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56 Usersclub Additions

- 15 SOPs
- 10 Examples/Checklists
- 3 Forms/Templates
- 7 FDA Presentations
- 21 Warning Letters

 

Online Audio Seminars come with 10+ Best Practice guides for easy implementation

 

Validation and Use of Excel Spreadsheets in Regulated Environments
Comply with GxPs for drugs, APIs and Devices, with FDA Part11, and with EU-PIC/S Annex 11
Recorded, available at any time

 

Validation and Use of Cloud Computing in FDA Regulated Environments

Comply with GXPs, Part 11, EU Annex 11 and other regulations

Recorded, available at any time

 

FDA Compliant Handling of Out of Trend Results in Pharmaceutical Quality Control

With Strategies and best Practice Guides for easy Implementation

 Recorded, available at any time

 

System Suitability Testing for FDA and USP Compliance

Setting parameters and limits for chromatographic and other methods

Recorded, available at any time

 

Analytical Equipment Qualification and System Validation for FDA Compliance

Combining the USP <1058> with the new GAMP(TM) Laboratory Computer Systems Guide

Recorded, available at any time

 

Managing Electronic Raw Data in Regulated Environments

Definition, generation, evaluation and archiving for FDA, ICH, PIC/S and EU compliance

Recorded, available at any time

 

FDA Compliant Use of (Certified) Reference Material

Strategies for selection, purchasing, testing and documentation

Recorded, available at any time

 

Regulatory Aspects of 'Biosimilar' Drugs

Understand and Implement recent FDA and updated EMA Guidances

Recorded, available at any time

 

Transfer of Analytical Procedures According to the New USP Chapter <1224>

With SOPs, templates and examples for easy implementation

Recorded, available at any time

 

Elemental Impurities According to the new ICH Q3D and USP 232/233 Guidelines

With updates on selected elements, limits, analytical procedures and schedule.

Recorded, available at any time

 

Quality by Design (QbD) for Analytical Method Development and Validation
Learn how to design robustness for easy transfer and to avoid OOS situations
Recorded, available at any time

 

Understanding and Implementing the New EU-PIC/S Annex 11

Prepare Yourself for the upcoming Inspections and Enforcement

Recorded, available at any time

 

Laboratory Equipment Qualification according to USP <1058>
With SOPs, Templates and Examples for Easy Implementation
Recorded, available at any time

 

Verification of Compendial Methods according to the Revised USP Chapter <1226>

Understand the new risk based approach and get real world case studies for testing

Recorded
Available at any time

 

Qualification and Use of Virtual Networks in Regulated Environments

With Strategies and Tool Kit for Compliance and System Uptime

Recorded, available at any time

 

Verification of Compendial Methods according to the Revised USP Chapter <1226>

Understand the new risk based approach and get real world case studies for testing

Recorded, available at any time

 

How to Prepare Yourself for FDA's on-going Part 11 Inspection Program

Learn what the FDA is looking for and how to respond

Recorded

 

Validation of Bioanalytical Methods and Procedures

Conduct and Document for Efficiency and FDA&EMA Compliance

Recorded, available at any time

 

Learning from Recent Warning Letters Related to GMP Laboratory Controls

For Preparation of FDA and International GMP Laboratory Inspections

Recorded, available at any time

 

Development and Validation of Stability Indicating Methods for FDA/ICH Compliance

Sample generation - method development - validation - documentation

Recorded, available at any time

 

with 10+ validation  examples, seminar with FDA's Dennis Cantellops and Ludwig Huber and with 13 SOPs for easy implementation.

 

 

 

 

Labcompliance News August 2013

FDA Releases Guidance on Quality Agreements for Contract Manufacturing

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements.” This guidance describes FDA's current thinking on defining, establishing, and documenting the responsibilities of each party involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP). In particular, the guidance describes how parties involved in the contract manufacturing and quality control  of drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy. The guidance can be viewed and downloaded from the FDA website.

New Stimuli Article on Method Development, Performance Qualification and Performance Verification

The members of the USP Validation and Verification Expert Panel have published a Stimuli article on lifecycle management of analytical procedures. In the article entitled "Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Verification", the authors suggest that the traditional approaches to validation, transfer, and verification should be integrated into the analytical procedure lifecycle process rather than be viewed as separate entities. The article has been posted as general announcement in advance of its publication in Pharmacopeial Forum 39(6) to allow additional time for public review and comment.

