QMS-160 Personal Hygiene Jewellery and Clothing Policy

1.0 DOCUMENT OWNER

Technical/Quality Manager

2.0 PURPOSE

The aim of this policy is to outline GMP requirements for personal hygiene, clothing and jewellery for all colleagues (employees, visitors and contractors) entering a GMP site.

3.0 SCOPE

3.1 This procedure applies to all colleagues, (i.e. all employees, casual / contract or permanent), contractors and visitors entering the GMP facility.

3.2 Clothing, jewellery and personal hygiene requirements for all colleagues are defined in this procedure.

3.3 This procedure is applicable to the GMP facility, incorporating Manufacturing, Packaging, Pharmacy, Airlocks, Warehouse, Dispensing and Laboratory areas.

4.0 RESPONSIBILITY \ BUSINESS RULES

4.1 It is the responsibility of all colleagues to adhere to the procedures listed in this SOP.

4.2 It is the responsibility of the host of all contractors and/or visitors entering the site building to ensure that they comply with this policy.

4.3 It is the responsibility of all colleagues who either work in or visit the Clean Zone to comply with this procedure. ‘Clean Zone’ is defined as an area within packaging/manufacturing (including the pharmacy dispensing area) which requires some form of gowning.

4.4 It is the responsibility of all people entering the building to ensure that Personal Protective Equipment (PPE) and clothing is worn in areas as indicated by the signage directly outside the various work areas and/or as required by any ‘Work Method Statements or Plans’ used for specific contracted works.

4.5 It is the employee’s responsibility to ensure jewellery is kept safe. Site authority takes no responsibility for loss of jewellery as a result of this policy.

4.6 Food and drink in this policy means all food and drink, including but not limited to lollies, chewing gum, cigarettes, tea, coffee and soft drinks. 

5.0 PROCEDURE

5.1 Clothing Policy – General Rules

5.1.1 Hair covers must be worn in the Packaging Hall, Warehouse Sampling Booth and the Manufacturing Area / Clean Zone. They must cover the ears and all hair.

5.1.2 Beard covers must be worn in the Packaging Hall, Warehouse Sampling Booth and the Manufacturing Area / Clean Zone if colleagues have facial hair – this includes beards, moustaches and extended sideburns. A beard cover must be worn if facial hair has not been clean-shaven for 2 days.

5.1.3 All hair covers and beard covers must be disposed of upon exiting the Packaging Hall, Warehouse Sampling Booth and Manufacturing Area / Clean Zone. Re-use of disposable hair / beard covers is not permitted.

5.1.4 Disposable shoe covers (or dedicated Clean Zone safety shoes) must be worn in the Packaging Hall, Warehouse Sampling Booth and Manufacturing Area / Clean Zone. Shoe covers must be disposed of upon exiting these areas.

Re-use of disposable shoe covers is not permitted. Should disposable shoe covers become ripped or torn they must be replaced.

5.1.5 Safety shoes are required in all downstairs areas with the following exceptions:

– No safety footwear is required for the downstairs offices when accessed from the upstairs offices via the stairwell.

– A walkway requiring flat, covered, leather/synthetic shoes are marked to provide access from the entry foyer to the airlock change room and downstairs offices.

5.1.6 Uniforms and laboratory coats are the property of the service provider and must not be taken offsite.

5.1.7 Company issued clothing must be clean at all times and must be stored in employees’ lockers when not in use.

5.1.8 Uniforms and laboratory coats must be changed at the following frequencies:

– Manufacturing and Packaging colleagues must change their uniforms at the end of each shift, or sooner if damaged or contaminated.

– Laboratory colleagues must change their white laboratory coats every week, or sooner if damaged or contaminated.

– All disposable clothing must be changed daily or sooner if damaged or contaminated.

5.1.9 Gloves must be worn by any colleagues coming into direct contact with product or with equipment that comes into contact with product. They must be replaced if worn or dirty.

5.1.10 Eye and ear protection must be worn as indicated on signage in the Manufacturing, Packaging, Laboratory and Warehouse areas.

5.1.11 Visitors must follow the same uniform / apparel procedures as colleagues, with the aid of temporary company uniforms or disposable garments if necessary. A qualified GMP colleague must escort them at all times.

5.1.12 If dedicated shoes are worn outside the Clean Zone (e.g. in the event of a fire alarm), the following decontamination procedure must be followed:

– Use a dedicated brush located in the airlock to scrub off any dirt before stepping over the step over bench.

– Spray the shoe with 70% alcohol and wait for the shoe to dry before entering the Clean Zone.

5.2 Personal Hygiene Policy – General Rules

5.2.1 All colleagues must undertake GMP training.

5.2.2 All colleagues must wash their hands with the anti-microbial soap / solution provided and dry them prior to and after meal breaks and after using a toilet.

5.2.3 For colleagues who may have contact with exposed product (i.e. in Packaging and in the Clean Zone), the following rules apply:

– Colleagues’ fingernails must be trimmed and clean.  No false nails or nail polish may be worn.

– No jewellery apart from a smooth wedding band may be worn. This must be covered with tape prior to entry into the Packaging area / Clean Zone or Warehouse Sampling Booth. No jewellery must come into contact with exposed product.

