How Gowning Practices Provide Clues to cGMP Compliance in Pharmaceuticals

A contamination-free workplace is critical for a pharmaceutical company to produce a quality product and ensure the safety of its patients. Many factors such as sophisticated equipment, cleanroom design and advanced technology contribute to the assurance of producing or developing a safe product, but one of the most visible and telling evidence of compliance is the means by which their employees gown themselves.

Gowning is not merely putting on protective clothing; gowning represents a commitment of the company to produce a quality product, discipline in producing a compliant product and adherence to regulatory standards. By observing how a company's employees gown themselves, conduct themselves and maintain hygiene in controlled areas of the facility, one can determine if that facility truly operates in accordance with current Good Manufacturing Practices.

Regulatory authorities, such as the U.S. Food and Drug Administration (FDA) and World Health Organization (WHO), often use an assessment of a facility's gowning practices during inspections as one of the major indicators of compliance culture.

The Importance of Gowning Procedures in the Pharma Industry

The majority of contaminated areas in the pharmaceutical production facility are due to workers; human beings bring skin flakes, hair, microorganisms and bacteria and even air emissions to cleanrooms

Gowning is a protection layer that exists between the operator and the product; it acts to keep the product protected while ensuring the operator is maintaining his or her environmental control.
Correct gowning methodology allows for:
1. Protection of the product from microbial or particle contamination
2. Maintenance of cleanroom classification standards
3. Compliance with regulatory requirements
4. Patient safety and health
Conversely, if a worker's gowning methodology does not follow the requirements above, that will result in contaminated products, batch rejections and/or finding during regulatory inspections or audits.

Gowning as an Indicator of cGMP Compliance

Gowning procedures are frequently reviewed during inspections or audits, as they provide immediate evidence of a manufacturer's quality culture and training program.

The presence of well-trained staff, or individuals who are performing this procedure properly, to observe the following company characteristics:
1. Strong training program
2. Implementation of standard operating procedures
3. Management commitment to quality
4. Awareness of microbiological contamination
Conversely, non-compliance with gowning procedures indicates a weak quality system and compliance gap.

Key Elements of Proper Gowning Practices

1. Structured Gowning Procedures

To be compliant, a pharmaceutical facility must have clearly defined procedure for gowning.
The procedure will typically include the following:

• To provide step by step instructions on how to gown correctly
• To identify proper gowning sequence
• To outline the gowning requirements for specific areas (i.e., Grade A, B, C, D)
• To emphasize appropriate removal of and disposal of gowns from areas of use.

Personnel should consistently follow gowning procedure in accordance with the company’s standard procedures to avoid contamination. Deviation from standard procedure is a clear indication of non-compliance.

2. Use of Appropriate Gowning Materials

All materials used for gowning must be appropriate for use in a clean room.
Gowning materials/items most frequently used include:

• Coveralls/gowns
• Head covers
• Face masks
• Gloves
• Shoe covers/boots

Materials must be:

• Non-shedding
• Sterile (in aseptic areas)
• Comfortable and provide appropriate fit

Using materials that are incorrect or out of conformance are strong indicators of lacking GMP practices.

3. Proper Gowning Sequence

The order of various elements found in procedures for gowning is critical to ensuring that contamination does not occur. Common gowning sequences consist of:

• Hand washing/cleaning/hygiene processes
• Wearing hair cover and beard cover
• Donning of garment (either coverall or gown)
• Wearing of gloves and shoe covers
• Final cleaning/sanitation process prior to entering clean room

Personnel who do not follow all steps or complete them in the correct order create a greater risk to contamination and are indicators of poor compliance.

4. Personnel Hygiene and Behavior

Gowning by itself is not enough, as the behavior of the personnel is equally as important.
Practices that promote good behavior include:

• Proper hand hygiene
• Not touching non-sterile surfaces
• Limited movement inside of the cleanrooms
• No jewellery/cosmetics/personal items

Moving garments or consistently touching surfaces are signs of improper behavior which indicates that personnel have been inadequately trained, as well as that there is a culture of poor compliance.

5. Training and Qualification

All personnel must receive training and qualification in the gowning procedures before entering controlled areas. The training program must contain the following:

• Theoretical education on contamination control
• Demonstration of gowning techniques and processes
• Periodic requalification sessions

Gowning qualification tests are also frequently conducted by facilities, including microbiological monitoring of personnel after gowning procedures. Personnel who have not been trained properly are one of the highest risk factors for causing contamination.

6. Gowning Integrity & Maintenance

The condition of gowning material is a reflection of compliance.
The proper practices for maintaining gowning material will be as follows:

• Regularly inspecting garments for damages
• Properly laundering and sterilizing of garments
• Storing garments in a controlled manner
• Establishing reuse limits (if applicable)

Garments that are damaged or have not been maintained properly may allow contamination to occur in the cleanroom.

