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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
www.labcompliance.com
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 www.labcompliance.com/solutions.
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 www.labcompliance.com/solutions.
Master Plan
Document Number: M-133 Ver. 1.xx
Laboratory Compliance
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Company Name:
Controls:
Superseded Document
N/A, new
N/A
Effective Date
January 1, 2014
Signatures:
Author
Approver
Reviewer
________________________________
Signature:
________________________________
Date:
________________________________
________________________________
Signature:
________________________________
Date:
________________________________
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:
________________________________
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Document Number: M-133 Ver. 1.xx
Laboratory Compliance
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Table of Contents
1. Introduction, Scope and Objectives of this Document...........................................6
1.1 Introduction..............................................................................................................6
1.2 The Laboratory........................................................................................................6
1.3 Scope of the Master Plan........................................................................................6
1.4 Objectives of the Master Plan.................................................................................6
2. Policy............................................................................................................................7
3. Structure of QMS Documentation.............................................................................8
3.1 Documentation Hierarchy........................................................................................8
3.2 Laboratory Compliance and Corporate Master Plans.............................................9
3.2.1 Risk Management Master Plan (19.1.1)..................................................................9
3.2.2 Equipment Qualification Master Plan (19.1.2).....................................................10
3.2.3 Computer System Validation Master Plan (19.1.3)................................................10
3.2.4 Network Qualification Master Plan (19.1.4).........................................................10
3.2.5 21 CFR Part 11 Compliance Master Plan (19.1.5)...............................................10
3.2.6 Training Master Plan (19.1.6)...............................................................................10
3.2.7 Calibration and Preventive Maintenance Master Plan (19.1.7)............................10
3.3 Processes..............................................................................................................11
3.4 Procedures and Work Instructions........................................................................11
3.5 Records..................................................................................................................11
3.6 Checklists, Forms, Templates, Examples.............................................................12
4. Organization and Responsibilities..........................................................................12
4.1 Management..........................................................................................................13
4.2 Quality Assurance..................................................................................................13
4.3 Department Manager and Supervisors.................................................................14
4.4 Analysts.................................................................................................................15
4.5 Safety Officer.........................................................................................................15
5. Facilities and Environmental Conditions...............................................................15
6. Document Control.....................................................................................................17
7. Internal Audits...........................................................................................................18
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Laboratory Compliance
8. Management Reviews...............................................................................................19
9. Staffing and People Qualification...........................................................................20
9.1 Procedure..............................................................................................................20
9.2 Training Courses and Tools for Pre- or Self-Study................................................21
9.3 Assessment Tools..................................................................................................21
10. Selection and Validation of Analytical Methods and Procedures........................22
10.1
Method Selection.............................................................................................22
10.2
10.3
10.4
Method Revalidation........................................................................................23
10.5
10.6
Equipment Identification...................................................................................24
11.2
Equipment Logs...............................................................................................25
11.3
11.4
11.5
11.6
Operation.........................................................................................................27
11.7
Maintenance.....................................................................................................28
11.8
Out of Service..................................................................................................28
11.9
11.10 Decommissioning.............................................................................................28
12. Sampling....................................................................................................................29
13. Reagents and Calibration Standards......................................................................30
14. Traceability of Measurements.................................................................................31
15. Stability Testing.........................................................................................................31
16. Handling of Test Items..............................................................................................32
17. Testing........................................................................................................................33
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18. Quality of Test Results and Failure Investigations...............................................34
18.1
18.2
18.3
18.4
18.5
20.2
Reference Publications....................................................................................39
20.3
Audio Seminars................................................................................................40
20.4
20.5
20.6
21. Attachments..............................................................................................................45
21.1
Laboratory Personnel.......................................................................................45
21.2
21.3
21.4
21.5
Equipment List.................................................................................................48
21.6
21.7
Equipment Records.........................................................................................50
21.8
21.9
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Master Plan
Laboratory Compliance
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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:
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Management support.
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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.
