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 criteria demonstrates that businesses can produce high-quality products as intended by pharmaceutical makers, hence assisting the healthcare sector as a critical partner in the healthcare 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.
At the end of the training participants will be able to:
- 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.
What exactly is GDP certification?
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.
Is GDP certification required?
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.
What is the distinction between GDP and GMP, and which is the better major of income?
If you’d like a copy of the current GDP guidelines, you can find them here GDP Guidelines. The primary distinction between GDP and GMP is that GDP refers to the wholesale distribution of medications, whereas GMP refers to their production.
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?
Why is GDP essential in the pharmaceutical industry?
From the early distribution of raw materials to the manufacturing plants through the final dispatch of completed pharmaceuticals to the end user, this scheme ensures that consistent quality management procedures are in place throughout your whole supply chain. Good Distribution Practices (GDP) is a quality standard for pharmaceutical warehouses and distribution centers. Pharmaceutical GDP regulations require that distributors of pharmaceutical products must comply with the regulations.
The Indian government has issued a consolidated paper on good distribution practices (GDP) for pharmaceutical products through the Central Drugs Standards Control Organization (CDSCO) to ensure the quality and identity of pharmaceutical products throughout the distribution process, including procurement, purchasing, storage, distribution, transportation, documentation, and record-keeping practices.
What does GDP inspection entail?
Good Distribution Practices (GDP) is a component of Quality Assurance that guarantees product quality is maintained via proper control of the many activities that occur during the distribution process.
GDP must be implemented in all pharmaceutical facilities in order to ensure that medicines that reach consumers meet the manufacturer’s quality, safety, and efficacy criteria at the time of release. Since this is a legal requirement, the TMDA performs GDP inspections for all facilities that manufacture, stock, or distribute medications, with the goal of ensuring that GDP criteria are followed.
The TMDA urges all owners of pharmaceuticals facilities to study the Guidelines carefully because they provide as a guide for inspectors when determining whether or not a facility complies with GDP criteria. Apart from compliance, property owners may gain from its adoption by being able to provide high-quality services and products to their clients, thereby meeting their needs. Businesses and service providers can get a competitive advantage by providing high-quality services and goods.
Due to the differences in the supply chains between the private and public sectors (MSD, Hospitals, Health Centers, and Dispensaries), GDP needs for the public sector may differ slightly from those specified on this website.
What is a GDP storage facility?
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 does GDP mean in the supply chain?
This isn’t merely a pedagogical exercise. The supply chain intersects with GDP computation in a number of ways. Changes in inventory levels are one of them, and they have a significant impact on GDP. FedEx, UPS, and a slew of other companies use their own unique estimations of GDP over time to determine how much they should invest in distribution centers, vehicles, and planes. Estimates of GDP growth also have an impact on many companies’ mid- and long-term demand plans, which has a direct impact on supply chain decisions.
Increases in supply chain investment in people, space, equipment, and other factors are frequently linked to increases in volumes, which are in turn linked to economic growth (even if there are always exceptions such as Amazon, and of course market share is always being won or lost by individual companies). Many businesses are expanding abroad in part because GDP growth in China, India, and other developing economies has outpaced that of established economies.
Furthermore, many analysts believe it will only take a few quarters of robust (3 percent+) GDP growth in the US to trigger major transportation capacity concerns, particularly in the truckload industry. I believe the prognosis is correct, but it will never be realized since we are unable to sustain two consecutive quarters of great growth.
So, what exactly is GDP? Let me begin by saying that, as is customary, attempting to obtain clear, reasonable answers to questions about what GDP is and how it is measured is a tiresome exercise. That is one of the reasons I am writing this column: to (hopefully) bring some clarity to everyone.
GDP is a metric that measures the value of goods and services generated by a country over a period of time. The United States has one method, which is mainly reliant on spending figures from businesses, consumers, and the government, rather than (yet) the measure of output. Other countries take comparable but not identical tactics, making direct comparisons between them difficult. China, for example, never appears to have a GDP below its declared goal levels.
Another important distinction is between “nominal” and “real” GDP. Current prices are used to calculate nominal GDP. As a result, nominal GDP may appear to be rapidly increasing during periods of high inflation. However, real GDP is nominal GDP multiplied by an inflation component to better reflect true output growth. But, as I’ll show later, that inflation component is not without disagreement.
