What requirements must a pharmacy meet to achieve GPP certification?

Pharmacy Personnel

Pharmacy personnel are the key players responsible for advising and dispensing medications to patients. To minimize the risk of misinformation and qualifications fraud, GPP standards specify:

• Depending on the retail model (pharmacy), the pharmacist responsible for expertise must have appropriate qualifications. Specifically, a pharmacy requires a university degree pharmacist, while a drugstore requires a pharmacist with at least a secondary degree, along with a valid practice certificate as per current regulations.
• The recruitment process must ensure adequate quantity, qualifications, and practical experience relative to the size of the retail establishment. Personnel should receive initial training on GPP standards and continuously update their knowledge. Additionally, they should not have legal violations or disciplinary actions related to the pharmaceutical sector beyond a warning.

Pharmacy Facilities

Addressing the question of GPP requirements, the facilities and technical aspects are crucial.

Location and Design

• The pharmacy must be located in a fixed site with a minimum area of 10 square meters. The construction must meet general hygiene requirements, be well-ventilated, clean, and provide adequate lighting for operations. 
• Separate areas should be designated to avoid confusion: display area, storage area, and area for interacting and exchanging information about medications with customers.

Equipment Requirements

GPP standards set high requirements for medication storage, necessitating that your pharmacy is equipped with all necessary devices.

• Storage equipment must prevent adverse environmental factors such as light, humidity, pollution, and insects. Storage conditions must meet the specifications on medication labels, with room temperature below 30°C and humidity below 75%. 
• Additionally, tools and packaging used for repackaging medications must adhere to strict storage requirements. Regarding records and documentation, the pharmacy needs a system to manage medication information, pharmaceutical regulations, and other related details. Medication information should be retained for at least one year after expiration or according to other specific regulations. 

Activities in the Pharmacy

Pharmacy Operations

Pharmacies must adhere to strict procedures for purchasing, selling, and storing medications, as well as managing pharmacists during practice.

Requirements for Purchasing Medications

Pharmacies should only dispense legal medications obtained from reputable suppliers. The medications must be intact, with complete packaging, correct information, and valid expiration dates as indicated on the label.

Requirements for Selling Medications

Pharmacies must provide complete information as required by the customer and offer accurate advice to ensure effective treatment. Pharmacists should dispense medications according to prescriptions, remind patients to follow the prescription, and must not engage in unauthorized advertising or solicitation.

Requirements for Storage

Medications must be stored according to the specifications on the label. Prescription medications should be stored and displayed separately, with a sign indicating “Prescription Medications.” Special control and hazardous medications must be stored separately, ensuring safety as per regulations.

Information Storage System

Pharmacies need to have a system for storing information about complaint medications, recalled drugs, and illegal medications, ensuring effective management and regulatory compliance.

Retail Pharmacists

Pharmacy staff must wear white coats and display name tags and job titles. When interacting with customers, they should maintain a polite and courteous attitude, and ensure customer information is kept confidential. The pharmacy’s responsible manager should be present during operating hours, except in cases of force majeure, and must delegate authority in writing to a suitably licensed pharmacist if absent.

What criteria are needed to apply for a construction permit for a GPP-certified pharmacy?

To ensure that a pharmacy meets GPP (Good Pharmacy Practices) standards, the following criteria must be adhered to:

• Pharmacy Size: The minimum area of the pharmacy must be 10 square meters, ensuring sufficient space to arrange and organize medications according to high modern quality standards.
• Arrangement and Organization of Medications: The pharmacy should have adequate space for the logical and convenient arrangement of medications, making it easy to locate and retrieve them. The arrangement must follow GPP standards to ensure the quality and safety of pharmaceuticals.
• Equipment and Storage Facilities: The pharmacy must be equipped with necessary storage facilities such as refrigerators, coolers, and other storage tools as required by medication labels. This ensures that medications are kept in optimal conditions, unaffected by environmental factors like temperature and humidity.
• Signage and Brand Identification: The pharmacy’s signage must meet GPP standards, with clear content appropriate for pharmaceutical sales. The signage should reflect professionalism and attract customers, helping them easily recognize your pharmacy’s brand.
• Sales Counters and Drug Cabinets: The sales counters and drug cabinets should be appropriately sized to allow pharmacists to efficiently locate and retrieve medications for customers quickly.
• Air Conditioning and Ventilation: The pharmacy should be equipped with air conditioning, positioned to cool the entire space, creating a comfortable environment for both staff and customers. Proper ventilation is also necessary to ensure the air remains fresh and clean.
• Standards Compliance and Customer Appeal: In addition to size, arrangement, and equipment, the pharmacy should focus on creating a friendly and professional environment. This includes maintaining cleanliness, neat decoration, and providing attentive and professional customer service.

