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


Qualified Person in the Pharmaceutical Industry

Understanding Qualification Requirements, Tasks, Liabilities and Responsibilities



Practical Risk Assessment in Laboratories: Step-by-Step
With Risk Master Plan, SOPs and Case Studies for Easy Implementation



Documentation for FDA and EU Compliance

Step-by-step Instructions with Sample Documents



How much Validation is Enough?

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

May 12, 2010


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

May 27, 2010


FDA's 21 CFR Part 11

Introduction and Strategies and Tools for Implementation



New  release on
August 25, 2009 

with 200 + eirs/483sb / warning letters





Labcompliance News, March 2010

Revised Draft of the Annex 11 to EU GMPs to be Released in the next few Weeks

In April 2008 the EU Commission Publishes has released the EU Part 11 Equivalent Annex 11 for Consultation. The industry was concerned about too stringent requirements. The committee did get 1400 comments. In the next couple on weeks a new more industry friendly version will be released. The number of pages did go down from actual 11 to 4 which is not too far away from the size of the original Annex 11 as published in 1993. To download the draft from 2008, click here.

FDA Inspection Focus on Security, Availability and Integrity of E-Records

FDA continues to enforce 21 FFR Part 11. Inspection focus is on data security, integrity and availability of e-records. Observations and deviations get more and more specific. For example a recent 483 lists observations such as 'missing back-up of HPLC and UV data', 'insufficient procedures and technical controls to access computers and data' and 'no protection of PC monitor screens (inactive screen saver)'. Furthermore, the 483 reads:  "Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel". and "No written procedures for this computer system that outlines the responsibilities and privileges of the personnel who utilize the software". Other observations include: "no written procedures for production and process controls, failure investigation not extended to other batches, suitability of testing methods not verified under actual conditions", The 483 inspectional observation  with 24 observations can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-231.  Learn all about 21 CFR Part 11 requirements and how to avoid 483's in the Labcompliance audio seminar

FDA Releases Guidance for  Product Sterilization Control

According to the guidance sterility requirements can be met without conducting a formal sterility test control of the sterilization process through parametric release can be demonstrated. Parametric release allows manufacturers to replace sterility testing of samples drawn from the finished product as a release criterion with acceptance criteria for the control of identified process parameters. Section IV of the guidance describes what submissions are required to obtain approval for parametric release.11 The approval of parametric release practices is based on an assessment of the applicant’s proposed critical process parameters and how they are control. The guidance  can be downloaded from the FDA website.

APIC Publishes Guidelines and Two Templates for Quality Agreements

The Active Pharmaceutical Ingredients Committee (APIC), published a guideline and two templates for quality agreements for manufacturer of APIs. The recommendations are in line with regulatory expectations and are useful in preparation for professional contracts, . 

Labcompliance Usersclub gets more Attractive with new Document Category

Members of the Labcompliance Usersclub currently can instantly download more than 500 documents: SOPs, checklists, validation examples, forms and  FDA Warning Letters & 483s, video clips. Now we have added a new category with master plans, primers and step-by-step implementation guidelines for various applications. The first addition is the FDA Inspection Survival Guide with 60+ pages full of recommendations on how to prepare your organization effectively for FDA ad other inspections. Special focus is on how to respond to 483's and to avoid FDA warning letters.   The Warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to M-222.  

"Stability Chambers not Re-qualified" Cited in Recent FDA 483

Considering that stability chambers play a major role in a company's stability testing program, the FDA requires stability chambers to be calibrated, qualified and re-qualified  under empty and load conditions. This became obvious in 483 inspectional observation.   : For example, one observation states: "You do not perform requalification of stability chambers." The FDA expects to challenge the camber under load: "The original qualification of all chambers only included mapping studies with empty chambers. The chambers were never challenged by filling the storage space and proceeding with mapping studies. These chambers were observed with to be fully loaded". Other observations included: insufficient number of people to perform the assigned task, annual report does not include distribution data,   no HPLC detector noise and drift check, carry over for HPLC injector not tested, no signature of a review person on laboratory test results. The 483 inspectional observation  with 24 deviations can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts: Scroll down to W-231.  Learn all about FDA compliance qualification and maintenance of stability chambers in the new Labcompliance audio seminar

New Supply Chain Guidance from TGA

Good Manufacturing Regulations require to qualify and approve suppliers of critical material. Now the Australian Therapeutic Drug Monitoring and Control Agency (TGA) released a new guidance on supplier qualification. The document is relevant to Non-Sterile Medicines and Complementary Medicinal Products and provides a formal and transparent process for the steps by which supplier qualification may be achieved. Recommended tools include evaluation of a questionnaires and other reference material and on-site audits.

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: Disaster Recovery for Computer Systems. To download your free copy, go to the Computer System Validation Package website.  Scroll down and click on the corresponding ICON on the left (offer expires on April 5, 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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