What is gmp

• Certification • ISO 9001:2015 (Quality) The International Standard for Quality Management Systems. • ISO 14001:2015 (Environment) The International Standard for Environmental Management Systems. • ISO 45001:2018 (Health & Safety) One of the International Standards for Occupational Health and Safety. • ISO 27001:2022 (Information Security) The International Standard for Information Security Management Systems. • ISO 22000:2018 (Food Safety) Ensure safety in the food chain and gain GFSI recognition with ISO certification. • IATF 16949:2016 (Automotive) Demonstrate best practice across the industry with IATF 16949 certification. • AS Aerospace Management AS9100/AS9110/AS9120 the International Standards for Aerospace Quality Management. • TL 9000 (Telecomms) Defines the QMS requirements for the Information and ICT industry. • Industries • Automotive We are the leading automotive sector certification body for IATF 16949 in China and have global experience across the automotive supply chain. • Aerospace We are one of the world's leading certification bodies for the aviation and aerospace industry - serving Lockheed, Boeing, Raytheon, NASA, European Space Agency and many more. • Construction We can assist with construction industry certification and training related to ISO and other standards. • Service Industry NQA is particularly well-positioned to help interpret the standards and has auditors familiar and comfortable with service environments. No tangible product? - No probl...

If you are a business owner who wishes to produce products that are safe and compliant with regulations, then you should consider getting GMP certification. Good Manufacturing Practices (GMP) certification is a voluntary process that demonstrates a company’s commitment to quality and safety. If you are looking to get GMP certified, then this blog post is for you! In it, we will discuss the basics of GMP certification and how to get GMP certification. What is GMP? Good Manufacturing Practices, or GMP for short, is a system of practices, protocols, and documentation that ensures that manufacturing goods like food, cosmetics, and medicines are consistently produced and maintained in accordance with recognized quality standards. GMP covers every step of the manufacturing process, including the following: a clearly defined manufacturing process, validated critical manufacturing steps, suitable premises, storage, and transportation, qualified and trained production and quality control personnel, adequate laboratory facilities, approved written procedures, and instructions, records demonstrating that all steps of the clearly defined procedures have been followed, complete traceability of a product through batch records and distribution records, and systems for recall. What is GMP Certification? GMP certification is a validation indicating that an organization is adhering to GMP guidelines and that the products are controlled and produced to proper quality standards. In order to g...

If you’re manufacturing food, drinks, or medicine, you know you have a sea of regulations and standards which you need to hit and adhere to. You knew that starting out. But it does leave you with two questions: • What are the regulations and standards that I should adhere to? • How do I get my organization to run in an effective manner so that we consistently adhere? Lots of companies are very good at asking the first question, but the second sometimes gets overlooked. This is how we end up with malpractice and lawsuits and all kinds of bad things. You don’t just have to know what the standards are, or intend to reach those standards, but you have to consistently hit those standards in order to be the successful safe business you want to be. That’s why in this • • • • What is CGMP? Current Good Manufacturing Practices explained Good Manufacturing Practices (GMP) are the recommendations for businesses which need to adhere to the guidelines set by regulatory bodies in regards to the manufacture or sale of a range of products: food, drinks, medicines, cosmetics, and medical devices, primarily. There are different regulatory bodies which oversee these terms depending on what country you’re in: • The United States has the • The United Kingdom has • South Korea hasthe • Australia hasthe • Bangladesh has the Directorate General of Drug Administration (DGDA) • South Africa has the Medicines Control Council (MCC) • Brazil has the • India hasthe • Pakistan has the Drug Regulatory Au...

