Need Help From Experts ?

» GMP Page ID : WP713 | Last Updated 23 Jun, 2018, 06:43AM
+91 - 8793766061

WHAT IS GMP CERTIFICATION?

Good manufacturing practice" or "GMP" is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation.

GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the company's responsibility to determine the most effective and efficient quality process.

Principles of GMP Standards :
  • Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
  • Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.
  • Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices)
  • Operators are trained to carry out and document procedures.
  • Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented.
  • Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
  • The distribution of the drugs minimizes any risk to their quality.
  • A system is available for recalling any batch of drug from sale or supply.
  • Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence.
For more information, Kindly mail us on info@rbmcertifications.com or Contact us at +91 – 9870285089 to get your organization GMP certified in the most effective and efficient manner while realizing the true benefits of the certification using our specialized implementation methodology that is less time consuming, fast, easy to understand and implement, result oriented, time bound and cost effective.

Contact Us

  503, WING A/15, Planet Millennium, Pimple Saudagar, Pune–411027, Maharashtra, India.

+91 - 9870285089

info@rbmcertifications.com

Mumbai | Pune

News Update

Latest Certification News & List of Our Few Satisfied Customers...
We are feeling proud to make this announcement that recently we provide our valuable Certification Services to 4 different units of one of the best organization of India in their field..

@ CMS India Pvt. Ltd.
@ FKL India Pvt. Ltd. has successfully got their QMS certificate. They are now ISO 9001:2008 Certified organization.
@ M. S. MINING has got their ISO 9001 Certificate.
@ Pagaria Advisory Pvt. Ltd has implemented Quality Management Systems inside their organization, & successfully got ISO 9001 Certificate.
@ Saisidha Sugar Equipments Pvt. Ltd. has got their ISO 9001 Certificate.
@ Kiran Public School has got their Certificate. Now they are also ISO 9001:2008 Certified.
@ Payal Foods & Beverages Pvt. Ltd. is now ISO 9001:2008 Certified. They got their certificate recently.
@ Koylanchal Public School has got their Certificate. Now they are also ISO 9001:2008 Certified.
@ Techno Jaya Jewellery Udyog has successfully got their QMS certificate.
@ Anurag Agarbatti Dhup Udyog is also now ISO Certified Organization.
@ Sameer Enterprises has got their Certificate. Now they are also ISO 9001:2008 Certified.
@ Chemion Engineering is now ISO Certified Organization.
@ Prayag Plastic Udyog got their ISO 9001 : 2008 Certificate.
@ Thunder Force PVT. LTD. has got their Certificate. Now they are also ISO 9001:2008 Certified.
@ Institute of Welding & NDT Technologies has got their Certificate. Now they are also ISO 9001:2008 Certified.
@ Persil Embroideries Pvt. Ltd. is now ISO Certified Organization. They got their ISO certificate after implementing QMS inside their Organization.
@ Wi-Fonic Technologies Pvt. Ltd. has got their Certificate. Now they are also ISO 9001:2008 Certified.
@ Techno Power & Electrical is now ISO 9001 Certified Organization.
@ Shri Yogi Raj Hospital has got ISO 9001 : 2008 Certificate after successfully implementation of QMS.
@ Converge Interiors Solutions Pvt. Ltd. is now ISO Certified.
@ ZKL Bearing has got their Certificate. Now they are also ISO 9001:2008 Certified.
@ Aspire Knowledge & Skills is now ISO 9001 Certified Organization.


Validate Certificates