Embed Size (px)
Citation preview
Good Manufacturing Practice
Training
Netzealous LLC
www.netzealous.com
• Good Manufacturing Practice, or GMP, is a set of practices and systems that are aimed at making sure that pharmaceutical products are manufactured in conformance with set requirements and standards. The aim of GMP, also referred to sometimes as cGMP or Current Good Manufacturing Practice, is to ensure that there is control and consistency in the pharmaceutical products, so that the processes used for controlling quality and consistency of the product can be traced back in the event of a problem. The aim of GMP is to implement measures that are aimed at eliminating risks in the production of the pharmaceutical product. In this process, cGMP requires manufacturers to employ the latest available systems and technologies for complying with regulations.
www.netzealous.com
• GMP covers all aspects of the manufacturing process, right from the sourcing of the material that go into the product till the end stage, namely its consumption. The FDA’s GMP regulations are covered under Chapter IV relating to food, and under Chapter V, Subchapters A, B, C, D and E for drugs and devices of the Food, Drug, and Cosmetic Act, and CFR Title 21, Part 210 and 211. The important quality of this regulation is that it has the power of law, as stated by this Act. So, the FDA can come down heavily on violators of this law and impose fines and punishments on them as stated by law. Typically, failure to comply with the FDA laws on these regulations can result in recalls, seizure, fines and even jail terms.
www.netzealous.com
Professional trainings relating to GMP
• Good Manufacturing Practice (GMP) regulations are very huge in number, they are complex, and they have very serious consequences. This is why it makes sense for pharmaceutical and food organizations to go through professional trainings that address the nitty-gritty of GMP. Getting trained on how to implement GMPs and cGMPs into their business and practice is an important step to ensuring that the pharmaceutical or food organization stays compliant with the regulations.
www.netzealous.com
GMP professional trainings from
NetZealous LLC
• NetZealous LLC, a Fremont, CA-based provider of professional trainings, is a reliable source for understanding the ways in which GMPs need to be understood and implemented. Trainings from NetZealous LLC is a very important aid to manufacturers in order to get their GMPs right, because as we have seen, not getting it right leads to complications.
• NetZealous LLC’s experts, who are drawn from some among the best names in the industry, give a thorough understanding of the way in which GMP practices need to be applied to the industry. These experts have worked in the industry for many years, and understand the minutest aspect of the regulation relating to GMP. NetZealous LLC imparts trainings in the form of webinars, seminars and in-house trainings to give a complete understanding of the various aspects of the legislation.
www.netzealous.com
• NetZealous LLC’s experts offer deep and clear understanding of the elements of GMP, such as:
• Personnel qualifications
• Complaint handling • Cleanliness
• Equipment verification
• Process validation
• Recordkeeping
• Sanitation
www.netzealous.com
• Plus, NetZealous LLC’s experts also bring a thorough understanding of all the latest updates that happen in the field of GMP, as issued by the FDA. In early July of 2016, the FDA issued a Technical Conformance Guide for Quality Metrics. Aimed at offering recommendations on data submission for supporting quality metrics, this guideline is part of the process validation lifecycle and pharmaceutical quality system assessment. It addresses issues relating to:
• Electronic submission
• Elements relating to optional and mandatory data
• Rules on data validation
• Specifications relating to the data element
www.netzealous.com
• NetZealous LLC’s experts carry a proper and perceptive understanding of matters of serious concern for regulatory professionals, such as these and other updates that keep coming up from time to time. Getting professional trainings from NetZealous LLC ensures that the organization stays up-to-date with whatever is happening in the industry.
www.netzealous.com
