Elements of an Approved Arrangement

You may choose to have separate procedure for each area or decide to have these incoporated into one GMP procedure. You will also need to conduct an GMP/GHP audit, on top of your internal audit programme, to ensure that the GMP/GHP practices are being carried out and managed with the requirements of your procedure. However, when conducting your GMP/GHP audit, you must include all areas of your premises, including the surroundings and any storage areas, and associated polices or procedures.

GMP & GHP audits should not be just a quick inspection with a tick or cross. The items and evidence that you assess as part of an GMP audit need to allow you to determine if your GMPs/GHPs are being followed, and you must keep records of these audits. Any issues identified during the GMP audit should be documented along with corrective and preventative actions, timeframes for completion and who is responsible for actioning the finding.

Some common observations to indicate that your site GMPs & GHPs are not being effectively managed includes:

• Deteriorating floors with cracks and potholes
• Deteriorating condition of walls, ceilings and equipment (e.g. damaged parts, rust, flaking paint), inadequate cleaning (e.g. mould growth, build-up of residues on equipment)
• Use of unlabelled chemicals or containers
• Improper storage of equipment and maintenance tools
• Protective clothing requirements not being followed
• Uncontrolled and overuse of adhesive tape as temporary repairs
• Accumulation of waste, debris and wood splinters on floors
• Uncontrolled garden surrounds
• Evidence of pest activity on site

During manufacturing, staff may get caught up with different priorities and forget the basics. This could be simple as forgetting to put items or utensils back where they belong or not sweeping or cleaning areas adequately. The use of shadow boards alongside regular equipment location checks and GMP audits can help ensure equipment storage requirements are met after use. Staff should be encouraged to follow a ’clean as you go’ approach to their day-to-day activities.

It is important to remember that this element covers not only the manufacturing areas, but also the building surrounds and any storage areas which may be onsite, along with all relevant policies and procedures.

When reviewing your GMP procedures and conducting internal GMP audits, you should take the following into consideration:

• Do you have a documented procedure which includes the requirement for staff to wear suitable protective clothing and observe good hygienic and manufacturing practices?
• Are all relevant personnel, including staff, contractors and visitors who may need to enter the manufacturing area suitably trained and complying with procedures?
• Are regular hygiene and housekeeping inspections conducted? Are there records kept for these?
• Are inspections up to date as per your proposed schedule?
• Are all areas including storage areas and external surrounds covered as part of regular internal audits?
• Are corrective actions from issues found during GMP audits recorded and rectified?
• Are chemicals clearly identified and stored correctly after use to ensure they do not inadvertently contaminate products?
• Are walls and ceilings cleaned effectively (e.g. no evidence of mould growth or residues)?
• Are rubbish bins emptied regularly and not overflowing? Do they have lids which are kept closed? Who is responsible for ensuring this?
• Are there designated areas for the separation and storage of waste and inedible material before their removal from the site?
• Are food waste containers clearly labelled or differentiated from non-food waste containers?
• Is equipment maintained to a standard of cleanliness that ensures there is no accumulation of any food waste, dirt, grease, or other foreign matter that could contaminate any dairy products?
• Are operators aware of how to clean equipment effectively? Are their areas clean and tidy? Is there any risk of contamination?
• Are there any other operations occurring at the site which can affect the site from producing a safe quality product?
• Are facilities for cleaning and sanitising equipment in contact with milk products readily accessible by food handlers?
• What controls are in place for managing personnel eating or drinking inside the site?
• Do staff enter processing areas through the designated access doors only?