What do the Professionals think about GMP?

26th March 2014

Manufacturing

GMP Definition

Good Manufacturing Practice (GMP) describes a set of guidelines which are laid down by the agencies that control authorisation, licensing and quality control for the manufacture of products. These guidelines are there to indicate the minimum requirements that a company must meet in order to ensure that products are safe for consumers and are of a high quality.

Good Manufacturing Practice ensures that products are consistently produced and controlled to the appropriate quality standards, through the ongoing and focussed documentation of products and procedures. 

How GMP is linked to profits

GMP Definition

When GMP is woven into a company’s culture, like it is at ReAgent, it doesn’t only benefit the customer in terms of a quality promise, but it also positively affects the company’s reputation and profit margin. Although the professionals that specialise in the field of GMP and quality-control focus on different benefits and ways of achieving GMP, there are a few universal ways that GMP can have an impact on profits.

Good Manufacturing Practice is beneficial to manufacturers as it helps to minimise waste in production. GMP involves following a strict set of guidelines, which have been documented in detail during previous manufacturing processes, and this reduces the risk of error because we are bound to consistency. We measure the quantities of all products and log all processes in a controlled manner to exact specifications and as a result, we’re not forced to dispose of large amounts of unwanted materials at the end of the process.

GMP is also a way to increase the guarantee of satisfied customers. Customers can be confident that the products they buy will be of a consistently high quality and will therefore choose to return to ReAgent for their future requirements, as well as recommend us to other potential customers. This helps us to receive a high number of new and returning customers as we continue to meet specifications and receive good feedback.

Marie Gale

Marie GaleStemming from an interest in soap and cosmetic manufacturing, Marie Gale began making handcrafted soap back in 1998. She went on to become President of the Handcrafted Soapmakers Guild, which is now known as the Handcrafted Soap & Cosmetic Guild. During her time as President, she came into contact with other soap and cosmetic makers and became more aware of the regulations that were affecting people in the industry.

“The quality assurance procedures and practices which ensure that products are consistently produced and controlled to the quality standards appropriate to their intended use.”

Gale began adopting GMP in her own soap-making, being very precise in the details she noted down as she went along. As a way of sharing what she was learning, she wrote the books ‘Soap and Cosmetic Labelling: How to Follow the Rules and Regs’ and ‘Good Manufacturing Practices for Soap and Cosmetic Handcrafters’

When questioned on twitter by somebody in the soap and cosmetic industry about why she wrote her book on GMP, Gale replied, “Since I actually LIKE reading regulations and I like writing, it seemed like a natural fit.”

Gale describes Good Manufacturing Practice as “The quality assurance procedures and practices which ensure that products are consistently produced and controlled to the quality standards appropriate to their intended use.”

To Gale, GMP doesn’t just account for carrying out a quality check after the product has been made, but involves building quality into every step along the way. By recording everything – not just products and processes, but how each process is carried out, including preparation of the working space and how and where ingredients were obtained – she can ensure her products turn out exactly the same. Every batch, every bar, every time.

In order to document everything, she focuses on making Batch Records. These are written records of what was done in the process of manufacturing each batch, and include an assigned batch number on each label for every batch.

Gale understands that consistency and control help to eliminate mistakes, reduce risks and assure that your products are always right. She says establishing good manufacturing practices will minimise unexpected mix-ups and product contamination.

Professor Manohar A. Potdar

Prof. Potdar is interested in the field of Good Manufacturing Practice of pharmaceuticals. He is currently a Professor at the Poona College of Pharmacy, in India, carrying out research in the following areas:

  • cGMP (Current Good Manufacturing Practice) and documentation
  • Pharmaceutical Validation
  • Quality Planning and Analysis

He is also the author of ‘Current Good Manufacturing Practices’ and ‘Pharmaceutical Quality Assurance: Through Current Good Manufacturing Practice, Documentation and Validation’. 

“In modern manufacturing environments, the significant characteristics of the product being manufactured should be defined from design to delivery, and control should be exercised over all changes.”

