with specific training for personnel who create, review, or approve batch records.

2. Scheduling and Organizing Training Sessions

The Training Department manages the logistics of scheduling, organizing, and conducting training sessions. This involves:

• Establishing Training Frequency: They determine the frequency of initial and refresher training, typically scheduling these quarterly, semi-annually, or annually based on company requirements.
• Coordinating with Departments: The department coordinates with supervisors in manufacturing, quality control, and quality assurance to ensure employees can attend the sessions without disrupting essential operations.
• Setting Up Resources: Arrangements for training rooms, equipment (e.g., projectors, laptops), and training materials are made in advance to ensure smooth, uninterrupted sessions.

3. Conducting Training Sessions

Conducting the training sessions effectively is another primary responsibility of the Training Department. This involves:

• Ensuring Experienced Trainers: Trainers who are knowledgeable in regulatory compliance, batch record documentation, and industry best practices should conduct the sessions.
• Providing Hands-on Practice: Trainees should have opportunities to complete sample batch records under supervision to gain practical experience. Hands-on practice is essential for understanding the nuances of batch record completion.
• Interactive Learning: Training sessions should include case studies, Q&A segments, and discussions on real-life examples of common mistakes and best practices.

4. Assessing Competency

Competency assessment is critical to ensuring that employees have understood the training material and can apply it accurately. The Training Department is responsible for:

• Developing Assessment Tools: This includes written tests and practical exercises to evaluate both theoretical knowledge and practical skill in handling batch records.
• Evaluating Performance: Assessments are reviewed to verify that employees can accurately complete batch records with minimal errors. Employees must meet a minimum competency threshold (e.g., 80% accuracy) to pass.
• Providing Feedback: Constructive feedback should be given to employees to address any gaps in knowledge or skills, and additional training sessions should be offered if necessary.

5. Documentation and Record-Keeping

Maintaining accurate and up-to-date records of all training activities is essential for compliance and audit purposes. The Training Department is responsible for:

• Recording Training Attendance: They ensure that attendance is recorded for each session and that participants sign an acknowledgment of completion.
• Maintaining Training Records: Each employee’s training history, including competency assessment results and retraining records, should be stored in a centralized database or Learning Management System (LMS).
• Ensuring Accessibility of Records: These records must be readily accessible for internal audits or regulatory inspections, verifying that all personnel handling batch records are adequately trained.

6. Identifying and Addressing Training Gaps

The Training Department must be proactive in identifying and addressing any gaps in the batch record training process. This involves:

• Analyzing Audit Feedback: They review internal audit findings to identify areas where employees may require additional training.
• Monitoring Employee Performance: If repeated errors or trends emerge in batch records, additional or remedial training sessions are scheduled to reinforce proper procedures.
• Updating Training Content: Training materials should be regularly reviewed and updated based on new regulatory guidelines, changes in processes, or feedback from audits and employee assessments.

7. Coordinating Retraining and Refresher Courses

The Training Department is also responsible for scheduling and conducting retraining or refresher courses. This is necessary when:

• Procedures Change: If there are updates to batch record procedures or regulatory guidelines, the Training Department promptly updates training materials and schedules refresher courses.
• Non-Conformance Issues Arise: If employees make frequent mistakes or there are incidents of non-compliance, the department organizes retraining sessions to reinforce correct procedures.
• New Hires or Role Changes: New employees and those transitioning into batch record-related roles should undergo initial training. Similarly, any employees who have been away from batch record handling for an extended period should attend refresher courses.

8. Supporting Continuous Improvement

Continuous improvement is essential to keep the batch record training program effective and relevant. The Training Department supports this by:

• Soliciting Feedback: Gathering feedback from trainees, supervisors, and auditors helps to improve the training content and delivery methods.
• Benchmarking Against Industry Standards: They stay informed of industry trends and best practices, incorporating new techniques or technologies into the training program as needed.
• Evaluating Training Effectiveness: Periodically reviewing the program’s effectiveness helps ensure that training objectives are met and that the organization maintains a high standard of documentation quality.