3.2.2
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Processes
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Checklists, Forms, Templates, Examples
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Management
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Set compliance and quality goals and objectives for The Laboratory
and develop plans to meet those goals and objectives.
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Manage complaints.
Ensure that job descriptions, tasks lists and training records are
maintained to demonstrate staff competence for the assigned tasks.
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Work areas are separated to ensure that analyses will not be adversely
affected within resources provided.
The Laboratory areas are separated from other sections in the building
such as administration services, lunch room and conference rooms.
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6. Document Control
Development and maintenance of documentation is controlled through document
control and management procedures (SOPs S105 and S504) (Ref. 20.4) that are
part of the management system. Documents include internal and external
documents. Examples for internal documents are SOPs, master plans and training
plans. Examples for external procedures are regulations, standards, test methods
and instrument operating manuals.
The procedure for document control ensures that:
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7. Internal Audits
Internal audits verify conformance of actual work with documented procedures.
They are conducted according to SOP S511 (Ref. 20.4. The procedure includes an
audit schedule that ensures that all entities are audited over a certain time period.
For an audit checklist, see E184 (Ref. 20.6). The internal audit program addresses
all elements of the compliance and quality systems, including testing and people
qualification. QA is responsible for the coordination of internal audits and also
develops an audit schedule.
The procedure for internal audits ensures that:
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8. Management Reviews
Management reviews verify continuous fitness for use and effectiveness of the
management system and initiate changes for improvements if needed. They are
conducted according to a procedure in SOP S510 (Ref. 20.4). The review serves
as a guide in making future determinations for the effectiveness and direction of the
quality and compliance system.
As a minimum, the review is performed annually. The review is conducted by The
Laboratorys executive management.
The procedure for management includes but is not limited to the following
elements:
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The findings and the actions that arise from the review are recorded according to
The Laboratorys management review procedure. If needed, corrective actions are
initiated.
Related SOP Reference 20.4
S510: Laboratory Management Review
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For external trainings the competence of the trainer and/or the company
providing the training is documented.
Analysts are trained and must demonstrate competence before they
generate the first analytical results.
Laboratory managers identify personnel to perform testing and
calibration, to qualify equipment, to issue test reports and operate
particular types of instruments.
All personnel are qualified for the assigned task, this includes all levels of
management and both full time personnel and temporary hires. As the
first step, the supervisor documents the assigned task, required skills,
the persons qualification and whether additional training is required or
not. An example for a form is shown in Attachment 21.3.
The competency of the trainee is demonstrated and documented after
the training. An example for a form is included in Attachment 21.4.
Competence and requirements are reviewed between the individual and
supervisor in annual meetings.
Training not only includes technical competence but also knowledge on
the FDA and equivalent international regulations.
Training in The Laboratory includes all methods and techniques that
personnel are asked to perform.
When training records are created, signed and maintained in electronic
form, the computer system complies with the FDAs 21 CFR Part 11 and
equivalent international regulations.
Training Courses and Tools for Pre- or Self-Study
Human resources together with laboratory management search for and
recommend training courses. Trainers come from The Laboratory and also
from outside. Training tools are available from The Laboratory library for preor self-study and to assist trainers in developing and conducting training
courses. A list of training tools is included in Chapter 20. They include:
Assessment Tools
The effectiveness of trainings and competence is evaluated and documented
following the SOP S513 (Ref. 20.4). Assessment tools include:
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Interview by supervisor or trainer.
Observation of an employee performing a procedure.
Testing blind QC samples.
Testing of known samples.
Testing of previously analyzed samples.
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accuracy
precision
specificity
limit of detection
limit of quantitation
linearity
range
ruggedness
robustness
Depending on the intended use and scope of the method, all or part of the
parameters will be tested.
Verification of Standard Methods
Standard methods generally follow the same life cycle principle. For standard
methods first define the scope and performance specifications of the method
as required by The Laboratory. If the scope of the standard method matches
the scope and specifications of The Laboratory method 100% only the
competence of The Laboratory and suitability of equipment to successfully run
the method will be verified. This typically includes repetition of two validation
experiments and running system suitability tests or quality control samples.
