Applicable Standard to Engineering

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   GMP       GMP certification quotation-request, ISO 9001 14001 27001 22000 13485 ohsas 18001 nabh nabl certification, training, implementation, certificate manual. GMP certification in Ahmedabad, Baroda,  Rajkot, Surat, Vaapi, Ankleshwar, Mumbai Bombay, Pune, Bangalore, Maharashtra, Gujarat, India USA, Canada, Europe, U.K., Europe, Asia & Africa, China Guideline

"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, and in some countries such as the USA regulations, 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.

All guidelines follow a few basic principles.

  • 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.
  • 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.

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.


Benefits
GMP implementation improves / leads to

  • POLICIES & OBJECTIVES set by 'top management'
  • Conformance to Legal and Regulatory Requirements
  • Recognition by regulators around the world of GMP as a good basis for addressing medical device design and manufacturing regulatory requirements
  • Controlled consistency of manufactured products
  • Managed productivity and efficiency, controlling costs
  • Competitive advantage and increased marketing and sales opportunities.
  • Improved customer perception of the organization's image, culture and performance.
  • improved internal and external Communications
  • greater understanding of the organization's processes
  • clear responsibilities and authorities agreed for all staff
  • improved use of time and resources
  • reduced wastage
  • greater consistency and traceability of products and services
  • Customer Confidence, Satisfaction and TRUST
  • Level of Assurance in Organisational QUALITY
  • Organisational PROFITABILITY
  • Ability to Differentiate Organisation for Competitive Advantage
  • Organisational Credibility & Reputation

Training
We offer a customized training programme on GMP for

Next Applicable Standard:  GMP
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Other Applicable Standards
ISO 9001, ISO 29001, API.

ISO certification quotation-request, ISO 9001 14001 27001 22000 13485 ohsas 18001 nabh nabl certification, certification, training, implementation, certificate manual. ISO certification in Ahmedabad, Baroda,  Rajkot, Surat, Vaapi, Ankleshwar, Mumbai Bombay, Pune, Bangalore, Maharashtra, Gujarat, India USA, Canada, Europe, U.K., Europe, Asia & Africa, China.

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