Pharmaceutical Good Distribution Practices (GDP) Certification displays your commitment to good distribution practices and quality in all aspects of your business.
Good Distribution Practices (GDP) is a quality system for pharmaceutical warehouses and distribution hubs. Pharmaceutical GDP regulations require that distributors of pharmaceutical products must comply with the regulations. From the early distribution of raw materials to production plants through the final dispatch of completed medications to the end user, the scheme ensures that consistent quality management procedures are in place throughout your whole supply chain. The most effective strategy to ensure that your quality management system corresponds with GDP advice is to have an independent audit of compliance against international GDP requirements.
SGS is a well-known leader in the pharmaceutical industry when it comes to certifications. Our highly-qualified auditors examine your procedures and policies, as well as those of your supply chain partners, during the pharmaceutical GDP certification process to guarantee that you continuously produce high-quality products as planned pharmaceutical manufacturers.
What exactly are GDP and GMP?
The ultimate goal of good distribution practice (GDP) and good manufacturing practice (GMP) is to ensure that medical devices and pharmaceutical products are safe, meet their intended use, and comply with regulations.
GMP is concerned with production procedures, whereas GDP is concerned with distribution. However, there are certain overlaps between manufacturing and distribution. What are the key distinctions between GDP and GMP?
What does GDP compliance entail?
Pharmaceutical product handlers must meet severe World Health Organization (WHO) standards for safety and security in order to receive Good Distribution Practices (GDP) accreditation. While GDP certification is not a global requirement, GDP requirements must be followed by EU pharmaceutical businesses and their logistical partners.
Who makes GDP law?
The FDA enforces GDP (Good Distribution Practices) in the United States, which are established in the Current Good Manufacturing Practices (CGMP) rule for human pharmaceuticals, which is included in Title 21 of the Code of Federal Regulations (CFR).
These regulations specify that all stakeholders in the supply chain must verify the identity, strength, quality, and purity of the medications they are responsible for manufacturing, importing, or distributing by properly controlling their activities.
Transparency and visibility are becoming increasingly important throughout complicated supply chains to guarantee that sensitive products are handled properly. In addition, the FDA is holding companies accountable for failing to properly validate their suppliers and distributors in order to comply with the regulations.
Is GDP relevant to medical devices?
The minimal requirements that a wholesale distributor must fulfill to ensure that the quality and integrity of medicines are maintained throughout the supply chain are known as good distribution practice (GDP).
- Medicines throughout the supply chain have been approved in conformity with EU legislation.
- Medicines are kept in the best possible condition at all times, especially during shipment;
- The correct products are delivered to the correct addressee in a timely manner.
In addition, the distributor should implement a tracing system and an effective recall method to enable the discovery of faulty products.
GDP also includes the sourcing, storage, and transportation of active pharmaceutical substances and other ingredients required in medicine manufacturing.
Regulatory expectations during COVID-19 pandemic
Marketing authorization holders, manufacturers, and importers of human medications can get advice on how to adjust the regulatory system to solve the COVID-19 pandemic’s issues, including GDP certifications and inspections:
- Questions and answers on regulatory expectations for pharmaceutical items for human use during the COVID-19 pandemic have been sent to stakeholders.
What is the formula for calculating GDP?
Gross domestic product (GDP) equals private consumption + gross private investment + government investment + government spending + (exports Minus imports).
GDP is usually computed using international standards by the country’s official statistical agency. GDP is calculated in the United States by the Bureau of Economic Analysis, which is part of the Commerce Department. The System of National Accounts, compiled in 1993 by the International Monetary Fund (IMF), the European Commission, and the Organization for Economic Cooperation and Development (OECD), is the international standard for estimating GDP.
What is GDP, for instance?
The Gross Domestic Product (GDP) is a metric that measures the worth of a country’s economic activities. GDP is the sum of the market values, or prices, of all final goods and services produced in an economy during a given time period. Within this seemingly basic concept, however, there are three key distinctions:
- GDP is a metric that measures the value of a country’s output in local currency.
- GDP attempts to capture all final commodities and services generated within a country, ensuring that the final monetary value of everything produced in that country is represented in the GDP.
- GDP is determined over a set time period, usually a year or quarter of a year.
