GMP Principle 5 – Designing, Constructing and Maintaining Facilities and Equipment

Good Manufacturing Practice principles 5&6 are probably the most critical principles to follow to the core if product safety and quality are to be assured. Yet again, for those reading this article for the first time I’ve dedicated several weeks to treat the 10 principles of GMP. It’s important therefore to understand what GMP is: Good Manufacturing Practice is defined as a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimise the risks involved in production which cannot be eliminated through testing the final product.

 

Facility Design & Construction

The design of manufacturing facilities for both food and pharmaceutical production has similar principles. Such facilities are normally segregated into zones depending on how sensitive the products being manufactured are to contamination, especially microbial contamination. The most important consideration when facilities are being constructed for such purposes is the risk of contaminating products being manufactured.

Hence – right from raw and packaging material storage, conveying of such materials to the production floor, through to actual production, the storage of intermediate products and the storage of finished products – facilities must be constructed in such a way as to prevent contamination. From my QHSE audit experience, workers’ amenities are among the facilities top management normally turn a blind eye to. Toilet facilities at offices where management normally sit are well-kept and maintained – but the opposite can be said of the workers’ toilet facilities.

Management should not be oblivious to the fact that cross-contamination is very likely if those on the shop-floor attend poorly-managed toilet facilities. One of the key areas of concern is the disregard for segregation of shop-floor space and locker and toilet facilities.  It is common practice, among SMEs especially, to have toilet facilities open directly onto production areas. This is against GMP principle 5, because the risk of contamination is very high in such instances.

Furthermore, floors are to be made of hygienic materials. Floors shall be smooth and nonporous to prevent ingress of materials that will eventually breed harmful microorganisms. Finishing touches to such facilities should follow hygienic standards. The use of paint that flakes at the least moisture-ingress should be avoided.

Walls should seamlessly flow into floors by coving to allow for easy cleaning and disinfection. In cases where there are very sensitive products involved, such as dairy products and drugs, it is important to zone the shop-floor into High-risk, medium-risk and low-risk areas; and if required by specific codes of practice, disinfection facilities provided when moving from one zone to the other.

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Personal Hygiene Facilities & Cleaning Implement Storage

Many industries have not yet understood the concept of hygiene stations. Factory buildings are usually completed before thoughts of hygiene stations come up. Hence, some hygiene stations are nothing more than a place of ordinary handwashing areas. It is also important to ensure there is adequate lighting provided in the facility. All lights in production and storage areas must be covered with sleeve-jackets to protect materials and products from accidental breakage of lamps.

One other facility that is mostly forgotten by both small and large companies is the area for washing, disinfecting and storage of cleaning equipment such as mops, mopbuckets, brushes and other cleaning materials. It is an eyesore to see cleaning materials scattered in corners of production facilities. In the haste to hide these items during audits, employees dump them behind process vessels and other obscure places.

Unfortunately for them, auditors normally find out. Remember also to build safety into facility construction. Safety considerations must be given high priority in the facility. For instance, fire evacuation plans, emergency exits, pedestrian walkways, road markings to separate people from moving objects like forklifts and vehicles etc. When a facility is built with GMP Principle 5 in mind, a solid place for the production of safe and quality products in a safe environment can be achieved.

 

Equipment Design & Construction

Several types of equipment are assembled for manufacturing processes. These may range from very simple equipment to heavy ones, depending on the type of product involved and also the target volumes. For a typical food or drug manufacturing setup, equipment may range from process vessels, product lines, pumps, instrumentation, conveyor systems, dispensers, packaging machines etc.

The integrity of products among other considerations would depend on the type of vessels that are involved. The use of certain high grades of stainless-steel is non-negotiable in food and drug manufacture. In some instances, mild-steel has been used to store crude palm oil at the back-end of certain food manufacturing processes; but intermediate products from this example must always be stored in stainless-steel tanks. In the case of mild-steel usage, category-specific GMP allows products to stay in such tanks for very minimum number of hours or days.

Principles of equipment design need to be employed when vessels are being fabricated. In manufacturing hygiene, the type of vessels, how they are designed, the type of pumps, welding integrity and other critical fabrication processes are looked at – all in a bid to prevent contamination of products. Knowledge in these areas would be key to the production team, engineering, R&D and Quality professionals in the business.

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Facility and Equipment Maintenance

If there is anything to attract the attention of top management with regard to sustaining production, it is the culture of maintenance. Fortunately, maintenance is a big part of the entire manufacturing process. The discipline to make it work is an attribute that needs to run through the business and not be limited to the maintenance department alone. Of all the maintenance activities available, preventive maintenance is the most important.

Hooking onto a preventive maintenance culture has many advantages, one of which is the reduction of breakdowns during production. Hence, a manufacturing facility and the many installed equipment have to be put on a maintenance schedule that should be rigorously followed. It is important to put specific maintenance personnel in charge of smaller sections of the facility to ensure a thorough maintenance job is done.

 

Conclusion

Principles 5&6 of Good Manufacturing Practice are essential if productivity is to be achieved in real terms. Without a good facility and equipment designed to enhance the safety and quality of products, a business is likely to go under a few years after its establishment. A good maintenance culture is essential for production sustainability – without which contamination issues increase and productivity drops significantly.

 

 

Johnson Opoku-Boateng is the Chief Executive & Lead Consultant, QA CONSULT (Consultants and Trainers in Quality Assurance, Health & Safety, Environmental Management systems, Manufacturing Excellence and Food Safety). He is also a consumer safety advocate and helps businesses with regulatory affairs. He can be reached on +233209996002, email: johnson@qaconsultgh.com.

 

 

 

 

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