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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

 

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 Development and Validation of Analytical Methods

Apply modern Lifecycle Management Principles for Analytical Methods

Recorded, available at any time

 

GMP Compliance for Quality Control and Contract Laboratories

Up-to-date FDA/EMA Requirements and Tools for Cost Effective Implementation

November 21, 2013

 

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 

 

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

 

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

 

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

 

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

 

 

 

 

ICH Released the New Q3D Guidelines for Elemental Impurities

The Q3D draft Guideline has been released for consultation under Step 2B of the ICH process. The guideline consists of three components: the evaluation of the toxicity data for potential elemental impurities, the establishment of a Permitted Daily Exposure (PDE) for each element of toxicological concern, and development of controls designed to limit the inclusion of elemental impurities in drug products to levels at or below the PDE Unlike USP the ICH guideline does not describe analytical methodology and equipment but refers to compendial procedures and equivalent validated methods. The guidance can be viewed and downloaded from the ICH website. To learn everything about the new guide and a comparison with related USP chapters, attend the new Labcompliance audio seminar "Elemental Impurities According to the new ICH Q3D and USP 232/233 Guidelines"

FDA Warning for Inadequate Storage of Reference Samples and Reagents

Reference Samples and reagents should be stored according to manufacturers recommendations to maintain the required quality. FDA verifies storage conditions during inspections This became clear during an inspection of a drug manufacturer which resulted in a 483 with 12 observations. Examples are: "Laboratory records do not include complete records of any testing and standardization of laboratory reference standards and reagents". "Biological Indicators were observed to be stored in Refrigerator on 06/22/10, which is not being monitored for storage at xx% RH as per manufacturers instructions" "Reagents were not logged into a drying Oven Log Book and were observed on 06/22/10 in the analytical room testing area desiccator. Reagents were stored in a crucible sealed with paraxin". The 483 can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-239.  To learn about FDA requirements for reference samples attend the audio seminar "FDA Compliant Use of (Certified) Reference Material".

FDA publishes Daft Guidance for Drug Establishment Registration

The guidance entitled "Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration " specifies the unique facility identifier (UFI) system for registration of domestic and foreign drug establishments. For drug establishment registration, FDA is specifying the following UFI System:  at this time, FDA’s preferred UFI for a drug establishment is the Data Universal Numbering System D-U-NS (DUNS) number, assigned and managed by Dun and Bradstreet. This guidance reflects current thinking in light of data standards, information technology, and information management resources. As these variables change over time, the FDA may revisit this guidance and the specification. The guidance is available for viewing and download on the FDA website.

More and more Organizations want to become PIC/S Members

With 43 participating authorities the Pharmaceutical Inspection Convention Cooperation Scheme (PIC/S) already today is one of the most powerful organizations for the regulated pharmaceutical and API industry. PIC/S' mission is "to lead the international development, implementation and maintenance of harmonized Good Manufacturing Practice (GMP) standards and quality systems of inspectorates in the field of medicinal products.". According to a PIC/S press release more and authorities want to join the organization. Examples are authorities from Turkey, Mexico, Hong Kong, Brazil, Japan, Korea and Iran,

FDA Answers Questions Related to ANDA Stability Testing for Drug Substances and Drug Products 

On June 20 this year the FDA published the final guidance on stability testing of generic drugs (see our Newsletter from July). Now the FDA has published a draft guidance that provides answers to questions from the public comments the FDA had received on the draft version of the guidance "ANDAs: Stability Testing of Drug Substances and Products" that was published on September 25, 2012. The guidance is expected to clarify the stability testing data recommendations for abbreviated new drug applications (ANDAs). The Guidance can be viewed and downloaded from the FDA website.

FDA expects Supporting Data for Extension of the Expiration Date of Reference Material

The extension of expiration dates of reference material should be supported by experimental data. This should prove that the quality of the reference material is maintained through the entire use of the material. This became obvious in an FDA warning Letter. The  reads: "There are no data to support extension of expiration for xxx Reference Standard". No further information is included on the type and extend of tests. The Warning letter can be downloaded from the Labcompliance Usersclub. Scroll down to W-217. Non members can preview excerpts. To learn everything about FDA's expectation for using reference materilal, attend the Labcompliance audio seminar and receive 10+ best practice guides for easy implementation, including an SOP and Checklist on handling (certified) reference material.

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 "Electronic Audit Trail: Specifications, Implementation and Validation". To download your free copy, go to the Part 11 Compliance Package website. Scroll down and click on the corresponding ICON on the left (offer expires on October 15, 2013). Labcompliance offers more than 150 SOPs that help to comply with FDA and ISO 17025 requirements. For titles and ordering, click here.

Audio Seminar Schedule

  1. FDA Compliant Use of (Certified) Reference Material
    Strategies for selection, purchasing, testing and documentation
    Recorded, available at any time
  2. 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
  3. Quality by Design (QbD) for Development and Validation of Analytical Methods
    Apply modern Lifecycle Management Principles for Analytical Methods
    Recorded, available at any time
  4. GMP Compliance for Quality Control and Contract Laboratories
    Up-to-date FDA/EMA Requirements and Tools for Cost Effective Implementation
    November 21, 2013
  5. 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.