Fausto Hernández
Director
ValidPro
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Logistics Success Through Cold Chain Management

By Miriam Bello | Wed, 10/07/2020 - 13:37

Q: What should the industry expect from COFEPRIS moving under the umbrella of the Ministry of Health?

A: Changes within the regulatory environment are relevant and have led to a complex situation. COFEPRIS is considered an international reference in regulatory matters by WHO, which puts it on the same level as the FDA, EMA or INDIMA. However, its decentralized status has recently changed with its attachment to the Ministry of Health. This change of perspective can endanger COFEPRIS’ status in the eyes of WHO due to the possibility of losing some independence related to its regulatory mandates. While it is too soon to know the extent of the impact from this move, we hope the government will allow COFEPRIS to keep its independence.

Q: How is ValidPro supporting pharmaceutical companies in light of the government’s UN medicine purchasing plan?

A: The government has violated the guidelines for the imports of such medicines. These drugs, which are already in the country, do not comply with a sanitary registration from Mexico. They can still request this but it is not the orthodox way of doing things when importing a drug. This situation could endanger the Mexican population because the safety of such medicines is not assured.

We are working with the local pharmaceutical industry, which is following COFEPRIS guidelines to comply with all usual regulatory measures and other requirements, such as good manufacturing practices and NOM-059, but it is the international companies that should be complying with these regulatory requirements.

Q: How has the pandemic impacted demand for your services?

A: Mexico is the No. 1 provider of medical devices in Latin America and one of the strongest for the US. We are constantly being approached by companies that produce medical supplies and medical devices due to our expertise. We have also noticed increased demand for our consultancy services regarding NOM-059, which applies to other services, such as management of quality control systems and process validation. These two areas ensure compliance with basic regulations regarding patient safety, including quality and product efficacy.

Another area is logistics. There has been an increase in the number of logistics operators in recent years after Mexico allowed manufacturers to sell medications directly. This drove many companies to allocate one storage building for the distribution of their products. There are three basic regulatory rules that logistics operators should comply with when dealing with medications. The first is the qualification of the storage facility to make sure it complies with the right temperature and humidity standards for keeping the product intact. The second is the implementation of quality control systems to ensure that they are keeping the product under the best conditions, as pharmaceutical products can be easily affected by temperature or light changes, which damage their efficacy. Third, for the drugs that require it, such as vaccines and insulin, companies must ensure cold chain management. This is a more complicated storage process as companies need to comply with all safety measures along the entire distribution chain, from manufacturing to the patient.

Q: As an expert in logistics for the healthcare sector, what role might ValidPro play in the distribution of a COVID-19 vaccine?

A: ValidPro is an expert in validating cold chain operations due to our work with many logistics operators. We are working to actively participation in the COVID-19 vaccine distribution process. When the vaccine arrives in Mexico, it will be taken to Liomont’s plant to be later distributed to all public institutions or even to the homes of patients, which means that the cold chain process will be extremely important in the coming months.

Q: What emerging business opportunities could the Mexican healthcare sector exploit?

A: Behind the pharmaceutical industry we have the pharma-chemical industry, which focuses on APIs. Mexico has a limited pharma-chemical industry. There are around 15 to 20 companies that produce APIs and this represents a great opportunity to ignite this industry and take advantage of our proximity to the US. The companies producing APIs in the country already distribute their products mainly to the US. API production is not a short-term goal but it is an area that is worth looking into because it is a great business opportunity for Mexico. If the country starts investing in this industry now, in five years we might be reaping the profits from that investment. In the long term, we can consolidate an industry that can attract more investment and generate quality employment. This will need to be a collaborative effort between the private sector and the government as the latter will be regulating the processes and supporting companies to make this a reality.

Q: How is ValidPro innovating its solutions portfolio?

A: We have two core businesses. The first is validation, which ensures that all corporate processes are aligned to the existing norms. The second is training, where we have an important group of professionals who help us train different sectors of the healthcare industry on relevant subjects, such as quality control systems, cold chain, sanitary measures and computer systems. All these areas require constant updating, which is why we strongly invest our time in delivering quality information and services to our clients to support their performance.

As a result of the COVID-19 pandemic, we started strengthening our presence in social media and trying to orient our services toward a global audience to reach more clients. Also, all our training has moved to digital platforms, which enables us to offer these programs to a wider audience. Now, we can approach Latin American countries with these services, as well. So far, the results from our social media strategy have been positive.

ValidPro has also built synergies with another consulting firm to grow horizontally. Our main goal with this is to improve our services and have greater capacity to offer them. Right now, our priority is to introduce our training services in Central and South America. ValidPro is also dabbling into calibration services because these are linked to validation processes. We are starting with an area focused on temperature, pressure and humidity.

 

ValidPro offers consulting, qualification, validation and training services to companies that manufacture, import, store, transport or distribute medicines for human and veterinary use

Miriam Bello Miriam Bello Journalist and Industry Analyst