Home | Contact Us | Newsletter | Usersclub | Books | Audio Seminars



 

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

 

How to Prepare Yourself for FDA's New Part 11 Inspection Program

Learn what the FDA is looking for and how to respond

Recorded

 

FDA Compliant Use of (Certified) Reference Material

With 10+ Best Practices for easy Implementation

Recorded

 

Effective HPLC Method Development and Validation

Preparation, conduct and documentation for FDA/EMA Compliance

Recorded

 

Validation of Excel® Spreadsheets: Step-by-Step

With Case Studies and Validation Protocols for Easy Implementation.

Recorded

 

Understanding and Preparing for FDA's New Part 11 Inspection Program

With 10+ Best Practice Guides for Easy Implementations

Recorded

 

Recent Warning Letters and 483's Related to Computer Validation and Part 11

With Case Studies to Avoid and Respond to 483's and Warning Letters

Recorded

 

Analytical Instrument Qualification According to USP <1058>

With SOPs, Templates and Examples for Easy Implementation

Recorded

 

New  release in
2010 

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

 

 

Labcompliance News, August 2010

FDA Inspection Clarifies what "Readily Available Documentation" Means

21 CFR Part 11 requires that electronic records should be "instantly" retrievable and inspectors expect that documentation  is "readily" available. One of the most frequently asked questions related to documentation and e-records is what "instantly" and "readily" means in terms of absolute time. Now an FDA inspection team has indirectly answered this question through listing "documentation not readily available" in a 483 inspectional observation from June 2010.. Inspectors have asked for 20 types of documentation. The 483 states: "Records associated with drug product production and control and within the retention period for such records, were not made readily available for authorized inspection".

The 483 lists the dates when the 20 documents were requested and when they were available. Furthermore, the inspector found that "Stability information provided was not provided in an organized fashion on 06/30/10. I requested that the firm organize the information and bring in a computer on 07/02/10 to view the contents of xxx".  This frequently happens: Inspectors as for printed documentation, and if the information is not satisfactorily, they want to review the records on the computer. The 483 can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-239. This information is especially important in light of upcoming FDA Part 11 inspection with focus on accuracy, integrity, authenticity AND availability of records. To learn about and to download 30 other Warning Letters/483s related to computer validation and Part 11 compliance  book the Labcompliance audio seminar "Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11". To learn everything about FDA's new Part 11 inspection program, click here

FDA Plans Using Internal Audit Reports for Risk Assessment

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program.'. Under this draft guidance, device manufacturers whose establishment has been audited under one of the regulatory systems implemented by the Global Harmonization Task Force (GHTF) founding members using ISO 13485:2003 may voluntarily submit the resulting audit report to FDA. If, based on that report, FDA determines there is minimal probability that the company will produce nonconforming and/or defective finished devices, then FDA intends to use the audit results as part of its risk assessment to determine whether that establishment can be removed from FDA's routine work plan for 1 year. Toi read the announcement, click here.

Printed HPLC Chromatograms not Considered a 'True Copy' of e-Raw Data

FDA's 21 CFR Part 211.180(d) requires that 21 CFR 211.180(d) requires records to be retained “either as original records or true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records. Examples are chromatograms, inputs, outputs and audit trails generated by computerized laboratory systems. The question has been heavily discussed whether printed HPLC and GC chromatograms and other records are considered 'true copies' of the electronic raw data meaning that e-raw data can be destroyed after print-out. FDA makes a clear statement in one of its CGMP Q&A websites:
"How do the Part 11 regulations and "predicate rule requirements" apply to the electronic records created by computerized laboratory systems and the associated printed chromatograms that are used in drug manufacturing and testing?" The answer is very clear: The printed paper copy of the chromatogram would not be considered a “true copy” of the entire electronic raw data used to create that chromatogram, as required by 21 CFR 211.180(d). The printed chromatogram would also not be considered an “exact and complete” copy of the electronic raw data used to create the chromatogram, as required by 21 CFR 211.68. The chromatogram does not generally include, for example, the injection sequence, instrument method, integration method, or the audit trail, of which all were used to create the chromatogram or are associated with its validity. Therefore, the printed chromatograms used in drug manufacturing and testing do not satisfy the predicate rule requirements in 21 CFR Part 211". It s common FDA inspection practice that FDA inspectors first review printed copies of chromatograms but expect that the electronic version is maintained and readily available for review if further information is required. Attend the Labcompliance Audio Seminar "Electronic Raw Data in Regulated Environments" to learn everything about GMP and Part 11 requirements for raw data.   Availability of required e-records will also be part of FDA's new Part 11 inspection program as planed for Q3/4 2010.