7. Cleanroom Entry and Exit Procedures

The ability to control the cleanroom's environmental conditions will also depend upon proper procedures for entering and exiting the cleanroom. When entry and exit procedures are adhered to, this is one method for maintaining an environment free from contamination.
Examples of Controlled Entry and Exit Procedures:

• Use of airlocks and changing rooms
• Defined Personnel Flow
• Separation of Clean and Dirty Areas

If the established entry and exit procedures are not adhered to, this will allow for possible cross-contamination and show a poor level of compliance with Good Manufacturing Practices (GMPs).

8. Monitoring and Verification

Monitoring and verification of gowning procedures are necessary to evaluate how effective gowning procedures are to controlling contamination.
Examples of Ways to Monitor Gowning Procedures:

• Surface Monitoring of Gowns
• Personal Monitoring (Finger Dabs, Contact Plates)
• Airborne Microbial Testing

Evaluating monitoring results will demonstrate whether or not gowning procedures are successful in controlling contamination. Ongoing failures in monitoring results may demonstrate that gowning practices are flawed.

Regulatory Guidelines Gowning Practices

Regulatory guidelines outline the supporting evidence for employee hygiene and gowning as part of contamination controls.

For example, the European Union Good Manufacturing Practice Annex 1 outlines extensive requirements for (the gowning of personnel wearing clothing that protects them from contact with sterile products). In addition, during inspections by FDA field inspectors, gowning areas are typically assessed for:

• Adherence to gowning policy
• Compliance to employee discipline
• Compliance to Cleanroom Behavior protocols
• Overall quality culture

Since gowning is visually apparent upon the first inspection of an area, gowning practices are typically one of the first item to be assessed for compliance during the inspection process.

Common Gowning Mistakes Indicating Non-Compliance

Common gowning errors that could indicate non-compliance issues include:

• Gowning sequence error
• Touching of outer surface of sterile garments
• Wearing of improperly fitted/damaged garments
• Inadequate hand hygiene
• Failure to ensure monitored/supervised gowning practice

Regulatory inspectors will often identify these events, resulting in increased risk of contamination and concern during the regulatory inspection process.

Role of Gowning in Contamination Control Strategy

Gowning is a critical component of the overall Contamination Control Strategy (CCS) as it relates to the production of pharmaceutical products. An overall effective CCS should include:

• Design of Facilities
• Environmental Monitoring
• Cleaning / Disinfecting

Gowning the integration of all four elements provides a secure and controlled pharmaceutical manufacturing environment.

Building a Culture of Compliance Through Gowning

Gowning practices say something about employees and their organization. The culture of compliance within your organization will help ensure:

• Employees value the importance of them
• Gowning Procedures are consistently followed
• Thousands of gowns that were used incorrectly are reported and addressed
• Continuous improvement occurs as a result of a culture of compliance

Management supports a culture of compliance with training, supervision and accountability.

In the pharmaceutical industry, gowning is more than just another activity; it is measurable and a visible sign of compliance with current Good Manufacturing Practices (cGMP).

Gowning is important for several reasons; it protects products from contamination, helps ensure the company is compliant with regulations and protects the safety of patients. Gowning also serves as a reflection of the quality culture of an organization.

Through an effective implementation of structure, training of personnel and ongoing monitoring of gowning practices, pharmaceutical companies need to implement comprehensive contamination control programs and continually establish quality standards.

The degree to which an organization grooms personnel gives insight into how well the organization complies with GMP – making gowning a significant indicator of operational excellence.

Frequently Asked Questions (FAQs) on Gowning Practices

Q1. What is gowning in pharmaceuticals?

Answer: The process of gowning (the technique of putting on clothing that protects against contamination) is very important to the pharmaceutical industry because it helps prevent contamination in clean rooms.

Q2. Why is gowning important in GMP?

Answer: The Gowning procedure is important in Good Manufacturing Practices (GMP) because it helps minimize contamination and also helps to confirm the quality and safety of a product.

Q3. What are common gowning components?

Answer: Common components of gowning include coveralls, gloves, masks, head/cap covers & shoe covers.

Q4. What is gowning qualification?

Answer: Gowning qualifications refer to the evaluation of whether personnel can put on a gown properly and not contribute to contamination in their environment

Q5. Which guidelines cover gowning practices?

Answer: Gowning practices are covered under current Good Manufacturing Practices (cGMP) and EU GMP Annex 1.

Q6. What are common gowning errors?

Answer: Common gowning procedures errors; skipping steps, touching sterile surfaces and poor personal hygiene practices.

Q7. How is gowning effectiveness monitored?

Answer: Monitoring of gowning effectiveness can be done by both microbial testing and environmental monitoring.

Q8. Can poor gowning lead to regulatory issues?

Answer: Yes, poor gowning can lead to regulatory issues, which can lead to contamination and issues being documented in inspection observations.

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