After a pharmaceutical product has been manufactured its journey is not ended. After the drug is manufactured, it is equally important to ensure that the product will continue to be of high quality, effective and safe during its storage, handling or distribution. This is where Good Distribution Practices (GDPs) become essential.
GDPs form a part of the worldwide quality assurance system and ensure that pharmaceutical products are maintained under the appropriate conditions when being stored, transported and handled, thus maintaining their integrity until they arrive at their final destination (the patient). The WHO, EMA and FDA are just three examples of international regulatory bodies that recognize the importance of GDPs.
The primary objectives of GDP are to prevent contamination or confusion between different products; degradation due to high/low temperature, humidity or light exposure; counterfeit or adulterated medicines from entering into the supply chain through errors or fraud.
GDP extends to all parties involved in the delivery of medication, such as: manufacturers, wholesalers, logistics providers and ultimately retailers.
1. Only those pharmaceuticals for which an authorized issuer has given express authority to distribute will be distributed.
2. The conditions under which pharmaceuticals will be stored and/or transported comply absolutely with the specifications governing the type of product being handled.
3. Adequate records and traceability exist.
4. The potential for counterfeit or substandard (i.e. inadequate for intended use) pharmaceuticals to enter into the supply chain is reduced.
5. The ability to effect regulatory compliance, and to execute product recalls effectively when required.
The following are the main controls which shall be utilized to assure compliance:
- Controlled temperature and humidity conditions
- A clean and segregated storage area
- Pest control and a sanitation program
- Secure systems to prevent the loss or damage to a product due to theft or tampering.
- Batch numbers
- Details surrounding the dispatch and receipt of product
- Temperature records
- Documents containing the details of any deviations from the established process and actions taken to correct them.
All records shall be organized in such a manner that they can be readily located for audits or inspections.
1. Vehicle Qualification - Vehicles must be verified for temperature control, humidity control and validated through online health checks towards their capability to operate between frozen and refrigerated temperatures.
2. Packaging - Products must be placed into insulated or refrigerated containers depending on their requirements.
3. Route Planning - A carrier who utilizes planning software to maximize the efficiency of a route will help to reduce transit time and reduce the chance of extended exposure to any external risks.
4. Monitoring Systems - The use of data loggers, temperature trackers and other methods for monitoring in real-time the temperature of the product while in transit.
5. Contingency Plans - Procedures to follow in the case of temperature excursions, vehicle breakdowns or shipment delays.
2. Complaints - Complaints received from either customers or distributors regarding product quality or the conditions of storage, will be documented and pursued to resolution through an investigation process.
3. Recalls - A recall system is available to provide a method to enable products that are considered damaged or at risk to be retracted from the marketplace. All effective recalls must complete checks to ensure that all affected batches have been properly reversed.
In addition, external auditors may also come to your facility to determine if you are meeting all of the requirements of the FDA and your Quality System.
1) World Health Organization (WHO) - Good Distribution Practices of Pharmaceuticals (Annex 5, TRS 957)
2) European Medicines Agency (EMA) - Guidelines on Good Distribution Practices for Medicinal Products for Human Use (2013/C343/01)
3) US Food & Drug Administration (FDA) Title 21 of the Code of Federal Regulations (part 803 (220-1395; part 820; and part 607 (14) Regulations Regarding Operating Procedures for Wholesale Distribution of Pharmaceuticals in the United States).
4) Central Drugs Standard Control Organization (CDSCO), India has GDP guidelines under the Drugs and Cosmetics Act
Compliance with the guidelines produced by the WHO, EMA and FDA organizations will help ensure that the quality of products complies the quality standards.
1. IoT Sensors: It offer real-time tracking of temperature/humidity.
2. Blockchain: It provides assurance of provenance and safeguards against counterfeit goods.
3. Automated Warehousing: It helps minimize human error.
4. Data Analytics: It can analyze trends to anticipate distribution risks.
Digital transformation is driving the logistics sector’s evolution within the pharmaceutical industry to facilitate secure, transparent pharmaceutical distribution.