Any parameter outside The Laboratory specification is validated similarly to
methods developed in The Laboratory (10.2).
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Method Revalidation
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confidentiality and integrity. To ensure data integrity computer systems comply with
the FDAs regulation for electronic records and signatures: 21 CFR Part 11.
Equipment Identification
Each item of equipment hardware and each computer system used for testing
has an identification number that is unique to each instrument. Information on
the equipment is entered in the system inventory database. Initial and/or
updated information includes:
instrument description
manufacturers name
date of installation
calibration/qualification/validation status
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qualification the vendors functional and performance specifications are
verified for compliance with The Laboratorys specifications.
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All parts are listed in the parts inventory database with criticality for
operation and anticipated usage.
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Equipment Temporarily Leaving The Laboratory
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Decommissioning
When equipment is taken out of service, The Laboratory ensures that the
equipment is taken out of the equipment inventory database. When computer
systems are taken out of service The Laboratory ensures that data generated
on the computer system are migrated to the new system following the
procedure in SOP S261 (Ref. 20.4).
Related SOPs Reference 20.4
S240: Qualification of Equipment
S259: Configuration Management and Version Control of Software
S261: Retirement of Computer Systems
S262: Change Control of Software and Computer Systems
S263: Validation of Macro Programs and other Application Software
S266: Development and Use of Spreadsheets in Part 11 and GxP Environments
S273: Auditing Software Suppliers: Preparation, Conduct, Follow-up
S274: Quality Assessment of Software and Computer System Suppliers
S321: Virus Checks of IT Systems
S509: Change Control of Analytical Equipment
S519: Risk Assessment for Laboratory Systems
S541: Maintenance of Laboratory Equipment
S628: Development of User Requirement Specifications for Analytical Equipment
S641: Calibration of Analytical Balances
S644: Qualification of Refrigerators
S656: Validation of Laboratory Computer Systems
S662: Risk-Based Validation of Laboratory Computer Systems
12. Sampling
Samples are usually taken from production. Persons taking samples are either
laboratory or production staff. In either case, sampling of substances, materials or
products for subsequent testing follows the SOP S531 (Ref. 20.4). Procedures for
sampling specific materials are available at the location where sampling is
undertaken. The procedure ensures that samples are taken according to a
sampling plan to be representative based on scientifically sound sampling
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methods. The procedure also requires recording of sampling data such as
sampling procedure used, location, the identification of the person who took the
sample, the substance name or description, batch number, quantity, equipment
used for sampling and environmental conditions, if relevant. An example for a
template is shown in Attachment 21.8.
Related SOP Reference 20.4
S531: Sampling for Analytical Testing
Standards and reagents are labeled with the standard or reagent name or
description, concentration, date of preparation and date of expiration.
Documented information is sufficient to allow traceability to the preparation
record that provides traceability of all ingredients.
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When working standards are prepared from certified standards, the quality
of the working standard is determined through experiments. For the comparison
acceptance criteria are specified before the tests and test methods are
validated.
Related SOP Reference 20.4
S532: Preparation of Calibration Standards
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Related SOP Reference 20.4
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Sample size and test intervals are based on statistical criteria for each
attribute examined to assure valid estimation of stability.
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Related SOP Reference 20.4
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The identification of samples follows the SOP S534 (Ref. 20.4). The
procedure ensures unique identification of samples through a sample number.
The sample number is used to track the sample from the time the sample is
collected until the analysis is completed. The sample number is also used to
provide traceability between the sample and test results.
The reserve sample consists of at least twice the quantity necessary for all
tests to determine whether the product meets its established specifications.
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Related SOP Reference 20.4
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17. Testing
Correct testing is most important to achieve accurate and reliable results. Analyst
use and follow a checklist to ensure that:
Each test follows a written procedure that is specific for the test.
The system is calibrated before the first sample run and within a series of
runs sufficient calibrations are performed.