Missing Requalification of Analytical Equipment draws FDA Warning Letter

FDA expects analytical equipment not only to be qualified before its initial use but also during ongoing use. This became obvious in a recent FDA warning letter that reads: "Your firm has failed to calibrate instruments and recording devices at suitable intervals in accordance with an established written program containing specific directions, schedules, limits for accuracy and precision, and provisions for remedial action in the event accuracy and/or precision limits are not met [21 C.F.R. § 211.160(b)(4)". For example, Your firm did not calibrate and qualify the xxx high performance liquid chromatography (HPLC) instrumentation adequately, in that there is no periodic qualification or evaluation of the pump, oven, injector, or detector. The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-278.  To learn everything how to qualify and re-qualify analytical equipment attend the audio seminar  "Integrated Analytical Equipment Qualification and System Validation" The seminar suggests extent and frequency of periodic requalification.

FDA issues Guidance for Industry on Risk-Based Monitoring

This guidance assists sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human drug and biological products, medical devices, and combinations thereof. The overarching goal of this guidance is to enhance human subject protection and the quality of clinical trial data by focusing sponsor oversight on the most important aspects of study conduct and reporting. The guidance describes strategies for monitoring activities that reflect a modern, risk-based approach that focuses on critical study parameters and relies on a combination of monitoring activities to oversee a study effectively. The guidance can be viewed and downloaded from the FDA website.

New FDA Draft Guidance on Delaying or Refusing a Drug Inspection

This guidance define the circumstances that FDA would consider to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of making a drug adulterated. The guidance is strongly recommended to read in preparation for upcoming FDA inspections  For example, readers may be surprised to learn that "Not allowing photography by an FDA investigator may be considered a limitation if such photographs are determined by the investigator(s) to be necessary to effectively conduct that particular inspection."
The guidance is available on the FDA website.

Lack of Reliability, Accuracy and Integrity of Electronic Raw Data a Serious Concern for the FDA

In a recent warning letter going to a pharmaceutical manufacturer the FDA documented a series of issues with electronic and other raw data data. Primary deviations included: "Laboratory records not complete", "Quality control control HPLC raw data files can be deleted from the hard drive using the common PC login used by all analysts. This deletion eliminates all records of sample injections and analyses", "Missing risk assessment on the impact of disabled audit trail", "Lost equipment activity logs (audit trails)", "At least one QC officer had the ability to delete electronic raw data". As a consequence the FDA recommended hiring a data integrity expert: "We highly recommend that you hire a third party auditor, with experience in detecting data integrity problems, to assist you with this evaluation and to assist with your overall compliance with CGMP." The company had responded to all related 483 observations, but most responses have been inadequate for a variety of reasons. The Warning Letter can be downloaded from the Labcompliance Usersclub. Scroll down to W-284. Non members can preview excerpts. Attend the Labcompliance audio seminar to learn everything about FDA requirements to ensure accuracy, integrity and reliability of electronic raw data.

Free Document of the Month

As a 'Thank You' for our visitors Labcompliance offers every month one document for free. This month's document is the SOP "Retrospective Validation of Computerized Systems". To download your free copy, go to the Spreadsheet Compliance Package website. Scroll down and click on the corresponding ICON on the left (offer expires on August 31 , 2013). Labcompliance offers more than 150 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

Audio Seminar Schedule

  1. GMP Compliance for Quality Control and Contract Laboratories
    Up-to-date FDA/EMA Requirements and Tools for Cost Effective Implementation
    November 21, 2013
  2. Are You ready for FDA's 'New' Inspection and Enforcement Practices?
    With Industry Proven Tool Kits for Preparation, Conduct and Follow-up
    December 5, 2013

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Publishers Note

PUBLISHER'S NOTE: Some of the documents presented in this News section may require registration to the Labcompliance Usersclub to access their information. At the time of the News release, all links to other websites functioned, but Labcompliance cannot guarantee the accuracy of the information and that the links will not disabled.