Local Storage Best Practices: What are BPA certifications?

 Manufacturing and marketing medicines are very dedicated tasks that only the best factories and drugstores in the medical field can perform. However, their supervision would not be possible without a certified manual: the Good Storage Practices (BPA for its acronym in Spanish). But what are the local storage best practices? This is a question that many manufacturers regularly ask themselves, and which SCR Consultants will answer as part of its corporate mission: to offer comprehensive solutions to companies.

What Are BPA Certifications?

The Good Storage Practices Manual is a set of standards that establishes the requirements and operating procedures to be followed by establishments that import, distribute and dispense pharmaceutical or related products. This, to guarantee the maintenance of optimal conditions and characteristics during the storage of drugs; thus becoming after the sanitary permits granted by the General Directorate of Medicines, Supplies and Drugs (DIGEMID), fundamental to guarantee the health of the final public. 

However, they are often compared to GMP (Good Manufacturing Practices) certifications when in reality they are applied in very different contexts. Just to give a quick review, while the local storage best practices are concerned with ensuring that health institutions know which companies are complying with all their obligations and standards, the latter check that their production is carried out under optimum conditions. In other words, one reviews the work environment and the other the process itself. 

Storage regulated by DIGEMID

In Peru, the entity in charge of supervising that pharmaceutical warehouses and factories comply with these standards is the General Directorate of Medicines, Supplies and Drugs (DIGEMID for its acronym in Spanish), while the National Center for the Supply of Strategic Health Resources (CENARES) grants official certificates under license from the Ministry of Health (MINSA). To achieve this, they must demonstrate that the drugs they produce, regardless of whether they are local or foreign, meet the highest standards of quality, safety and effectiveness. 

Good Practice Manual

According to the official document entitled «Good Storage Practices» shared by MINSA, there are a series of requirements that warehouses must comply with in order to have access to the GHP certificate, such as having information on the size of the area and accesses for both entry and exit. SCR Consultants will give you a brief summary of the most important points of local storage best practices:

1. Quality Assurance System. This is where the control of pharmaceutical products and medical devices is carried out. Each company is obliged to prepare a quality manual to guarantee the correct compliance of all processes, describing actions in risk management, process validations and qualification of equipment and personnel.
2. Personnel. With the quality manual, the Technical Director of the operation must be responsible for its compliance with the appropriate number of personnel (taking into account factors such as experience to be hired). 
3. Facilities, Equipment and Instruments. The premises must have an appropriate infrastructure and instruments that guarantee the proper storage of medicines. They should also have a space reserved for the administrative office, regardless of whether they are drugstores or warehouses. 
4. Documentation. These are documents that are legible and understandable to the general public, ranging from technical data sheets for the distribution of storage areas to diagrams for product registration. On the part of the personnel, they must have knowledge of everything related to their area of work. 
5. Claims. One of the most important points is that it gives the public the power to access mechanisms that facilitate the presentation of their complaints in case they are not satisfied with their work. And although it may sound contradictory, it is necessary to make the owners take corrective actions and solve their shortcomings.

Get your BPA certificate with SCR Consultores 

With more than 10 years of work in the Peruvian and Bolivian market, SCR Consultores offers you guarantee and experience in quality management for your company to be certified with the local storage best practices. Do not complicate yourself by looking for legal bases or requirements that demand greater investment of time and money. We have extensive experience in conducting audits and advisory services related to the certification, recertification or sanitary authorization of pharmaceutical establishments. 

Our experience includes the following services:

Integral audits of the supply chain.

Advice on implementation and certification of Good Storage Practices for Medical Devices, Pharmaceutical and Sanitary Products.  

Advices and certifications of Good Distribution and Transportation Practices for Medical Devices, Pharmaceuticals and Medical Devices. 

Advice for certification in Good Manufacturing Practices for Pharmaceutical Products.

Advisory services and audits for the start-up or restart of activities, expansion of warehouses and transfer of storage processes of pharmaceutical establishments.

Outsourcing of the quality assurance area of pharmaceutical establishments.

Contact Us

With almost 10 years of uninterrupted work in Peru, we have the best experienced specialists in regulatory project management. Learn more about local storage best practices by Clicking Here. You can also inquire about the rest of our services by calling (511) 711-9070 or by sending us an email to jludena@scrconsultores.com.pe. We are located at Calle Río de la Plata N ° 305 – 315, San Isidro. Lima, Perú. SCR Consultores, guiding the path of the national industry. We are waiting for you!