– No makeup or false eyelashes may be worn.

5.2.4 No food or drink or personal medication may be consumed or stored in Manufacturing / Clean Zone / Packaging / Warehouse / Laboratory areas.

5.2.5 The consumption and storage of food, drink and personal medication is prohibited throughout the Manufacturing building and Engineering building with the following exceptions:

– Short-term storage of food and drink is permitted in the change rooms off the foyer, in the lab entrance area and in the offices on the upper floor of the Manufacturing building, provided that food/drink is stored in suitable containers that prevent dropping of food scraps or spillage of liquids.

– Water may be consumed in the areas of the Manufacturing building where water coolers are provided, with the provision that all associated rubbish be removed or placed in the appropriate receptacles provided.

5.2.6 A sign is placed on the automatic doors prior to the entry to the Manufacturing and Warehouse areas in the Production building indicates that no food or drink is permitted beyond that point.

5.2.7 Site colleagues working in the Demountable are not subject to the restrictions in this SOP when in the demountable but must adhere to this policy when in the Manufacturing building or Engineering building.

5.2.8 Any organized function involving food and/or drink must be organized to occur outside the Manufacturing building or Engineering building.

5.2.9 Sales of charity lollies for fundraising, etc., must be conducted outside the Manufacturing Plant or in the areas where goods may be stored.

5.3 Company Health Practices

5.3.1 All colleagues should receive a medical examination upon recruitment. After the first medical examination, examinations should be carried out when necessary for work and personal health.

5.3.2 Colleagues or contractors with a communicable disease (e.g. cold or flu) must advise their Team Leader if working in close vicinity of exposed raw materials or product. The site authority reserves the right to reassign the duties of colleagues with communicable diseases.

5.3.3 Colleagues or contractors with open lesions, cuts etc on exposed surfaces of the body must report to the Team Leader before taking up or resuming duties. All such lesions, cuts etc must be covered with sterile non-permeable dressings, e.g. Band-aids.

5.4 Production Area – Gowning

5.4.1 The Production Area includes the Core Area Clean Zone, the airlocks, and the Packaging Areas. The Clean Zone includes all filling rooms and service areas.

5.4.2 Hair and beard covers must be worn in the Production Area, as outlined in Section 5.1.

5.4.3 Dedicated shoes or disposable shoe covers must be worn in the Production Area.

5.4.4 The Jewellery Policy as outlined in Section 5.2 applies to the Production Area.

5.4.5 Each Manufacturing and Packaging colleague in this area has an individually identified locker in the airlock change room. These lockers contain dedicated shoes only. Lint free and anti-static garments are provided on a rack in the airlock change room. (See Figure 1).

5.4.6 All manufacturing and packaging colleagues must change into their dedicated clean zone safety shoes in the airlock. ‘Street’ shoes are to be stored in lockers only.

5.4.7 A step-over bench is provided for the safe and clean transfer of personnel into the Clean Zone.  When entering the airlock, collect shoe covers (if appropriate) and hair net/beard cover, sit on the bench and put shoe covers on (if appropriate) before stepping on to the other side of the bench.

5.4.8 Do not jump or step straight over the bench. Sit down to change shoes or to apply shoe covers.

5.4.9 Other site personnel (other than Manufacturing/Packaging colleagues), visitors, approved contractors, casual employees and service providers must wear safety shoes or enclosed shoes, a lint free, anti-static garment (on top of their existing clothes), disposable shoe covers, a hair cover and a beard cover (if applicable) (See Figure 2). 

The jewellery policy as outlined in Section 5.2 applies. Visitors and contractor service people are not permitted in the clean zone unsupervised. They are restricted to the corridors within the Clean Zone and are not permitted to enter any manufacturing rooms within the Clean Zone.

5.4.10 Upon exiting the Production Area Clean Zone, colleagues must change out of the garments and hang them on the dedicated hangers. When leaving the Clean Zone, sit on the bench and remove dedicated shoes prior to stepping onto the other side of the bench.

When wearing shoe covers, it is acceptable to step over the bench and then remove the covers. All used shoe covers must be disposed of in the bin provided.

If a garment is soiled, it is placed in the soiled garment collection bin in the airlock change room. Garments worn by visitors, approved contractors and service providers are disposed of in the soiled garment collection bin. Colleagues’ garments must be changed as outlined in Section 5.1.

5.4.11 If Packaging colleagues need to access the warehouse via the warehouse airlock with dedicated shoes, disposable shoe covers must be used. 

All colleagues must change out of their dedicated garments and hang them on dedicated hangers. The packaging floor steward, responsible for moving pallets of materials from the warehouse to the packaging floor and vice versa, should use the dedicated ride-on pallet truck.  Should the need arise to step off the pallet truck while in the warehouse (or to use a standard pallet truck), shoe covers must be worn which are stored on the pallet truck itself or in the warehouse airlock. These must be disposed of prior to stepping back onto the packaging floor.

