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Effective Training Practices for FDA
Compliance

What to train - How much to Train - How to Document Effectiveness

Available on Demand

 

Test Scripts and Protocols for Equipment and Computer Validation
With SOPs , examples scripts and protocols for FDA and EMEA compliance

Sep 18, 2008

 

Residual Solvent Analysis According to USP <467>
Understanding and implementing the revised chapter

Oct 16, 2008

 

Validation of Existing/Legacy Systems
Regulatory requirements and tools for implementation

Oct 23, 2008

 

Bioanalytical Method Validation
Conduct and Document for Efficiency and FDA and EMEA compliance

Nov 06, 2008

 

Raw Data in FDA Regulated Environments
FDA/EU compliant recording, maintenance and archiving

Nov 13, 2008

 

NEW BOOK EDITION

Dr. Ludwig Huber

 

 

Labcompliance News, August 2008

FDA Releases Draft Guidance for Residual Solvent Analysis (USP <467>)

The Food and Drug Administration (FDA) has released a new draft guidance for industry entitled ``Control of Residual Solvents in Drug Products Marketed in the United States.'' The guidance has recommendations on how to comply with the new USP chapter <467> RESIDUAL SOLVENTS that has been released on July 1, 2008. For example, the draft guidance also defines the conditions under which analytical procedures other than those described in USP <467> will be accepted. The new guideline can be downloaded from the FDA Website. To learn everything about residual solvent analysis according to the new USP chapter and FDA guidance and to receive 10+ best practice documents for easy implementation, click here.     

FDA Released New Guidance Regulatory Submissions in Electronic Format

The guidance with the title:   "Providing Regulatory Submissions in Electronic Format – Postmarketing Individual Case Safety Reports" is one in a series of guidance documents intended to assist applicants making regulatory submissions in electronic format to FDA's CDER and CBER. This guidance discusses general information related Drug products marketed for human use with approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs), Prescription drug products marketed for human use without an approved NDA or ANDA, Biological products, including therapeutic vaccines,marketed for human use with approved biologic license applications (BLAs) and submission tracking numbers (STNs) Human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulated under section 361 of the Public Health Service Act,

Quality and Validation Issues Draw FDA Warning Letter

A device manufacturer received a warning letter for several deviations related to quality management, other quality system and validations. The company did not have  implemented with executive responsibility to ensure the quality policy has been fully implemented and maintained. Also there was no quality plan for over three years. The FDA also found that the company did not establish and maintain purchasing control procedures". Deviations related to validation have been: "Failure to validate your water purification systems" and "Failure to validate your software used for fluid delivery and heat disinfection in your water purification systems". The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 205).

New Version 3.0 of the Computer System Validation Package Released

On August 15 Labcompliance has released a new major revision of the popular computer system validation package. The new version includes 6 new SOPs, 2 new audio seminars, 7 new validation examples. In addition most other key documents have been updated to reflect most recent recommendations from FDA and international agencies and from industry task forces.. For additional information and ordering, click here.

New FDA Rule and Guidance for Early Stage Clinical Drug Development

On July 18 The U.S. Food and Drug Administration issued a final regulation that makes early phase 1 clinical drug development safe and efficient by enabling a phased approach to complying with current good manufacturing practice (CGMP) statutes and FDA investigational requirements. To facilitate this new approach, the regulation exempts most phase 1 investigational drugs from the requirements in 21 CFR part 211. at the same time the FDA released a companion guidance that describes an approach manufacturers can use to implement manufacturing controls that are appropriate for the phase 1 clinical trial stage of development. The approach described in this guidance reflects the fact that some manufacturing controls and the extent of manufacturing controls needed to achieve appropriate product quality differ among the various phases of clinical trials.

New USP Chapter <467> Residual Solvents Effective Since July 1, 2008

On July 1, 2008 the new USP-NF General Chapter <467> Residual Solvents finally come into effect. Main change to the previous official version is the adoption of Q3C in the general chapter of the USP while eliminating the Organic Volatile Impurities (OVI) tests from the individual monographs. Using the risk based approach more than 60 solvents have been broken down in three classes with different toxicity and therefore with different requirements for maximum limits. To learn everything about the changes of <467> and to receive 10+ best practice documents for easy implementation, click here

FDA Warning Letter Issued for not Validating Software

A device manufacturer was cited for not validating device software design. The letter reads;  "Failure to establish and maintain adequate procedures for validating the device software design to conform to the intended uses. For example: The validation results do not meet the pre-determined acceptance criteria, and there was no documentation why the results were acceptable. The validation reports do not contain an evaluation of the validation data and activities. Nor does it contain validation analyses and conclusion". The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 204). Learn all about FDA compliant software and computer system validation and get master plans, SOPs and other documents for easy implementation with the Labcompliance Computer System Validation Package.

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: Subcontracting of Testing and Calibration.. To download your free copy, go to the ISO 17025, scroll down and click on the corresponding ICON on the left (offer expires on September 15). Labcompliance offers more than 100 SOPs. For titles and ordering, click here.

New Audio Seminars - Updated Schedule

  1. Effective Training Practices for FDA Compliance
    What to train - How much to Train - How to Document Effectiveness
    Sept 4, 2008
  2. Test Scripts and Protocols for Equipment and Computer Validation (205)
    With SOPs , examples scripts and protocols for FDA and EMEA compliance
    Sep 18, 2008
  3. Residual Solvent Analysis According to USP <467> (206)
    Understanding and implementing the revised chapter
    Oct 16, 2008
  4. Validation of Existing/Legacy Systems (207)
    Regulatory requirements and tools for implementation
    Oct 23, 2008
  5. Bioanalytical Method Validation  (208)
    Conduct and Document for Efficiency and FDA and EMEA compliance
    Nov 06, 2008
  6. Raw Data in FDA Regulated Environments (209)
    FDA/EU compliant recording, maintenance and archiving
    Nov 13, 2008

IVT Conferences

  1. IVT's 5th Annual
    Method Validation Conference
    October 14-16, 2008
    Hyatt Fisherman's Wharf in San Francisco, CA.
  2. IVT
    Computer System Validation
    October 14-16, 2008
  3. IVT
    PharmSep Symposium
    September 9-11, 2008
    Pennsylvania Convention Center, Philadelphia, PA

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