Computing GDP
Let’s look at how to calculate GDP now that we know what it is. GDP is the monetary value of all the goods and services generated in an economy, as we all know. Consider Country B, which exclusively produces bananas and backrubs. In the first year, they produce 5 bananas for $1 each and 5 backrubs worth $6 each. This year’s GDP is (quantity of bananas X price of bananas) + (quantity of backrubs X price of backrubs), or (5 X $1) + (5 X $6) = $35 for the country. The equation grows longer as more commodities and services are created. For every good and service produced within the country, GDP = (quantity of A X price of A) + (quantity of B X price of B) + (quantity of whatever X price of whatever).
To compute GDP in the real world, the market values of many products and services must be calculated.
While GDP’s total output is essential, the breakdown of that output into the economy’s big structures is often just as important.
In general, macroeconomists utilize a set of categories to break down an economy into its key components; in this case, GDP is equal to the total of consumer spending, investment, government purchases, and net exports, as represented by the equation:
- The sum of household expenditures on durable commodities, nondurable items, and services is known as consumer spending, or C. Clothing, food, and health care are just a few examples.
- The sum of spending on capital equipment, inventories, and structures is referred to as investment (I).
- Machinery, unsold items, and homes are just a few examples.
- G stands for government spending, which is the total amount of money spent on products and services by all government agencies.
- Naval ships and government employee wages are two examples.
- Net exports, or NX, is the difference between foreigners’ spending on local goods and domestic residents’ expenditure on foreign goods.
- Net exports, to put it another way, is the difference between exports and imports.
GDP vs. GNP
GDP is just one technique to measure an economy’s overall output. Another technique is to calculate the Gross National Product, or GNP. As previously stated, GDP is the total value of all products and services generated in a country. GNP narrows the definition slightly: it is the total value of all goods and services generated by permanent residents of a country, regardless of where they are located. The important distinction between GDP and GNP is based on how production is counted by foreigners in a country vs nationals outside of that country. Output by foreigners within a country is counted in the GDP of that country, whereas production by nationals outside of that country is not. Production by foreigners within a country is not considered for GNP, while production by nationals from outside the country is. GNP, on the other hand, is the value of goods and services produced by citizens of a country, whereas GDP is the value of goods and services produced by a country’s citizens.
For example, in Country B (shown in ), nationals produce bananas while foreigners produce backrubs.
Figure 1 shows that Country B’s GDP in year one is (5 X $1) + (5 X $6) = $35.
Because the $30 from backrubs is added to the GNP of the immigrants’ home country, the GNP of country B is (5 X $1) = $5.
The distinction between GDP and GNP is theoretically significant, although it is rarely relevant in practice.
GDP and GNP are usually quite close together because the majority of production within a country is done by its own citizens.
Macroeconomists use GDP as a measure of a country’s total output in general.
Growth Rate of GDP
GDP is a great way to compare the economy at two different times in time. This comparison can then be used to calculate a country’s overall output growth rate.
Subtract 1 from the amount obtained by dividing the GDP for the first year by the GDP for the second year to arrive at the GDP growth rate.
This technique of calculating total output growth has an obvious flaw: both increases in the price of products produced and increases in the quantity of goods produced result in increases in GDP.
As a result, determining whether the volume of output is changing or the price of output is changing from the GDP growth rate is challenging.
Because of this constraint, an increase in GDP does not always suggest that an economy is increasing.
For example, if Country B produced 5 bananas value $1 each and 5 backrubs of $6 each in a year, the GDP would be $35.
If the price of bananas rises to $2 next year and the quantity produced remains constant, Country B’s GDP will be $40.
While the market value of Country B’s goods and services increased, the quantity of goods and services produced remained unchanged.
Because fluctuations in GDP are not always related to economic growth, this factor can make comparing GDP from one year to the next problematic.
Real GDP vs. Nominal GDP
Macroeconomists devised two types of GDP, nominal GDP and real GDP, to deal with the uncertainty inherent in GDP growth rates.
- The total worth of all produced goods and services at current prices is known as nominal GDP. This is the GDP that was discussed in the previous parts. When comparing sheer output with time rather than the value of output, nominal GDP is more informative than real GDP.
- The total worth of all produced goods and services at constant prices is known as real GDP.
- The prices used to calculate real GDP are derived from a certain base year.
