Tag Archives: inspection

  • SCG’s thoughts on the last 10%

    For the Pharmaceutical industry, it is difficult for consumers to tell the difference between an excellent, acceptable or poor quality product.  For this reason, safety, quality and reliability problems can go undetected  until the FDA detects them during an inspection or after investigation for a product recall.  By then, the problems can be out of control and can result in a Warning Letter or Consent Decree. The below excerpt can be found here: “ // // Seth’s Blog: The …

  • 483 Audit Forms

    … should not go unnoticed. A 483 audit is issued after the conclusion of an FDA inspection. This form states that certain conditions were cited as “in violation” of FDA standards/regulations. The FDA investigator feels that the practices or conditions surrounding the product at hand is in question and therefore a change needs to be set forth, in order for operation to continue. A company must understand the problem at stake as well as the violations that are in play as a way to avoid an …

  • New Data on the Inspection of Human Cell & Tissue Products by the FDA

    A recent report charting inspectional information by the FDA for human cell/tissue therapeutic products shows a marked increase in inspection activity. The period covered is 2003-2010 and reports an increase in the number of inspections by about 250%, with an average duration of each inspection of 40-45 hours. During that period, voluntary compliance actions taken by companies as a result of inspections has increased 255% and official action taken has increased 240%. This is against a background …

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

    Although FDA inspections of clinical sites are not an indictment of something being wrong with a clinical site, it can nevertheless still be a scary experience, especially if you are not properly prepared. An FDA inspection is basically a quality assurance process that is used to confirm clinical data management/integrity and regulatory compliance.  Here we show you how to make it a piece of cake for your site and your nerves. Kinds of inspections -The most common FDA inspection is the …

  • How to Perform a Mock Audit

    … team and others who witnessed the activity. -Input from the participants about what happened during the audit and about the value of the activity. -The creation of an action plan to take care of compliance issues and organizational deficiencies that surfaced during the exercise. -A follow-up report to make sure the action plan is put into practice. Take advantage of the debriefing process to ask the participants about any negative feelings that came up during the mock audit.  A mock inspection …

  • How to Get Through a Successful Pre-Approval Inspection

    If your company is associated with the pharmaceutical industry in any way, whether it be manufacturing, supplying, or research and development, there’s a pretty good chance that your company will be audited with some kind of FDA inspection down the line.  When by chance, your company is audited, they will have to pass a series of FDA inspection tests, to ensure that your company is running in compliance to FDA standards, and that all your research and manufacturing information can be …

  • REMS Risk Management Strategies

    … any potential side effects.  New safety information may be defined as any information that might be derived from a clinical trial, adverse event reports, post approval studies, or any other scientific information that may have emerged. If your pharmaceutical company is expecting a REMS review, the most important thing you can do is to develop a strong REMS strategy to counter your upcoming inspection.  The best way to do this is to contact a pharmaceutical consultancy firm that specializes in …

  • What You Should Know About Your cGMP Inspection

    … requirements. This includes pharmaceutical laboratories, or any other manufacturing area that is being used for in-process or finished product testing. The cGMP inspection may be limited to specific issues regarding your pharmaceutical operation, or may encompass a complete evaluation of your laboratory’s total compliance with cGMP regulations.  Whatever the specific objective for your cGMP inspection is, it will be thoroughly explained to you in great detail, before the inspection has …

  • Compliance Tips For cGMP Inspections

    Successfully managing a cGMP inspection begins first with developing a clear cut company plan, which will define the roles and responsibilities of everyone that will be involved in the inspection.  Because the FDA can arrive at your company without any prior notification, it is important that you thoroughly, and regularly train and prepare all personnel, so they will be ready to act if an unannounced inspection takes place.  But how do you thoroughly plan and prepare your company for a cGMP …

  • Failing an FDA Inspection

    Although your company may prepare itself sufficiently, even going over and above the necessary steps in preparing for your FDA audit inspection, there is still a chance that your company may not pass the test.  So what then?  So what happens if all your pre-inspection preparation is all for nothing, and you failed your inspection anyway?  Well it doesn’t exactly mean that you’ll get thrown in jail, or have your company wiped off the books anytime soon, but it may cause serious …

  • How to Prepare Your Company for an FDA Inspection

    Preparing your company for an FDA inspection is no easy task, but if you do all the adequate preparation necessary and know all the key points your company will be inspected on, your company has a much better chance of success.  Like it or not, if your business is involved in any way with the FDA, sooner or later, your company will face inspection.  If your company is not adequately prepared your company or its products can be seized, penalized, or even brought up on charges. Instead of …

  • Be Prepared When the FDA Knocks on Your Door

    This is the drug manufacturer’s nightmare: the phone rings and an FDA official announces an upcoming inspection.  Even though they are clearly necessary, FDA inspections are a weight on pharmaceutical companies’ shoulders.  Without these inspections, pharma companies cannot keep the FDA’s approval to sell their products. It is the FDA’s duty to call in advance to announce an inspection, its purpose, duration, and number of people involved.  On inspection day, the FDA official will ask …