By adhering to these requirements, your pharmacy will not only meet GPP standards but also build customer trust and satisfaction, enhancing your pharmacy’s reputation and brand.

Pharmacies Can Easily Achieve GPP Standards Using SPHACY Pharmacy Services

Benefits of Using SPHACY GPP Software

• Interconnected Benefits: By using SPHACY GPP, pharmacies ensure data connectivity with the National Drug Database as required. This not only ensures legal compliance but also supports precise and rigorous data management.
• Easy GPP Compliance: SPHACY GPP provides the necessary conditions for pharmacies to achieve GPP certification—an essential requirement for legal operation and improving service quality. The software helps pharmacies efficiently complete the necessary processes.
• Time and Cost Savings: With SPHACY GPP, pharmacies can significantly save time and costs in managing daily operations. The software automates many processes, reducing workload and optimizing performance.
• Better Purchasing Rates: In addition to management support, SPHACY GPP helps pharmacies access purchasing channels with better prices, providing greater economic benefits.
• Comprehensive Consulting Support: SPHACY GPP offers legal and recruitment consulting services, ensuring that pharmacies operate within the law and have quality human resources. The experienced consulting team will assist with any related queries.

SPHACY Provides Optimal Management Solutions for Pharmacies

• Extensive and Diverse Drug Catalog: SPHACY GPP offers a comprehensive and varied drug catalog, ensuring that pharmacies have access to all products listed in the National Drug Database. This facilitates easy inventory management and effective customer service.
• User-Friendly Interface: The software is designed with a friendly, easy-to-navigate interface, allowing pharmacy staff to quickly become familiar with and perform tasks without difficulty.
• Legal Consulting and Accreditation Documentation: SPHACY GPP not only supports management but also provides legal consulting for opening a pharmacy and preparing accreditation documents. The expert team offers detailed guidance to help you navigate legal procedures smoothly.
• Integrated Pharmaceutical Reports: The software includes various pharmaceutical and pharmacy management reports, allowing pharmacies to monitor and manage key metrics in a scientific and transparent manner.
• Data Import and Bookkeeping Services: SPHACY GPP supports data import and bookkeeping services as required, ensuring accuracy and compliance with legal regulations.
• Cross-Platform System: SPHACY GPP operates on both App and Web-app platforms, allowing users to access and manage information anytime, anywhere, providing maximum convenience.
• Licensing Certificate Consulting: In addition to management, SPHACY GPP offers consulting services for licensing certificates, helping pharmacies meet professional and legal requirements in the pharmaceutical industry.

Outstanding Features of SPHACY GPP Software

• Data Import/Export for Medications and Sales Invoices: Manage medications and sales invoices efficiently. You can import and export data using common software through Excel files, ensuring quick and accurate data transfer. Additionally, the software supports exporting invoices in XML format, meeting modern management and control requirements, saving time, and enhancing work efficiency.
• Prescription Sales, Dose Combo Sales, and Retail Sales: The “Prescription Sales” feature allows you to enter prescriptions, check interactions, and store prescription history. The “Dose Combo Sales” feature helps create medication packages by dosage, improving treatment effectiveness. The “Retail Sales” feature manages individual unit sales, inventory, pricing, and promotions, providing the best service for customers.
• National Drug Database Prescription Integration: This feature allows pharmacies to input, check interactions, and store prescription history according to national standards. It ensures accuracy and safety in prescribing, helping pharmacies comply with regulations and enhance patient care quality.
• Pharmaceutical Reporting and Management Reports: Includes pharmacy management reports, quality control logs, special control medications, and business data management systems.
• Recruitment Channels and Legal Consulting for Clients: The customer support team, with high expertise, is ready to provide consulting and support on software registration procedures and pharmacy accreditation/re-accreditation.
• Pharmacy Operations Management via Software: Automates and optimizes daily pharmacy activities. From inventory management, sales, to prescription tracking and customer care, the software supports effective management and improves service quality, saving time and reducing errors.

Conclusion

To achieve GPP certification, pharmacies must adhere strictly to standards concerning facilities, personnel, management processes, and customer care. Meeting these requirements not only enhances service quality and ensures consumer safety but also builds reputation and trust with customers. Investing in GPP certification is a crucial step in establishing a pharmacy’s position in the pharmaceutical industry and contributes to improving community health standards.