Labcompliance News

August 2010

• FDA Inspection Clarifies what "Readily Available Documentation" Means
• FDA Plans Using Internal Audit Reports for Risk Assessment
• Printed HPLC Chromatograms not Considered a 'True Copy' of e-Raw Data
• No Failure Investigations after Failed GC Calibration Cited by FDA
• FDA Video Training Updated
• Do You Know what FDA Does? Learn about FDA Basics from the FDA.
• FDA Warning for Insufficient Number of System Suitability Test Runs

July 2010

• New FDA Draft Guidance on CMC Post-approval Changes
• 'Spreadsheet Calculations not Verified'  Cited in FDA Warning Letter
• The UK MHRA Updates Guidance for Stand Alone Contract Laboratories
• FDA Announces New Inspections with Focus on Part 11
• Free FDA Training on Human Drug Regulations
• FDA Warning for Missing Verification of Expiration Date Calculation

June 2010

• EU Guidance on Classification of Medical Devices Updated
• New Spreadsheet Quality Package Available as Download
• Genzyme Corp. Signs Consent Decree to Correct Manufacturing Quality Violations
• PIC/S Assessment of FDA Membership Targeted for the Next Comittee Meeting
• Software Testing Raw Data not Saved Cited in FDA Warning Letter
•  New Template for Drug API Quality Agreements

May 2010

• FDA's Updates the Preapproval Inspections/Investigations Manual
• FDA-483 with 11 Observations Related to QC Laboratory Controls
• PIC/S Publishes Example for Quality Risk Management Implementation
• Labcompliance Tutorial on ISO 17025 Updated
• 3 Inspectional Observations Related to FDA's Dietary Supplement GMP's
• FDA Publishes  Guidance for Industry: ICH Q8, Q9, and Q10 - Questions and Answers
• FDA Inspection Reports - Ideal  Case Studies for Dietary Supplement GMPs

April 2010

• FDA Inspections for 21 CFR 111 (Dietary Supplements) will Become Common
• Pharmacopoeial Discussion Group (PDG) Recommendations for Dissolution Testing
• WHO Publishes Guideline for the Production and Control of Starting Materials
• 51-Page FDA Inspection Report Related to Dietary Supplements
• How Much Validation is Enough?
• FDA Focus on Integrity, Security and Authenticity of E-Records
• Video on Software Regulation with John Murray on FDA's Website

March 2010

• Revised Draft of Annex 11 to EU GMPs to be Released in the next few Weeks
• FDA Inspection Focus on Security, Availability and Integrity of E-Records
• FDA Releases Guidance for  Product Sterilization Control
• APIC Publishes Guidelines and Two Templates for Quality Agreements
• Labcompliance Usersclub gets more attractive with new Document Category
• "Stability Chambers not Re-qualified" Cited in Recent FDA 483
• New Supply Chain Guidance from TGA

February 2010

• FDA Launches a new Risk-Assessment Tool for Better Drug and Food Import Control
• ICP Systems for Metal Impurity Analysis Must be Part 11 Compliant
• USP Changes Dissolution Performance Verification Tests
• OOS of Stability Chambers not Investigated" Draws FDA Warning Letter
• FDA Publishes New Guidance for Calibration of Dissolution Apparatus
• FDA Warning for Data Manipulation

January 2010

• A Vendor's Statement is not Enough Evidence for Software Validation
• USP Proposes three new Chapters for Heavy Metal Impurity Analysis
• FDA  'Advice' on Validation and Use of Excel®
• Not Putting Finished Drugs on Accelerated Stability Studies Draws FDA Warning
• New Audio Seminars in 2010 - Schedule Available
• New FDA Guidance on Assay Development for Immunogenicity Testing
• Updated FDA Guidance for Non-Clinical Safety Studies

December 2009

• FDA Warns Drug Manufacturer for not including Dissolution in the Stability
• FDA Releases New Revision of ICH Guidance Q8
• The First 'Closeout Letter' Posted on the FDA Website
• 50 New Documents in the Labcompliance Usersclub
• FDA Releases Final Guidance on Residual Solvent Analysis
• Increasing FDA Focus on Computer Validation
• GHTF Publishes Guidance on Corrective and Preventive Actions

November 2009

• Should Computer Based Training Record Systems Comply with Part 11?
• FDA Continues to Enforce Part 11
• USP General Chapter Allows more Flexibility for Method Changes
• "Missing Method Validation Electronic Rawdata" Cited in FDA Warning Letter
• USP Plans General Chapter on Transfer of Analytical Methods
• 15 New SOPs from Labcompliance

October 2009

• New USP General Chapter for Metal Impurity Analysis under Development
• Averaging of OOS Test Results Draws FDA Warning Letter
• FDA Issues Guidance on Risk Evaluation and Mitigation Strategies (REMS)
• Missing Evaluation of HPLC Detector Noise/drift Cited in FDA Warning Letter
• New FDA Guidance for Microbiological Data for Antibacterial Drug Products
• FDA's Current Inspection Focus is on OOS, Failure Investigations and CAPA
• Warning Letter: OOL/OOS Results Generated by a Contract Lab not Investigated
• Labcompliance Network Compliance Package Available as Download

September 2009

• FDA Issued Import Alert Against Drugs from Canadian Drug Manufacture
• Laboratory Compliance Package Version 2 Released
• FDA Updates "Warning Letters" Web page
• FDA's Acceptance of Corrective Work Plan Sends Shares 40 % up
• EMEA Mandates Electronic Submissions in eCTD format by January 2010
• A Comparison of CROs in India and China
• Labcompliance Computer System Validation Package Available as Download

August 2009

• FDA Commissioner Announces Six Steps to Improve Enforcement
• FDA's New Enforcement Program will Begin on September 15, 2009.
• New FDA Inspection Package
• FDA Launches New Center for Tobacco Products  
• New FDA Guidance for Control of Melamine Contamination  
• New FDA Guidance on Postmarketing Studies and Clinical Trials
• New FDA Guidance on Impurities in Drug Substances