There are a variety of methods for calculating a country’s overall output, it turns out. The official method for calculating GDP in the United States, which is calculated by the Bureau of Economic Analysis, a branch of the Commerce Department, is as follows:
Oh, if only it were that easy. However, there are a series of “accounts” within each of these categories, particularly the private consumption figure.
You may have heard, as I have, that consumer spending accounts for two-thirds, 70 percent, or something like that of the economy.
That is, in fact, a little misleading.
For example, under the private consumption category, what we would consider consumer expenditure in a broad sense food, vehicles, flat-screen televisions, and the like now only accounts for roughly 40% of the US economy at any given time.
So, why do we keep hearing about the 70% figure? Because that is essentially the private consumption account’s proportion of GDP, but the private consumption category includes a variety of other items in addition to what we may term genuine consumer spending. This includes, for example, the vast majority of health-care expenditures, such as Medicare payments, insurance payments from company coverage, and so on. It also contains “imputed services,” which, believe it or not, assigns a monetary value to people who take care of their homes, get free checking from their bank, and other “output” for which no money is exchanged.
There’s also additional strange stuff in the private consumption statistic that’s too complicated to explain here. However, real consumer spending accounts for roughly 40% of GDP, not 70%.
The government component is the total of the government’s final goods and services expenditures. It covers public employee salaries, military weapon purchases, and any investment expenditures made by a government. Transfer payments, such as social security or unemployment benefits, are not included.
Investment refers to a company’s capital expenditures, which can range from machines and buildings to software and even inventories.
Net exports are calculated by subtracting imports from total exports. This would be a positive number in China. It is a negative figure in the United States, which has never-ending trade deficits.
There are a few supply chain links that are clear. We know that most US corporations have large cash reserves, much of which is held offshore, and that they are not increasing their investments in facilities, equipment, technology, and other areas.
The lack of investment is undoubtedly a contributing reason to the slow GDP growth. Strong company investment, for example, was a major driver of rapid economic growth in the 1980s.
When you’re a good supply chain management and you reduce your inventory levels, you’re also lowering GDP. As a result, when inventory levels fell in 2009, it contributed to a drop in GDP growth (which, of course, turned negative for a time) on top of the enormous hit from lower consumer spending. In general, it would be a wash if a corporation leveraged cash savings from reduced inventory levels to recruit additional people or make capital investments, but this isn’t explicitly measured.
When a business shutters a manufacturing in Michigan and relocates it to China, the value of those newly imported goods is deducted from GDP. Furthermore, if we assume that most workers who lose their jobs cut back on their spending for a period of time until and unless they find comparable work, GDP will be reduced by that amount.
The US trade deficit in 2013 was a whopping $471 billion dollars, despite the fact that it was the lowest since 2009. (While increased exports and some reshoring may have had a role, the primary driver was the surge in US energy production, which considerably cut oil imports.)
In 2013, the US nominal GDP was at $16.8 trillion. So, the trade deficit ($471 billion) divided by the size of the economy equals 2.8 percent (I’m sure there’s more to it than that). Last year, real GDP growth in the United States was only 1.9 percent. Reducing the trade deficit would have increased that number significantly – let alone establishing a trade surplus.
As a result, what is beneficial for one company may not be good for the economy as a whole.
The nominal GDP is decreased by an inflation factor to arrive at real GDP. Do you mean the consumer price index? While the CPI calculation is complicated and contentious enough, the BEA’s component adds even more intricacy to the equation. Many people believe it understates inflation and, as a result, overstates real GDP growth.
The BEA has just begun to generate a new economic indicator dubbed “gross output,” which gauges the “make” economy, or total sales from raw material production through intermediate producers to final wholesale and retail trade. It’s roughly twice the size of GDP and significantly more volatile, with a market capitalization of more than $30 trillion by the end of 2013. Many economists say it is a superior measure – or at least an important alternative – to GDP because of considerable double counting from raw materials going through stages to become final items. Soon, there will be more on this.
I hope some of this was useful and clear. Understanding GDP, in my opinion, is an important part of supply chain finance literacy.
Was Gilmore’s GDP discussion helpful to you? Is there anything more you’d like to say? Let us know what you think in the comments area below.
What are some GDP examples?
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 exactly is the distinction between GDP and GLP?
Both GMP and GLP are utilized in pharmaceutical manufacturing facilities, however they differ greatly. GMP applies to the entire manufacturing facility, whereas GLP applies exclusively to the quality control laboratory.