No Failure Investigations after Failed GC Calibration Cited by FDA

The FDA expects to follow up on failed laboratory instrument qualification to determine the root cause and to initiate corrective actions to prevent re-occurrence. This became obvious during a recent FDA inspection which resulted in a warning letter with several violations. The warning letter reads: "There was no documentation that an investigation was conducted to determine the root cause of the failed calibrations of the Gas Chromatograph (GC) on 9/18/08 and 10/20/08 that were identified and cited during the May 2008 FDA inspection. In addition, your firm failed to implement adequate corrective action to prevent recurrence.". Furthermore the FDA inspector noted that the quality control unit failed to adequately train personnel to perform their duties for Operation of the Gas Chromatograph, and failed to follow procedures in the conduct of GC Calibrations.. The Warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-240.  To learn everything about FDA and USP requirements for analytical instrument qualification  attend the audio seminar "Calibration and Qualification of Analytical Instruments".

FDA Video Training Updated

The FDA Center for Drug Evaluation and Research has updated the popular continuing education program Drug Review and Related Activities in the United States and has renamed the updated program to reflect legislative changes and improved operations. The new title is The Past, Present, and Future of FDA Human Drug Regulation. For registration, click here

Do You Know what FDA Does? Learn about FDA Basics from the FDA.

Each month, different Centers and Offices at FDA will host an session where the public can ask questions to senior FDA officials about a specific topic or just listen in to learn more about FDA. If you are interested, click here. The website has also links to basic FDA information, for example: What does FDA do, what does FDA regulate, how to contact FDA, how is FDA organized, how many people are employed by FDA and in what areas do they work? 

FDA Warning for Insufficient Number of System Suitability Test Runs

A drug manufacturer conducted only five test runs instead of six for system suitability testing  for  a dissolution assay: "System suitability conducted for Dissolution Assay per laboratory test methods evaluates only five replicate injections for Relative Standard Deviation (RSD). For NMT 3%. USP requires six replicate injections for instrument precision and accuracy". Other deviations included: E-Records not "readily" available, impact of equipment failures on batch not investigated, inadequate follow up of complaints, and, reference samples not stored under conditions as recommended by the manufacturer. The Warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-239.  To learn about FDA and USP requirements for system suitability testing attend the audio seminar "System Suitability Testing for FDA and USP compliance".

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 Auditing Analytical Laboratories. To download your free copy, go to the ISO 17025 Laboratory Accreditation Package website. Scroll down and click on the corresponding ICON on the left (offer expires on August, 2010). Labcompliance offers more than 120 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

Audio Seminar Schedule

 

  1. System Suitability Testing for FDA and USP Compliance
    With 10+ Best Practices for easy Implementation
    September 9, 2010
  2. FDA Regulations for (Bio)Pharmaceutical Industry
    Get an Overview on Principles and Key Requirements in just one Hour
    September 23, 2010
  3. FDA Compliant Use of (Certified) Reference Material
    With 10+ Best Practice Guides for Easy Implementation
    October 7, 2010
  4. Effective HPLC Method Development and Validation
    Preparation, conduct and documentation for FDA/EMA Compliance
    October 21, 2010

2-Day Workshop in Shanghai, China

 

New or Updated Sites

Click here to tell others in your company about compliance news

 

Recent Warning Letters and 483's Related to Computer Validation and
Part 11
Labcompliance.com