July 2009

• FDA Publishes Article on Drug CGMPs and how they Contribute to Drug Quality
• U.S. Marshals Seize Drug Products to Prevent Repeated Drug Quality Problems
• South East Asia Moving to Harmonized GMP Inspections
• Labcompliance Tutorial on ISO 17025 Updated
• FDA Requests Meeting with Senior Management to Discuss Inspection Outcome 
• FDA Requests Certification by an Outside Consultant

June 2009

• Harmonization Steps Move Forward in Yokohama, Japan
• FDA Data Standards Council Launched New Website  
• New FDA Guidance on Regulatory Submissions in Electronic Format
• New FDA Guidance on Research of Radioactive Drugs
• "Failure Investigation not Extended Outside the Lab " Cited in FDA Warning Letter

May 2009

• Review of IVT's 10th Computer System Validation (CSV) Conference
• New Version 2.0 of the ISO 17025 Accreditation Package Released
• New FDA Guidance on the Submission of Bioequivalence Data.
• Is it a Cosmetic or a Drug. FDA. or Both? FDA Provides Answers.
• ICH Working Group Answers Questions about Q8/Q9/Q10

April 2009

• FDA Releases Final ICH Guidance Q10
• Brazilian New GMP's Rely on EU Annex 11 for Regulating Computerized Systems
• New FDA Guidance on Pharmacopoeial Texts - Sterility Test
• 'Advice' from the FDA on Part 11 in an Establishment Inspection Report
• FDA Presentation: Writing An Effective 483 Response
• "Computer System not Maintained in Validated State" Cited in FDA Warning Letter
• PIC/S Publishes Inspection Guide for APIs
• Brazil is Becoming a Top Emerging Pharmaceutical Market

March 2009

• New FDA Guidance on Anticancer Pharmaceuticals.
• New Primer on Analytical Instrument Qualification and System Validation for Free
• FDA Takes Regulatory Action Against Ranbaxy’s Plant in India
• Requirements of ISO 17025 for Computer Systems
• President Barack Obama Announces New FDA Commissioner
• New FDA Guidance on Pharmacopoeial Texts - Dissolution Test
• Readability Problems with 10 Year old PDF Files?
• New FDA Guidance on Pharmacopoeial Texts - Uniformity of Dosage Units.

February 2009

• FDA Introduces Globalization Act of 2009
• FDA's Spreadsheet Expert Answers Questions on Excel Validation
• FDA Guidance: Standardized Numerical Identification for Prescription Drugs
• FDA CDER Plans for New Guidances in 2009
• New FDA Guidance Refers to ISO/IEC 17025 for Laboratory Testing

January 2009

• New FDA Guidance for Clinical Investigators and Sponsors
• FDA, EU and GAMP 'Advice' on Using Excel®
• FDA Opens Three Offices in China
• ICH Finalizes Annex to Q8 With Principles of Quality by Design
• New PIC/S Brochure Published
• "Incomplete Risk Analysis" Cited in FDA Warning Letter
• ISO 17025 Workshop at Analytica Vietnam
• Labcompliance offers eight different in-house compliance  workshops

December 2008

• Handbook for Requesting Special Information and Records from FDA
• FDA Publishes New Guidance on Genotoxic and Carcinogenic Impurities
• More Regulatory Agencies to Join PIC/S
• FDA Warning Letter Issued for not Validating a Planning System
• Top Five FDA Citations related to Biological Drugs, Intermediates and Substances
• 50 New Documents in the Labcompliance Usersclub
• "Investigations and CAPA Records not Maintained" Draws FDA Warning Letter

November 2008

• Seven New SOPs from Labcompliance
• FDA Warning Letter for Inadequate Process Validation
• Integrity and Security of Electronic Records Issues Again in a Warning Letter
• FDA Publishes Article on Product Recalls
• FDA Presentations on New Approaches and Expectations for Process Validation
• FDA Publishes New Guidance on Process Validation
• New Network Qualification Package Released
• FDA Does not Require three Validation Batches for API and Drug Release

October 2008

• FDA to Open Inspection Office in China This Year
• FDA Recommendations for Product-Specific Bioequivalence
• FDA Expects to Investigate OOS Results Obtained During Computer Validation
• FDA Publishes SOP for Handling Regulatory Electronic Communications
• Missing Verification of CAPA Effectiveness Cited in FDA Warning Letter
• Amendment of FDA Regulations Regarding Changes to NDA, BLA and PMA
• Warning Letters and Import Alert for Drug Manufacturer
• FDA Published its Fourth Issue of the Drug Safety Newsletter
• New ICH Guidance: Dose Selection for Carcinogenicity Studies

September 2008

• FDA Publishes Amendments to the cGMPs for Finished Drugs
• FDA Launches New Health Professionals Website
• Stability and Impurity testing cited in FDA Warning Letter
• FDA Published ICH Draft Guidance for Non-clinical Safety Studies
• Device Manufacturer Lacked Test Scripts for Training Data Bases
• GMP Annex 7 "Manufacture of Herbal Medicinal Products"  Revised

August 2008

• FDA Releases Draft Guidance for Residual Solvent Analysis (USP <467>)
• FDA Released New Guidance Regulatory Submissions in Electronic Format
• Quality and Validation Issues Draw FDA Warning Letter
• New Version 3.0 of the Computer System Validation Package Released
• New FDA Rule and Guidance for Early Stage Clinical Drug Development
• New USP Chapter <467> Residual Solvents Effective Since July 1, 2008
• FDA Warning Letter Issued for not Validating Software

July 2008

• USP Chapter <1058> on Analytical Instrument Qualification Release on Aug 1
• ICH Guideline Q10 "Pharmaceutical Quality System" Released
• Wrong Interpretation of USP Chapter <1226> Cited in FDA Warning Letter
• ICH Q3A Guidance "Impurities in New Drug Products" Revised
• FDA Warning Letter Issued for Not Verifying Software Design Changes