3.2 Supervisors/Department Heads

1. Understanding Training Requirements and Standards

Supervisors and department heads must be thoroughly knowledgeable about batch record requirements, industry standards, and regulatory guidelines, such as Good Manufacturing Practice (GMP) and FDA regulations. This understanding enables them to:

• Interpret Regulatory Expectations: Supervisors should understand what regulators expect from batch records and how these requirements translate into daily production activities.
• Ensure Training Compliance: They must ensure that training requirements are met for all personnel, regularly reviewing the training content to stay up-to-date on standards.
• Communicate Standards to Team Members: By clearly explaining the importance of batch record accuracy and compliance, they instill in employees the critical role these records play in product safety and quality.

2. Overseeing and Supporting Batch Record Training Sessions

Supervisors play an active role in overseeing the batch record training process, ensuring employees receive and understand the training. Their responsibilities include:

• Facilitating Access to Training: Supervisors must ensure that team members are scheduled for training sessions and have the time and resources to attend without disrupting production.
• Coordinating with the Training Department: They work closely with the Training Department to arrange training sessions and ensure relevant topics are covered based on their department’s specific needs.
• Monitoring Participation: Supervisors keep track of which team members have completed required training and identify employees needing refresher sessions or additional support.

3. Providing On-the-Job Training and Guidance

In addition to formal training sessions, supervisors and department heads provide on-the-job training to reinforce learning. This hands-on approach includes:

• Demonstrating Correct Procedures: Supervisors often demonstrate how to accurately fill out batch records, especially for complex sections, and provide guidance on best practices for documentation.
• Answering Questions and Addressing Concerns: Employees may have specific questions or uncertainties about batch record procedures, and supervisors serve as a primary point of contact to clarify any doubts.
• Providing Real-Time Feedback: By reviewing records immediately after they are completed, supervisors can give instant feedback, reinforcing correct procedures and addressing any issues as they arise.

4. Monitoring and Assessing Employee Competency

A critical responsibility of supervisors and department heads is to monitor the competency of their team members in batch record documentation. This involves:

• Conducting Competency Assessments: Supervisors may perform competency evaluations, observing employees during the batch recording process and reviewing their completed records to assess accuracy.
• Identifying Training Gaps: By evaluating performance, supervisors can identify gaps in understanding or skill levels and recommend additional training or support for those employees.
• Documenting Competency: They document each employee’s competency in batch record tasks, providing evidence for compliance purposes and supporting the organization’s quality management system.

5. Ensuring Adherence to Batch Record Procedures

Supervisors are responsible for maintaining a high level of procedural adherence within their teams. They ensure that team members follow established guidelines and instructions when filling out batch records. Responsibilities in this area include:

• Regular Record Review: Supervisors periodically review batch records to verify completeness, accuracy, and compliance with regulatory standards. They check for common errors, omissions, or discrepancies that may affect product quality or compliance.
• Implementing Corrective Actions: When errors are identified, supervisors work with team members to correct them and provide training on avoiding similar mistakes in the future.
• Reinforcing the Importance of Compliance: Supervisors regularly remind their team of the importance of following documentation procedures accurately and reinforce a culture of compliance through positive reinforcement and corrective feedback.

6. Facilitating Continuous Improvement and Best Practices

As frontline managers, supervisors and department heads have unique insights into batch record procedures and can help identify areas for improvement. They support continuous improvement by:

• Collecting Feedback on Training: Supervisors can gather feedback from employees on batch record training programs and relay this information to the Training Department to improve future sessions.
• Implementing Best Practices: By analyzing errors and process gaps, supervisors can establish best practices for batch record documentation and share these with their teams to promote consistency and efficiency.
• Encouraging Proactive Problem-Solving: Supervisors encourage employees to report issues they encounter with batch records and work together to find solutions that enhance accuracy and compliance.

7. Handling Retraining and Remedial Actions

Supervisors and department heads are responsible for identifying when retraining or remedial actions are necessary, especially in cases where documentation issues persist. This includes:

• Initiating Retraining Sessions: Supervisors coordinate with the Training Department to organize refresher courses for employees who may need additional support or who show repeated errors in documentation.
• Addressing Performance Concerns: For employees who continue to struggle with batch record accuracy, supervisors develop performance improvement plans and work closely with them to reinforce key documentation skills.
• Documenting Remedial Actions: Supervisors keep records of any additional training, coaching, or corrective actions taken, which serves as proof of compliance and quality assurance efforts.