5.5 Production Area – People Movement

5.5.1 To access the Core Area, colleagues should use the Core Area Airlock.

5.5.2 To access the Packaging Area, colleagues should use the Packaging Airlock.

5.5.3 Movements between the Core Manufacturing Area and the Packaging Area should be via the Packaging/Manufacturing Corridor. The glass doors at the packaging lines should not be used to access the Core Area Corridor or vice versa.

5.6 Production Area – Transport of Materials

5.6.1 All goods entering the Core Manufacturing Area must be stored on a clean plastic or metal pallet. Wooden pallets may be used in other areas.

5.6.2 Materials delivered to the Production Area are taken into the Core Area material transfer airlock by means of a forklift or pallet truck. This airlock is used for the transportation of materials only and should not be used as a walkway for personnel. The materials are then collected by personnel from within the airlock by means of a pallet truck or forklift designated for use inside the clean zone area only.

5.6.3 Goods for removal from the Clean Zone are deposited in the airlock by means of a pallet truck or forklift and are collected by personnel from the outside area for transportation to their destination.

5.7 Pharmacy

5.7.1 The Pharmacy Clean Zone includes the weighing room, the weighing room air lock, the change room, the dispensed job staging area, and the air-conditioned portion of the raw material store. The change room for this area is off the air lock between the weighing room and the storage rack area.  Colleagues in this area must wear a disposable Tyvek suit or grey uniform (Figures 3 and 4).

5.7.2 Upon exiting the Clean Zone, colleagues must change out of the Tyvek suit or grey uniform.

5.7.3 Colleagues in other areas of the Pharmacy must wear clothing in line with Production Area requirements (Section 5.4) as a minimum.  Should access to the Clean Zone be required, clothing requirements apply (Figures 3 and 4).  White cotton overalls should be used where appropriate depending upon the work to be undertaken (Figure 5).

5.8 Warehouse – Sampling Booth

5.8.1 Colleagues must wear a disposable Tyvek suit or grey uniform, safety shoes and disposable shoe covers (Figures 6 and 7). This clothing must be put on whilst inside the sampling booth (including when cleaning the sampling booth) and before any raw material container is opened.     

5.8.2 The Jewellery Policy as outlined in Section 5.2 applies to the Warehouse Receiving Dock Sampling Booth.

5.8.3 Upon exiting, colleagues must change out of the Tyvek suit or grey uniform.

5.8.4 Warehouse colleagues must wear a site issued uniform that includes a yellow fluorescent top or vest and safety shoes.

5.8.5 Any visitors entering the warehouse area must wear a fluorescent yellow vest, with the word ‘Visitors’ printed on the back (Figures 8 and 9).

5.8.6 Appropriate breathing apparatus/dust mask and/or glasses are to be used in the Warehouse Sampling Booth.

5.9 Laboratory (Chemistry and Microbiology)            

5.9.1 Laboratory white coats must be worn before gaining access to the Laboratory areas (see Section 6 for a definition of the Laboratory) (Figure 10).  Reference SOP QO-S00581.

5.9.2 All visitors / infrequent colleagues must wear a laboratory coat (located in the foyer cabinet) before gaining access to the Laboratory areas.

5.9.3 Laboratory white coats may not be worn outside the laboratory building.

5.9.4 Please refer to SOP LAB-110 Safety Procedure in Laboratory for instructions on the use of safety glasses or prescription safety glasses, safety shoes and the maintenance of long hair.

– Safety glasses must be worn when working with the autoclave, preparing or pouring media, or handling glassware.

5.10 Engineering Department

5.10.1 Engineering / Maintenance Colleagues must wear the uniform provided which is a long sleeve light blue shirt, blue trousers and safety shoes (Figure 11).

5.10.2 Maintenance Colleagues may enter the Production Areas wearing their uniform but must comply with the area policies on lint-free clothing, hair and beard covers, safety shoes, disposable shoe covers and jewellery.

5.11 Summary of Gowning Requirements per area

* If dedicated shoes are worn. Otherwise, shoe covers must be worn

** Hair to be contained neatly

*** Must be worn when working with autoclave, preparing or pouring media or when handling glassware.

6.0 DEFINITIONS / ACRONYMS

6.1 Definitions

Clean Zone:       

This zone consists of the airlocks, Core Area, Packaging area, all associated corridors and the Dispensary Pharmacy.

Contractors / Service Providers:

Colleagues who are contracted and approved to perform some work on site within the manufacturing facility. An example is a contractor who comes on site to fix or service machinery.

Laboratory:

Areas within either the Chemistry or Microbiology Laboratories including the laboratory bench top areas, instrument rooms and laboratory wash bays.

Laboratory – Other Areas:

Areas including the offices of the managers and supervisors/team leaders, the entrance foyer, and the mezzanine filing area.

Production Area:

This consists of the airlocks, Core Area and associated corridors, and the Packaging Area.

Visitors:

In this document, the term ‘Visitor’ is used to describe a person who does not routinely work within the production building. Examples include visitors on tours who will not be touching or interfering during the manufacturing process.

Transit Areas:

Area including the corridor between the entrance foyer and the packaging airlock change room and the downstairs offices.

Appendix: Gowning requirements demonstrations