Master PlanPage 1 of 52
Document Number: M-133 Ver. 1.xx
Laboratory Compliance

Master Plan

Laboratory Compliance

January 2014

This is an example of a Master Plan. 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.

Publication from

Global on-line resource for validation and compliance

Copyright by Labcompliance. This document may only be saved and viewed or printed for personal use. Users may not transmit or duplicate this document in whole or in part, in any medium. Additional copies and licenses for department, site or corporate use can be ordered from

While every effort has been made to ensure the accuracy of information contained in this document, Labcompliance accepts no responsibility for errors or omissions. No liability can be accepted in any way.

Labcompliance offers books, master plans, complete Quality Packages with validation procedures, scripts and examples, SOPs, publications, training and presentation material, user club membership with more than 300 downloads and audio/web seminars. For more information and ordering, visit

Company Name: /
Controls:
Superseded Document / N/A, new
Reason for Revision / N/A
Effective Date / January 1, 2014
Signatures:
Author / I indicate that I have authored or updated this Master Plan according to applicable business requirements and our company standards.
Name:______
Signature:______
Date:______
Approver / I indicate that I have reviewed this Master Plan, 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 Master Plan and find that it meets all applicable quality requirements and company standards. I approve it for use.
Name:______
Signature:______
Date:______

Table of Contents

1.Introduction, Scope and Objectives of this Document

1.1Introduction

1.2The Laboratory

1.3Scope of the Master Plan

1.4Objectives of the Master Plan

2.Policy

3.Structure of QMS Documentation

3.1Documentation Hierarchy

3.2Laboratory Compliance and Corporate Master Plans

3.2.1Risk Management Master Plan (19.1.1)

3.2.2Equipment Qualification Master Plan (19.1.2)

3.2.3Computer System Validation Master Plan (19.1.3)

3.2.4Network Qualification Master Plan (19.1.4)

3.2.521 CFR Part 11 Compliance Master Plan (19.1.5)

3.2.6Training Master Plan (19.1.6)

3.2.7Calibration and Preventive Maintenance Master Plan (19.1.7)

3.3Processes

3.4Procedures and Work Instructions

3.5Records

3.6Checklists, Forms, Templates, Examples

4.Organization and Responsibilities

4.1Management

4.2Quality Assurance

4.3Department Manager and Supervisors

4.4Analysts

4.5Safety Officer

5.Facilities and Environmental Conditions

6.Document Control

7.Internal Audits

8.Management Reviews

9.Staffing and People Qualification

9.1Procedure

9.2Training Courses and Tools for Pre- or Self-Study

9.3Assessment Tools

10.Selection and Validation of Analytical Methods and Procedures

10.1Method Selection

10.2Validation of Methods Developed by The Laboratory

10.3Verification of Standard Methods

10.4Method Revalidation

10.5Using Alternative Methods

10.6Using Software for Automated Method Validation

11.Equipment and Computers

11.1Equipment Identification

11.2Equipment Logs

11.3Qualification of Equipment Hardware

11.4Off-the-Shelf Computer System Validation

11.5Validation of Software Developed In-House

11.6Operation

11.7Maintenance

11.8Out of Service

11.9Equipment Temporarily Leaving The Laboratory

11.10Decommissioning

12.Sampling

13.Reagents and Calibration Standards

14.Traceability of Measurements

15.Stability Testing

16.Handling of Test Items

17.Testing

18.Quality of Test Results and Failure Investigations

18.1Ongoing Performance Control of the Analysis System

18.2Out-of-Specification Results and Failure Investigations

18.3Root Cause Analysis and Corrective and Preventive Action Plans

18.4Data Review and Validation

18.5Reporting Test Results

19.Identification and Management of Records

20.References

20.1Primers and Master Plans

20.2Reference Publications

20.3Audio Seminars

20.4Standard Operating Procedures

20.5FDA and International Regulations, Guidelines and Presentations

20.6Worksheets, Checklists, Forms, Templates, Examples

21.Attachments

21.1Laboratory Personnel

21.2Document Master List

21.3Template and Example to Document Training Requirements

21.4Template to Document Training

21.5Equipment List

21.6List with Authorized Users of Equipment

21.7Equipment Records

21.8Recording Sampling Data

21.9List of Records to be Archived

21.10Checklist for Testing

Master Plan

Laboratory Compliance

1.Introduction, Scope and Objectives of this Document

1.1Introduction

This Laboratory Compliance Master Plan documents The Laboratory’s approach and steps for compliance with FDA and equivalent international regulations.

