Good Documentation Practices for the Laboratory - Institute of ...

Good Documentation Practices for the Laboratory February 2011 Ludwig Huber Caleb Ng

NG Caleb Ludwig Huber

E-Mail: [email protected] E-Mail: [email protected]

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Overview • • • • •

Documentation Overview Documentation requirements Laboratory records requirements Streamline development and approval process Examples: Master plans, validation documents, training documentation, logbooks, notebooks • Maintenance and archiving: paper vs. electronic • Paperless data and document management – Enterprise content management – OpenLAB ECM – Electronic laboratory notebook – OpenLAB – Sample workflows

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Documentation Hierarchy Policy Master Plan

High level, strategic documentation (regulations, business, quality)

Training Maintenance Validation, Audits

Process related documentation, approaches (SOPs)

Test procedures Operating manuals, QC procedures Product test records, validation results, training records, chromatograms, log-book entries

Product/event related documentation (work instructions, also called SOPs or test scripts, protocols) Laboratory records (event related documentation)

+ external references (publications, standards, training certificates) Slide 3

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Laboratory FDA Regulations Required Records for GMP • A(1): Sample description and source identification and location, date taken • A(2): Test method, validation results, system suitability results • A(3): Sample weight • A(4): Test results, incl. Spectra, Chromatograms • A(5): Calculations used for testing • A(6): Comparison of test results and standards • A(7): Signature of test person • A(8): Signature of reviewer of test results • B: Method change logs incl. reason for the change • C: Calibration records • D: Records of stability testing Implicit • Training records, corrective/preventive actions

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FDA Warning Letters - Procedures • The firm does not have a written procedure that includes requirements for the performance verification of HPLC and GC systems (W-161)

• Please submit documentation, with English translation, of these corrections (W-148)

Reference: www.fdawarningletter.com

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FDA Warning Letters - Records • Laboratory records do not include all raw data. For example, weights determined during the preparation of standard solutions were not recorded (W-148) • Employee training needs were not addressed and training was not documented.(W-128) • During the inspection, our investigation requested to see investigations of process deviations and out of specification laboratory results. She was informed that these investigations are conducted but not documented (W-102) Reference: www.fdawarningletter.com Slide 6

FDA Warning Letters Example: Validation Records • Acceptance test results for the xxx System were not adequately documented. • Specifically, final acceptance records for release of the xxx System did not document the results of the acceptance activities or equipment/software used in conducting the tests, and were not signed by the individual who performed the acceptance activities (W-128)

Reference: www.fdawarningletter.com

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EU GMP Requirements Medicinal products for human and veterinary use Volume 4: Good manufacturing practices Chapter 4: Documentation • Specifications • Batch processing records • Procedures and records – Receipt, sampling – Testing

Example for documents required by EU but not by FDA: Validation master plan, design qualification through Annex 15) Slide 8

Streamline the Documentation Process • Create master list and categories • Define format • Define development system • Define contents: e.g., logbook vs. notebook • Define development and implementation process

Policy Master Plan Training Maintenance Validation, Audits Test procedures Operating manuals, QC procedures Product test records, validation results, training records, chromatograms, log-book entries

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Use Consistent Documentation Across the Company • • • • •

Validation master plan Supplier qualification Risk assessment Validation procedures Templates for records → Improves efficiency → Improves consistency

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GxP Specific Contents and Format - General • Contents of records: Minimum requirements specified in regulations • Format: some format standardization used across industry

Signatures practice for authoring, review and approval 1) Author 2) Technical content verification 3) QA/QC verification

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Streamline Implementation Process • • • • • • • • • •

Initiation Development Initial review Approve Train Use Change and version control Regular review Remove Archive

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Evaluate or Define Tools for Authoring and Review • Word processing program, e.g., MS word • Document management system • Styles and style guides – Automated heading and level numbering – Automated paragraph formatting – Hyperlinked and updated cross references – Headers and Footers

Across department - site - globe Slide 13

Develop Procedure and Templates for Different Types of Documents • • • •

Master plans (with templates) SOPs Test scripts Training (part of training master plan)

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Master Plans: Examples and Contents • Examples – Manufacturing site master plan – Laboratory – Training – Validation (computer, networks, equipment) • Contents – Policy – Approaches to handle compliance (high level) 1. Answer the FDA inspector‘s question: What is your company‘s approach for …? 2. Required by EU GMPs Slide 15

SOPs: Considerations • • • • • •

Who writes the SOPs Level of detail Training before use How to enforce use of current version Periodic review frequency Style (presence, shall, will, should, must)

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Example: Training Needs and Records • Demonstrate Compliance with GxP regulations: ―People should be qualified for the assigned task • Document assigned tasks • Document qualification • Document training needs • Document (success of) trainings

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Documenting Training Job description Qualification requirements

Name Education Experience Gaps, Trainings plan 

Trainings

Supervisor (name, signature) Type, content Date Duration

This documentation should be kept separated from other personnel files, for example performance evaluations

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Example: Validation and Testing • Demonstrate Compliance with GxP regulations: ――Equipment should be suitable for intended use‖ • Define ―intended use‖ and expected results • Develop test script, test and document expected results and actual results • Document ‗evidence‘ of testing – Well documented and executed test scripts – Screen capture etc, if it makes sense Slide 19

Validation Plan Template Scope of the Plan Product Description Validation Strategy Responsibilities Supplier Assessment Risk assessment Testing Strategies DQ IQ OQ PQ Traceability matrix Procedures Approval Documentation control

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Specifications vs. Test Results Test Traceability Hyperlink to Test Protocol Parameter

Specification

Injection Volume