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50 Additions in December 2009

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  • FDA Warning letters, related to compliance and/or validation, to learn from mistakes others made. Keywords and sample extracts make it easy to search for selected topics.
  • FDA 483 inspectional observations, related to compliance and/or validation, otherwise difficult to get. Keywords and sample extracts make it easy to search for selected topics.
  • Example Standard operating procedures related to validation and other compliance and quality issues
  • Templates, examples, checklists that help to implement GxP regulations
  • FDA publications and presentations, some are not available otherwise on the Internet
  • Easy access to official documents from FDA and European agencies
  • Interviews with FDA representatives to learn how to interpret regulations and guidelines
  • Reference publications and presentations of compliance gurus, sometimes not (yet) published anywhere else
  • Video clips with FDA officials about FDA's drug GMP initiative, risk based inspections and the new scope of part 11
  • Members get $100 discount for each Labcompliance Audio Seminar
    Currently you can order from over 100 recorded seminars, and more are coming every month

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  • Price: US$ 379.- for 12 months (includes Equipment Validation Master Plan)
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50 Additions in December 2009

On December 15, 2009, we add(ed) 50 new documents to the Labcompliance Usersclub Library. They include

  • 13 SOPs
  • 11 Examples/checklists/templates
  • 7 FDA Presentations
  • 9 Reference Papers and Presentations from Private Authors
  • 1 FDA Guidance
  • 1 Videoclip with an FDA official
  • 11 FDA selected GxP Warning Letters/483s/EIRs

Below find the list of new documents. To easily find the documents, click on the headlines, and use the browser's search function

Equipment Qualification

  • SOP: Development of User Requirement Specifications for Analytical Equipment (S-628)
  • SOP Procedures:  and Deliverables for Qualification of USP <1058> Instrument Categories (S-630)
  • Developing and Maintenance of Test Scripts for Analytical Systems (635)
  • Example: Suggestions for USP Analytical Instrument Categories (E-315)
  • Example: Validation Report - HPLC System (E711-11)
  • USP Presentation : Analytical Instrument Qualification According to USP 1058 (p-517)

Computer/software validation

  • SOP Revalidation of Software and Computer Systems (S-260)
  • SOP Development and Use of Spreadsheets in Part 11 and GxP Environments (S-266)
  • SOP Responsibilities for Computer System Validation (S-277)
  • Checklist: Cost effective Software and Computer System Validation (E-150)
  • Template and Examples: Computer System Retirement Plan (E-173)
  • Example/Template: Excel Spreadsheet Requirement Specifiaction (E-268)
  • Checklist: Computer Systems in ISO 17025 Environments (E-610)
  • Performance Qualification – Chromatography Data System (E781-09)
  • Example: Computer System Validation - Policy (K-1318)
  • Presentation: Validation of Existing/Legacy Systems (P-214)
  • Computer System Incident Report (K-1361)

Network Qualification

  • SOP Revalidation of Software and Computer Systems (S-260)
  • SOP Responsibilities for Computer System Validation (S-277)
  • Presentation: IT Infrastructure and Network Qualification (P-264)
  • Computer System Incident Report (K-1361)

Laboratory Compliance

  • SOP SOP: Internal Audits – Preparation, Conduct, Follow-up (S-108)
  • SOP Handling Out-of-Specification Results (S-115)
  • SOP Archiving GLP Data and Other Documents (S-151)
  • SOP Validation of Spreadsheet Applications (S-264)
  • SOP Development and Use of Spreadsheets in Part 11 and GxP Environments (S-266)
  • SOP Retention and Archiving of Electronic Records (S-315)SOP: Development of User Requirement Specifications for Analytical Equipment (S-628)
  • SOP Procedures:  and Deliverables for Qualification of USP <1058> Instrument Categories
  •  (S-630)Developing and Maintenance of Test Scripts for Analytical Systems (635)
  • Example: Suggestions for USP Analytical Instrument Categories (E-315)
  • Example: Performance Qualification – Chromatography Data System (E781-09)
  • Example: Validation Report - HPLC System (E711-11)
  • Checklist: Computer Systems in ISO 17025 Environments (E-610)
  • Presentation: Handling Out-of-Specification Tests Results and Failure Investigations (P-505)
  • Presentation: Quality Assurance and Compliance in Laboratories (P-506)
  • Crafting an Efficient & Cost-effective Lab Compliance Program (P-509)
  • Effective Verification of Compendial Methods (P-518)
  • FDA Presentation: Residual Solvents: FDA-Regulatory Perspective (G-276)
  • FDA Presentation: Investigating OOS Test Results for Pharmaceutical Products (G-334)
  • FDA Guide: Residual Solvents Marketed in the United States (F-513)

(Electronic) Records/Part11

  • SOP Retention and Archiving of Electronic Records (S-315)
  • SOP Data Backup and Restore (S-317)
  • Example: User Requirement Specifications for 21 CFR Part11 (E-307)
  • Case Studies: Part 11 Implementation (E-411)
  • Presentation: FDA's New Enforcement of 21 CFR Part 11 - 2009 (P-307)
  • Template: Part11 Training Accountability (K-1413)
  • FDA Presentation: Part 11 -Where we were, where we are and where we are going (G-328)
  • FDA Presentation: Data Integrity and Fraud – Another Looming Crisis? (G-330)
  • Video: FDA: Part 11 Update 2009 by John Murray (FDA Task Force Member) (V-221)

General Compliance/Regulatory Updates

  • SOP Handling Out-of-Specification Results (S-115)
  • SOP Archiving GLP Data and Other Documents (S-151)
  • Checklist: FDA Inspections (E-165)
  • Presentation: Writing Effective SOPs for Regulatory Compliance (P-132)
  • Presentation: Six steps to Successful FDA GMP Inspections (P-133)
  • Presentation: Towards an ASEAN Sectoral MRA on GMP Inspection (P-160)
  • Template: Training Records (K-1023)
  • FDA Presentation: Pharmaceutical Ingredient Supply Chain (G-208)
  • FDAInspections Presentation:  and Risk: A Regulatory Perspective (G-219)
  • FDA Presentation: cGMP Inspections (G-224)
  • FDA Presentation: API Inspections (G-225)
  • Writing An Effective 483 Response (G-229)

Warning Letters/483 Inspectional Observations/EIRs

  • We added 12 Warning Letters (W-213-224)

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