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’s the distinction between GDP and GMP?
The primary distinction between GDP and GMP is that GDP refers to the wholesale distribution of medications, whereas GMP refers to their production.
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.
Who is the authority on proper pharmaceutical storage?
Materials and pharmaceutical items should be stored off the floor, with enough space between them to allow for cleaning and inspection. Pallets should be kept clean and in good repair at all times. 4.4 Cleanliness and the absence of collected garbage and vermin are essential in storage rooms.
WHO recommendations Appendix 7?
Annex 7 of the World Health Organization, Geneva, 2006. (WHO Technical Report Series, No. 937). These guidelines give regulatory bodies advice on how to define the conditions for multisource (generic) pharmaceutical product approval in their individual nations.
What is GMP in the pharmaceutical industry?
GMP refers to a system for guaranteeing that products are consistently manufactured and controlled in accordance with quality standards. It’s intended to reduce any risks associated with pharmaceutical production that can’t be avoided by testing the finished product. The main risks are: unexpected product contamination, which can result in health problems or even death; incorrect labeling on containers, which could lead to patients receiving the wrong medicine; and insufficient or too much active ingredient, which can lead to ineffective treatment or side effects. GMP includes every area of production, from raw materials, facilities, and equipment to employee training and personal hygiene. Each process that has the potential to affect the completed product’s quality requires detailed, written procedures. There must be processes in place to offer recorded verification that proper procedures are followed consistently at each step of the manufacturing process, every time a product is manufactured. The World Health Organization (WHO) has published extensive recommendations for good manufacturing practice. Many countries have developed their own GMP regulations based on WHO guidelines. Others, such as the Association of Southeast Asian Nations (ASEAN), the European Union, and the Pharmaceutical Inspection Convention, have standardized their criteria.
Is GMP a legal requirement?
Manufacturers of active ingredients for the production of human medicines for the EU market are required to register with the national competent authority of the Member State in which they operate.
GMP must be followed by active substance manufacturers. Furthermore, the finished product’s maker must confirm that the active ingredients used were prepared in accordance with GMP.
Importers of active substances destined for the European market must also register. Unless a waiver applies, each shipment must also be accompanied by a certificate from the competent authority of the country in which it is produced that it complies with GMP requirements equivalent to those in the EU.
What is a GDP certificate, exactly?
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. 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 pharmaceutical certifications around the world. 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 is the purpose of the MHRA Orange guide?
The Medicines and Healthcare Products Regulatory Agency (MHRA) (Medicines and Healthcare products Regulatory Agency) The 2022 version of Rules and Guidance for Pharmaceutical Manufacturers and Distributors, also known as “The Orange Guide,” is a must-have reference for all UK pharmaceutical manufacturers and distributors.
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.