System suitability tests are performed before the first sample run and for
sequences within and at the end of the sequence.
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Regular analysis of quality control samples and monitoring the data and
trends in quality control charts. Control criteria and corrective actions are
specified for quality control sample results. Discrepant results are documented
and The Laboratory supervisor is informed. The supervisor initiates follow-up
activities, e.g., flags test results.
Out-of-Specification Results and Failure Investigations
Deviations from expected test results are handled following the SOP S115
(Ref. 20.4). This procedure ensures that:
Analysts together with the supervisor document the OOS, each step
of The Laboratory failure investigation and investigation results.
The supervisor together with the analyst identifies the root cause of
the failure.
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Root Cause Analysis and Corrective and Preventive Action Plans
The Laboratory continually revises and improves processes if necessary.
Failure investigations and evaluation of OOS results are one way to identify
problems. Other sources are customer complaints, internal and external
inspection findings and problems identified in management reviews. The
Laboratory has a formal CAPA program that follows the SOP S114 (Ref. 20.4).
Because of its close connection to testing, OOS results and RCA and CAPA
failure investigations are discussed in the chapter Quality of Test Results,
although RCA and CAPA may not only be initiated through OOS test results as
explained above.
Following the SOP S114 ensures:
A team is formed to implement the plan. The team may be crossfunctional if appropriate. For example, the local or corporate IT department
may get involved to find the root cause of a problem associated with a
computer system.
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As the last step the QA officer or his/her designee reviews the data,
releases the test result and the final report is issued.
Name of analyst.
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Related SOP Reference 20.4
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Records are dated and identify the person who established the records.
The definition of raw data follows the FDAs risk-based approach for Part
11. The Laboratory follows SOP S137 (Ref. 20.4).
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20. References
This chapter lists the documents that are available to assist in implementing the
master plan.
Primers and Master Plans
1. Risk Management Master Plan.
Example included in the Labcompliance Laboratory Compliance
Package: www.labcompliance.com/books/lab-compliance.
2. Equipment Qualification Master Plan.
Example included in the Labcompliance Laboratory Compliance
Package: www.labcompliance.com/books/lab-compliance.
3. Computer System Validation Master Plan.
Example included in the Labcompliance Computer System
Validation Package: www.labcompliance.com/books/computers.
4. Network Qualification Master Plan.
5. 21 CFR Part 11 Compliance Master Plan.
Example included in the Labcompliance Part 11 Compliance
Package: www.labcompliance.com/books/part11.
6. Training Master Plan.
7. Calibration and Preventive Maintenance Master Plan.
8. Good Automated Manufacturing Practice, Guide for Validation of
Automated Systems in Pharmaceutical Manufacture, Version 3,
March 1998, Version 4, December 2001 www.ispe.org.
9. Primer, FDA/EU Compliance in Analytical Laboratories.
Example included in the Labcompliance Laboratory Compliance
Package: www.labcompliance.com/books/lab-compliance.
10. Primer, Computer System Validation, Labcompliance, 2005, 40
pages.
Example included in the Labcompliance Computer System
Validation Package: www.labcompliance.com/books/computers.
Reference Publications
All are included in the Laboratory Compliance Package from Labcompliance:
www.labcompliance.com/books/lab-compliance.
1. A123: CAPA A Fundamental Quality Subsystem.
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2. A122: Preventing Out-of-Specification (OOS) Situations Caused by
Laboratory Errors.
3. A154: Definitions: Qualification vs. Verification, Calibration and
Validation.
4. A164: Qualification of Equipment and Computerized Systems.
5. A183: Implementing 21CFR Part 11 in Laboratories.
6. A188: 21 CFR Part 11 Compliance for Pharmaceutical Laboratories:
A Supplier's Perspective.
7. A194: Implementing 21CFR Part 11: Data Migration and Long Term
Archiving for Ready Retrieval.
8. A234: Equipment Qualification in Practice.
9. A239: Selecting Parameters and Limits for Equipment Operational
Qualification.