June 2008

• "FDA Globalization Act of 2008": New Fees, More Inspections, More Documentation
• "Spreadsheets and Other Software Not Validated" Cited in FDA Warning Letter
• EU Guidance for the Conduct of Good Clinical Inspections
• FDA Hiring Initiative for its Public Health Mission
• New FDA Guidance on Regulatory Submissions in Electronic Format
• EU Guidance for Exchange of GCP Inspection Reports

May 2008

• Cost Reductions for Computer System Validation through GAMP® 5
• "The Software Controlling Processes not Validated" Draws FDA Warning
• Case-Study: Stability Indicating Methods
• FDA Regulations Relating to Good Clinical Practice and Clinical Trials
• "No Procedures for Software Design Validation" Cited in FDA Warning Letter
• New Article: Electronic Records&Signatures - Legal Requirements and Technology
• Labcompliance Conducting the 100th Audio Seminar

April  2008

• EU Commission Publishes New Part 11 Equivalent Annex 11 for Consultation.
• FDA Releases Information on Risk Evaluation and Mitigation Strategies (REMS).
• New FDA  Guidance for Industry: Coronary Drug-Eluting Stents-Nonclinical and Clinical Studies
• FDA Warnings for Part 1 1 Deviations but Part 11 not Mentioned
• FDA Guidance: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
• FDA Withdraws Part 211 Update
• New Revision of EU GMP Annex 13 Available for Public Consultation
• Warning Letter: Software for Trend Analysis not Validated
• Part 11 Package now With Video Seminar

March 2008

• 22 New SOPs from Labcompliance
• USP <1058> on Analytical Instrument Qualification (AIQ) is Coming
• FDA Publishes a Data Base with Acronyms and Abbreviations
• Revised GMP Annex 1 of the EU GMP Guide Now Available
• 20+ Recent FDA Warning Letters Related to CSV and Electronic Records
• No Validation of CAPA Effectiveness Draws FDA Warning Letter
• ICH Q9 Implemented in EU GMP Guide as Annex 20

February 2008

• New ISO 17025 Accreditation Package
• New FDA Guidance Regarding the Labeling of Non-Prescription Human Drugs
• New FDA Guidances in 2008
• ILAC Published a Guideline for Providers of Proficiency Testing Schemes
• New FDA Guidance Regarding the Labeling of Dietary Supplements
• Lack of Method Transfer or Revalidation Protocol Cited in an FDA Warning Letter
• OECD Advice for Archiving

January 2008

• New Annex to Q8:  Pharmaceutical Development
• FDA Uses Excel® Spreadsheets in Its Own Laboratories
• No Validation of Excel Spreadsheets Draws FDA Warning Letter
• Argentina and Malta new PIC/S Members
• Labcompliance.com Gets Second Highest Score as The Most Relied Website
• US FDA Laboratories follow ISO 17025 Standard Procedures
• U.S. to Help India with Building an FDA Equivalent to the US

December 2007

• Audio Seminar Schedule for 2007
• PIC/S Explanatory Notes on the Preparation of a Site Master Plan
• How  Much Can You Change Compendial Method?
• New PIC/S Guide for Blood Establishments
• Revised Text of 21 CFR Part 211 Published
• FDA 'Advice' on Using Spreadsheets
• Agilent Technologies Compliance Services Ranked #1 - Again

November 2007

• GAMP® Good Practice Guide: Electronic Data Archiving
• FDA Advices on Investigating OOS Test Results
• Canadian Digital Information Strategy Published
• The Popular Method Validation Tutorial is Back
• New EMEA Guideline for Stability Testing
• FDA Warning Letter Issued for Incomplete GLP Study Report
• Article on MHRA Inspection Findings
• API Manufacturer Cited for Incomplete Batch Records and Poor Laboratory Practices

October 2007

• New Book Edition: Validation and Qualification in Analytical Laboratories
• FDA Continues to Reinforce Electronic Audit Trail
• New Computer System Validation Tutorial
• 40+ Validation Templates and Examples and  from Labcompliance 

September 2007

• PIC/S Releases New Versions of GMP Guides
• EU GMP Annex 2 “Manufacture of Biological Products” available for comments
• EMEA Answers Questions Questions Related to Harmonized Test Methods in Microbiology
• Recent FDA Inspection Findings Related to Part 11 and Computer Systems
• New Part 11 Tutorial
• 85 SOPs from Labcompliance 

August 2007

• New Interactive Video Seminars for Cost Effective FDA/EU Compliance
• USP Chapter on Verification of Compendial Methods to be released in December
• Updated Contact List at FDA CDER  
• New FDA Process Validation Guidance under Development

July 2007

• New FDA Guide on Analytical Method Transfer
• FDA Update on 21 CFR Part 11
• Lack of Method Transfer or Revalidation Protocol Cited in an FDA Warning Letter
• FDA GMP Update
• New Review Article on Computer Validation

June 2007

• New FDA Guidance Welfare of Study Subjects and Supervisory Responsibilities of Investigators
• 32 New Documents in the Labcompliance Usersclub
• FDA Continues to Inspect for 'Part 11' Requirements
• New FDA Guidance on Chemistry, Manufacturing and Control Changes to an Approved NADA or ANADA
• FDA Issues Draft Guidances for Online Access of Bioequivalence Studies for Generic Drugs
• Sponsor of Clinical investigation Receives Warning Letter for Inadequate Monitoring of the Investigation
• Implementing the FDA Guidance on 'Using Computerized Systems in Clinical Investigations'

May 2007

• FDA Perspective on Risk Based Validation of Computer Systems
• Final FDA Guidance on 'Using Computerized Systems in Clinical Investigations' Released
• Falsified Data Generated in Tests of Drugs Led to Bankruptcy of a Generic Drug Manufacturer
• Free Video Webcast: How USP Chapter <1058> on Analytical Instrument Qualification Will Effect You
• FDA Compliance Update: Data Integrity and Fraud - Another Looming Crisis
• Joint GMP Auditing Program for the Europe Economic Area (EEA)