As a trainer and consultant for the pharmaceutical industry, Prof. Potdar says that Quality Assurance, Quality Control and Good Manufacturing Practices go hand-in-hand. He also states that everyone involved in the production or distribution of Quality Pharmaceutical Products must be familiar with these three forms in the fullest and true meaning.

Potdar sees planning to be a vital component in GMP, and says that Good Manufacturing Practice should be put in place from the planning stage, not just during manufacturing; “In modern manufacturing environments, the significant characteristics of the product being manufactured should be defined from design to delivery, and control should be exercised over all changes.”

Prof. Potdar also believes that establishing GMP is initially the responsibility of management, but that all workers involved should be aware of procedures and follow them carefully. He says that management need to determine the structure of the organisation and be sure to document everything, as the system will only be effective when the objective of the quality system is clearly defined.

Phillip B. Crosby

Philip CrosbyPhillip Crosby is a businessman and author with an interest in quality management practices, who describes quality as “the result of a carefully constructed cultural environment. It has to be the fabric of the organisation, not part of the fabric.”

Crosby has written an impressive amount of books, including ‘Quality without Tears’ and ‘Quality is Free’ .

To Crosby, Good Manufacturing Practice is all about maintaining quality throughout the entire manufacturing process. He was successful in his role as a Senior Quality Engineer at The Martin Company to develop the Pershing Missile where he went on to develop the Zero Defects concept, which he refers to as the quality standard.

“Quality is the result of a carefully constructed cultural environment. It has to be the fabric of the organisation, not part of the fabric.”

Crosby states that “quality is free. It is not a gift, but it is free. What costs money are the ‘un-quality’ things – all the actions that involve not doing jobs right the first time.” This quotation illustrates why it’s vital to exercise Good Manufacturing Practice throughout the whole process, to avoid making mistakes and having to pay unexpected expenses to rectify the errors.

Good Manufacturing Practice at ReAgent

GMP helps us to offer a 100% quality guarantee at ReAgent. All staff are trained in GMP awareness and understand the consequences of contaminated, incorrect or wrongly labelled products and the correct practices are reinforced on a strict basis.

Operators take responsibility for their own working areas – all working areas are cleared before any new process begins and on completion of each batch of product, and staff follow guidelines to describe the correct method of cleaning and preparing areas. This is to ensure complete cleanliness and avoid cross-contamination. Once an area has been cleaned, all operators sign documentation to confirm this, so all other employees are aware that this space has been prepared for the next manufacturing process of a different product.

GMP Documentation

Good Manufacturing Practice involves the documentation of all processes

We weave GMP into every stage of the manufacturing process. This includes the methods we use for labelling. All labels are printed in-house and details of each batch are referred to the product label as part of a strict releasing system to ensure correct labelling. Label reconciliation is taken seriously at ReAgent to account for the number of labels printed, used and destroyed. A sample of each batch is retained on the work instruction for at least three years.

All labelling, other paperwork and batch manufacturing records are completed using GMP, as we’ve found this to have multiple benefits;

  • Consistency – all paperwork is completed in the same way, by following specific guidelines. This ensures batches can be compared and that all paperwork contains the same relevant information
  • Control – paperwork is completed to strict standards to ensure it is regularly and properly completed. This is useful when referring back to previous batches
  • Accuracy – all staff take great care in making sure paperwork contains only correct information that is as specific as possible. It is vital to log accurate details, so that all batches can be completed to the same high standard
  • Reconcilable – all paperwork must be completed appropriately in accordance with the standards set, so it always meets industry guidelines set by authorities
  • Traceable – we document all of the procedures we carry out. Staff have access to an online system where information about batches can be logged, so we can easily check on the status of previous products if needed

Reading the advice from experts in the field of Good Manufacturing Practice presents some benefits of regular quality checks and documentation that some may never have considered before. Some key points to pluck out here include the importance of working GMP into every stage of the manufacturing process to avoid spending money on repairing mistakes at the end, writing down anything and everything you do in the process, and how vital it is that every single product you manufacture is safe and of the highest possible standard. 

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