Good Manufacturing Practices (GMP) are guidelines developed by the World Health Organization (WHO) to ensure the safety and quality of manufactured products. Some countries also develop their own GMP guidelines. No matter the country, however, the purpose of GMP is to establish quality control in manufacturing to minimize contamination.
When it comes to the manufacturing of pharmaceuticals, cleaning is an important part of GMP. So, pharmaceutical companies must be compliant with GMP cleaning standards.
Below, we’ll discuss what GMP cleaning is and the various standards pharmaceutical companies need to uphold to be compliant.
What is GMP?
GMP guidelines ensure the quality and safety of pharmaceutical products. These guidelines regulate product safety, risk management, quality control, and personal training in the manufacturing process.
When it comes to manufacturing pharmaceuticals, contamination or cross-contamination of certain products could be life-threatening to its users. Therefore, adhering to GMP cleaning guidelines is essential. Further, non-compliance with GMP has serious consequences in the United States.
GMP includes both cleaning and sanitation. While these may seem like the same thing, they are two different but crucial processes.
Cleaning is the use of physical or mechanical means to remove both visible and microscopic contamination. The cleaning of pharmaceutical instruments and surfaces after manufacturing a product is vital.
Effective use of cleaning agents removes contamination. These agents include things such as detergents and solvents. The use of detergents under specific conditions is necessary to avoid damage to any equipment or any subsequent products.
GMP cleaning usually starts with a visual inspection. Then, the physical or mechanical removal of contamination and thereafter cleaning validation.
Cleaning validation is an important part of the GMP cleaning process. This is the assessment of cleaning methods. By doing this, you can ascertain whether the cleaning methods and agents are effective and whether they suit the products and equipment.
Cleaning is only partially effective in preventing contamination. So, GMP requires that surfaces and equipment are also sanitized. Sanitation reduces the risk of microbiological contamination even further.
However, chemicals used to sanitize surfaces and equipment are often harsh in nature. As such, this process is often followed up with further cleaning. This is to remove the residue of any harsh chemicals that may damage equipment or compromise the safety of certain pharmaceutical products.
GMP Cleaning Standards
Often, the facilities used for manufacturing are not single-use facilities. For example, facilities may use different rooms to manufacture different products. This puts the products at a greater risk of contamination. Therefore, cleaning and sanitizing the entire facility is necessary to comply with GMP.
This entails the regular cleaning of surfaces and areas of the facility with constant human contact. Maintaining indoor air quality is another way to ensure a clean facility. Using HVAC systems can help to achieve this. Indoor air quality prevents cross-contamination as dust is unable to travel between rooms.
Cleaning of Equipment
Manufacturing equipment comes into direct contact with pharmaceutical products during the process of production. Therefore, GMP cleaning standards require strict compliance to ensure products are not compromised.
If companies do not clean equipment properly, the residue of a previous product may be present. Further, mixing two products, even where the quantities are relatively small, can lead to safety and quality issues.
Validated cleaning is essential when it comes to equipment maintenance and cleaning. Not only does it ensure that cleaning techniques and standards are effective but it also protects and promotes the longevity of the equipment.
In other words, the products used on the equipment must be well suited to it. This means that the harsh cleaning chemicals will not lead to the deterioration of the machine or its parts.
Storage of equipment post clean is a part of the process that companies often overlook. Once the equipment is clean, you must follow proper storage procedures. This prevents re-contamination of the equipment due to exposure.
Lastly, when using water to clean equipment, it is important to let it dry properly before storing it. This is because damp equipment may lead to the growth of bacteria.
Keeping clear and accurate records is key to preventing contamination and ensuring compliance with GMP cleaning standards. These cleaning records should reflect when, how, and who cleaned the equipment. Further, the records should reflect the type of cleaning agents that were used as well as the type of product that was previously in contact with the equipment.
These records also need to detail the cleaning processes to ensure that they were correct. If cross-contamination of a product does occur, consulting the cleaning records of equipment should be the first point of action. Therefore, using cleaning records is beneficial as it avoids potential uncertainty and can assist with finding a solution should cross-contamination occur.
A CIP system, or Clean-in-Place system, is a type of automated cleaning. The CIP method cleans the interior of pipes, vessels, filters, and other fittings. This method requires no major disassembly of the machine or equipment.
By minimizing the disassembly of the equipment, there is little to no downtime in the manufacturing process. Further, the nature of the automated process ensures the equipment is properly cleaned from the inside out.
Usually, a good CIP system does not require any harsh chemicals or detergents. Rather, it relies on water, kinetic energy, temperature, and time to clean effectively.
Some CIP systems do, however, require detergents and chemicals. If this is the case, using the correct cleaning agents is important to prevent damage to the machine.
Final Thoughts on GMP Cleaning Standards
Quality control in the manufacturing of pharmaceutical products is essential. Therefore, compliance with GMP cleaning standards is vital.
Practicing GMP cleaning is especially important to protect pharmaceutical products from contamination and cross-contamination. Any contamination of these products could pose safety risks to its users. So, it is crucial to prevent this from happening.
Complying with GMP cleaning standards is also legally required. Any non-compliance could have serious consequences, such as the seizure or recall of products, a fine, or even jail time. So, make sure your company is compliant with GMP cleaning standards today.