What is GMP? GMP refers to the Good Manufacturing Practices that consist of processes, procedures, and documentation. It can help to avoid recalls and fines and also reduce losses and waste. GMP addresses problems around cleanliness, handling complaints, valid process usage, sanitation and hygiene, record keeping, and employee qualifications. It also ensures the safety, purity, and effectiveness of its products by taking proactive measures. Manufacturers can understand how to implement GMP quality in their specific environments by following Good Manufacturing Practices guidelines. GMP regulation and guideline consider the following areas: • Quality management and complaints • Building and facilities • Equipment and raw materials • Qualification and validation • Recordkeeping and documentation • Inspections & quality audit Request an Online Demo How is GMP Different from cGMP? The Good Manufacturing practices guidelines ensure that the entire process from record keeping to packaging is done correctly and precisely. There is some difference between GMP and cGMP even though both GMP and cGMP assure quality. The “c” is added to cGMP to assure systems have accurate design, tracking, and control of manufacturing processes and facilities. A manufacturer assures the identity, strength, quality, and purity of drug products through controlled manufacturing operations by Implemented by the US cGMP is more expensive than regular GMP as it mostly uses new, innovative technology availab...

At Transparent Labs, we get asked all the time, “ Why does Transparent Labs not display GMP/cGMP seals on products or website?” The answer is quite simple – the FDA does not issue GMP certifications or seals and displaying one is illegal. All manufacturing facilities are required to follow GMP regulations (which cover categories such as sanitation, cleanliness, equipment verification, purity testing, record keeping, product complaints, etc.) Failure to adhere to established regulations can result in product recalls, inventory seizure, substantial fines, and even jail time. Why do some companies display GMP seals? Using the FDA or GMP logo and claiming it as a seal or certificate is illegal. The FDA does not approve or certify manufacturing facilities or products. It is up to the manufacturer to ensure that GMP regulations and standards are followed. There is no approval process, only punishments if NOT followed.  Workarounds / What is NSF GMP and NPA GMP-Certification? These are legitimate, yet often deceiving ways of showing compliance to GMP regulations. NSF and NPA are private organization, completely distinct and separate from the FDA. For a fee, they will conduct a plant audit, based on the standards as set forward by the FDA for GMP. These are for profit companies, providing a certification used for marketing (and industry regulating) purposes. NSF GMP and NPA GMP-certifications should not be used to distinguish GMP compliant companies from non-compliant compa...

Understanding the GMP requirements and their grades can be challenging at times, especially with different regulatory bodies in other countries. What are the differences between a Grade A, Grade B, Grade C, or Grade D cleanroom environment? This article will cover: • The differences between the grades • Their • Examples of applications for each GMP grade • Graphic charts (number of airborne particles, etc.) Regulators such as the FDA in the United States or Health Canada ensure the quality of drug products. They put strict and precise regulations for drug manufacturers in the pharma industry. The Good Manufacturing Practices (GMP) for manufacturing sterile medicinal products were created to ensure that the drugs are safe and contain the ingredients and amounts they claim. These criteria are intended to reduce the risk of microbiological, particle, and pyrogen contamination. Also known as the current Good Manufacturing Practices (cGMP), the regulations cover production processes, quality control, packaging, personnel, and GMP facility. This article will focus on the latter, the good manufacturing practices for the cleanroom environment of your GMP Facility. GMP Cleanroom Requirements for Grade A, B, C, and D Facility Cleanrooms do not entirely remove contamination; instead, they regulate it to a tolerable level. In cases where operations are likely to cause defects in the final product, a higher degree of cleanliness is required to avoid contamination. Some operations, such...

Understanding the GMP requirements and their grades can be challenging at times, especially with different regulatory bodies in other countries. What are the differences between a Grade A, Grade B, Grade C, or Grade D cleanroom environment? This article will cover: • The differences between the grades • Their • Examples of applications for each GMP grade • Graphic charts (number of airborne particles, etc.) Regulators such as the FDA in the United States or Health Canada ensure the quality of drug products. They put strict and precise regulations for drug manufacturers in the pharma industry. The Good Manufacturing Practices (GMP) for manufacturing sterile medicinal products were created to ensure that the drugs are safe and contain the ingredients and amounts they claim. These criteria are intended to reduce the risk of microbiological, particle, and pyrogen contamination. Also known as the current Good Manufacturing Practices (cGMP), the regulations cover production processes, quality control, packaging, personnel, and GMP facility. This article will focus on the latter, the good manufacturing practices for the cleanroom environment of your GMP Facility. GMP Cleanroom Requirements for Grade A, B, C, and D Facility Cleanrooms do not entirely remove contamination; instead, they regulate it to a tolerable level. In cases where operations are likely to cause defects in the final product, a higher degree of cleanliness is required to avoid contamination. Some operations, such...

