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

 

Effective Training Practices for FDA
Compliance

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

Recorded

 

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

Recorded

 

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

Recorded

 

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

Recorded

 

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

Recorded

 

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

Recorded

 

NEW BOOK EDITION

Dr. Ludwig Huber

 

 

Labcompliance News, September 2008

FDA Publishes Amendments to the cGMPs for Finished Drugs

On Sept 8, 2008, the FDA published changes to FDA's drug GMP regulations (Part 210/211) as final rule. This finalizes the first phase of FDA incremental approach to modifying the cGMPs for finished drugs. The first version has already been published in Dec 2008 as final rule but was withdrawn in April as a result of a significant  adverse comments from  industry. The amended rule will be effective on Dec 8, 2008. Major updates are in the area of aseptic processing, asbestos filters and verification of certain operations a second individual. Current cGMPs require that certain operations are performed and signed by one person and verified and signed by a second individual. The amended rule requires only one signature if the operation is performed by a validated automated instrument. Examples are equipment cleaning and maintenance and batch production and control records.

FDA Launches New Health Professionals Website

FDA recently launched a new Health Professionals web page as part of a larger effort by the agency to increase interactions and communications with health professional organizations. The webpage provides useful, timely, and accessible information to the nation's physicians, nurses, pharmacists, and other members of the health professional team.

Stability and Impurity testing cited in FDA Warning Letter

A drug manufactured has been cited for inadequate stability and impurity testing. The letter reads: Failure to establish a stability testing program which includes reliable, meaningful, and specific test methods'. In addition, although your firm conducts impurity testing for xxxx tablets, xxxx softgels, xxxx caplets and xxxx tablets, it does not have written procedures for impurity testing". Furthermore the FDA found other deviations from cGMP regulations especially in the area of electronic records integrity. They include: no failure investigation, no procedures to ensure authenticity, integrity, and security of electronic records, system administrator privileges assigned to chemists, chromatograms manipulated, and methods used by outside contractor not validated. The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 203).

FDA Published ICH Draft Guidance for Non-clinical Safety Studies

The guidance entitled "Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing authorization for Pharmaceuticals" has been preleased at Step 2 of the ICH Process, It has been transmitted by the ICH Steering Committee to the regulatory authorities of the three ICH regions (the European Union, Japan and the USA) for internal and external consultation. The purpose of the document is to recommend international standards for, and promote harmonization of, the nonclinical safety studies recommended to support human clinical trials of a given scope and duration and marketing authorization. Harmonization of the guidance for nonclinical safety studies will help to define the current recommendations and reduce the likelihood that substantial differences will exist between regions. This guidance should facilitate the timely conduct of clinical trials, reduce the use of animals in accordance with the 3R (reduce/refine/replace) principles and reduce the use of other drug development resources. This should promote safe and ethical development and availability of new pharmaceuticals.

Device Manufacturer Lacked Test Scripts for Training Data Bases

A device manufacturer received a warning letter for several deviations related to computer validation and other quality issues. For example: "Software validation used to document employee training was deficient in that the test scripts were not available to show the execution of the software validation protocol. It appears that at least five (5) tests specified in the. approved protocol were not performed". Other deviations in the letter are: no procedures for failure investigations, no procedures to report and follow quality problems, corrective actions identified but not implemented, corrective action, no acceptance procedures for in-process products, no procedures to verify conformance of purchased products, inadequate complaint investigation, failure to identify training needs, training requirements incomplete, no procedures for internal audits, no sampling procedures, sampling plans not reviewed, wrong procedure in document. The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 206).  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.

GMP Annex 7 "Manufacture of Herbal Medicinal Products"  Revised

This revision has been made to specify application of GMP provisions for active substances used as starting materials (Part II) for the manufacture of herbal medicinal products. Additional changes are in particular related to the new Directive 2004/24/EC on traditional herbal medicinal products. The document applies to all herbal starting materials: medicinal plants, herbal substances or herbal preparations. The new Annex will come into operation on 01 September 2009.

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: Retention and Archiving of Electronic Records. To download your free copy, go to the Computer System Validation Tutorial, scroll down and click on the corresponding ICON on the left (offer expires on October 1). Labcompliance offers more than 100 SOPs. For titles and ordering, click here.

2 Day Interactive Workshop by Dr. Ludwig Huber

  1. ECHO Consulting Group
    Computer System Validation and Part 11 Compliance for (Bio)Pharmaceutical and Device Industry
    Jan. 20/21, 2009 San Juan, PR, USA
    Learning through examples: 50% of the time will be dedicated to case studies

New Audio Seminars - Updated Schedule

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

Conferences

 

http://www.echo-cg.com/calendar.html

 

  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

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