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GMP, or Good Manufacturing Practice, is a globally recognized standard for overseeing the control and administration of pharmaceutical manufacturing, testing, and overall product quality. It establishes specific guidelines outlining the approach to quality assurance. The certification in GMP ensures that products are manufactured in alignment with rigorous quality standards.
The GMP requirements are not rigid; instead, they are flexible and straightforward to implement. Moreover, these requirements empower manufacturers to determine the most effective way to implement the necessary controls.
Prerequisites for GMP Certification include the regulation of manufacturing facility design, equipment and machinery design, procedures and operational principles, as well as environmental conditions. Manufacturing practices and processes, encompassing health and safety, maintenance, and other aspects, must be explicitly defined, validated, and controlled to ensure uniformity and adherence to specifications.
Operators involved in production, quality assurance/quality control, logistics, factory management, and product control throughout the manufacturing process should be knowledgeable, trained, and competent. Additionally, meticulous records must be maintained for manufacturing, quality control, and logistics, demonstrating adherence to defined procedures and instructions.
According to regulatory requirements, these records should be retained for a period of 5 to 10 years, covering aspects from manufacturing to quality control and logistics to ensure compliance throughout the supply or sale process.
GMP stands for Good Manufacturing Practice, and the term is used globally to manage the control and management of pharmaceutical manufacturing, testing, and overall quality. It defines certain guidelines that discuss the quality assurance approach. GMP certification ensures that products are produced in accordance with quality standards.
Manufacturing facility design, equipment and machinery design, procedures and operating principles, and environmental conditions must all be controlled.
Manufacturing practices and processes, such as health and safety, maintenance, and so on, must be clearly defined, validated, and controlled to ensure consistency and compliance with specifications.
The expense associated with GMP certification, as outlined by the Food and Drug Administration, is contingent on the company’s size. For companies with fewer than 20 employees and those with more than 20 but fewer than 500 employees, the cost of certification is typically determined based on the size of the company.
GMP or cGMP certification signifies that the facility/company/organization is following guidelines set by organizations such as WHO or FDA, as well as meeting local nationalized standards and guidelines.
Ensures maintenance of hygiene and cleanliness standards throughout the manufacturing and logistics chains.
Implementation of good documentation practices, including well-documented manuals, procedures, standard operating procedures, operational controls, risk assessments, and regulatory compliances.
Applies to the design and operation of Medical Devices, IVD products/items, Medicines/Drugs/pharmaceuticals, active pharmaceutical ingredients, Diagnostics products/items, and Food items, covering management of processes and products.
Demonstrates and establishes personnel competence, including technical competence.
Establishes the organization's system for dealing with Non-Conformities and Complaints, ensuring proper reporting to Regulatory bodies when necessary.
esults in cost reduction and optimal resource utilization.
Serves as proof of delivering safe and high-quality products and items.
Ensures compliance with all international, national, and local regulations.
Increases customer assurance, rapport, and trust.
Facilitates entry into international markets by meeting recognized standards.
romotes a professional culture within the organization.
This leads to a decrease in complaints, fines, product returns, re-processing, rejections, non-conformities, and claims.
Certease serves as a comprehensive platform to address your legal and financial requirements, connecting you with trusted professionals. Our clients express satisfaction with our legal services, consistently rating us highly and offering regular updates due to our commitment to simplifying legal processes.
Throughout the GMP Certification process, our clients can easily monitor progress on our platform. If you have inquiries about the certification process, our knowledgeable representatives are just a phone call away. Certease ensures that your interactions with professionals are not only efficient but also enjoyable. For additional details and information, please visit our official website at www.certease.com
Directly or indirectly improving the organization’s profits in the short/long term in a sustainable manner
Our seasoned professionals bring expertise to every project, ensuring precision and success.
Our dedicated team ensures reliability and prompt solutions around the clock, Count on us for unwavering support.
Our experts bring verified proficiency to address your specific needs. Choose assurance, choose excellence.
Tailored to suit your specific business needs, our services make it effortless for you to obtain high-quality certifications.
Trusted by over 2,000 companies worldwide, Certease empowers a diverse range of businesses, from dynamic startups to global enterprise leaders, enabling them to enhance and expand the scope of their customer relationships.
"It was a good experience with Certease, We had slight hesitation as certease was a new name in consultation but they proved it wrong, they never acted like inexperienced in consultation business instead they are more professional."
"Overall, the certease team does a fantastic job on getting certification for our company in a given timeline, the team has been proactive and very responsive."
Very pleased with services which was delivered by the entire Certease team for our HACCP & ISO certification requirement for our company. Special thanks to Rahul D'souza who was there since day one and helped us throughout & finished the project within the given time frame. Very satisfied with the work and would highly recommend. the documentation work was really standout. Thanks again Certease team.
I recently had the pleasure of engaging with Certease for ISO 9001 consultation and certification, and I must say that my experience has been nothing short of exceptional. From the moment we initiated the process until the final certification, Certease, along with their consultants Mr. Karthik and Mr. Rajesh, demonstrated a level of professionalism and dedication that truly stood out. What truly impressed me was their transparent communication at every step. They kept us well informed about the progress, potential challenges, and necessary adjustments, fostering a sense of trust and confidence throughout the process. The successful ISO 9001 certification we obtained is a testament to Certease's proficiency and commitment to excellence. T
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