1.2The Laboratory

The Laboratory performs analyses of raw material, intermediates and finished products and performs stability tests at a pharmaceutical manufacturing site. The site manufactures drugs for the United States and international markets. Most of the processes are considered high risk because pharmaceutical quality control laboratories are the last control step in drug manufacturing and after the analysis result is released the drug products are shipped to the market. As of the release date of this master plan (March 2006), The Laboratory has 85 employees, 8 of them are employed part time.

1.3Scope of the Master Plan

  • Analytical laboratories in (bio)pharmaceutical manufacturing.
  • US FDA and equivalent international GxP regulations.
  • This master plan has been developed for a pharmaceutical quality control laboratory, however, the principles and approaches can be easily customized and applied to other FDA regulated laboratories, e.g., regulated development laboratories and for clinical studies.

1.4Objectives of the Master Plan

This laboratory master plan has several objectives:

  • It serves as a guideline for how cGMP requirements can be implemented efficiently and consistently in The Laboratory.
  • It answers the inspector’s question about the company’s approaches for compliance in The Laboratory.
  • It demonstrates management commitment and support for compliance in laboratories through its policy statement.
  • It helps personnel at all management levels understand how compliance is approached and implemented in The Laboratory.
  • Assists in the preparation of project plans.
  • It helps to produce and maintain high quality analytical data.

2.Policy

The Laboratory produces high quality data and fully complies with US FDA and equivalent international GxP regulations in a cost-effective manner. This is achieved through:

  • Effective communication of the master plan to all employees and assurance of correct understanding of the plan.
  • Following documented processes and procedures for cGMP and quality relevant operations.
  • Clear definition of roles and responsibilities for management and staff.
  • Ongoing monitoring of FDA and international guidelines and timely adaptation of processes and procedures if necessary.
  • Risk-based processes and procedures.
  • Continuous evaluation and improvement of processes and procedures.
  • Validation of critical processes, equipment hardware and computer systems.
  • Adequate design and control of facilities and environmental conditions.
  • GxP compliant recording and archiving of data.
  • Evaluation and investigation of deviations from expected results with root cause analysis and corrective and preventive action plans.
  • Suitable handling of samples, chemicals and standards.
  • Regular system suitability tests or quality control checks before and in between sample analyses.
  • Reviewing and validating analytical data.
  • Sufficient and appropriately qualified and trained personnel.
  • Auditing of actual processes for compliance with documented processes and procedures.
  • Management support.
  • Annual review of processes and procedures.

3.Structure of QMS Documentation

This section of the master plan describes various types of documents and how they interrelate with each other.

3.1Documentation Hierarchy

There are different types of documentation as illustrated in the documentation pyramidin Figure 1.

The master plan is the top tier of the document hierarchy. It describes the approaches to achieve compliance and quality data. It also includes policy statements describing the intent and goal of The Laboratory and key points on how these goals can be achieved. The compliance master plan does not include detailed processes or procedures on how to achieve compliance but it does have a list of the processes and procedures.

A process describes how various compliance and quality requirements can be achieved. For example, it describes how the requirement “people should be qualified for the assigned task” can be implemented.

Procedures are step-by-step instructions on how to exactly perform a specific task for a specific instrument. Depending on what the task is this can have the form of an SOP or a test script. Examples are how to analyze sample X, how to calibrate balance A from vendor B or how to test a specific chromatographic data system.

Records are generated on a day-by-day basis. Examples are analytical results from product tests or calibration records of a balance.