10. A273: Risk-Based Validation of Commercial Off-the-Shelf Computer
Systems.
11. A264: (Laboratory) Equipment Qualification and Computer System
Validation.
12. A553: Qualification of High-Performance Liquid Chromatography
Systems.
13. A603: Validation of Analytical Methods: Review and Strategy.
14. A605: Validation of HPLC Methods.
15. A607: Evaluation and Validation of Standard Methods.
16. A633: Preparation and Qualification of Certified Reference Material
and Working Standards.
17. M133: Laboratory Compliance Master Plan.
18. M610: 100 Most Frequently Asked Questions and Answers Related
to Laboratory Compliance.
Audio Seminars
1. FDA/EU Compliance in Analytical Laboratories (135).
Included in the Laboratory Compliance Package from
Labcompliance:
www.labcompliance.com/books/lab-compliance.
2. Validation of Software and Computer Systems in Analytical
Laboratories (112).
3. Validation of Computerized Laboratory Systems (106).
Implementing the new GAMP Laboratory Systems Guide.
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4. Laboratory Equipment Qualification (114).
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15. S267: Validation of Electronic Laboratory Notebooks. (*)
16. S268: Using Electronic Laboratory Notebooks in an FDA Regulated
Environment. (*)
17. S270: Validation of Electronic Document Management Systems. (*)
18. S271: Validation of Commercial Off-the-shelf (COTS) Computer
Systems (*).
19. S272: Auditing Computer Systems. (*)
20. S273: Auditing Software Suppliers: Preparation, Conduct, Followup. (*)
21. S274: Quality Assessment of Software and Computer System
Suppliers. (*)
22. S314: Record and Data Identification and Management.
23. S315: Retention and Archiving of Electronic Records. (*)
24. S316: Scanning of Paper Records for GxP Compliant Archiving. (*)
25. S317: Data Back-up and Restore. (*)
26. S321: Virus Checks of IT Systems.
27. S504: Generation and Maintenance of SOPs for Laboratories. (*)
28. S509: Change Control of Analytical Equipment. (*)
29. S510: Laboratory Management Review.
30. S511: Auditing Laboratory Systems.
31. S513: Training for Laboratory Personnel. (*)
32. S519: Risk Assessment for Laboratory Systems. (*)
33. S530: Laboratory Failure Investigations. (*)
34. S531: Sampling for Analytical Testing.
35. S532: Preparation of Calibration Standards.
36. S533: Measurement Traceability.
37. S534: Handling of Laboratory Test Items.
38. S541: Maintenance of Laboratory Equipment.
39. S551: Stability Testing.
40. S612: Validation of Analytical Methods.
41. S613: Validation of Chromatographic Methods. (*)
42. S614: Transfer of Analytical Methods.
43. S621: Ongoing Performance Control of Analytical Equipment.
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44. S628: Development of User Requirement Specifications for
Analytical Equipment. (*)
45. S641: Calibration of Analytical Balances. (*)
46. S644: Qualification of Refrigerators. (*)
47. S656: Validation of Laboratory Computer Systems. (*)
48. S662: Risk-Based Validation of Laboratory Computer Systems. (*)
49. S671: Analytical Data Review and Validation.
50. S672: Reporting of Analytical Test Results.
FDA and International Regulations, Guidelines and Presentations
Documents or links included in the Laboratory Compliance Master Plan:
www.labcompliance.com/books/lab-compliance.
1. Guidance for Inspectors and other FDA Personnel
Guide to Inspection of Microbiological Pharmaceutical Quality
Control Laboratories.
2. Guidance for Inspectors and other FDA Personnel
Guide to Inspection of Pharmaceutical Quality Control Laboratories.
3. PIC/S Aide Memoire: Inspection of Pharmaceutical Quality Control
Laboratories.
4. FDA 21 CFR 211
Current Good Manufacturing Practice for Finished Pharmaceuticals.
5. Guidance for Inspectors
Drug Manufacturing Inspections.
6. 21 CFR 11
Electronic Records Electronic Signatures.