8. Maintaining Batch Record Documentation and Readiness for Audits

Supervisors ensure that batch records are maintained accurately, complete, and readily accessible for internal and external audits. Their responsibilities here include:

• Ensuring Record Completeness: Supervisors verify that all batch records are signed, dated, and contain all required information before they are submitted for final review.
• Preparing for Audits: Supervisors ensure that batch records are well-organized, easily accessible, and meet regulatory requirements in case of an audit. They may conduct mock audits to check for potential issues.
• Responding to Audit Findings: If an audit reveals documentation issues, supervisors address these findings with corrective actions and ensure any required adjustments are implemented in the batch record process.

9. Promoting a Culture of Quality and Compliance

Beyond enforcing standards and monitoring performance, supervisors and department heads play a crucial role in creating a culture that prioritizes quality and compliance. They foster this environment by:

• Setting an Example: By consistently following documentation protocols themselves and demonstrating high standards, supervisors set an example for their team to follow.
• Recognizing Good Performance: They recognize and reward team members who consistently adhere to batch record procedures, encouraging others to follow suit.
• Encouraging Open Communication: Supervisors create an environment where employees feel comfortable asking questions or reporting issues, which helps maintain a proactive approach to quality and compliance.

3.3 Employees

1. Understanding the Importance of Batch Records

Employees should start by understanding the critical role batch records play in the organization and the industry.

• Comprehending Regulatory and Quality Standards: Employees need to be familiar with Good Manufacturing Practices (GMP), FDA guidelines, and other relevant regulations that govern documentation standards in batch records.
• Recognizing the Role of Batch Records in Product Safety: Batch records ensure that every product manufactured adheres to the intended specifications, making them essential for safeguarding product quality and patient safety.
• Acknowledging the Impact on Compliance and Audits: Inadequate documentation can lead to regulatory non-compliance, impacting the organization’s ability to operate. Employees must recognize that accurate batch records help prepare the organization for regulatory audits and inspections.

2. Actively Participating in Training Sessions

Employees involved in batch record training are expected to take an active role in the training process to develop their documentation skills.

• Attending All Scheduled Training: Employees are responsible for attending all mandatory training sessions, whether they are initial or refresher courses, and making up any sessions they miss.
• Engaging in Training Activities: Employees should actively engage in training by asking questions, seeking clarification, and participating in discussions to enhance their understanding.
• Utilizing Provided Training Materials: Training sessions often include manuals, guides, and other resources. Employees are encouraged to review these materials thoroughly to reinforce their learning.

3. Following Established Documentation Procedures

Adhering to proper documentation procedures is one of the primary responsibilities of employees involved in batch record training.

• Recording Information Accurately and Legibly: Employees must ensure that every entry in the batch record is accurate, complete, and legible. Errors, omissions, and illegible handwriting can lead to compliance issues and potential product recalls.
• Using Correct Terminology and Abbreviations: Employees should use standardized terms, units, and abbreviations as per the organization’s guidelines, ensuring consistency in all documentation.
• Maintaining Real-Time Documentation: Entries in batch records should be made in real-time as processes occur. Delayed entries can lead to inaccuracies and may be flagged during audits.

4. Ensuring Completeness and Accuracy of Records

Completeness and accuracy are essential for batch records to meet regulatory and quality requirements.

• Double-Checking Entries: Employees should review their entries to ensure that they are complete and accurate before submitting the batch record. This includes verifying dates, times, quantities, and other critical details.
• Correcting Errors Properly: If errors occur, employees should follow the organization’s protocol for corrections, typically by striking through the incorrect entry with a single line, adding the correct information, and initialing the change.
• Documenting All Necessary Details: Every aspect of the batch process, from ingredient quantities to processing times and environmental conditions, must be thoroughly documented in the batch record.

5. Following Good Documentation Practices (GDP)

Good Documentation Practices (GDP) are essential to ensure that records are consistent and reliable.

• Writing Clearly and Legibly: Employees should ensure that their handwriting is clear, readable, and without excessive abbreviations that could cause confusion.
• Signing and Initialing Entries Where Required: All batch record entries require signatures or initials to verify who documented the information, providing accountability.
• Ensuring Date and Time Accuracy: Employees must accurately record the date and time for each documented action, as these details are essential for tracing and verifying process steps.