Figure 1. Documentation Hierarchy

3.2Laboratory Compliance and Corporate Master Plans

Master plans are documents that lay out a company’s approach for specific activities, e.g., how to achieve compliance for a laboratory. Approaches for laboratories cannot be isolated from other activities and master plans in the organization. For example, risk management strategies as defined in a corporate risk management master plan should also apply to laboratory system validation. Training for laboratory staff should be conducted and documented following the company’s training master plan.

Although this laboratory compliance master plan provides enough information to implement a compliance program in The Laboratory, it does not give enough details for supporting tasks. For example, it does not include detailed information for validating computer systems, on preparing, conducting and documenting trainings, or information on password conventions and risk management strategies. However, these activities are also important for The Laboratory’s compliance strategies. Therefore there must be a tight link between The Laboratory master plan and other master plans. For a better understanding this chapter describes other master plans available in the organization.

3.2.1Risk Management Master Plan (20.1.1)

The risk management master plan describes the company’s approach for risk assessment and risk management, for example, to comply with the FDA’s Part 11 Guidance: “Scope and Applications” based on a “justified and documented” risk assessment. It is used as a source for project specific individual risk management project plans.
An example master plan is included in the Laboratory Compliance Package from Labcompliance.

3.2.2Equipment Qualification Master Plan (20.1.2)

The equipment qualification master plan describes the company’s approach for qualifying equipment such as analytical instruments. It also details steps for equipment qualification and owners and deliverables for the qualification phase.

3.2.3Computer System Validation Master Plan (20.1.3)

The computer system validation master plan describes the company’s approach for validation of software and computer systems. It is used as a source for project specific individual validation plans.

3.2.4Network Qualification Master Plan (20.1.4)

The network qualification master plan describes the company’s approach for qualifying IT infrastructure and networks. It is used as a source for project specific individual qualification plans.

3.2.521 CFR Part 11 Compliance Master Plan (20.1.5)

The Part 11 compliance plan describes the company’s approach and steps for implementing compliant electronic records and electronic signatures.An example master plan is included in the 21 CFR Part 11 Compliance Package from Labcompliance:

3.2.6Training Master Plan (20.1.6)

The training master plan describes the company’s approach on how to identify training needs for employees, how to develop and implement a training plan, how to conduct trainings and finally how to document the trainings. Trainings for laboratory staff should follow the recommendations in this master plan.

3.2.7Calibration and Preventive Maintenance Master Plan (20.1.7)

The calibration and preventive maintenance master plan describes the company’s approach for calibration and maintenance of equipment.

3.3Processes

Processes describe how various compliance and quality requirements can be achieved. For example, it describes how the requirement “people should be qualified for the assigned task” can be implemented. Another example is how to make sure that “equipment is suitable for its intended use”. In this case the processes on equipment qualification apply to instrument categories such as analytical equipment hardware or more specific to an instrument family such as UV-VIS Spectrophotometers, but processes are not like specific instruments identified by a product number. For a better understanding process flow charts should be included in a process description.

Processes typically are documented in standard operating procedures. A list of SOPs for various processes is included in Reference 20.4.

3.4Procedures and Work Instructions

Routine activities follow documented procedures. These are typically defined as standard operating procedures and/or work instructions. While master plans describe the tasks and approaches, procedures and work instructions give step-by-step instructions on how to do the tasks. Examples for SOPs are procedures for training, for qualification of equipment, for validation of commercial off-the-shelf systems, for change control and for risk assessment. An example for a work instruction would be how to execute a test script.

3.5Records

FDA and equivalent international regulations require a specific type of information to be retained for a specific amount of time.. For example, 21 CFR 211.194 defines which laboratory records should be retained and archived and the duration. Examples are results of product tests and measurement parameters, calibration results, sample descriptions and instruments used for testing.

Besides the records explicitly mentioned in regulations, the FDA expects that other records are available to demonstrate compliance with the CGMP regulations. Examples are training records to demonstrate compliance with people training and environmental monitoring records to comply with the requirement to adequately control environments.