April 2007

• Labcompliance Offering Interactive Courses - Worldwide
• Update Annex 11: Using Computers in GMP
• "Failure to Check for Accuracy of Inputs to and Outputs from HPLC Instruments " Draws FDA Warning Letter
• New EMEA Guidance for Herbal Medicines
• New USP Chapter <467> Residual Solvents Coming into Effect July 1, 2007
• FDA Warning Letter Issued for Inadequate Assessment of the Cross-contamination Risk

March 2007

• Report on GMP Inspection Deficiencies Available from the EMEA Website
• Updated Harmonized Protocol for Proficiency Testing
• An Inspector’s Perspective on Equipment Qualification
• "FDA Hierarchy of Computer Concerns?"
• New Publication: Ensuring a Culture of Quality
• Video Presentation How to Prepare Your Organization for the 'New' Part 11 now available on CD

February 2007

 

• An Inspector’s Perspective on Computerized Systems Validation
• "Databases for Data Analysis and other tracking and trending functions not validated", Draws FDA Warning Letter
• FDA Update on the Drug Quality Reporting System
• "Inadequate Equipment Calibration and Record Keeping", Cited in FDA Warning Letter
• Six Sigma Primer for Laboratories

January 2007

 

• Video Presentation and Toolkit: How to Prepare Your Organization for the 'New' Part 11
• USP Chapter 1058 (Analytical Instrument Qualification) Close to Final Version
• "Inadequate Documentation and Review of Bioequivalence Studies" Draws FDA Warning Letter
• FDA 'Advices" on using Excel in Regulated Environments
• "Equipment not Routinely Calibrated, Inspected, and Checked for Accuracy" Draws FDA Warning Letter
• EMEA Posts Q&A's on the Internet
• "Validation activities must be documented", FDA Warning Letter Says
• Australia TGA Releases the 14th Edition of Guidelines on the GMP Clearance of Overseas Medicine Manufacturers
• "Delegation of clinical study tasks to an individual not qualified to perform such tasks" Cited in FDA Warning Letter

December 2006

• FDA Uses Excel® Spreadsheets in Its Own Laboratories
• 25 Pages Network Qualification Project Plan Added to the Network Quality Package
• FDA Asks for Input on Electronic Submission of Regulatory Information
• "Equipment not Routinely Calibrated, Inspected, and Checked for Accuracy" Draws FDA Warning Letter
• PIC/S Releases Draft Guidance on GMPs for Pharmacies and Hospitals
• New ICH Draft Guidance to Facilitate Regulatory Acceptance of Analytical Procedures
• New Article: Using GS/MS in FDA Regulated Environment

November 2006

• Ludwig Huber speaks at IPC in Mumbai, India, on Dec 1 and 2, 2006
• New FDA Guidance: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations
• 28 New Documents in the Labcompliance UsersClub
• New FDA Draft Guidance: Drug Interaction Studies — Study Design, Data Analysis, and
  Implications for Dosing and Labeling
• Contract Testing Laboratory not Audited, FDA Warning Letter Says
• Citizen Petition to Increase FDA Inspections of Foreign Drug Manufacturers.
• EMEA Guideline for Test Procedures and and Acceptance Criteria for Herbal Medicinal Products Effective
• Free - New Routine Pharmaceutical Analysis Compendium CD

October 2006

• FDA Releases Final Industry Guidance on Handling OOS Test Results
• Obsolete Documents should be Promptly Removed from all Points of Use
• Service Records not Maintained, FDA Warning Letter Says
• "Calibration of Instruments not always Conducted at Suitable Intervals" draws FDA warning letter
• New Article on Automated Dissolution Method Validation
• FDA Expects a Procedure for Evaluation of Suppliers, Contractors, and Consultants.
• "Missing HPLC Peak not Investigated" Cited in FDA Warning Letter
• FDA Announces Electronic Submissions Gateway

September 2006

• Google Search for Labcompliance
• Record Retention for Hybrid Systems
• IVT Conferences Come to Singapore
• New FDA Industry Guidance: Lot Release Protocols in Electronic Formats

August 2006

• New Solutions from Labcompliance
• "Electronic Raw Data Not Saved" Cited in FDA Warning Letter
• Labcompliance Welcomes LIMSfinder.com
• How Written SOPs Facilitate Processes in a Preformulation Physical-Pharmacy Laboratory

July 2006

• US FDA Intends to Join PIC/S
• FDA Publishes ICH Q9 Risk Management Document as Industry Guidance
• Joint US FDA/ISPE Industry cGMP Training at the Peking University
• Learn all about Validation and Compliance in the Summer College from Labcompliance
• FDA Continues Inspections for Part 11 Compliance

June 2006

• How to Predict the Future of Part11?
• FDA Withdraws or Changes Seven Industry Guidances
• Inadequate Equipment Qualification Draws 14 Item FDA Warning Letter
• Joint Workshop on Validation In Laboratories by FDA's Nicholas Buhay and Dr. Ludwig Huber
• FDA Publishes ANDA Checklist for CTD and eCTD Format
• GAMP Good Practices Guide for Validation of Laboratory Computer Systems
• USP Senior Chemist Spoke About The Analytical Instrument Qualification Chapter
• Acting Director of FDA's Office of Compliance Gives an Update on Part 11
• FDA to Charge Industry for Re-inspection
• New Publication on Using Spreadsheets in cGMP Environments

May 2006

• An Inspector’s Perspective on Computerized Systems Validation
• 36 New Documents in the Labcompliance Users Club
• FDA Publishes a Guidance for Nonclinical Safety Evaluation of Drug or Biologic Combinations
• New Preamble and Economic Analysis in 'New' Part 11
• New Publication on Analytical Balances
• Supervisor Signature Does not Give Sufficient Level of Accountability", FDA Warning Letter Says.
• New Version of the Macro&Spreadsheet Package Released