6. Seeking Clarification and Guidance

Employees should actively seek clarification whenever they are unsure about any aspect of batch record documentation.

• Asking Supervisors or Trainers: Employees are encouraged to ask their supervisors, trainers, or colleagues if they are uncertain about any part of the documentation process.
• Requesting Additional Training if Needed: If an employee feels that further training is necessary, they should request additional support. Supervisors and the training department are there to help ensure all employees are confident and competent in batch record procedures.
• Referring to Standard Operating Procedures (SOPs): SOPs are invaluable resources for employees to reference specific procedures and ensure that they are following documented instructions correctly.

7. Complying with Confidentiality and Security Policies

Since batch records contain sensitive information, employees must handle them with care and follow all relevant security protocols.

• Safeguarding Documentation: Employees should avoid sharing batch records with unauthorized individuals and ensure that records are stored securely.
• Following Data Protection Policies: Employees are required to follow data protection and confidentiality policies, especially when handling electronic records, to maintain the integrity and security of information.
• Maintaining Confidentiality: In some cases, batch records may contain proprietary information. Employees must be careful to protect this information from disclosure.

8. Participating in Regular Assessments and Competency Evaluations

Employees should be prepared to participate in regular assessments to ensure ongoing competency in batch record documentation.

• Completing Competency Tests: Employees may be required to take tests or assessments to validate their knowledge and skills in batch record documentation.
• Accepting Feedback for Improvement: Supervisors may provide feedback on batch record documentation. Employees should accept feedback constructively and apply it to improve their documentation practices.
• Participating in Retraining if Necessary: If areas for improvement are identified, employees should willingly participate in retraining sessions to address any gaps in their understanding or performance.

9. Reporting Documentation Issues or Observed Errors

Employees have a responsibility to report any issues or errors they observe in batch records, whether made by themselves or others.

• Identifying and Reporting Documentation Errors: Employees must identify and report documentation errors to supervisors immediately to ensure they are corrected in a timely manner.
• Reporting Systemic Issues: If an employee notices recurring issues in batch documentation, they should report this to their supervisor. This may indicate a need for process improvements or additional training.
• Promoting a Culture of Transparency and Accuracy: By reporting errors and addressing documentation issues promptly, employees contribute to a workplace culture that values accuracy, transparency, and accountability.

10. Contributing to Continuous Improvement Initiatives

Employees play a critical role in contributing to process improvements and refining documentation practices.

• Providing Feedback on Training Programs: Employees should offer feedback on training sessions to help the training department enhance future programs.
• Suggesting Improvements to Documentation Practices: Employees may have insights into potential improvements for batch record processes, which can increase efficiency and accuracy.
• Participating in Lean or Process Improvement Projects: Employees involved in batch record training may be asked to participate in continuous improvement initiatives that help streamline documentation practices and reduce the risk of errors.

3.4 Quality Assurance (QA)

1. Designing and Implementing Batch Record Training Programs

One of the main responsibilities of the QA department in batch record training is to develop comprehensive training programs tailored to the needs of different employees.

• Developing Training Modules: QA is responsible for creating and structuring training modules that cover all aspects of batch record documentation. These modules must align with regulatory standards such as Good Manufacturing Practices (GMP) and FDA requirements.
• Customizing Training Based on Roles: Employees have different levels of involvement in batch records, depending on their roles. QA designs specific training for operators, supervisors, and managers, addressing each group’s responsibilities in documentation.
• Including Practical Exercises: QA should include hands-on exercises and case studies in the training to allow employees to practice real-world scenarios, helping them understand the nuances of batch documentation and how to handle common issues.

2. Ensuring Adherence to Regulatory Standards

QA has a key responsibility to ensure that batch record training aligns with relevant regulatory standards, guaranteeing compliance across documentation practices.

• Incorporating GMP and GDP in Training: QA must ensure that Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) are embedded in all batch record training materials, ensuring employees understand the importance of following these guidelines.
• Staying Updated with Regulatory Changes: Regulations evolve over time, and QA has to stay current with these updates to ensure that training programs and batch record practices remain compliant with the latest standards.
• Providing Guidance on Compliance: QA should emphasize the critical nature of compliance in every training, educating employees on the consequences of non-compliance, including potential recalls, legal consequences, and damage to the organization’s reputation.