- It is possible to compare economic growth from one year to the next in terms of production of goods and services rather than the market value of these products and services by leaving prices constant in the computation of real GDP.
- In this way, real GDP removes the effects of price fluctuations from year-to-year output comparisons.
Choosing a base year is the first step in computing real GDP. Use the GDP equation with year 3 numbers and year 1 prices to calculate real GDP in year 3 using year 1 as the base year. Real GDP equals (10 X $1) + (9 X $6) = $64 in this situation. The nominal GDP in year three is (10 X $2) + (9 X $6) = $74 in comparison. Because the price of bananas climbed from year one to year three, nominal GDP grew faster than actual GDP during this period.
GDP Deflator
Nominal GDP and real GDP convey various aspects of the shift when comparing GDP between years. Nominal GDP takes into account both quantity and price changes. Real GDP, on the other hand, just measures changes in quantity and is unaffected by price fluctuations. Because of this distinction, a third relevant statistic can be calculated once nominal and real GDP have been computed. The GDP deflator is the nominal GDP to real GDP ratio minus one for a particular year. The GDP deflator, in effect, shows how much of the change in GDP from a base year is due to changes in the price level.
Let’s say we want to calculate the GDP deflator for Country B in year 3 using as the base year.
To calculate the GDP deflator, we must first calculate both nominal and real GDP in year 3.
By rearranging the elements in the GDP deflator equation, nominal GDP may be calculated by multiplying real GDP and the GDP deflator.
This equation displays the distinct information provided by each of these output measures.
Changes in quantity are captured by real GDP.
Changes in the price level are captured by the GDP deflator.
Nominal GDP takes into account both price and quantity changes.
You can break down a change in GDP into its component changes in price level and change in quantities produced using nominal GDP, real GDP, and the GDP deflator.
GDP Per Capita
When describing the size and growth of a country’s economy, GDP is the single most helpful number. However, it’s crucial to think about how GDP relates to living standards. After all, a country’s economy is less essential to its residents than the level of living it delivers.
GDP per capita, calculated by dividing GDP by the population size, represents the average amount of GDP received by each individual, and hence serves as an excellent indicator of an economy’s level of life.
The value of GDP per capita is the income of a representative individual because GDP equals national income.
This figure is directly proportional to one’s standard of living.
In general, the higher a country’s GDP per capita, the higher its level of living.
Because of the differences in population between countries, GDP per capita is a more relevant indicator for measuring level of living than GDP.
If a country has a high GDP but a large population, each citizen may have a low income and so live in deplorable circumstances.
A country, on the other hand, may have a moderate GDP but a small population, resulting in a high individual income.
By comparing standard of living among countries using GDP per capita, the problem of GDP division among a country’s residents is avoided.
What does GDP training entail?
GDP illustrates that businesses value quality in all aspects of their interactions with customers and the pharmaceutical sector.
The GDP program introduces the pharmaceutical sector to Good Distribution Practices (GDP) and their role in assuring the safety of pharmaceutical products throughout transit and storage. Compliance with GDP requirements demonstrates that businesses can produce high-quality products as intended by pharmaceutical makers, thereby assisting the healthcare industry as a critical partner in the supply chain.
GDP guidance, both regulatory and legislative, has a significant impact on pharmaceutical product manufacturing. Participants will have the opportunity to share and discuss GDP guidance and experiences pertaining to the drug manufacturing business with peers and industry professionals during this workshop.
The course covers the entire pharmaceutical product supply chain for human medications, from raw material producers to completed product manufacturers, with a focus on the warehousing and distribution procedures.
- Recognize how their contribution fits into the organization’s quality structure.
- Understand how different departments work together to represent pharmaceutical product quality, safety, and efficacy as a cross-functional responsibility.
- Understand why Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) guidelines are important, and cultivate a positive attitude toward GDP in particular.
Is a higher or lower GDP preferable?
- The gross domestic product (GDP) is the total monetary worth of all products and services exchanged in a given economy.
- GDP growth signifies economic strength, whereas GDP decline indicates economic weakness.
- When GDP is derived through economic devastation, such as a car accident or a natural disaster, rather than truly productive activity, it can provide misleading information.
- By integrating more variables in the calculation, the Genuine Progress Indicator aims to enhance GDP.