April 2006

• FDA Publishes a Compliance Program Guidance Manual for API Process Inspections.
• The 4Q Model for Equipment Qualification is Becoming Official
• Update on FDA’s 21 CFR Part 11 - With Free SOP for Implementation
• New FDA Guidance for Submissions Using the eCTD Specifications

March 2006

• FDA Releases Final Guidance for GMP Inspection Dispute Resolution
• "GC and HPLC Qualification SOPs Should be Uniform" FDA Inspection Report Says.
• FDA Releases Updated Draft Guidance on Impurities in New Veterinary Medicinal Products
• Lack of Complete Records of Modification Modifications Cited in FDA Warning Letter

February 2006

• 92 Slides Presentation on API Inspections
• Harmonization of Laboratory GMP Inspections?
• Lack of IQ/OQ/PQ Documentation Cited in FDA Warning Letter

January 2006

• Audio Seminar Schedule for H1-2006 completed!
• EPA Publishes the Final Version of CROMERRR in the Federal Register
• Recording Pass/Fail not Enough for Testing, FDA Warning Letter Says
• EMEA: Questions & Answers on Audits of Active Substances Manufacturers

December 2005

• Labcompliance in 2005
• 'Missing Computer System Audits' and 'No Review of Computer Audit Trail Cited in FDA 483
• Recent CGMP Presentations by FDA Professional
• European Guidelines for Electronic Records
• FDA Human Drug CGMP Notes

November 2005

• FDA Draft Guidance on Electronic Drug Recalls
• Computer System Validation Package
  With a Primer, Master plan, 20 SOPs, Examples, Tutorial, Audio Seminar and Two Years On-line Updates
• Part 11 Update
• New ICH Guideline: Data Elements and Standards for Drug Dictionaries M5
• New Publication on Compliance and Procedural Training
• 85 Item 483 Observation for Pharmaceutical Manufacturer
• The FDA Continues to Enforce Part 11 Deviations

October 2005

• FDA's New “Drug Watch” for Emerging Drug Safety Information
• New Internet Quality&Compliance Package
• New Publication: The Growing Scope of Records Management
• FDA Cites Instrument Calibration and other Laboratory Controls in a Warning Letter

September 2005

• 30 New Documents in the Labcompliance Users Club
• New FDA Draft Guidance: ANDAs - Impurities in Drug Products
• Inadequate Corrective and Preventive Actions Draws FDA Warning Letter

August 2005

• FDA Recommends Withholding Approval of New Drug Applications with API's From Non-Compliant Manufacturer
• Expert Advice for Risk Management
• FDA Finds Deviations in Laboratory, Materials and Labeling/Packaging Systems

July 2005

• New ISPE/GAMP Guide Guide for Laboratory Systems Released
• New FDA Guidance: Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients.
• Three New Articles: Supplier Audits, QA/QC Stability testing and Quality Control Laboratories

June 2005

• New FDA Warning Letter with Part 11 Issues
• Lack of Risk Analysis Cited in FDA Warning Letter
• Lack of Software Validation and Inadequate Supplier Management Draws FDA Warning Letter
• New Article on Quality Systems Approach to Pharmaceutical cGMP Regulations

May 2005

• New Network Qualification Package Released
  Now with 13 SOPs, 3 Gap Analyses, 8 Validation Examples, IVT Network Qualification Standard, Video presentation, Audio Seminar and Two Years On-line Updates
• FDA Perspective on Laboratory Inspections
• Links to 30 International GMP Regulations and Guidelines

April 2005

• Network Compliance with Sarbanes-Oxley, E-Sign Act, HIPAA and Part 11
• Commission of the European Union Proposes Changes to EU GMP Guides
• FDA Warning Letter Report 2004 Published
• FDA Issues Draft Guidance on Immunotoxicity Studies
• New Article on Validating Automated Systems
• Failure to Extend Failure Investigations to Other Batches Draws FDA Warning Letter

March 2005

• 15 New Documents in the Labcompliance Users Club
• New Newsletter Category: Free Document of the Month
• New Article: Analytical Technology Moving from the Lab to the Line
• No Backup Procedures and No Validation of Computer Systems and Draw FDA Warning Letter
• Links to 30 International GMP Regulations and Guidelines
• New Article: Method Development of Swab Sampling for Cleaning Validation of a Residual API
• New FDA Guidance on Changes to an Approved NDA or ANDA

February 2005

• FDA Inspection Package Version 2 Released
• Links to FDA Guidelines for Computer Validation
• New FDA Guidance on Impurities in Drug Substances
• Inadequate Investigation on Contamination Raises FDA's Concern
• New Newsletter Category: Free Document of the Month
• Labcompliance Seminars: An Overwhelming Success Story

January 2005

• Audio Seminar on Using Internet and Intranet in Regulated Environments Available for Download
• Links to 26 FDA 'Predicate Rules'
• Update from David Horowitz, US FDA, on FDA's 21 st Century GMP Initiative
• Recent FDA Warning Letter for Missing Software Revalidation Protocols
• USP Announces Harmonization of General Chapters
• Principles of Computer Validation

December 2004

• Audio Seminar on Excel® Spreadsheets Available for Download
• New Guidance on Evaluation of Stability Data
• New Publication on Stability Testing
• FDA Denies Entry of APIs Into the United States due to the Significant GMP Deficiencies
• New US FDA Office in India

November 2004

• Current Status and Future Directions of Part 11
• FDA Answers Frequently Asked Questions About the 21st CGMP Initiative
• FDA Citations for Quality System Violations
• FDA Issues Final Report on Its “21st. Century” Initiative
• New Labcompliance Website with links to predicate rules

October 2004

• FDA Inspection Report Advices to Upgrade HPLC Systems
• New FDA Quality System Guide for Drug CGMPs.
• Five New Guidance Documents from the FDA
• Laboratory Compliance Event of the Year: More than 1500 Professionals had Signed up

