What is GMP?

Good Manufacturing Practice or GMP is a universally-accepted quality management system comprising a collection of design techniques, manufacturing methods and validation protocols to ensure products that are safe, consistent and ready to use. GMP applies to different manufacturing sectors, mainly foods, dietary and nutritional supplements, complimentary and alternative medicines, drugs and pharmaceuticals.

Do you need GMP?

If your business operates in any of the sectors mentioned above, you should indeed be familiar with the principles of GMP. Your facility should be designed with GMP in mind, it should be operated according to GMP on a daily basis and you should be able to illustrate to any outside parties that you have adequate validation, auditing and process controls in place to ensure a safe and consistent product.

Being GMP-compliant is important to ensure the safety and satisfaction of your customers and in many cases is a necessity in order to legally be able to sell into a particular market. It follows therefore, that having a manufacturing facility that is designed and operated according to GMP principles is also an important tool for ensuring increased market-share and a strong brand.

Project Assignments’ role in assisting you in GMP

Project Assignments’ core competencies lie in the designing and start-up of new, upgraded or refurbished manufacturing facilities. It is far easier to ensure that any new or upgraded design is conducted with GMP principles in mind, as opposed to having to retrofit or change equipment to be GMP-compliant at a later stage. Since our engineers are experienced in the various features that make a facility conform to GMP, our team is well-positioned to help you ensure your factory design is inherently sound in this regard.

Issues such as sanitary equipment design (for easy and effective cleaning), adequate space (for operation and maintenance), ergonomic layout (to ensure uncomplicated, unidirectional flow of people and materials, with no cross-overs), reliable supply of utilities (for consistent equipment operation) and comprehensive yet cost-effective instrumentation and monitoring (for proper control) are all important design features. The facility as a whole (i.e. building, building services and site) also has an impact on GMP-compliance – floor drains, floor finishes, walls and panels, cabling and conduiting, structural steel, air quality and cascade pressure control, compressed air and steam quality, piping materials and construction, ante rooms, location of production offices, laboratories and workshops, handling and inspection of raw materials, finished goods storage and quarantine areas – Project Assignments can ensure all of these features are considered and conform to best practice.

Once a facility has been designed, Project Assignments can also perform an important formal review of the design, the Design Qualification or DQ, a crucial validation step in GMP.

During and on completion of a factory build or upgrade, Project Assignments can add value through checking the installation against the original design, drawings and specifications – the Installation Qualification or IQ validation step.

Following a new factory build or upgrade in which we have been involved, being familiar with the manufacturing intent and the design basis, Project Assignments can also assist with training of operations and maintenance staff, as well as formulation of the appropriate policies and procedures, to ensure that GMP is observed once the facility is brought into operation.

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