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Main Kakrola Road, New Delhi
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  • Legal Status of Firm

    Limited Company (Ltd./Pvt.Ltd.)

  • Year of Establishment

    2006

  • Annual Turnover

    Rs. 5 - 10 Crore

  • Indiamart Member Since

    Oct 2013

Current Good Manufacturing Practices (CGMPS)

करंट गुड मैन्युफैक्चरिंग प्रैक्टिस (CGMPS)
₹ 10,000/ yearGet Latest Price
Type of Certification
New Certification
Type Of Industry
Manufacturing
Type Of Service Provider
Compliance
Mode Of Report
Hard Copy
Internal Audit
Yes
Current Good Manufacturing Practices (cGMPs) for human pharmaceuticals affect every American. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. Most people, however, are not aware of cGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives. Recently, FDA has announced a number of regulatory actions taken against drug manufacturers based on the lack of GMPs.
What are cGMPs?
cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.The cGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement. Accordingly, the "c" in cGMP stands for "current, " requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. Systems and equipment that may have been "top-of-the-line" to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today''s standards.It is important to note that cGMPs are minimum requirements. Many pharmaceutical manufacturers are already implementing comprehensive, modern quality systems and risk management approaches that exceed these minimum standards. Current Good Manufacturing Practices Accredium Certification Good manufacturing practice (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products.Good Manufacturing Practice (GMP)
Accredium Certification Good Manufacturing Practice (GMP) A GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. Accredium Certification WHO & GMP .
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Current Good Manufacturing Practices (CGMPS)

Product Details

Company Details

Product Specification

Type of CertificationNew Certification
Type Of IndustryManufacturing
Type Of Service ProviderCompliance
Mode Of ReportHard Copy
Internal AuditYes
Service LocationAll India

Product Description

Current Good Manufacturing Practices (cGMPs) for human pharmaceuticals affect every American. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. Most people, however, are not aware of cGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives. Recently, FDA has announced a number of regulatory actions taken against drug manufacturers based on the lack of GMPs.

What are cGMPs?


cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.

The cGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement. Accordingly, the "c" in cGMP stands for "current," requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. Systems and equipment that may have been "top-of-the-line" to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today''s standards.

It is important to note that cGMPs are minimum requirements. Many pharmaceutical manufacturers are already implementing comprehensive, modern quality systems and risk management approaches that exceed these minimum standards.

Current Good Manufacturing Practices Accredium Certification Good manufacturing practice (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products.Good Manufacturing Practice (GMP)

Accredium Certification Good Manufacturing Practice (GMP) A GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

 

Accredium Certification WHO & GMP .

 


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About the Company

Year of Establishment2006
Legal Status of FirmLimited Company (Ltd./Pvt.Ltd.)
Nature of BusinessService Provider
Number of Employees51 To 100 People
Annual TurnoverRs. 5 - 10 Crore
IndiaMART Member SinceOct 2013
Established in 2006, Accredium Confirmity Assessment Service (P) Ltd. has grown into a leading certification, Audit and Inspection body with the goal of delivering a certification service which goes beyond simply ticking the boxes. As an approved and accredited, ISO 9001 and 27001 Certification body, we provide certification to an extensive range of ISO standards and management standards.
Our service range comprises of Verification Service, Screening Services, and Management Service. Our offered service is famous amongst clients for execution as per client need and timely completed. Apart from this, we render these verification and management services at the market leading prices.
Accredim Conformity Assessment Services Pvt Limited is established as a third party conformity assessment body since 2005. Accredium is one of the leading and fast growing certification bodies across the globe with focus on customer satisfaction through value-added services. ACASCERT auditors are especially competent in scope & industry.Acredium believes in a Professional approach, which is blended with specific industrial & auditing experience. Accredium's process approach based assessment procedure prevents lapses of client systems, boosts employee’s morale, and better customer confidence and ultimately ensures effectiveness of the management. Accredium is also Largest and best ISO Certification services across the world for ISO 9001, ISO 14001, OHSAS 18001, HACCP ISO 22000, ISO 27001, SA 8000, ISO 17025, ISO 17020, ISO 15189, ISO 13485 standards. We provide ISO audit, ISO internal audit, ISO pre-assessment & certification. Due Diligence, Background Check of Employees, Background Check of Businesses, Market Survey,
We are helping our customers in achieving ISO certifications from globally reputed & widely respected ISO certification and is member of QCI (Quality Council of India) . The company has built up a vast base of associates comprising an extraordinary powerful pool of intellectual resources that can be seamlessly harnessed in the execution of tasks of any degree of complexity.
Accredium provided Social Compliance Auditing, Supply Chain Audit, Energy Audit , Social Compliance Audit Services, Electrical Safety Audit, Energy Audit, Provider for Supply Chain Audits, SEDEX, COC Audits, WRAP, Compliance services , ETI , SMETA , FLA Audit Services, BSCI Audit Services SA8000 Social , BSCI Audit Services SA8000 Social Compliance Audit.
Accredium also do Statutory & Compliance Services, Business Compliance Services, CE Marking,GMP,HACCP,,ISO 13485:2005,ISO 14001:2015,ISO 22000:2005,ISO 27001:2013,ISO 29990:2010,ISO 9001:2015,ISO Consultant,ISO-TS 16949:2009,ISO/IEC 20000-1:2011NABH,NABL,OHSAS 18001:2007,SA 8000,TL 9000 .
we have
  • Certified more than 15000 clients worldwide
  • Offices in all metro cities of India
  • Our certificates are recognised globally
  • We have clients from Government & private sectors both
  • All our auditors and technical experts are certified by IRCA/NRBPT/RAB-QSA and other equivalent boards
  • Accredium is member of QCI, APECX CHAMBER OF COMMERCE

Since the inception of our firm, we have been well-supported by our team of highly skilled professionals. Our employees are carefully recruited through rigorous selection procedures conducted by our team of human resource professionals. Furthermore, they are trained on a regular basis in order to enhance their technical skills as per our organizational goals. Also, we maintain a cordial relationship with our patrons due to our vast industrial experience, timely execution, quality assurance, and transparent business policies.
Current Good Manufacturing Practices (CGMPS)
Current Good Manufacturing Practices ...
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Seller Contact Details

Rakesh Ji

Main Kakrola Road, Main Kakrola Road New Delhi - 110059, India

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