September 2004

• 26-Item FDA 483 and a Warning Letter for API Manufacturer in India
• FDA Perspective on Laboratory Inspections
• More than 20 New Documents in the Labcompliance Users Club

August 2004

• Reference Samples and Retention Samples: New Annex to the EU GMP Guide
• Insight on FDA Inspections and Recommendations
• New Solutions from Labcompliance
• 21 CFR Part 11 and Risk Assessment: Adapting Fundamental Methodologies to a Current Rule
• New FDA Warning Letter Statistics
• New Warning Letter for Inadequate SOPs

July 2004

• Validation Master Plan vs. Master Validation Plan, Validation Project Plan and SOP
• FDA's Expectations for Laboratory Method Validation and Instrument Qualification
• Recent FDA Warning Letter for Invalidation of Tests Results Without Adequate Scientific Rationale
• Case Study: Upgrading a Pharmaceutical Laboratory to Part 11 Compliance at AstraZeneca.
• Who is responsible for the Validation of Computer Systems?
• What is the Problem with SOPs?

June 2004

• Update on FDA's Public Meeting on Part 11 and Draft Agenda
• FDA's Public Part 11 Meeting Cancelled
• How to Avoid FDA 483's and Warning Letters
• Recent FDA Warning Letter for Inadequate Equipment Calibration and Software Validation
• New Publication: Using Macros and Spreadsheets in a Regulated Environment
• FDA Warning Letter for no or Inadequate Risk Analysis
• New Article: Best Practices in Pharmaceutical Systems Validation and Part 11 Compliance

May 2004

• Ten New Documents in the Labcompliance Usersclub for Instant Download
• My Computer System is High, Medium or Low Risk. What does this mean?
• Update on Part 11 by FDA's John Murray
• New FDA Drug cGMP Expected to be Released in August
• FDA Compliant Configuration Management and Change Control
• IVT Computer System Validation Conference - The Most Successful Computer Validation Event Ever

April 2004

• Spreadsheet Design and Validation - Update
• FDA Announces Public Part 11 Meeting
• New GAMP Guide on Laboratory Systems Presented at Interphex 2004
• New Part 11 Book for Clinical Trials
• New Article: Process Analytical Technology - Changing the Validation Paradigm
• FDA Warning Letter for Inadequate Method Validation
• Risk Based Computer Validation

March 2004

• New Book on Computer Validation
• Spreadsheet Design and Validation for Part 11 and GxP Compliance
• New Part 11 Intro Article
• New GAMP Guide for Laboratory Computer Systems

February 2004

• Model SOPs: New Service from Labcompliance
• Inadequate Excel Spreadsheet Validation Cited in a Recent FDA Warning Letter
• Inadequate Excel Spreadsheet Validation Cited in a Recent FDA Warning Letter

January 2004

• Strategies to Define Part11 Scope and Controls
• Industry Advice on Part 11 and Legacy System
• FDA 'Advice' on Spreadsheets
• FDA Warning Letter for Inadequate Invalidation of OOS Results
• FDA Starts Pilot Program for Dispute Resolution
• Validation of Spreadsheet Applications and Macros

December 2003

• Take Advantage of Popular Conference Presentation Materials
• Eurachem Updates "Traceability in Chemical Measurement" Guide
• FDA Developing an Integrated Agency-wide Quality Systems Guidance
• FDA's National Expert Recommends Validation of Networks for Part 11 Compliance

November 2003

• FDA is Developing an Agency Wide Quality Systems Guidance
• Ten New Trend Warning Letters/Inspectional Reports (483's) in the Usersclub Section
• Using Excel™ in Part 11 Environment
• NIST Released Security Metrics Guide For Information Technology Systems
• Validation Master Plan vs. Master Validation Plan, Validation Project Plan and SOP

October 2003

• What are predicate rules and how can I get them?
• New version: Macro and Spreadsheet Quality Package
• How to Qualify Data Centers
• Ten Success Factors for Effective Risk Management

September 2003

• Reconfirmed: GMP Training Records don't Need to Comply with Part11
• PIC/S Releases Final Guide on Computer Systems in GxP Environments
• FDA Changes the Compliance Program Guide for Pre-Approval Inspections
• FDA Issues Draft Guidance on Voluntary Process Analytical Technology
• FDA's Progress Toward "21st Century" Regulation of Pharmaceutical Manufacturing
• FDA Releases Final Part 11 Guidance on Scope and Application

August 2003

• GMP Training Records don't Need to Comply with Part11
• New Version of the Network Quality Package released
• Part 11 Equivalent Regulations in Europe
• FDA Compliance Officer Emphasizes the Importance of Validation Master Plans
• FDA's System-based Approach to Inspections Reflected in Warning Letters

July 2003

• Final Part 11 Guidance Most Likely to be Released on August 20
• FDA's Approach to Identify High Risk Facilities and Systems for Inspections
• 'Advice' on Using Spreadsheets from FDA Inspection Reports
• Question and Answers on Active Pharmaceutical Ingredients
• Canadian Therapeutics Good Directorate Updates Guidance on Risk Classification
• EU Note for Guidance on Validation of Non-Standard Processes

June 2003

• Steps to Qualify Network Infrastructure
• Verification of File Integrity with MD5 Hash Calculations
• Five Warning Letters Added to Users Club
• FDA Published Draft Guidance on Multiplex Tests
• Test Procedure: 'Authorized System Access' Added to the Users Club
• Validation and Control of Quantitative Bioanalytical LC/MS Methods

May 2003

• The New FDA Part 11 Guidance: What has really changed?
• Benefits of Electronic Records/Signatures in Drug Discovery
• FDA Published a Proposed Rule on Dietary Supplement GMP's
• Results from the Joint FDA/PQRI Workshop on Risk Based Approaches
• Risk Assessment and Risk Management Key Topics at CSV/Part 11 Conference
• Systems Without Risk Assessment are Classified as 'High Risk Systems'
• Interview with FDA CDER Director on Part 11
• PhRMA's thoughts on risk based approach for cGMPs

April 2003

• Interactive Video Training and Worksheets for Computer Validation
• FDA Guidance on Electronic Common Technical Document Specification
• Establishment Inspection Reports More Valuable than 483's and Warning Letters
• Update on FDA's New Initiative on Drug Product Quality
• Do we Really Need a Design Qualification?