The Laboratory acquires and maintains all records as required by the FDA and equivalent international regulations for at least the specific time as defined in regulations. The exact retention period for each type of record is defined by corporate policies.

3.6Checklists, Forms, Templates, Examples

Checklists, forms, templates and examples help implement compliance effectively and consistently. Examples are checklists and worksheets for vendor qualification, handling out-of-specification results and for Part 11 compliance. Templates are available for system documentation, test protocols, maintenance and change logs.

4.Organization and Responsibilities

Responsibilities of management and staff are defined and annually reviewed. While the Quality Assurance department is responsible for setting up compliance systems, implementation and maintenance of the system is the responsibility of each manager, supervisor and employee. Copies of job descriptions, job applications, resumes and annual reviews are kept on file in the Human Resources department.

Figure 2. Org Chart

Attachment 21.1 lists laboratory personnel with names, positions, education level and years of experience (total/current position).

4.1Management

Management is responsible for reviewing, approving, supporting and communicating the quality and compliance policy to employees.

Responsibilities and tasks include:

  • Management team is responsible for annually reviewing the compliance and quality system.
  • The president has executive responsibility for compliance and shall create an atmosphere where compliance and quality are the highest priority.
  • The vice presidents are responsible for overseeing the development, implementation and maintenance of compliance systems.
  • Each manager and supervisor is responsible for assuring that the compliance systems are implemented in his/her area.

4.2Quality Assurance

The Quality Assurance department sets up the compliance system and assists The Laboratory in the development, implementation and maintenance of the system. Tasks and responsibilities include:

  • Set compliance and quality goals and objectives for The Laboratory and develop plans to meet those goals and objectives.
  • Manage and participate in periodic audits to assure that compliance systems are implemented faithfully and effectively.
  • Train and advise management, supervisors and staff on quality aspects and regulations and internal policies.
  • Recommend solutions to compliance problems and verify when any problems have been resolved.
  • Report quality related issues to management.
  • Manage FDA and other external inspections and audits. Initiate corrective and preventive actions if necessary.
  • Oversee initial and ongoing instrument calibration and qualification.
  • Oversee the annual maintenance service.
  • Oversee the documentation, archiving and distribution of laboratory standard operating procedures.
  • Generate SOPs for non-analytical quality related operations.
  • Review all SOPs and other documents for completeness and compliance with company standards and regulations.
  • Review analytical data.
  • Issue data summaries for annual product reviews.
  • Organize annual management review of the compliance system.
  • Manage vendor assessment and audits.
  • Manage complaints.

4.3Department Manager and Supervisors

Lab managers and supervisors implement company policies and standards in their laboratories.

Tasks and responsibilities include:

  • Assure compliance with FDA and equivalent international regulations.
  • Responsible for the overall technical quality of the work performed in The Laboratory.
  • Supervision of all personnel in The Laboratory.
  • Ensure management procedures, applicable standards and specifications are followed.
  • Develop job descriptions for staff working in their departments.
  • Ensure that sufficiently qualified, skilled and trained personnel and other resources are available to perform the assigned tasks.
  • Ensure that job descriptions, tasks lists and training records are maintained to demonstrate staff competence for the assigned tasks.
  • Ensure that The Laboratory has appropriate equipment and supplies.
  • Schedule analytical sample analysis and ensure completion of analyses within required schedule.
  • Provide technical assistance to analysts regarding the selection of appropriate analytical methods.
  • Review and approve analytical method validation protocols and stability study protocols.
  • Review and validate all data before it is reported as final.
  • Generate and maintain Standard Operating Procedures (SOPs) for laboratory operation within his/her own work area.
  • Schedule initial and ongoing equipment qualification and preventive maintenance.
  • Assist analysts with handling out-of-specification situations, failure investigations, root cause analysis and corrective and preventive action plans.
  • Identify and report any opportunities to improve efficiency, compliance and quality.

4.4Analysts