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GMP / cGMP

Goods Manufacturing Practices – Fundamentals & Vocabulary

ISO 15378 : 2011

Achieving Sustained Success in Packaging Quality

ISO 22716 : 2007

Achieving Sustained Success in GMP for Cosmetics

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GMP/cGMP/ISO 15378/ISO 22716

GMP (Good Manufacturing Practice) and cGMP (current Good Manufacturing Practice) are crucial quality management systems that establish guidelines for the production, testing, and control of pharmaceutical products and medical devices. These standards ensure that manufacturing processes are conducted in a consistent and controlled manner to guarantee product quality, safety, and effectiveness.

ISO 15378 is a specific standard within the ISO family that focuses on the requirements for the production and control of primary packaging materials for medicinal products. 

By adhering to GMP/cGMP and ISO 15378, organizations can demonstrate their commitment to quality, safety, and regulatory compliance. These standards help to establish robust quality management systems and ensure that pharmaceutical products and medical devices are manufactured and packaged in a manner that meets the highest quality standards. Compliance with GMP/cGMP and ISO 15378 not only enhances customer confidence but also enables organizations to access global markets and meet regulatory requirements effectively.

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GMP / cGMP / ISO 15378 : 2011 / ISO 22716 : 2007

The Relevance of the World's favorite Standard Persists to this day.

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What you need to know about - GMP

GMP, is a set of guidelines and regulations that ensure the quality, safety, and consistency of pharmaceutical products, medical devices, and food products. It encompasses various aspects of production, including facilities, equipment, personnel, processes, and documentation. Compliance with GMP is crucial for organizations in the healthcare and food industries to meet regulatory requirements and maintain product integrity. It involves implementing stringent quality control measures, conducting thorough inspections, and adhering to standard operating procedures. By adhering to GMP, organizations demonstrate their commitment to producing safe and effective products, minimizing the risk of contamination, and ensuring consistent quality throughout the manufacturing process. Key elements of GMP include proper facility design and maintenance, employee training and qualification, thorough record-keeping, robust quality control testing, and effective product traceability. Adhering to these principles helps organizations mitigate risks, ensure product efficacy, and maintain the highest standards of quality and safety.
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What you need to know about - cGMP

cGMP, or current Good Manufacturing Practice, is a set of regulations and guidelines that ensure the quality, safety, and consistency of pharmaceutical products, medical devices, and dietary supplements. Compliance with cGMP is crucial for organizations in the healthcare industry to meet regulatory requirements and maintain consumer trust. It involves implementing standardized processes, rigorous quality control measures, and thorough documentation to ensure consistency and reliability in every step of the manufacturing process. By adhering to cGMP, organizations demonstrate their commitment to producing safe, effective, and high-quality products. This not only protects consumers but also enhances the reputation and credibility of the organization. It also fosters consumer confidence, enhances brand reputation, and promotes market access by meeting the stringent requirements of regulatory authorities. Compliance with cGMP not only protects consumers but also enables organizations to thrive in a highly regulated and competitive market by delivering products that meet the highest standards of safety, efficacy, and quality.
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What you need to know about- ISO 15378

ISO 15378 is a standard that provides guidelines for organizations involved in the production and control of primary packaging materials for medicinal products. Compliance with ISO 15378 demonstrates a commitment to quality, safety, and regulatory compliance in the pharmaceutical industry. It covers various aspects such as facility design, equipment qualification, personnel training, documentation control, traceability, and risk management. By adhering to this standard, organizations can ensure the consistent quality of primary packaging materials, enhance patient safety, and strengthen customer confidence. ISO 15378 also helps organizations streamline processes, improve efficiency, and maintain long-term sustainability.
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What you need to know about - ISO 22716

ISO 22716 is an international standard that outlines Good Manufacturing Practices (GMP) for Cosmetic Products. Compliance with ISO 22716 demonstrates a commitment to quality, safety, and regulatory compliance in the cosmetic industry. It covers various aspects such as facility design, equipment qualification, personnel training, documentation control, traceability, and risk management. Adhering to this standard helps organizations ensure consistent product quality, enhance consumer safety, and streamline processes. ISO 22716 fosters consumer confidence, strengthens brand reputation and supports market access by meeting regulatory requirements.
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Why Choose
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[b advancy] Certifications USA is a leading certifications body, accredited under ISO/IEC 17021, specializing in offering comprehensive conformity assessment services for Management Systems. Our unwavering commitment lies in delivering impartial and proficient Certification Services that not only meet but exceed industry standards. Here are compelling reasons why you should choose our services:

Unmatched Accreditation: We met the highest benchmarks of impartiality and competence. Our accreditation assures you of the utmost reliability and credibility in the certification process.

Expert Team: Our team comprises highly experienced and dedicated auditors, and trainers who possess extensive expertise in their respective fields, and assisting businesses in achieving compliance with international standards, ensuring the highest level of quality and excellence.

Comprehensive Certification Services: We offer a diverse range of certification services tailored to meet the unique needs of businesses, regardless of their size or industry. From quality management systems to environmental sustainability, our services cover a wide spectrum of management systems.

Client-Centric Approach: We are resolutely committed to providing our clients with the best possible service experience. 

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