March 2003

• FDA Publishes Concept Paper On Premarketing Risk Assessment
• Inadequate Training Frequently Cited Deviations in Warning Letters
• All FDA Warning Letters Reviewed by Centers
• New FDA Guidance for Stability Testing
• FDA's Progress Report of the 483 Communications Working Group
• New FDA Draft Guidance for Drug Chemistry, Manufacturing, and Controls Information

February 2003

• FDA releases new part 11 draft guidance
• Version 2 of the Labcompliance Network Quality Package Released
• EU Annex 11 and 27 page APV Interpretation available as PDF Files
• Computerized Systems and Part 11 Compliance for Bioresearch Monitoring
• FDA Withdraws Part11 E-copies Guidance
• ISPE Submits White Paper to FDA: Risk-Based Approach to 21 CFR Part 11
• FDA Starts New Initiative to Speed up New Drug Approval
• FDA Adds Electronic Copies Guidance to the Investigations Operations Manual

January 2003

• Waning Letter confirms: "If it's not documented it's a rumor"
• Pharmaceutical GMP’s for the 21st Century: FDA’s New Initiative on Drug Product Quality
• 18 Additional Warning Letters/Inspectional Reports (483's) in the Usersclub Section
• Checklist for Network Qualification and System Validation
• Automated Balance with Part 11 Support
• FDA Update on Part 11

December 2002

• Advice on Selecting and Using Biometric Devices for Authentication
• On-going Discussion About Long Term Reprocessing of Data
• Software Validation Plan and Risk Analysis Important but not Enough
• Implementing Networked Data Systems in Laboratories Regulated by FDA Part 11

November 2002

• IVT Awards Labcompliance Editor as 'Presenter of the Year'
• FDA's Part 11 Guidance on Electronic Copies for e-Records
• FDA Guidance: Handling and Retention of BA and BE Testing Samples
• New Website for Qualification and Compliance of Networks
• GAMP 4 CD ROM available

October 2002

• Examples for requirement specifications and test cases
• Network Infrastructure Qualification & System Validation Conference
• Part 11 Checklist for Analytical Laboratories
• Contingency Planning Guide for Information Technology Systems
• New FDA Initiative To Enhance Pharmaceutical Good Manufacturing Practices
• Validation of Macros/spreadsheets and Network Qualification hot conference topics

September 2002

• FDA's Part 11 Industry Guidance on Maintenance of Electronic Records
• FDA Warning on Laboratory Equipment, Records and Spreadsheet Applications

August 2002

• Using Macros and Spreadsheets in a Regulated Environment
• On-going Discussion About Durable and Volatile Memory
• Biometric Devices for Authentication
• Website on Establishing Electronic Standards

July 2002

• Understanding the FDA Part 11 Validation Guidance
• M 500$ Fine:FDA Sets Clear Sign to Continue Enforcement
• Paul Motise: GxP Data on E-Proms Should Comply with Part 11
• EMEA Releases Draft Guidance on Stability Testing

June 2002

• ew Validation Reference Book from Interpharm Validation of Computerized Analytical and Networked Systems
• Boost Efficiency Through E-Records/Signatures Systems
• Risk Analysis and Risk Assessment Becoming More Important

May 2002

• Paul Motise Presentation on Part 11 Validation Guidance
• Technologies Supporting Security Requirements in Part 11
• Network Qualification and Validation of Macros/spreadsheets hot topics
• FDA's Part 11 Industry Guidance on Time Stamps
• FDA Warning Letterer Requests Pre-audit and Certification Through Outside auditor

April 2002

• FDA Releases Draft Guidance: PET Drug Products - cGMP
• Major Revision of the Labcompliance Glossary
• CITAC Publication on Traceability

March 2002

• New Links Added to FDA Dockets Web Page
• Using Macros and Spreadsheet Calculations in Regulated Environment
• NIST Releases Security Guide

February 2002

• PIC/S "Good Practices for Computerized Systems in Regulated Environments" available as Draft for Comments
• Warning: Part 11 Applies to all Electronic Records to Support of FDA documentation

January 2002

• Warning Letter for Insufficient Testing of Networked Data Systems
• FDA Representative Reports about Problems with Legacy Systems
• Warning Letters for Incomplete Structural Validation, Non-validated Compilers and Incomplete Laboratory Records
• FDA released final guidance: General Principles of Software Validation
• Free on-line seminars on 21 CFR Part 11 updates
• Warning Letter for Non-compliant E-Drawings
• Gamp 4 for Validation of Automated Systems Released

December 2001

• PhRMA Sends Response to FDA's Part 11 Guidance
• FDA Releases Final API Guidance
• Inadequate Spreadsheet Validation Cited in a Warning Letter
• Article on Qualification of Equipment and Computerized Systems

November 2001

• New FDA Industry Draft Guidance on Bioanalytical Method Validation
• The Future State of Computer Validation, Part two published
• New Part 11 FDA Industry Draft Guidance with Glossary of Terms
• Article Series on 21 CFR Part 11 available in Japanese

October 2001

• Twenty new Warning letters on the Users Club pages
• New Part 11 FDA Industry Draft Guidance on Validation
• New Article on Traceability of Analytical Measurements

September 2001

• Update and Q&A's on Part 11 from FDA's Christine Nelson
• EU GMP Annex 15 on Validation and Qualification in Operation
• New publication: The Future of Computer Validation

August 2001

• Canada: Health Canada Issues New Drug Validation Guidance
• Update on Part 11 from FDA's McCormack
• Validation of a Biological Incubator's Incubation Time

