How to Avoid Contamination Issues with the Help of GMP Audit?

What is contamination, and how can to prevent contamination during a GMP audit in your manufacturing unit? And the role of GMP certification in preventing contamination in any production unit.

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During the manufacturing process, any types of impurities or substances that can be added to your products related to food and pharmaceutical products are known as contaminants. Mainly, those foreign substances that can compromise product quality, safety, and efficacy, whether it is physical, chemical, or biological elements. The issue of GMP audit to prevent contamination arises in a manufacturing unit due to poor hygiene and poor training of workers. Also, due to bad cleaning of equipment, using contaminated raw materials, and a poorly designed manufacturing environment.

In that case, the contamination control plan for GMP compliance ensures that there is no issue of contamination found in any production unit. For which the certification body conducts some audits and inspections, in terms of ensuring that there are no bad elements mixed in any product. Always make sure that your manufacturing unit has a clean and hygienic environment, so that if any authority conducts an audit or inspection in your unit, any contamination issues are not found in your production unit. 

1. GMP Audit Contamination Issue: Types and Causes

There are some types of GMP audits to prevent contamination issues found in a production unit, which can be physical, chemical, biological, and cross-contamination. Preventing them becomes an important part, mainly for the food and pharma industries, because these sectors are known to be very sensitive, due to which preventing them from any foreign substance becomes an important part for any authority. And there are some common causes due to which these contaminations take root in a facility.

Type of contamination:

1. Physical – This type of contamination includes those particles that are present in the form of physical, like dust, dirt, fibers, hair, or metal shavings. These are found in high amounts in any unit.
2. Chemical – This includes those substances that are present in the form of lubricants, cleaning agents, moisture, or gases found in any manufacturing unit.
3. Biological – This includes those substances which present in the form of microbiotics, such as bacteria, viruses, fungi, yeast, and spores.
4. Cross-contamination – usually as a result of poor cleaning or improper segregation, when a product becomes contaminated by another product or waste from an earlier batch.

Common causes

1. Due to workers – Due to having poor hygiene, not properly providing training to your employees or workers, and using tools improperly can promote contamination.
2. Equipment – If your old batch has some GMP audit to prevent contamination, then there is are high chance that it will also affect new batches in your production unit if the equipment is not cleaned properly between uses.
3. With raw materials – Sometimes, impure substances can transfer from raw materials, such as microbial contamination or pest infestation can cause serious contamination.
4. Due to the environment – Air, surfaces, and water can also cause contamination because many types of impure substances are also transferred from air and water. Due to having a poorly designed manufacturing unit.
5. From the process – The danger of contamination can be increased by improper facility design, poor cleaning and maintenance, labeling, and improper regulation.

2. The Role of GMP Certification in Preventing Impurities

These contaminations become a major problem for many manufacturers and businessmen, as well as for the health and well-being of many consumers and buyers. In that case, the guidelines of hygiene protocols for GMP inspections play their role in preventing those in any production unit. GMP mandates strict quality control, hygiene, and process standards during the time of production, due to which any bad substance doesn’t enter the products.

There is the main role of GMP certification for prevent contamination because the certification bodies of GMP also ensure cleanliness and well-designed facilities, proper equipment calibration, personnel hygiene protocols, and validated manufacturing processes in terms of reducing many potent substances from entering the production unit.

Ensures the Facility and equipment

1. Design of unit –  GMP certificate apply online ensures that any facility is designed to promote cleanliness, with features like easy-to-clean floors, walls, and ceilings, and proper ventilation, which stops dust and bad particles from entering.
2. Separate areas – The guidelines of GMP say that there must be enough space required for different stages of production and storage in any facility.
3. Maintaining tools – Good Manufacturing Practices mandates calibrated, maintained, and properly storation of equipment which are used in any production process, to prevent bad substances that come with unhygienic equipment.
4. Manages your waste – To avoid contamination and pests, proper waste management and disposal systems are necessary in any unit, according to says guidelines of GMP.

Train your personnel in hygiene

1. Training under hygiene – All of your employees and workers must be trained under the strict guidelines of GMP and are prohibited from eating, drinking, or smoking in production areas.
2. Clean clothes – GMP says that for maintaining hygiene in a manufacturing unit, the workers also wear proper and clean clothes to prevent contamination from garments.
3. Prevented items – The workers are not allowed to bring some restricted items, like cell phones, pens, and other potential contaminants that cause contamination in a unit.

Controlling Process and Quality

1. Simplifying process – The manufacturing unit is to be defined, validated, and documented, which brings consistency and reliability in a unit.
2. Quality control – Throughout the production process, strict quality control is implemented, which includes inspecting each batch for standards, safety, and quality.
3. Raw material – Raw materials are to be controlled properly, including ensuring no harmful substances are present.
4. Montering – GMP guidelines say that the procedures of the manufacturing unit are regularly reviewed and monitored to identify and mitigate risks, to make sure that all things are working properly.

3. Which Sectors Have a High Risk of Contamination?

Mainly, all industries have a risk of contamination, but there are some sensitive industries in which GMP audit to prevent contamination becomes an important part. Those sectors are Food and beverage, Pharmaceuticals, Healthcare, and Biotechnology. These industries are directly related to the health and well-being of many consumers and buyers. Due to ensuring safety in this sector is compulsory.

1. Food and beverage – The Food and beverage industries have always had a risk of contamination related to biological, chemical, and physical agents in their production units. This leads to recalls, financial loss, and severe foodborne illnesses.
2. Pharmaceuticals – This sector is related to medicines and medical devices, which is why contamination becomes a major risk that can compromise the medication’s safety and efficacy.
3. Healthcare industry – This includes health-related products, due to which having contaminations in those products can lead to healthcare-associated infections and a serious threat to patient safety.
4. Biotechnology – Having contamination related to the biotechnology industry can affect research, product development, and manufacturing of biotech items. That’s why maintaining a proper, controlled environment is essential to protect against contamination from microorganisms and other particulates.

4. Avoid Contamination Risks with LegalRaasta’s GMP Service!

Building a business takes time, and you shouldn’t have to do it alone. At LegalRaasta, we provide founders, manufacturers, and startups with real, hands-on support. Our team includes everything as we are GMP certified, providing Virtual CFO services along with company registration, LLP, and NBFC formation, among other things. We are not just handing over papers; we help you understand your numbers and operate better. With LegalRaasta, you get practical expertise and efficient processes and a partner who is invested in your long-term growth. So, provide your legal and compliance work to us while you focus on what matters, taking your business to a new level.