Labcompliance News

May 2013

• USP Offers Free Compendium with Testing Standards for Herbal Ingredients used in Traditional Medicines
• Generic Drug Manufacturer agrees to pay M$500 Fine for GMP Violations
• Excipient and Pharmaceutical Manufacturers are Concerned about the USP Timeline for Chapters <232/233>
• Laboratory Data Integrity Issues Cited as FDA GMP Deviations

April 2013

• FDA Releases Draft Guidance on Setting Limits for Mutagenic Impurities
• FDA Releases Final Guidance for Computer System Validation
• Revised EU GMP Guide Requires formal Transfer of Analytical Methods
• Detailed Comparison between EU & Indian GMP Requirements for APIs
• ICH Releases M7 Step 2 Guidance for Mutagenic Impurities
• FDA Warning: Paper print-outs of e-records incomplete, missing e-audit trail, no back-up of raw data

March 2013

• FDA Answers Questions related to User Fees for Generic Drugs
• New FDA Guidance on Formal Dispute Resolution
• "No Acceptance Testing during Method Transfer" cited in FDA 483
• New Global Guidelines and Regulations Impacting Validation Professionals
• New Publication on Recent Developments of Biosimilar Products
• FDA 483 Observation caused by  wrong SOP for Method Transfer

February 2013

• USP General Notice suggest USP Reference Standards to be a MUST for USP Compendial Standards
• "CGMP Regulations not included in the Training program" draws FDA Warning Letter
• FDA Announces the Availability of the ICH Q11 Guidance
• 14 New SOPs Available since February 1.
• EMA published a Concept Paper on Revision of Annex 15 of the EU GMP
• FDA expects Deviations from GLP SOPs to be Authorized and Documented

January 2013

• FDA CDER Presents FY 2012 Review
• FDA Expects Periodic Requalification of GCs and HPLCs
• FDA Presentation on Quality by Design for Analytical Methods
• FDA Warning Letter for Insufficient  Training and inadequate Response
• FDA expects Multifold Increase of Foreign Generic Drug Manufacturer Inspections
• NATA Updates Technical Note for the Validation of Test Methods

December 2012

• New FDA Guidance: Electronic Source Data in Clinical Investigations
• EU/PICS GMP Annex 11: The new global Standard for Computer Management and Validation
• How to Qualify Manufacturers of APIs: Questions and Answers
• FDA understands the Industry's  Need for Virtual Networks and Cloud Computing
• New ICH/FDA Guidance on Genotoxicity Testing for Pharmaceuticals
• How to Qualify IT Infrastructure?

November 2012

• FDA publishes ICH Guidance on Development and Manufacture of Drug Substances
• USP Postpones the official Date for Chapters <232/233>
• Three easy steps towards FDA compliant Electronic Signatures
• New Zealand and Taiwan to join PIC/S
• Biosimilars Handbook available from the European Generic Medicines Association
• Updates on Using Cloud Computing in Regulated Environments

October 2012

• New  FDA Guidance for ANDA Stability Testing
• EMA answers Questions related to Specification Limits of Genotoxic Impurities
• PIC/S Adopts EU GMP Annex 11 as PIC/S Annex
• Learning from Recent FDA GLP Warning Letters
• Japanese Guidelines for Computerized Systems and Electronic Records&signatures available
• More EMA GMP Inspections caused by significant quality or GMP problems

September 2012

• New  FDA Guidance for Pyrogen and Endotoxins Testing
• FDA Recommends 3rd Party Consultant for Lab Equipment Qualification
• Video on FDA Drug Development and Approval
• EURACHEM Releases the 3rd Edition of the Measurement Uncertainty Guide

August 2012

• USP Proposes Changing the General Chapter 'Weight and Balances'
• EMA Releases Guideline on 'Real Time Release Testing'
• New Guideline on the use of Near Infrared Spectroscopy (NIRS)
• ISPE Releases New Guidance for 'Pharmaceutical Change Management'
• FDA Warning Letter Issued for Missing Verification of Analytical Methods
• FDA Video explains the 'Accelerated Approval Program'

July 2012

• New FDA List with New/Revised/Withdrawn Guidances available
• New Part 11 Compliance Package for Trouble-free Implementation
• EGA Answers Questions about Biosimilar Medicines
• All Drug and API Manufacturers must Control Elemental Impurities
• Half of FY11 FDA GMP Warning Letters tied to Batch Failures
• FDA Update on Ongoing-Activities and Product Recalls
• MHRA answers Frequently Asked Questions related to OOS

June 2012

• Indonesia Joins PIC/S
• Labcompliance releases new New Computer System Validation Package
• FDA Presentation on International Compliance Issues
• Free E-Book on Virtualization of Computer Systems and Networks
• EMA Releases Draft Guideline on Similar Biological Medicinal Products
• Korea applies for PIC/S membership

