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71 New Usersclub Additions
last update
December 1, 2014

- 20 SOPs
- 23 Examples/Checklists
- 7 Forms/Templates
- 4 Master Plans
- 4 Reference papers
- 13 Warning Letters

 

Five 2-day In-person Interactive GMP, Part11 and Validation seminars available in America, Europe and Asia delivered by Dr. Ludwig Huber.  . 

 

Now with Qualification of Virtual Networks

With three audio seminars

With 28 SOPs. 

 

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

 

Comparing GLP with GMP

Learn about similarities and differences and when to apply one or the other

Recorded, available at any time

 

FDA/EU Compliant IT Infrastructure and Network Qualification

With Strategies and Tool Kit for Compliance and System Uptime

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

 

Laboratory Equipment Calibration and Qualification according to USP <1058>

With SOPs, Templates and Examples for easy Implementation

Recorded, available at any time

 

Understanding the New EU-GMP Annex 15 on Validation and Qualification

New requirements and strategies for implementation

Recorded, available at any time

 

Validation of Analytical Methods according to the New FDA Guidance

Understanding FDA's New Lifecycle Approach Towards Method Validation

Recorded, available at any time

 

Impact of Quality by Design on the Analytical Laboratory

Learn through examples on development and validation of analytical procedures

Recorded, available at any time

 

Transfer of Analytical Methods According to the New USP Chapter 1224
With SOPs, templates and examples for easy implementation

Recorded, available on demand 

 

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

With Strategies and best Practice Guides for easy Implementation

 Recorded, available on demand

 

System Suitability Testing for FDA and USP Compliance

Setting parameters and limits for chromatographic and other methods

Recorded, available on demand

 

Analytical Equipment Qualification and System Validation for FDA Compliance

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

Recorded, available on demand

 

Managing Electronic Raw Data in Regulated Environments

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

Recorded, available on demand

 

FDA Compliant Use of (Certified) Reference Material

Strategies for selection, purchasing, testing and documentation

Recorded, available on demand

 

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

 

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

 

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.

 

 

 

New EU GMP Annex 15 requires Factory and Site Acceptance Testing

While formal factory acceptance testing (FAT) and site acceptance testing (SAT) in the past have been engineering tasks but not regulatory requirements, this seems to be changing now. The new EU GMP Annex 15 on  validation and qualification requires FAT and SAT for equipment with novel and/or complex technology.  Related tests should confirm that the equipment complies with User Requirement and Functional specifications at the vendor site. FAT includes review of documentation and may include tests depending on risk  SAT is functional testing at the users site, to supplement FAT. Main questions if SAT and FAT testing should be conducted under GMP conditions and if so if FAT/SAT test can be leveraged to reduce OQ testing at the users site. All this will be covered in the new seminar from Labcompliance: Understanding the New EU-GMP Annex 15 on Validation and Qualification - New requirements and strategies for implementation. The guide is available for download on the EC website.

FDA Publishes 2014 Annual Report on Inspections of Establishments

According to the Food and Drug Administration Safety and Innovation Act
(FDASIA) FDA publishes at the beginning of every year an inspection report that covers data of the proceeding fiscal year ending on September 30. The report includes the number of GMP related domestic and foreign establishments and the number of domestic and foreign GMP inspections. Quite interesting is a comparison of the percentage of foreign establishment vs. foreign inspections. A breakdown of the number shows that 80% of the total GMP inspections were domestic, the share of domestic GMP establishments was only 63 %. This number explains very well why the FDA plans to increase the number of foreign inspections and to reduce the number of domestic inspections. The inspection report can be downloaded from the FDA website.

EMA Releases new Guideline on Process Validation

This document is intended to provide guidance on the process validation information and data to be provided in regulatory submissions for the finished dosage forms of chemical medicinal products for human and veterinary use. The general principles also apply to active substances. This guideline replaces the previous note for guidance on process validation . The guideline is brought into line with ICH Q8, Q9 and Q10 documents and the possibility to use continuous process verification in addition to, or instead of, traditional process validation described in the previous guideline has been added and is encouraged. The guidance can be viewed and downloaded from the EMA website

FDA warns Pharmaceutical Labeler Facility for incomplete API Records

The company did not maintain complete records for your APIs. "You did not retain records for the complete traceability for the APIs distributed by your firm. For example, our inspection found that records for 23 lots of APIs did not contain the batch numbers, manufacturing dates, and expiration or retest dates. We also observed inconsistent record retention practices with regard to the original manufacturer including the manufacturer's identity, address, batch number, purchase, receipt, transportation, distribution, and Certificates of Analysis (COAs)." In addition, the warning letter cited missing distribution records. "Your inventory records did not contain sufficient information to identify and track the APIs received by, and distributed from CBSChem Limited. "For example, records for xxx APIs did not contain invoice numbers. As such, your firm was unable to provide receipt and distribution records for these APIs." Furthermore the company failed to transfer all quality or regulatory information received from the API manufacturer to the customers. The Warning Letters can be downloaded from the Labcompliance Usersclub. Scroll down to W-289. Non members can preview excerpts.

Final Version of the Chapter 6 Quality Control of the EM GMPs published

The European Commission has published the final version of Chapter 6 Quality Control of the EU GMP Guidelines. The deadline for coming into operation and enforcement is October 1, 2014. The major difference to the previous version is the addition of five paragraphs with requirements for technical transfer of testing methods. For example, the technical transfer should be described in a transfer protocol that should include identification of training requirements, identification of testing to be performed, identification of standards and samples to be tested, identification of any special transport and storage conditions of test items and acceptance criteria.    The chapter can be viewed and downloaded from the EC-EU website. To learn more about requirements and examples for analytical method transfer attend the Labcompliance seminar and received a tool kit such as checklist, SOP and example transfer protocol.

 FDA expects GMP regulated Method Development Data

FDA's new draft guidance on "Analytical Procedures and Methods Validation for Drugs and Biologics" requires the industry to "Submit development data within the method validation section if they support the validation of the method". The guidance mentions as examples for parameters that may be evaluated during method development: specificity, linearity, limits of detection (LOD) and quantitation limits (LOQ), range, accuracy, and precision. The guide specifically refers to robustness tests: To fully understand the effect of changes in method parameters on an analytical procedure, you should adopt a systematic approach for method robustness study (e.g., a design of experiments with method parameters). While so far typical method development and optimization experiments are not regulated this seems to be changing. Attend the new Labcompliance seminar "Validation of Analytical Methods according to the New FDA Guidance" to fully understand and get recommendations which experiments must be GMP regulated and which not to minimize the effort for additional documentation.

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 Best Practice Document "Checklist: 21 CFR Part 11, Electronic Records & Signatures ". 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 May 15 , 2014). Labcompliance offers more than 150 SOPs and examples that help to comply with FDA and ISO 17025 compliance. For titles and ordering of the examples click here.

Audio Seminar Schedule

  1. Impact of Quality by Design on the Analytical Laboratory
    Learn through examples on development and validation of analytical procedures
    May 15, 2015
  2. Comparing GLP with GMP
    Learn about similarities and differences and when to apply one or the other
    June 5, 2014

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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.