7. Guidance for Industry
21 CFR Part 11; Electronic Records; Electronic
Signatures, Scope and Applications.
8. Guidance for Industry (draft)
Mass Spectrometry for Confirmation of the Identity of Animal Drug
Residues.
9. Guidance for Industry (draft)
Analytical Procedures and Methods Validation.
10. Guidance for Industry
Bioanalytical Method Validation.
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11. FDA Guidance
Requesting Methods Validation for Abbreviated New Drug
Applications (ANDAs).
12. FDA Industry Guidance
Investigating Out-of-Specification (OOS) Test Results for
Pharmaceutical Production.
13. Guidance for Industry
General Principles of Software Validation.
14. Annex 11 of EU GMP
Computerized Systems.
Worksheets, Checklists, Forms, Templates, Examples
All included in the Laboratory Compliance Package from Labcompliance:
www.labcompliance.com/books/lab-compliance.
1. E184: Worksheet: Laboratory Audit.
2. E116: Checklist Out-of-Specification Situations (OOS).
3. E255: Requirement Specifications for Chromatographic Data
Systems.
4. E269: Requirement Specifications for Excel Applications.
5. E308: User Requirement Specifications - 20 Good/Bad Examples.
6. E131: Template/Examples: Test Protocol for Excel Spreadsheet
Application (with traceability matrix).
7. E322: Template/Examples: Computer System Identification.
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21. Attachments
Laboratory Personnel
This is a template to document laboratory personnel with name, position/title,
education level and years of experience.
Name
Position
Education
Years of Experience
total/current
Document ID
(Number, Rev)
Date of
Last
Review
# Copies
Distributed
Dec 15,
2005
N/A
Description
Location
Date of Issue
or Revision
S-233
Ver. 1.0
SOP: Qualification
of Analytical
Instruments
QC Lab
E-362
Ver. 3.0
Requirement
Specifications for
Excel Worksheet
#2534
QC Lab
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Template and Example to Document Training Requirements
Employee:
Supervisor:
Department:
Date:
Job Description:
Assigned Tasks:
Required
Qualification
Understands
requirements of
21 CFR Part 11.
Education, Previous
Experience or Training
Courses
Attended 3 day training
course on 21 CFR Part 11.
Certificate available.
(Additional)
Training Required
Yes 0
No 0
Yes 0
No 0
Yes 0
No 0
Yes 0
No 0
Yes 0
No 0
FOR INTERNAL
Master Plan
Document Number: M-133 Ver. 1.xx
Laboratory Compliance
Page 48 of 53
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:
Date
Signature
FOR INTERNAL
Master Plan
Document Number: M-133 Ver. 1.xx
Laboratory Compliance
Page 49 of 53
Equipment List
This is a template to document the available equipment in the lab.
Equipment
ID
Description
Manufacturer
Location
Date of
Installation
Qualification
Status
FOR INTERNAL
Master Plan
Document Number: M-133 Ver. 1.xx
Laboratory Compliance
Page 50 of 53
Equipment ID:
Description:
Date
Name of User
Function
Signature
FOR INTERNAL
Master Plan
Document Number: M-133 Ver. 1.xx
Laboratory Compliance
Page 51 of 53
Equipment Records
This is a template to record equipment events such as calibrations,
(re)qualification, performance checks, modifications, updates, damages,
malfunctions and repairs.
Equipment ID:
Serial Number:
Description:
Location:
Installation Date:
Date
Event
Activity
Responsible
Person
Signature
FOR INTERNAL
Master Plan
Document Number: M-133 Ver. 1.xx
Laboratory Compliance
Page 52 of 53
Sampling Location:
Sampling Equipment:
Sampling Procedure:
Date
Environmental Conditions
Observations
Person
Description
Storage
Media
Storage
Location
Archiving
Period
FOR INTERNAL
Master Plan
Document Number: M-133 Ver. 1.xx
Laboratory Compliance
Checklist for Testing
Item
Page 53 of 53
Description
Check
FOR INTERNAL