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FEBRUARY 1, 2013

56 New 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

 

How to Effectively  Build a GLP Laboratory

Step-by-step from design to compliant and cost-effective implementation

Recorded, available at any time

 

Setting up a Quality System for Pharmaceutical Laboratories

Understanding and Implementing ICH Q10 and other Quality Systems

Recorded, available at any time

 

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

With SOPs, templates and examples for easy implementation

March 21, 2013

 

Elemental Impurities According to the Final USP Chapters 232/233

With updates on the new ICH Q3D Guide: Elements, Limits 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

 

Efficient Training Practices for FDA and International Compliance
Learn what to train - How much to Train - How to Document Effectiveness
February 7, 2013

 

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

 

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

 

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

 

Validation and Use of Excel® Spreadsheets in Regulated Environments

Comply with Part 11, QSR, and Annex 11.

Recorded
Available at any time

 

Implementing the New USP Chapters 232/233 for Elemental Impurities

Learn how to comply with FDA, USP and ICH Requirements

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

 

Raw Data in FDA Regulated Environments

FDA/EU compliant recording, maintenance and archiving

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

 

FDA Compliant Use of (Certified) Reference Material

With 10+ Best Practices for easy Implementation

Recorded, available at any time

 

Analytical Instrument Qualification According to USP <1058>

With SOPs, Templates and Examples for Easy Implementation

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 February 2013

USP General Notice suggest USP Reference Standards to be a MUST for
USP Compendial Standards

USP proposes several changes to the general notices. E.g., Labcompliance has reported about suggested obsolescence of the USP General Chapter <231> on May 2014. Another proposed change is related to reference material. The suggestion is to declare USP Reference Standards as a must for compendial standards.  "Only those results obtained using USP Reference Standards may be used to conclusively demonstrate conformance to or compliance with those USP standards for which the USP Reference Standard is specified'. For a summary of the proposed changes and timeline for implementation click here

"CGMP Regulations not included in the Training Program" draws FDA Warning Letter

No or incomplete training continues to be one of the top citations in FDA warning letters. FDA expects that a complete training not only includes quality and technical aspects but also training on regulations. In a recent inspection the FDA inspection team noted: "Your firm does not provide CGMP training to employees". The letter also recommended and adequate response: "In response to this letter, provide a copy of your CGMP training program and a timeline for completion of training for all employees." The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-281.  To learn everything establish a complete FDA compliant training program  attend the new audio seminar: "Efficient Training Practices for FDA and International Compliance " The seminar material includes more examples for FDa observations and specific recommendations how avoid 483 inspectional observations and warning letters.

FDA Announces the Availability of the ICH Q11 Guidance

The guidance entitled “Q11 Development and Manufacture of Drug Substances describes approaches to developing and understanding the manufacturing process of a drug substance and provides guidance on what information should be provided in certain sections of the Common Technical Document (CTD).  The discussion of principles in the guidance is intended to apply only to the manufacture of drug substance, not the manufacture of finished drug products. The guidance is available for view and download from the FDA website.

14 New SOPs Available since February 1.

With the addition of 14 new SOPs our offering now includes 160 SOPs. They are available in Word and PDF format and can be used as they are or as a starting point for further customization. For a complete list and ordering click here.

  • Qualification of Virtual Networks (S-292)
  • Using Cloud Computing in Regulated Environments (S-293)
  • Review of Electronic Audit Trail (S-323)
  • Integrity and Security of Electronic Records (S-324)
  • Using Electronic Signatures in Regulated Environments (S-325)
  • Auditing Laboratories for ISO 17025 Compliance (S-511-02)
  • Purchasing of Services for Laboratories (S-514-02)
  • Quality Assessment of Laboratory Service Providers (515-02)
  • Laboratory Complaint Handling for ISO 17025 (S-520-01)
  • Improving the Effectiveness of the Laboratory Management System (S-520-11)
  • Laboratory Facilities and Environmental Control (S-520-16)
  • Selection of Analytical Methods and Procedures (S-605)
  • Development and Validation of Analytical Methods through Quality by Design (S-609)
  • Retrospective Validation of Laboratory Computer Systems (S-663)

EMA published a Concept Paper on Revision of Annex 15 of the EU GMP

Annex 15 on Qualification and Validation was originally published in 2001. Since then the manufacturing and regulatory environment has changed significantly and an update is required to this annex to reflect this changed environment. Changes will include new guidance and also the removal of text that has been superseded or included elsewhere in the GMP Guide. Though not a comprehensive listing,  some of the main GMP changes include:  New text on change control in Chapter 1., the implication of Product Quality Reviews on validation activities, the work that is on-going to revise the requirements for dedicated facilities in Chapters 3 and 5 and
the revised Annex 11.The draft concept paper can be downloaded from the EMA website.

FDA expects Deviations from GLP SOPs to be Authorized and Documented

This became clear during a inspection of a FGLP facility. The letter reads: "All deviations from standard operating procedures (SOPs) were not authorized by the study director and documented in the raw data". Furthermore the letter noted other GLP violations: "Study not conducted according with the protocol, data entries not signed by the person responsible for recording the data, QAU did not periodically submit the status on each study, the receipt and distribution of each batch not documented, unforeseen circumstances with impact on quality not noted and no corrective actions were taken, experimental data not accurately documented".The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-280.  To learn everything on how to set up an FDA compliant GLP laboratory  attend the audio seminar "How to Effectively Build a GLP Laboratory".

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 "SOP: Qualification of PC Clients". To download your free copy, go to the Network Quality Package website. Scroll down and click on the corresponding ICON on the left (offer expires on February 28 , 2013). Labcompliance offers more than 150 SOPs and other documents that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

2-day Seminar with Dr. Ludwig Huber

Validation and Part 11/Annex 11 Compliance of Computer Systems
June 05/06, 2013
Elite World Hotels, Turkey

Audio Seminar Schedule

  1. Transfer of Analytical Procedures According to the New USP Chapter <1224>
    With SOPs, templates and examples for easy implementation
    March 21, 2013
  2. Elemental Impurities According to the Final USP Chapters 232/233
    With updates on the new ICH Q3D Guide: Elements, Limits and Schedule
    April 25, 2013

New or Updated Sites

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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.