May 2012

• New Version 3.0 of the ISO 17025 Accreditation Package Released
• USP Chapters <232/233> for Elemental Impurities Approved
• FDA Warning letter: Paper print-outs of e-records incomplete, missing e-audit trail, no back-up of raw data
• EMA Releases Quality Guideline Concerning Biological Investigational Medicinal Products
• 'Advice' from FDA on Using Excel in Regulated Environments
• Japan Applies for PIC/S Membership

April 2012

• "Your Response is not Adequate, Because .....": is the most frequent Warning Letter statement
• PIC/S publishes Inspection Guide on Quality Risk Management  Systems
• Number of FDA Warning Letters still Increasing
• 12 Months FDA Update Presented by FDA Officials
• Consent Decree requests Drug Manufacturer hiring 3rd Party Auditors to resolve "Data integrity" Issues
• EMA answers Frequently Asked Questions related to Biosimilar Products Applications
• "Rationale for inspection of Reserve Samples is not based on Statistical Assessment" draws FDA 483

March 2012

• New FDA Guidance on Safety Data Collection
• FDA Warning Letter: Import Alert for Polish API Manufacturer
• FDA CDER Launches New Web Education Series on Drug Review Process
• FDA Continues with Part 11 Inspections and related Warning Letters
• Chinese Pharmacopeia 2010 Edition Available in English
• "Samples not Representative" cited in FDA Warning Letter
• New FDA Guidance on Acceptance of Foreign Clinical Studies

February 2012

• FDA issues Draft Guidance on Biosimilar Product Development
• The USP <1224> for Method Transfer is coming in May: Are you ready?
• FDA Warning Letters in 2011 Increased 155% from 2010
• EMA Guideline on Quality of Herbal Medicinal Products Final
• Inadequate Transfer of analytical methods cited in FDA Warning Letter
• English Version of the New Chinese GMPs available on the WHO Website

January 2012

• Joint EMA and FDA Inspections starting in January
• Free E-Books on Cloud Computing and Virtualization of Networks
• Product Recalls and Temporary Manufacturing Halt after FDA Inspection
• FDA Publishes Updated ANDA Checklist
• FDA Expects Robustness Testing during Method Validation
• USP Chapter <1224> on Transfer of Analytical Procedures official in May 2012

December 2011

• WHO continues to publish Inspection Report Summaries
• FDA expects Global Corrective Actions for Inspectional Observations
• PPD Publishes White Paper on Clinical Developments for Biosimilar Drugs
• Inadequate SOPs for Analytical Method Validation and Transfer cited in FDA Warning Letter
• EU will require Certificates for API Imports from  third Countries
• FDA expects an SOPs to manage Out-of-Trend (OOT) Situations

November 2011

• 50 New Documents in the Labcompliance Usersclub
• FDA Focus on Computer Validation Ongoing
• FDA Answers Questions related to ICH Q8/Q9/Q10 Implementation
• "Corrective Action for inadequate Method Validation too late", FDA Warning Letter says
• PIC/S Reaches Membership Milestone: 40 Members
• Missing Robustness Testing for Analytical Methods cited in FDA Warning Letter
• Russia to follow India and China as Pharma Drug and API Manufacturer

October 2011

• Device Manufacturer Cited for not Having Supplier Quality Agreements
• EMA Guideline on Bioanalytical Methods Validation Effective by Feb 1, 2012
• FDA requires formal Stability Assessment of In-house Prepared Standard Solutions used for Quantitative Analysis
• FDA Published FY2010 Inspectional Observation Summary
• FDA Proposes Enhancing Search Criteria for Inspections Database
• Inadequate Response to 483 Observations Causes Part 11 Warning Letter

September 2011

• Health Agency helps Industry Preparing for an Initial Drug GMP Inspection
• FDA Official Reports about Part 11 Related Inspectional Observations
• "Failure to Provide Adequate Study Direction", cited in FDA Observation
• IT Infrastructure Qualification vs. Validation of Networked Systems
• USP Publishes Six New General Chapters on Spectroscopy Methods
• Recent Warning Letter Related to 21 CFR Part 11
• First US FDA India Seminar on Computer System Validation & Part 11 Compliance a big Success

August 2011

• "Excel Spreadsheet not protected against unauthorized Use" cited in FDA 483
• WHO Publishes Guidance on Technology Transfer
•  New free Tutorial on Risk Management
• Studies Conducted by CRO May Require Reevaluation, FDA Says
• FDA Commissioner Dr. Hamburg Talked about Sharing Global Inspection Data
• FDA Warning Letter Issued for Missing Verification of Compendial Methods

July 2011

• USP: Current and Future Directions
• FDA Update on Part 11
• EU GMP Annex 11 enforced since July 1
• Response to 483 after 15 business days declined by FDA
• FDA Introduces a Spectral Library to Detect Improper Ingredients in Drugs
• New Article on Quality Risk Management Principles With Case Studies

