5 Ways to Avoid cGMP Problems With FDA

5 Ways to Avoid cGMP Problems With FDA

July 16th, 2013 // 12:51 pm @

Latest FDA and cGMP Compliance News

Everyone fears getting a 483 or warning letter. These sanctions can lead to serious problems for pharmaceutical companies. cGMP violations are very costly in terms of public image and repairing the damage. We find that most problems can be avoided by following these steps:

  1. Ensure full compliance with cGMP regulations. There is more enforcement of cGMPs these days, so it is important that you fully grasp the cGMP requirements and are implementing fully effective quality operations. Some of the most common 483 citations that we see related to cGMPs include no written procedures for quality control; no product specifications, batch records and master manufacturing controls; poor documentation and retention. We recommend that you work with a cGMP expert to help you to avoid cGMP problems, and we have a new cGMP webinar that could be helpful for you too.
  2. Set up strategies to deal with audits, enforcement actions and recalls. You should not wait until trouble strikes to determine a response. You should have SOPs set up in advance to handle enforcement actions, FDA inspections and other compliance problems. Having a procedure set up well in advance for dealing with compliance problems will make your inspection go easier and can avoid more enforcement. Good SOPs also will ensure that any recall will be done in an efficient manner.
  3. Understand what claims can be made about your products. The enforcement at FDA also deals with product claims, and FDA works with the FTC to make sure that companies do not make unsubstantiated claims. You need to know what types of claims can and can’t be made about your medical product. Also, remember that your claims have to be backed up by reliable and accurate scientific evidence. FDA is  becoming more active in issuing warning letters for inaccurate product claims, particularly for unsubstantiated disease claims.
  4. Stay up to date on regulatory changes. FDA regulations can be confusing. One of the great ways to understand the stance of the agency on a cGMP topic is to review the warning letters that FDA issues every month on its website. You will grasp the regulations that the agency is enforcing and the types of situations at companies that lead to a violation of the FD&C Act.
  5. Due diligence and risk management. Due diligence reviews on a regular basis is very important for your business model to be sustainable. During this review, your firm can go over the regulatory situation for each product and also talk about potential risks for each of your company’s activities and products. Due diligence reviews usually involve expert consultations and this can help you to pinpoint any upcoming cGMP shortfalls that may be on the horizon.

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