Tag Archives: document

  • 483 Audit Forms

    So what’s with this 483 audit form and where do I go from here? Faced with a 483 audit form? If this is the first time your company has received a document of this nature your initial thoughts may be… now what? In order to understand the true implications of a 483 citation, it may help to think of it in terms of a speeding ticket. It’s a road block or a cause for reevaluation of your current state. Although not necessarily a serious offense, it’s an important warning to your company that …

  • Behind The Increasing Need for Pharmaceutical Consultants

    … standards for process and product quality don’t hinder innovation, and it will mostly likely raise costs for pharmaceutical companies. September 2004: The FDA promulgated a document titled Process Analytical Technologies (PAT), which encourages early adoption of advances in industry technology. Although acquiring and using new, state-of-the-art technology is sometimes necessary, it undoubtedly has its costs. September 2006: The FDA promulgated another document, titled Quality Systems Approach …

  • FDA Inspection Wizard: What’s Scary Can Turn Out to Be a Piece of Cake

    … for and stored. These things are normally checked: -Communication capability with the IRB, including the initial submission document, adverse event reporting, and progress reports -Totality of accountability documentation for the receipt, storage, administration, and return of test article (drug, device, etc.) -Compliance with the study protocol and documentation that each deviation/amendment received the approval of the IRB and the sponsor -Aptness of the informed consent process -Timely and …

  • Management Responsibilities and Automation Techniques in Regulated Pharma Environments as Per a Suggested Quality System Model

    … regulations, the FDA’s Critical Path Initiative, ISO 9000 standards, and/or the requisites of foreign regulatory bodies. However, in the ‘Quality Systems Approach to Pharmaceutical cGMP Regulations’ support document, the FDA introduces a potential Quality Systems model that could offer the elements that pharmaceutical companies require to start, or keep on, growing a top-functioning Quality System capable of meeting the institution’s regulations and requisites. The quality …

  • Key Elements of a Business Plan for a Pharmaceutical Business

    The importance of a comprehensive business plan for any new business cannot be overlooked, and this importance increases exponentially for a business as complex as a pharmaceutical business.   A business plan serves not only as a roadmap for the management team, but also as a complete blueprint of what the business will accomplish.  This document is necessary if you want to entice potential investors to put money in your new venture. Critical elements of any business plan include a …

  • Compliance Tips For cGMP Inspections

    … Once you are ready to begin the FDA inspector will notify your company the exact purpose for the inspection, and roughly how long it will take for them to complete their audit.  You will want to supply the inspectors with an office room, or conference room, so that they can set up a base of operation, and review their records and files. The inspection itself, usually involves a combination of physical plant inspection, as well as possibly document and record review.  This may also include any …

  • Counterfeiting: The FDA Seeks Guidance on New PCIDs

    Counterfeiting has long been a serious problem in the pharmaceutical industry; counterfeit medications are often sold over the Internet as the real thing and can have fake or even harmful ingredients.   The FDA is now seeking guidance on its 11-page document that recommends the use of PCIDs or physical-chemical identifiers that can be used to determine whether or not a product is the real thing. These identifiers should use the minimum amount of ink or other substances necessary to provide …

  • Surviving FDA Inspectors

    … INSPECTOR’S QUESTIONS: Watch your manners, too. Never engage in an argument with an inspector and definitely avoid arguments between peers in front of him. These will create a terrible impression, and you’ll regret it later. If you don’t understand something, kindly ask for an explanation. He’ll be more willing to explain even sections of regulations if he notices you respect his job. 4.    DON’T WAIT UNTIL THE LAST MINUTE TO PRODUCE EVERY document. Providing all documents in a …

  • Dealing With FDA Pre-Aprroval Inspections

    … inspectors (a list of Do’s and Don’ts will be much welcomed),and preparing a document room to provide key documents to the inspection team as requested. A key part of this process is to make sure that people are appropriately prepared to answer questions about their responsibilitires so that they minimize the chances of making mistakes or saying the wrong things Which can lead to ambiguities. 3. Confirmatory evidence: Generate documented evidence of compliance with FDA regulations; be …

  • Strategies for Efficient Energy Use in Pharmaceutical Manufacturing Plants

    … whole motor system instead of revising each part at a time. To get into action the best approach would be following some basic steps, as follows: identify all motor applications in the plant, such as pumps or fans; document their different conditions and technical specifications; compare the requirements in your plant to the use of the system to evaluate its consumption rate, which will help verify if the size of the motors is correct; gather all the data regarding different upgrades or …