3. Conducting Training Sessions and Workshops

QA plays an active role in delivering training sessions to ensure that employees are well-versed in batch record practices.

• Leading Initial and Ongoing Training Sessions: QA is responsible for conducting both initial training for new hires and ongoing refresher courses for all employees involved in batch documentation.
• Organizing Specialized Workshops: In addition to regular training, QA may hold workshops focusing on specific topics, such as error handling, corrective actions, and proper documentation techniques, to reinforce key skills.
• Utilizing Interactive Training Methods: QA should employ interactive training methods, including quizzes, group discussions, and role-playing exercises, to engage employees and reinforce their understanding of batch record requirements.

4. Reviewing and Approving Batch Records

QA must review completed batch records to ensure they are accurate, complete, and compliant before approving them for further processing.

• Conducting Thorough Reviews: QA is responsible for meticulously reviewing each batch record, verifying that all entries are complete, accurate, and free from errors or omissions.
• Cross-Checking Data: QA compares entries with production reports, equipment logs, and material usage records to confirm that documented information matches actual production conditions.
• Ensuring Compliance with Corrective Actions: If corrective actions are taken during production, QA ensures that they are documented properly in the batch record and that the actions meet regulatory and organizational standards.

5. Providing Guidance on Error Handling and Documentation Corrections

QA must instruct employees on how to handle and document errors correctly to maintain data integrity.

• Educating on Error Correction Procedures: QA trains employees on the proper methods for correcting errors in batch records, including single-line strikethroughs, adding the correct information, and initialing corrections.
• Clarifying Documentation Expectations: QA sets expectations regarding documentation precision and guides employees on avoiding common errors, ensuring employees understand the criticality of maintaining data integrity.
• Enforcing Error Reporting and Resolution: QA emphasizes the importance of promptly reporting errors and ensuring they are properly resolved, helping to prevent future mistakes.

6. Monitoring Compliance and Conducting Audits

QA is responsible for regularly monitoring compliance with batch record standards and conducting audits to identify areas for improvement.

• Performing Routine Checks: QA conducts routine checks to confirm that employees adhere to batch record protocols, addressing any lapses in documentation standards.
• Conducting Internal Audits: Regular internal audits help QA identify potential weaknesses in batch record practices, allowing them to make proactive adjustments to training and documentation procedures.
• Enforcing Corrective and Preventive Actions (CAPA): Based on audit findings, QA may implement corrective and preventive actions (CAPA) to address documentation issues, ensuring continuous improvement and regulatory compliance.

7. Providing Feedback and Coaching to Employees

QA plays a vital role in providing feedback to employees on their batch record documentation practices, ensuring continuous improvement in their skills.

• Giving Constructive Feedback: QA reviews employees’ batch records and provides feedback on documentation accuracy, legibility, and completeness, offering specific advice for improvement.
• Coaching for Error Prevention: When patterns of errors emerge, QA provides coaching to employees to help them understand and prevent common mistakes.
• Conducting Follow-Up Training as Needed: If certain employees require additional support, QA arranges follow-up training sessions to reinforce best practices in batch record documentation.

8. Maintaining Training Records and Documentation

QA is responsible for maintaining records of all batch record training activities, ensuring accurate records of employee competency and compliance.

• Documenting Training Attendance: QA keeps track of attendance for all batch record training sessions to verify that all relevant employees have completed their required training.
• Tracking Competency Assessments: QA maintains records of competency assessments, helping to identify employees who may need additional support or retraining.
• Ensuring Training Documentation Completeness: QA reviews and maintains documentation of training sessions, ensuring records are complete, current, and available for internal and external audits.

9. Supporting Continuous Improvement Initiatives

QA contributes to continuous improvement in batch record training by identifying and implementing improvements to training practices.

• Gathering Employee Feedback on Training Programs: QA gathers feedback from employees on training effectiveness, allowing them to refine training materials and approaches based on direct input.
• Analyzing Error Trends: QA monitors trends in batch record errors and uses these insights to make targeted improvements in training and documentation practices.
• Enhancing Training Materials: Based on audit findings, QA continuously updates training materials, integrating new standards, improved practices, and relevant case studies to keep training up-to-date and impactful.

10. Facilitating External Audits and Regulatory Inspections

QA is instrumental in facilitating external audits and inspections, showcasing the organization’s commitment to high standards in batch record management.

