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


Electronic Raw Data in Regulated Environments

Definition, generation and archiving for FDA Part 11, HIPAA and SOX compliance

Recorded, available on demand


Implementing FDA's 21 CFR 111 for Dietary Supplements
Introduction, Strategies and Tool-kit for Implementation

Recorded, available on demand


How much Validation is Enough?

Developing a Company Wide Strategy and Tools for Cost-effective Implementation



Analytical Instrument Qualification According to USP <1058>

With SOPs, Templates and Examples for Easy Implementation

Recorded, available on demand


GMP Compliance for Quality Control Laboratories: Step-by-Step

FDA Requirements and Tools for Implementation

Recorded, available on demand


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, available on demand


New  release on
August 25, 2009 

with 200 + eirs/483sb / warning letters





Labcompliance News, April 2010

FDA Inspections for 21 CFR 111 (Dietary Supplements) will become Common

The final version of FDA's regulation on dietary supplements has been released in 2007 and FDA started inspecting larger manufacturers in 2009. From June 25, 2010, all companies manufacturing dietary supplements have to comply with GMPs and FDA inspections will become increasingly common also for small companies with less than 20 employees. All companies are advised to train employees on GMPs and to prepare the necessary documentation for inspections. Labcompliance will conduct an audio seminar "Implementing FDA's 21 CFR 111 for Dietary Supplements". The speaker gives an introduction to the rule and shares information from past FDA inspections. Attendees will get 10+ best practice documents such as SOPs, checklists and case studies for easy implementation. For more information and registration, click here.

Pharmacopoeial Discussion Group (PDG) Recommendations for Dissolution Testing

FDA has published an industry guidance based on Annex 7 of Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions. The guide lists conditions when Pharmacopeial Dissolution Test for Solid Dosage Forms, JP 6.10 Dissolution Test, and USP <711> Dissolution, can be used as interchangeable in the ICH regions. For example, the text states that an appropriately rigorous mechanical calibration method such as ASTM  E2503-07 and a recently published  FDA Recommendation, when properly executed, should satisfy the current good manufacturing practice (CGMP) requirement for dissolution apparatus calibration under 21 CFR 211.160 (b)(4)). The guide can be downloaded from the FDA website.

WHO Publishes Guideline for the Production and Control of Starting Materials

This guideline is intended to assist applicants or MA holders in assessing the required level of quality of “specified starting materials” that will be used for the manufacture of an API. WHO takes an interesting approach which is to balance costs vs. level of GMP compliance. Quality control for starting materials should include tests for impurities, such as isomers, residual solvents, and others impurities. Quality standards such as GMP principles and recognized pharmacopoeia monographs for specified starting materials may only be applied if they provide significant public health benefits. The draft is currently released to only a specified audience for comment. Together with a more detailed summary it is available through the Rx-360 website, the international pharmaceutical supply-chain consortium,

51-Page FDA Inspection Report Related to Dietary Supplements

FDA has started inspecting manufacturers of dietary supplements for compliance with 21 CFR 111. It is quite its interesting to see which departments will be inspected and what aspects inspectors might focus. A good source of information are FDA Establishment Inspection Reports (EIR), especially when they are detailed. One such EIR has 51 pages. The inspection was performed as a High Priority Inspection. The report is a detailed protocol on who had been interviewed, which departments have been inspected and what the inspection focus was. One of the focus was on how OOS. failure investigations and corrective actions are handled. The report ended with a listing of six inspectional observations and one voluntary correction. The EIR with six 483 observations can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-232.  Learn all about 21 CFR Part 111 requirements and how to avoid 483's in the Labcompliance audio seminar.

How Much Validation is Enough?

This question has ever come up since validation and testing of equipment and processes has been requested by the FDA and other agencies. The real issue is that answers are different from different people with different motivations. For example, QA managers tend to ask for more to protect themselves not only 100% but 150%. On the other hand operations manager want to keep the extend of validation to a minimum because they have to pay the bill. FDA has generic answers, such as "the nature and extend of validation depends on the risk a process or system has on (medicinal) product and patient safety". There is no more specific advice from the FDA., but inspectors will come and tell you after the inspection. To escape from this dilemma companies hire external consultants, but these also may have their motivation which is to secure follow up business and kindly offer validation services if the company does not have enough resources. The real good answer only can come from  an organization wide structured approach that documents the principles and rational and defines validation activities for different scenarios. Such an approach has been presented by Dr. Ludwig Huber as plenary lecture at the recent IVT European Validation Week in Dublin Ireland.  This important topic will also be delivered as an Labcompliance audio seminar. Attendees will receive 10+ best practices guides for cost-effective implementation.

FDA Focus on Integrity, Security and Authenticity of Electronic Records

While FDA was quiet about computer systems between 2002 and 2006. This has changed significantly. Computer systems and electronic records did become an inspection focus for pharmaceutical, API and device industry. Deviations have been cited related to all key Part 11 requirements such as limited and authorized access, electronic audit trail, back-up and archiving of raw-data, system security and discharge of  e-records after print-out. To see recent examples, click here.  To prepare your organization for FDA inspections, and to avoid FDA warning letters related to electronic records, attend the upcoming Audio seminar: Electronic Raw Data in Regulated Environments. For more info and ordering, click here

Video on Software Regulation with John Murray on FDA's Website

The FDA has posted a video presentation with an introduction to software regulation. The presenter is John Murray, one of FDA's expert on validating and using computers in FDA CDRH regulated environments. According to John Murray the the presentation  is not a complete thesis on medical device software  but only serves as an introduction, there is an expectation that more software related presentations will be developed in the future.

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: Internal Audit - Preparation, Conduct, Follow-up. To download your free copy, go to the FDA Inspection Package website.  Scroll down and click on the corresponding ICON on the left (offer expires on May 10, 2010). Labcompliance offers more than 120 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

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