If you are a business owner who wishes to produce products that are safe and compliant with regulations, then you should consider getting GMP certification. Good Manufacturing Practices (GMP) certification is a voluntary process that demonstrates a company’s commitment to quality and safety. If you are looking to get GMP certified, then this blog post is for you! In it, we will discuss the basics of GMP certification and how to get GMP certification. What is GMP? Good Manufacturing Practices, or GMP for short, is a system of practices, protocols, and documentation that ensures that manufacturing goods like food, cosmetics, and medicines are consistently produced and maintained in accordance with recognized quality standards. GMP covers every step of the manufacturing process, including the following: a clearly defined manufacturing process, validated critical manufacturing steps, suitable premises, storage, and transportation, qualified and trained production and quality control personnel, adequate laboratory facilities, approved written procedures, and instructions, records demonstrating that all steps of the clearly defined procedures have been followed, complete traceability of a product through batch records and distribution records, and systems for recall. What is GMP Certification? GMP certification is a validation indicating that an organization is adhering to GMP guidelines and that the products are controlled and produced to proper quality standards. In order to g...

What is GMP? GMP refers to the Good Manufacturing Practices that consist of processes, procedures, and documentation. It can help to avoid recalls and fines and also reduce losses and waste. GMP addresses problems around cleanliness, handling complaints, valid process usage, sanitation and hygiene, record keeping, and employee qualifications. It also ensures the safety, purity, and effectiveness of its products by taking proactive measures. Manufacturers can understand how to implement GMP quality in their specific environments by following Good Manufacturing Practices guidelines. GMP regulation and guideline consider the following areas: • Quality management and complaints • Building and facilities • Equipment and raw materials • Qualification and validation • Recordkeeping and documentation • Inspections & quality audit Request an Online Demo How is GMP Different from cGMP? The Good Manufacturing practices guidelines ensure that the entire process from record keeping to packaging is done correctly and precisely. There is some difference between GMP and cGMP even though both GMP and cGMP assure quality. The “c” is added to cGMP to assure systems have accurate design, tracking, and control of manufacturing processes and facilities. A manufacturer assures the identity, strength, quality, and purity of drug products through controlled manufacturing operations by Implemented by the US cGMP is more expensive than regular GMP as it mostly uses new, innovative technology availab...

At Transparent Labs, we get asked all the time, “ Why does Transparent Labs not display GMP/cGMP seals on products or website?” The answer is quite simple – the FDA does not issue GMP certifications or seals and displaying one is illegal. All manufacturing facilities are required to follow GMP regulations (which cover categories such as sanitation, cleanliness, equipment verification, purity testing, record keeping, product complaints, etc.) Failure to adhere to established regulations can result in product recalls, inventory seizure, substantial fines, and even jail time. Why do some companies display GMP seals? Using the FDA or GMP logo and claiming it as a seal or certificate is illegal. The FDA does not approve or certify manufacturing facilities or products. It is up to the manufacturer to ensure that GMP regulations and standards are followed. There is no approval process, only punishments if NOT followed.  Workarounds / What is NSF GMP and NPA GMP-Certification? These are legitimate, yet often deceiving ways of showing compliance to GMP regulations. NSF and NPA are private organization, completely distinct and separate from the FDA. For a fee, they will conduct a plant audit, based on the standards as set forward by the FDA for GMP. These are for profit companies, providing a certification used for marketing (and industry regulating) purposes. NSF GMP and NPA GMP-certifications should not be used to distinguish GMP compliant companies from non-compliant compa...