- Prevention of product recalls and regulatory penalties
- Building trust between health care providers/patients
- Improved efficiency and transparency within the supply chain
- Supporting global trade through harmonization of quality standards
Maintaining pharmaceutical product quality, safety and efficacy during the storage and distribution process requires following the Good Distribution Practices (GDP). Ensuring GDP compliance requires the increased attention of all parties involved (manufacturers, distributors, etc.).
All GDP principles must be incorporated into the daily operations because consequences of failing to comply with them negatively affect public health, result in sanctions imposed by government agencies and can destroy patient trust within the pharma industry. As the complexity of global supply chains continues to grow, the need for reliable and effective distribution systems will continue to be a priority.
What is Good Distribution Practice (GDP)?
Good Distribution Practices are a set of quality standards for the warehousing and movement of pharmaceutical products. The purpose of GDP is to provide assurance that a product will retain its quality and its identity during the distribution process from the manufacturer to the end-user.The primary objectives of GDP are to prevent contamination or confusion between different products; degradation due to high/low temperature, humidity or light exposure; counterfeit or adulterated medicines from entering into the supply chain through errors or fraud.
GDP extends to all parties involved in the delivery of medication, such as: manufacturers, wholesalers, logistics providers and ultimately retailers.
Objectives of GDP in Pharmaceuticals
Good Distribution Practices provide assurances that:1. Only those pharmaceuticals for which an authorized issuer has given express authority to distribute will be distributed.
2. The conditions under which pharmaceuticals will be stored and/or transported comply absolutely with the specifications governing the type of product being handled.
3. Adequate records and traceability exist.
4. The potential for counterfeit or substandard (i.e. inadequate for intended use) pharmaceuticals to enter into the supply chain is reduced.
5. The ability to effect regulatory compliance, and to execute product recalls effectively when required.
Key Principles of Good Distribution Practices
Good Distribution Practices are established on a few cornerstone principles which define how the distribution of products shall be undertaken.1. Quality Management System
The distribution of products must be supervised by a Quality Management System (QMS). The QMS should establish roles, responsibilities and procedures that will assure that product quality is maintained at all times.2. Competence of Personnel
In order to meet Good Distribution Practice, it is important that all personnel who will come into contact with the product during its handling, storage and transportation have been trained and are appropriately qualified. All persons who handle, store, and transport products shall have a complete understanding of Good Distribution Practice as well as hygienic requirements and proper documentation.3. Premises and Equipment
Distribution centres, warehouses and distribution vehicles shall be constructed and maintained in a manner that provides protection to the pharmaceutical product from damage due to the environment and/or from physical damage.The following are the main controls which shall be utilized to assure compliance:
- Controlled temperature and humidity conditions
- A clean and segregated storage area
- Pest control and a sanitation program
- Secure systems to prevent the loss or damage to a product due to theft or tampering.
4. Documentation
Record keeping is essential for the traceability and accountability of the pharmaceutical product. The records must contain the following information:- Batch numbers
- Details surrounding the dispatch and receipt of product
- Temperature records
- Documents containing the details of any deviations from the established process and actions taken to correct them.
All records shall be organized in such a manner that they can be readily located for audits or inspections.
5. Storage Conditions
The storage conditions of all pharmaceutical products should be in line with the manufacturer's recommendations for that specific product. Both vaccines and biologic medications are considered temperature-sensitive medications and are required to be managed with a "cold chain," and should have a method of continual monitoring and alarm for deviations.6. Transportation
The method of transportation should be done in an environmentally controllable manner to protect the integrity of the product. Vehicles should be qualified by the manufacturer for temperature mapping, and data logging devices should be used to log the actual conditions throughout the time of transit.GDP Requirements During Storage and Handling
The requirements for good distribution practice (GDP) during storage and handling include:1. Temperature Control
The storage and transport of all temperature-sensitive products must occur within a specified range (for example, 2–8°C or 15–25°C). All excursions from the required temperature will be investigated, documented, and evaluated for the potential effect on the quality of the products.2. Product Segregation
To avoid confusion and contamination, products should be segregated by the following:- Returned goods
- Damaged/expired products
- Quarantined/released stock
- Counterfeit/recalled products
3. Cleaning & Sanitation
Regular cleaning schedules will help reduce contamination. Validation and documentation of cleaning agents and procedures must be performed.4. Stock Rotation
Stock rotation will occur using FEFO (First Expiry, First Out) or FIFO (First In, First Out) principles to minimize waste and to prevent the distribution of expired stock.5. Security Measures
Access to the pharmaceutical storage areas must be restricted to authorized individuals. The use of security systems and surveillance will be used to prevent the theft/diversion of controlled substances.GDP Requirements During Transportation
Transportation is usually a very vulnerable phase of distribution, however GDP provides mechanisms to preserve the integrity of the products during shipping, for example:1. Vehicle Qualification - Vehicles must be verified for temperature control, humidity control and validated through online health checks towards their capability to operate between frozen and refrigerated temperatures.
