Online Safety Community

Good Manufacturing Practices are essential for ensuring quality

Good Manufacturing Practices (GMPs) constitute one of the core components that go into the manufacture and distribution of foods, drugs and other pharmaceutical products. Good Manufacturing Practices are prescribed by regulatory agencies from around the world, the FDA and the EMA being among them.

The guidelines set out by these regulatory agencies are aimed at bringing about standardization in the process of manufacture of these products and to ensure their quality. The utmost diligence of organizations that manufacture these products is called for.

goodManufacturingPracticesThe FDA attaches the highest importance to quality, since drugs and pharmaceuticals are consumed by millions of Americans for a variety of diseases and conditions. Keeping this in mind, the FDA has formulated guidelines with which manufacturing maintains set quality standards across a range of products ranging from foods to pharmaceuticals. The whole set of guidelines for manufacturing products in a variety of industries and activities is clubbed under the collective term, “Good Manufacturing Practices (GMP)”. The FDA attaches the highest importance to quality, since drugs and pharmaceuticals are consumed by millions of Americans for a variety of diseases and conditions. Keeping this in mind, the FDA has formulated guidelines with which manufacturing maintains set quality standards across a range of products ranging from foods to pharmaceuticals. The whole set of guidelines for manufacturing products in a variety of industries and activities is clubbed under the collective term, “Good Manufacturing Practices (GMP)”.

Since these best practices keep changing from time to time and the latest developments overshadow the existent ones; the FDA expects manufacturers to keep abreast of the latest regulations it passes, called cGMP, meaning “current” Good Manufacturing Practice.

No single set of standardsgoodManufacturingPracticesGMPs and cGMPs are not a single, rigid and monolithic set of standards or rules that everyone is expected to implement in their manufacturing systems. The regulatory agencies prescribe a broad set of general principles, from which a manufacturer from particular industries have to implement at a minimum level of quality requirements, the ones appropriate to it. Further, these guidelines offer options on the ways by which those regulations that are relevant to it can be accomplished. The organization needs to determine the one that suits it best for implementing that system.

Purpose of Good Manufacturing PracticesgoodManufacturingPracticesWhy the regulatory agencies take this task upon themselves is because the consumer is not in a position to identify a spurious product or one that has not been through all these scientifically designated processes. The fundamental purpose for which the regulatory agencies require adherence to the CGMP regulations is that compliance to these guidelines is a means to assuring the following:

goodManufacturingPracticesIn order to achieve this, drug manufacturers have to take all the steps needed to control the 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.

The FDA believes that putting all these steps and processes in place through this formal system of controls by a pharmaceutical company is a means to prevent mix-ups, contamination failures, deviations and errors. In addition to ensuring that drug products that go through these processes meet their quality standards; the cGMPs help to put in place systems with which proper design, monitoring, and control of manufacturing processes and facilities are assured.

Highlights of GMPs/cGMPsThe nature and role of current Good Manufacturing Practices can be summarized into the following:

goodManufacturingPractices

The GMP regulatory requirements in the EU

The EMA, being the regulatory agency for the EU; oversees the implementation of cGMP guidelines. The EMA’s guidelines apply to all the Member States of the European Union. The purpose for which these guidelines are set out by the EU is more or less the same as that for which other agencies such as the FDA lay out these rules. The essential reason for which this is done is to ensure that the pharmaceutical or any other regulated products:

goodManufacturingPracticesThe EU’s directives on GMP are listed out in its important legal frameworks and guidelines. These include:

  • Regulation No. 1252/2014 and Directive 2003/94/EC, which are for active substances and medicines for human use
  • Directive 91/412/EEC, which relates to medicines for veterinary use
  • Directive 2001/83/EC and Directive 2001/82/EC, which prescribe related provisions.

 

click to continue reading

Views: 29

Comment

You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Latest Activity

Jam Blanco posted a blog post

Making Temporary Construction Fencing Panels

Fencing at construction sites is necessary since it keeps both workers and the general public safe from mishaps on site. If there aren’t any clear boundaries marking off a zone, anyone can wander in and get seriously hurt. With the right precautions in place you can avoid costly lawsuits, fines, deaths and stress.…See More
13 hours ago
John Robinson posted events
17 hours ago
Training Doyens posted events
19 hours ago
swetha posted a blog post

Nebosh IGC Training course - Chennai

Nebosh course in Chennai can be obtained by the safety individual who is doing work, fresher or any engaged indiviuals. The Nebosh course period is 18 days. As we are offering both class room teaching as well as e-learning training with comprehensive of book resources. If you want to perceive a profession in Health and safety sector GWG will give you a best Nebosh training in Chennani.We are…See More
yesterday

Forum

Python Condition Objects Tutorial in 2018

If you have knowledge of other programming languages, then you would know the importance of conditional statements. Conditional statements are required for taking decisions. Whenever we operate the…Continue

Tags: course, certification, training, languages, programming

Started by Elena Lauren Apr 2.

Automation Anywhere. How do I pick a value from dropdown 1 Reply

Automation Anywhere. How do I pick a value from dropdown. I tried 'set text' from a copied variable. Its very slow, and also doesnt…Continue

Tags: anywhere, automation

Started by emmablisa. Last reply by venkatesh Mar 29.

Agile overcome common software security challenges

Paradoxically, security is a negative goal. To secure something, you must understand how insecure it is. Start by trying to break it or by figuring out how other people might break it. The same is…Continue

Tags: agile, scrum, security

Started by nicolewells Mar 23.

Understanding Data Parallelism in MapReduce

In order to understand the goals of MapReduce, it is important to realize for which scenarios MapReduce is optimized. The MapReduce programming model is created for processing data which requires…Continue

Tags: program, Implementation, Mapreduce

Started by gracylayla Mar 14.

TensorFlow serving vs TensorFlow service

I have a question regarding the difference between TensorFlow Serving versus TensorFlow service. (Sorry that I'm not familiar with this at all.)I found TensorFlow serving's definition, which is "…Continue

Tags: training, online, tensorflow

Started by emmablisa Feb 27.

Badge

Loading…

© 2018   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service