• Ensuring Readiness for Audits: QA ensures that all batch records are complete, accurate, and accessible for regulatory audits, demonstrating that the organization’s documentation practices are compliant.
• Providing Support During Inspections: During external audits or inspections, QA provides information, answers questions about batch records, and clarifies documentation practices to inspectors.
• Implementing Post-Audit Improvements: If inspectors identify areas for improvement, QA takes responsibility for updating training and documentation practices based on their recommendations.

4. Definitions

4.1 Batch Record

• A comprehensive documentation of the production process and testing steps for a specific batch of product, including ingredients, quantities, equipment, and personnel involved.

4.2 Training Program

• A structured session or series of sessions designed to educate personnel on proper batch record procedures and ensure regulatory compliance.

4.3 Competency Assessment

• An evaluation method used to verify that personnel can accurately and independently complete and review batch records after training.

5. Materials and Equipment

5.1 Training Manual

• A comprehensive manual that includes detailed procedures for filling out batch records, common errors, troubleshooting steps, and regulatory guidelines.

5.2 Standardized Batch Record Forms

• Copies of the batch record templates used within the facility, provided for training and hands-on practice.

5.3 Training Room

• A designated area equipped with the necessary resources (e.g., projectors, computers) to conduct training sessions effectively.

6. Procedure

6.1 Training Program Development

• The Training Department designs a detailed program that covers all aspects of batch record completion and review. The training should include:
  • Understanding the purpose of each section of the batch record.
  • Recognizing common errors and how to avoid them.
  • Following guidelines for data accuracy, such as rounding rules, unit consistency, and notation clarity.
  • Complying with regulatory requirements regarding batch record documentation.

6.2 Training Session Scheduling

• Training sessions should be scheduled regularly (e.g., quarterly, semi-annually) and upon hiring new employees or introducing updated procedures.
• Supervisors or department heads coordinate with the Training Department to enroll employees in the next available session.

6.3 Conducting Training Sessions

• Training sessions should be led by a qualified instructor who provides:
  • An overview of regulatory requirements for batch records (FDA, GMP, ISO, etc.).
  • A walkthrough of a sample batch record, highlighting key points and potential issues.
  • Hands-on practice with a batch record simulation where employees complete records under guided supervision.

6.4 Competency Assessment

• After the training session, employees undergo a competency assessment. The assessment should include:
  • A written test on theoretical knowledge.
  • A practical assessment where employees complete a sample batch record.
  • A review of the completed batch record by the trainer or QA personnel.
• Employees must score above a minimum threshold (e.g., 80%) to be deemed competent in batch record handling.

6.5 Documentation of Training

• Following training and competency assessment, the Training Department records each employee’s training in the company’s Learning Management System (LMS) or training log.
• Documentation includes the employee’s name, date of training, training content, and results of the competency assessment.
• Employees must sign an acknowledgment of training completion.

6.6 Ongoing Training and Retraining

• Retraining sessions are scheduled for employees who have:
  • Made repeated errors in batch records.
  • Been absent from batch record handling for an extended period.
  • Completed additional training due to updates in regulatory or company standards.

7. Evaluation and Auditing

7.1 Internal Audits

• QA conducts periodic audits of batch records to verify compliance and detect any training gaps.
• Audit results are shared with the Training Department to address any identified issues in future training sessions.

7.2 Continuous Improvement

• Feedback from audits and employee performance is used to improve and update the training program.
• The Training Department periodically reviews training materials to ensure alignment with current regulatory standards and company procedures.

8. Records and Documentation

• All training records, competency assessments, and related documentation must be stored and maintained for a minimum of <specify period> in compliance with company and regulatory guidelines.
• Digital records should be maintained in the company’s Learning Management System (LMS) or a centralized database for easy access and retrieval.

9. References

• Good Manufacturing Practices (GMP) Guidelines
• FDA Regulations on Batch Record Keeping
• Internal Quality Manual
• ISO 9001: Quality Management Systems

10. Revision History

Revision No.	Date	Description of Change	Approved By
1.0	<Date>	Initial Release	<Name/Title>
1.1	<Date>	Minor updates to training format	<Name/Title>

---

11. Approval

Name	Title	Signature	Date
<Approver’s Name>	<Approver’s Title>	<Signature>	<Date>