2. Packaging - Products must be placed into insulated or refrigerated containers depending on their requirements.
3. Route Planning - A carrier who utilizes planning software to maximize the efficiency of a route will help to reduce transit time and reduce the chance of extended exposure to any external risks.
4. Monitoring Systems - The use of data loggers, temperature trackers and other methods for monitoring in real-time the temperature of the product while in transit.
5. Contingency Plans - Procedures to follow in the case of temperature excursions, vehicle breakdowns or shipment delays.
Handling Returns, Complaints and Recalls
1. Returns - Returned goods will be examined for signs of tampering, to see whether there are any signs of temperature excursions, and to ensure that the product is authentic. Only products that will pass quality control and meet the specified requirements may be re-sold.2. Complaints - Complaints received from either customers or distributors regarding product quality or the conditions of storage, will be documented and pursued to resolution through an investigation process.
3. Recalls - A recall system is available to provide a method to enable products that are considered damaged or at risk to be retracted from the marketplace. All effective recalls must complete checks to ensure that all affected batches have been properly reversed.
Audits and Self-Inspections
To ensure compliance with the Good Distribution Practice (GDP), regular internal or self-audits and checking must be conducted. They can help you find opportunities for improvement and discover any weaknesses that may exist in your operations.In addition, external auditors may also come to your facility to determine if you are meeting all of the requirements of the FDA and your Quality System.
Regulatory Framework for GDP
All major international organizations have published GDP:1) World Health Organization (WHO) - Good Distribution Practices of Pharmaceuticals (Annex 5, TRS 957)
2) European Medicines Agency (EMA) - Guidelines on Good Distribution Practices for Medicinal Products for Human Use (2013/C343/01)
3) US Food & Drug Administration (FDA) Title 21 of the Code of Federal Regulations (part 803 (220-1395; part 820; and part 607 (14) Regulations Regarding Operating Procedures for Wholesale Distribution of Pharmaceuticals in the United States).
4) Central Drugs Standard Control Organization (CDSCO), India has GDP guidelines under the Drugs and Cosmetics Act
Compliance with the guidelines produced by the WHO, EMA and FDA organizations will help ensure that the quality of products complies the quality standards.
Role of Technology in GDP Compliance
Today’s modern technological advancements enable better GDP execution through the following:1. IoT Sensors: It offer real-time tracking of temperature/humidity.
2. Blockchain: It provides assurance of provenance and safeguards against counterfeit goods.
3. Automated Warehousing: It helps minimize human error.
4. Data Analytics: It can analyze trends to anticipate distribution risks.
Digital transformation is driving the logistics sector’s evolution within the pharmaceutical industry to facilitate secure, transparent pharmaceutical distribution.
Importance of GDP Compliance
The ability of good distribution practice (GDP) compliance to safeguard patients is mainly based on its ability to guarantee that the pharmaceutical products they receive are safe and effective. Additionally, GDP compliance provides other benefits, including:- Prevention of product recalls and regulatory penalties
- Building trust between health care providers/patients
- Improved efficiency and transparency within the supply chain
- Supporting global trade through harmonization of quality standards
Maintaining pharmaceutical product quality, safety and efficacy during the storage and distribution process requires following the Good Distribution Practices (GDP). Ensuring GDP compliance requires the increased attention of all parties involved (manufacturers, distributors, etc.).
All GDP principles must be incorporated into the daily operations because consequences of failing to comply with them negatively affect public health, result in sanctions imposed by government agencies and can destroy patient trust within the pharma industry. As the complexity of global supply chains continues to grow, the need for reliable and effective distribution systems will continue to be a priority.
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