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

Labcompliance News, May 2003

May 30, 2003

The New Electronic Records/Signatures Draft Guidance: What has really changed?

On 20 February, FDA published a new 21 CFR Part 11 draft guidance. Rumors that the new guidance means Part 11 will no longer be enforced are wrong. However there is lots of uncertainty? The main question is: can I print all my data on paper and delete the electronic records? More than ever the new guidance refers to predicate rules and to justified and documented risk assessment. This paper authored by Wolfgang Winter and Ludwig Huber and published in Biopharm gives specific examples on which records can and which ones can not be deleted. The paper can be downloaded from the Labcompliance users club , R-055.

May 30, 2003

Benefits of Electronic Records/Signatures in Drug Discovery

 Most companies have focused their electronic signature/records efforts on manufacturing, on clinical trials, and on development, because that has been the focus of FDA's 21 CFR Part 11 auditing efforts. But it also makes good common sense to design a discovery automation system to comply with electronic records/signature standards, even though you may consider it unlikely that the FDA will every demand these records. Main reason is much easy patent protection: Compliance with electronic records&signature standards like FDA's 21 CFR Part 11 will ensure that you have full support for patents. When implementing key requirements such as electronic audit trail and binding signatures with records you will be able to supply exact records supporting any filing or later patent dispute. Dr. Patrick Coffey has published a paper entitled:: Discovery Automation - The Benefits of 21 CFR Part 11 Compliance — Even if the FDA Never Asks for Your Records. On 15 pages the paper describes an approach to designing and implementing a cost effective drug discovery system that takes advantage of part 11 like electronic records&signatures for patent filing. The paper can be downloaded from the Labcompliance users club , R-054

May 19, 2003


FDA Published a Proposed Rule on Dietary Supplement GMP's

The FDA is proposing cGMP regulations 21 CFR Part 111 and 112 for dietary ingredients and dietary supplements. The rule would require manufacturers to evaluate the identity, purity, quality, strength, and composition of their dietary ingredients and dietary supplements. The proposed rule is one of many actions related to dietary supplements that the FDA is taking to promote and protect the public health. This indicates that the FDA may put more focus on food companies where the inspection efforts will be on companies companies at greatest risk for good manufacturing practice (GMP) problems.

May 6, 2003

Risk Assessment and Risk Management Key Topics at CSV/Part 11 Conference

Risk management and assessment have been amongst the key topics at IVT's Conference on Computer Validation and Electronic Records and Signatures in Washington. For about 300 delegates Ludwig Huber presented a paper on "Relating FDA's New GMP Risk-Based Initiative to Computer Validation and Part 11 and Jeff O'Neill talked about "Developing an Effective Risk Assessment Plan". Huber did point out that several paragraphs of FDA's new Part 11 guidance require a 'justified and documented' risk assessment; for example, paragraphs on audit trail, validation, e-copies and record maintenance. Huber also pointed out that risk management and risk assessment are not the same. While risk assessment includes risk analysis and evaluation risk management also includes risk mitigation and on-going control. The recommendation was to first develop a company wide risk management master plan that is used as a framework for individual project plans. Labcompliance has developed a package that includes a risk management master plan and an SOP for risk assessment of computer systems in part 11 environment. For more information, click here.

May 6, 2003

Results from the Joint FDA/PQRI Workshop on Risk Based Approaches

The Product Quality Research Institute (PQRI) organized a workshop entitled "A Drug Quality System for the 21st Century". The workshop was co-sponsored with the FDA and was part of FDA's 21st CGMP Initiative: A Risk Based Approach. One of the objectives of the workshop was to get a common definition of 'risk' between the industry and the FDA. There was no consensus on what risk is, except that the risk should be product based. There was also consensus that the risk changes during the product lifecycle. Types of identified risks included: patient (safety), business and regulatory. The benefits of risk based systems have been identified for the industry as: Fewer, more efficient, science based inspections resulting in increased consistency. Faster and more consistent reviews with the potential for reduced regulatory burden. Bruce Burlington of Wyeth, a former director of Center for Devices, gave a presentation on behalf of the PhRMA. One of his recommendation was: we need to identify risk levels and criteria to determine which levels we are in and apply accordingly.

May 6, 2003


Systems Without Risk Assessment are Classified as 'High Risk Systems'

Dr. Sandy Weinberg, Professor at the Muhlenberg College, gave a presentation on "Risk Based Regulatory Compliance for Laboratory Instrumentation" at IIR's Equipment Validation/qualification conference in Chicago on May 2nd. He pointed out that risk assessment is a process defined in the Safe Medical Device Act and since long time has been applied to the regulatory process for medical devices. He predicted that one of the standard questions during GMP inspections will be for a 'justified and documented risk assessment'. If such document is not available systems will automatically be classified as high risk systems. Dr. Weinberg had predicted FDAs CGMP initiative since more than a year ago and he also mentioned that the same approach is being used by other regulatory agencies. Weinberg recommended to use system requirement specifications and past experience as input for risk analysis and to estimate probability of occurrence and severity to define high, medium and low risk systems. Labcompliance has developed an SOP for risk assessment of computer systems used in part 11 environment. The SOP includes template matrices for risk analysis analysis and evaluation and definitions for probability and severity as basis for risk categories high/medium/low. For more information, click here.


May 1, 2003


Interview with FDA CDER Director on Part 11

In February 2003 the FDA released a draft guidance that narrows the scope of part 11 and is very much in line with FDA's new cGMP initiative for risk based inspections. In an interview with Bio·IT World, the director of the Center for Drug Evaluation and Research (CDER), Janet Woodcock, explained the reasoning behind the FDA's policy shift and what this change means for biotech and biopharmaceutical firms in 2003. Questions have been related to whether part 11 will disappear, how the policy changes will affect new drug approval process and what other policy changes are expected this year.


May 1, 2003


PHARMA's thoughts on risk based approach for cGMPs

The Pharmaceutical Research and Manufacturing Association has published a paper on their thoughts on risk based approaches for GMP's. According to this paper the major goal of the cGMPs is to provide patients with a product that has an equivalent identity, safety, strength, quality and purity to the one used to establish the clinical database. The basis for making "risk-based" decisions is the risk to patients. The document is very relative to what could be considered part 11 records once the new cGMPs are updated. The 12 page paper can be downloaded from the Users Club (G-010 ). For preview and ordering the Usersclub, click here.