Current Good Manufacturing Practices – What are cGMPs? | Ion Labs Podcast



the statements in the following podcast have been evaluated by the Food and Drug Administration the products that we talk about on this podcast are not intended to diagnose treat cure or prevent any disease individual effects may vary among products if you have an existing medical condition please consult your doctor prior to use pharmaceutical quality affects every American FDA regulates the quality of pharmaceuticals very carefully the main regulatory standard for ensuring pharmaceutical quality is the current good manufacturing practice regulation for human pharmaceuticals consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective most people however are not aware of C GMP s or how FDA assures the drug manufacturing processes meet their basic objectives recently the FDA announced a number of regulatory actions taken against drug manufacturers based on the lack of cGMP s first and foremost what are CG and peace well see GMP refers to current good manufacturing practice regulations enforced by the US Food and Drug Administration or better known as the FDA see GMP s provide for the systems that ensure proper design monitoring and control of manufacturing processes and facilities adherence to the see GMP regulations assures the identity strength quality and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations this includes establishing strong quality management systems obtaining appropriate quality raw materials establishing robust operating procedures detecting and investigating product quality deviations and maintaining reliable testing laboratories this formal system of controls at a pharmaceutical company if adequately put into practice helps to prevent instances of contamination mix-ups deviations failures and errors this assures that drug products meet their quality standards the see GMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically sounds processing methods and testing procedures the flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement the c-in-c GMP stands for current requiring companies to use technologies and systems that are up to date in order to comply with the regulations systems and equipment that may have been top-of-the-line to prevent contamination mix ups and errors ten or twenty years ago may be less than adequate by today's standards it is important to note that cg MPs are minimal requirements many pharmaceutical manufacturers are already implementing comprehensive modern quality systems and risk management approaches that exceed these minimum standards YRC GMP is so important a consumer usually cannot detect through smell touch her sight that a drug product is safe or if it will work while cGMP is required tasting testing alone is not adequate to ensure quality in most instances testing is done on a small sample of a batch for example a drug manufacturer may test a hundred tablets from a batch that contains two million tablets this is done so that most of the batch can be used for patients rather than destroyed by testing therefore it is important that drugs are manufactured under conditions and practices required by the cGMP regulation to assure that quality is built into the design and manufacturing process at every step facilities that are in good condition equipment that is properly maintained and calibrated employees who are qualified and fully trained and processes that are reliable and reproducible are a few examples of how see GMP requirements help to assure the safety and efficacy of drug products another common question is how does the FDA determine if a company is complying with cGMP regulations well the FDA inspects pharmaceutical manufacturing facilities worldwide including facilities that manufacture active ingredients and the finished product inspections follow a standard approach and are conducted by a highly trained FDA staff the FDA also relies upon reports of potentially effective drug products from the public and the industry the FDA will often use these reports to identify sites for which an inspection or investigation is needed most companies that are inspected are found to be fully compliant with the cGMP regulations another common question is if a manufacturer is not following cGMP s our drug products safe for use if a company is not complying with cGMP regulations any drug it makes is considered adulterated under the law this kind of adulteration means that the drug was not manufactured under conditions that comply with cGMP it does not mean that there is necessarily something wrong with the drug for consumers currently taking medicines from a company that was not following cgmp s the FDA usually advises these consumers not to interrupt their drug therapy which could have serious implications for their health consumers should seek advice from their health care professionals before stopping or changing medications regulatory actions against companies with poor cgmp s are often intended to prevent the possibility of unsafe and/or ineffective drugs in rare cases the FDA regulatory action is intended to stop the distribution or manufacturing of product the impact of cGMP violations depends on the nature of those violations and on the specific drugs involved a drug manufacturer in violation of cGMP may still meet its labelled specifications and the risk that the drug is unsafe or ineffective could be minimal thus the FDA's advice will be specific to the circumstances and the health care professionals are best able to balanced risks and benefits and make the right decision for their patients what can the FDA do to protect the public when there are C G and P violations if the failure to meet cGMP s results in the distribution of a drug that does not offer the benefit as labeled the company may have to recall that product this protects the public from further harm by removing these drugs from the market while the FDA cannot force a company to recall a drug companies will usually recall voluntarily or at the FDA's request if a company refuses to recall a drug the FDA can warn the public and can seize the drug the FDA can also bring a seizure or injunction case in court to address cGMP violations even where there is no direct evidence of a defect affecting the drug performance when the FDA brings a seizure case the agency asks the court for an order that allows federal officials to take possession of the drug when the FDA brings an injunction case the FDA asks the court to order a company to stop violating CGM PS both seizure and injunction cases often lead to court orders that require companies to take many steps to correct cGMP violations which may include repairing facilities and equipment improving sanitation and cleanliness performing additional testing to verify quality and improving employee training the FDA can also bring criminal cases because of cGMP violations seeking fines and even jail time so knowing all this how would a new drug company learn about cg MPs and about the FDA's expectations on complying with them well it's simple business owners can always reference fda.gov which also contains links to the cGMP regulations guidance documents and various resources to help drug companies comply with the law businesses can also go to ayan labs comm to understand how a cgmp certified and an FDA registered facility educates their client base and operates on a day to day basis if you want to learn a little bit more please read our blog article all about it online on our website at ion Labs calm and by all means please like us on facebook follow us on instagram and be sure to subscribe to our youtube page to make sure that you stay updated on all of our brand new podcasts and videos that we release as always I'm Max and thank you for listening to the ion Labs podcast

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