Dressing the part for GMPs

During my visits to dietary-supplements manufacturing facilities, one line of questioning continually surfaces: what are the Good Manufacturing Practices (GMPs) requirements for proper dress in the manufacturing environment? What is the 'accepted norm' in the industry?

I am always amazed to see the wide variation in compliance based on how companies interpret the regulatory requirements. Some companies seem to believe that being 'GMP compliant' simply means having really nice, clean uniforms with glove and hairnet dispensers located throughout their facilities. This approach, though good, might not necessarily be required and definitely should not be the only thing on which a company focuses.

Let's take a quick look at how I think companies can 'dress the part' for GMPs: the requirements, some interesting interpretations and solutions, and ways to exceed the requirements to create a feeling that quality-control standards are being met throughout an operation.

Uniforms: Regulations do not stipulate uniforms. GMP regulations, however, do insist that individuals maintain a high level of cleanliness, especially where open product is being processed.

To uphold a specific level of cleanliness throughout their facilities, many companies choose to provide clean uniforms (some fully color co-ordinated!), smocks, or lab coats to their employees. A few companies forego the uniforms, which can be somewhat costly to supply and keep in good condition. Regardless, any clothing — uniform or not — must always be clean to satisfy safety issues in addition to GMP requirements.

From a perception standpoint, however, operations personnel donned in well-kept uniforms makes a powerful first impression on auditors or visitors.They immediately have a sense that the entire facility is also orderly and well maintained. Obviously, the opposite impact is created if a guest walks into a facility and sees individuals dressed in torn jeans, tennis shoes, or flip-flops and T-shirts.

Gloves: Always wear gloves! It is essential that anyone working in product areas wear clean gloves at all times. Companies should ensure that a good supply of clean, well-fitting gloves is constantly available to employees. They also should mandate that employees change their gloves on a regular basis.

Obviously, gloves should be replaced after visiting a restroom each time. Further, gloves should not be used for note taking or keeping track of machine settings, lot numbers or someone's phone number.

And if gloves develop tears or holes? Toss them! In addition, my opinion is that maintenance personnel are not compliant when the fingers of gloves are cut off in order to more easily handle tools and turn nuts and bolts with bare fingers.

Hairnets and face covers: Though not necessarily an evident contamination-safety issue, finding a hair in one's product is probably one of the most disturbing experiences a consumer can have. Beyond the apparent hair issue, dead skin, oils, etc., are also a contamination risk if a person's head is not covered.

Therefore, the regulatory requirements are fairly strict regarding the wearing of hairnets in all processing areas. Even if one is completely bald, a person is still obliged to wear a hairnet because it is the law. The GMPs do not provide any exceptions to this rule. For those who have hair, the hairnets must cover all of the hair. Those with extra-long hair might need to use two hairnets. In addition, any facial hair should always be hidden with a face cover regardless of the individual.

As with gloves, changing hairnets and face covers regularly is important. While visiting a customer, an operator once told me that he was saving the company money by not changing his hairnet regularly. I pointed out that the cost of a hairnet is minimal and his attempted contribution towards improving the company's bottom line, though appreciated, really wasn't benefiting the company.

In addition, manufacturing personnel working directly with product are recommended to wear long sleeves or arm covers.

Shoe covers: GMPs specifically require closed-toe shoes only. They don't stipulate shoe covers. Nevertheless, some companies do specify that their employees wear special shoes or covers on their shoes. Many facilities have specialized floor finishes that the company is trying to protect and preserve. Obviously, shoe covers should be disposed of properly after use, and should never be worn in the facility after they have been worn outside the facility.

Summary: Cleanliness is the chief criteria behind GMP regulations, and should be the prime factor driving apparel-related decisions. The appearance of the workforce influences first impressions of auditors, customers and other visitors. A well-tended look sends a vital message about the overall quality and professionalism of an entire operation.

Brian Frisby is manager of business development for the Americas for Capsugel (and a certified quality auditor). Respond: [email protected]

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