July 2001

• New FDA Draft Guideline on Mass Spectrometry
• New Warning Letters on 21 CFR Part 11
• ISO/IEC 17025 Gap Analysis
• The impact of 21 CFR Part 11 on Global Manufacturing and Product Safety

June 2001

• New Validation Master Plan
• What FDA Inspectors Want to See About Computer Validation
• New Guidance on Equipment Qualification of Analytical Instruments:
• New article from R.D.McDowall: Containing the 21 CFR 11 Problem

May 2001

• New publication on Part 11. Biometrics-Based Authentication - Limitations and Possibilities
• New FDA Guidance: Statistical Approaches to Establishing Bioequivalence

April 2001

• FDA Warning Letter on Analytical Equipment Calibration and Validation of Software
• ISO 9000:2000 Available On-line

March 2001

• Update on FDA's Part 11 compliance policy guides
• New article: Electronic Signatures and Records in Practice
• FDA releases program for device manufacturer inspections

February 2001

• New Bioavailability/Bioequivalence Guide from the FDA
• What does that mean: "Use of Device Checks" in 21 CFR Part 11?
• EPA Proposes New Rule for Electronic Reporting and Electronic Records
• 21 CFR Part 11 for Manufacturing and the Analytical Laboratory

January 2001

• NARA Releases Guidance for Records Management
• LabCompliance UsersClub with 50% more information
• New Internet Seminar Series on 21 CFR Part 11

December 2000

• ISO 9001:2000 passed by an overwelming majority
• New Publication: 21 CFR Part 11:Importance of instrument control and data acquisition

November 2000

• New publication: Impact of Part 11 on Chromatography Data Systems
• New section on 'Method Validation' in the LabCompliance Forum

October 2000

• FDA releases new industry draft guidance on method validation
• New publications on FDA 21 CFR Part 11 for laboratories
• New FDA warning on 21 CFR Part 11: corrective action plan

September 2000

• GAMP develops guideline for 21 CFR Part 11
• Is the Scope of Part 11 Changing?
• New Trends in GLP/GMP: Presentation at IDMA convention:

August 2000

• US EPA Develops Electronic Records Keeping Rule
• Eurachem-Eurolab Draft on Proficiency Testing
• Workshop: Quality in analytical laboratories
• Follow up of joint PDA/FDA Conference on 21 CFR Part 11
• PDA Technical Report No. 32 on vendor audits now available
• New Publication: 21 CFR Part 11: Long term archiving and 'ready' retrieval
• Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

May 2000

• FDA 483 Observations and Warning Letters from LabCompliance
• Tutorial on method validation
• Impact on FDA's E-records/signature rule on pharma labs

April 2000

• PIC Computer System Draft guidelines

March 2000

• PDA Technical Report on Supplier Audits
• Free primer on 'GLP/GMP in Laboratories'
• Article on data integrity and security for 21 CFR 11

February 2000

• EU GMP Draft Validation Master Plan
• New presentation on 21 CFR Part 11
• ISO/IEC Guide 25 revised to ISO 17025
• Announcement: FDA Meeting on Part 11

January 2000

• FDA Guidance on Method Validation

December 1999

• Free Validation Master Plan
• New ICH documents published on the EMEA web site.
• Part 11 FDA Industry Training - Video Available
• New Publication: 21 CFR Part 11: Security Aspects
• ICH Criteria for Biotechnology Products

November 1999

• 21CFR 11 and Paul Motise: Presentation Highlights and Questions/Answers
• New PDA Report: Validation and Qualification of Computerized Laboratory Data Acquisition Systems

October 1999

•  New edition of the USP published
• US bill would validate digital signatures
• Part 11 FDA-Industry Training on Oct 21
• UK Attempt to Validate DNA Technology
• FDA ORA Guide to Inspections of Quality Systems
• FDA 483's and Warning Letters Related to Computers
• New ISO Guide 25
• New Article on Internet Resources for Computer Validation
• New Book on Computer Validation from Teri Stokes
• Suppliers of Biometric Devices for E-signatures

September 1999

• New site with FAQ's on 21CFR Part 11
• Suppliers for (Certified) Reference Material
• New section with journals and trade magazines
• The Impact of Part 11 on Chromatographic Data Systems

August 1999

• Implementation steps for 21CFR Part 11
• Do you have questions for the FDA?

June 1999

• Glossary on compliance, validation etc
• New FDA Compliance Policy Guide on e-records-/signatures
• FDA Guidance on 'Computerized Systems Used in Clinical Laboratories' released
• New article on validating HPLC methods
• Article: how instrument vendors help with accreditation
• Searching LabCompliance by keywords

May 1999

• The industry's view of 21CFR Part 11
• More than 500 validation seminar attendees in Japan
• New proficiency testing scheme launched
• Guidelines for the in-house production of reference materials
• Video on FDA's 21CFR11 industry training available
• Detailed question/answers from the FDA on e-sig/records
• More new links   

April 1999

• Article series on implementation of 21CFR part 11
• Mutual Recognition Agreement between the US and the EU
• PhRMA Comments on Draft FDA Guidance: OOS results

March 1999

• International Symposium on Spectroscopy&QualityControl
• New links to more than 20 companies providing compliance services
• OECD GLP Consensus Papers Online
• Laboratory Guide to Method Validation from EURACHEM
• New section on electronic records/signatures: 21 CFR Part 11

February 1999

• New presentation:: Moving from paper to elecronic records
• New article on qualification of HPLC systems
• Seminar: Validation of computerized analytical systems

January 1999

December 1998

• FDA industry training on 21 CFR Part 11
• New reference book on validation shipping
• Article on qualification of HPLC systems

November 1998

• FDA draft guidance on OOS results

September 1998

• FDA Draft Guidance on 'Computerized Systems Used in Clinical Laboratories'

August 1998

• Article: Validation of Analytical Methods
• Article: Equipment Qualification in Practice