June 2011

• FDA Warning Letters increasing by 30% in FY 2011
• Periodic Evaluation and Review of Computer Systems Legally Required
• FDA expects to Validate or Verify the Accuracy of Bioanalytical Methods
• New FDA Guidance about Enforcement of Safety Reporting Requirements for INDs and BA/BE Studies
• Shares fall 5 Percent Caused by an FDA GMP Warning Letter
• Part 11 Related Deviations Cited in  FDA Warning Letter
• FDA Publishes Names and Addresses of Inspected Facilities
• Approvals for Biopharmaceuticals nearly doubled in the past Decade

May 2011

• FDA Requests 'Global' Improvements to address Raw Data Issues
• EMA Answers Questions Related to the New EU Annex 11
• New FDA Guidance for Submission of Summary Bioequivalence Data
• FDA recommends to hire a Third Party Auditor for detecting (Raw) Data Integrity Problems
• Free FDA Web Seminar on Foreign Inspections
• Can Electronic Raw Data be deleted after Printouts?
• USP Updates Draft Chapters 232&233 for Analysis of Metal impurities

April 2011

• FDA Warning Letter Issued for Inadequate Use of Excel Spreadsheets
• PIC/S Publishes Questions & Answers Document Regarding Distribution Activities for APIs
• Microsoft Offers SharePoint 2010 Configuration Guidance for Part 11 Compliance
• FDA  is Using Excel in its own Regulated Environments
• "Raw Data for Annual Instrument Re-Qualification not Maintained" cited in Warning Letter
• Is the U.S. Really Slower than Europe in Approving New Drugs?
• Labcompliance Offers Workshop for Validation of Analytical Methods

March 2011

• FDA Starts to Look for Measurement Uncertainty
• New FDA Draft Guidance: Electronic Source Documentation in Clinical Investigations
• FDA 483 for Insufficient Number of Qualified People
• USP Proposes to Update Chapter on Verification of Compendial Methods
• "SOP does not Ensure Sample Integrity" cited in FDA 483
• Can Vendors Offer 'FDA Compliant' or "Part 11 Compliant" Software?
• 73 New Documents added to the Labcompliance Usersclub

February 2011

• The EU Annex 11 Can Become Important for FDA Regulated Industry
• FDA Warning Letter for Inadequate Transfer of Analytical Methods
• Laboratory Controls #1 Deviations in FDA GMP Inspections
• Inadequate Performance Qualification" cited in FDA Warning Letter
• USP Publishes the New Chapter <1224> for Analytical Method Transfer
• FDA Publishes the Final Version of the Process Validation Guidance
• FDA Part 11 Inspections Starting with Delay

January 2011

• New EU GMP Annex 11 on Computerized Systems Released
• FDA Published Advance Notice of Rulemaking for GLP Revisions
• "Stability Testing Co-eluting Peaks not Identified", cited in FDA Warning Letter
• USP Pharmacopeial Forum (PF) now for Free
• Number of GLP Warning Letters and Number of Deviations Increasing

December 2010

• FDA Releases New Guidance for ANDAs:  Impurities in Drug Products
• FDA Warning: Stability Indicating Methods not Selective, not Validated or not Followed
• EMA Publishes Guideline on Similar Biological Medicinal Products
• EMA Publishes Guidance on the Investigation of Bioequivalence
• FDA Expects Forced Degradation in the Presence of all APIs, Warning Letter Says
• Labcompliance ISO 17025 Tutorial Updated
• Outsource Analytical QC Testing Yes or No?

November 2010

• FDA Will Join PIC/S in January 2011
• FDA Warning: Computers Must be Revalidated Before Put in Operation After Changes
• EMA Posted Questions & Answers about Post Approval Changes
• FDA Guidance for Early Clinical Trials with Live Biotherapeutic Products
• FDA Guidance on the Need of IND for Conducting Clinical Trials
• Free 76-page Primer on Method Validation Available

October 2010

• Spreadsheets Should be Verified for Accuracy, FDA Warning Letter says
• Do all EU GMP Inspections Cover the Quality Risk Management Process?
• Again and Again,  Part 11 Related Deviations Cited in  FDA Warning Letter
• FDA Issued Final Rule on Safety Information During Clinical Trials
• New Part 11 Compliance Package Available as Download
• FDA  'Advice' on Validation and Use of Excel®

September 2010

• FDA Publishes Guidance on Capillary Electrophoresis
• Free 28-page White paper on Supply Chain Security from ISPE
• FDA Warning Letter for Inadequate Validation of Analytical Methods
• FDA Publishes Questions and Answers on Product Recall
• Free FDA Web Seminar about Generic Drugs
• FDA Warning for Inadequate Storage of Reference Samples and Reagents

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

For Labcompliance News before 2010, Click Here