What is who GMP approved companies?

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What is WHO GMP approved companies?
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UNDERSTANDING WHO GMP APPROVED COMPANIES
In the world of pharmaceuticals, the importance
of quality and safety cannot be overstated.
WHO GMP, or World Health Organization Good
Manufacturing Practices, is a certification that
assures products are consistently produced and
controlled according to quality standards. This
certification is a mark of excellence,
signifying that a company adheres to
stringent manufacturing practices, ensuring
the safety and efficacy of its products.
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What is WHO GMP Certification?
WHO GMP certification is a system that ensures
products are manufactured under high-quality
conditions, minimizing risks involved in
pharmaceutical production. It covers all aspects
of production, from the raw materials to the
finished products, ensuring they meet the
required standards for safety, quality, and
efficacy. This certification is crucial for
companies that aim to supply their products
globally, as it is recognized internationally.
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How to Get WHO GMP Certification?
Obtaining WHO GMP certification involves a
thorough and rigorous process. Here is a
step-by-step guide on how companies can achieve
this prestigious certification
Initial Assessment
Stress management
01
05
Documentation
Exercise
02
06
Training
03
Statistics
07
Facility and Equipment
04
08
Conclusions
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DOCUMENTATION
01
INITIAL ASSESSMENT
Develop comprehensive Standard Operating
Procedures (SOPs) for all aspects of
production. Ensure all processes are
well-documented and controlled.
Conduct an internal audit to evaluate current
manufacturing practices against WHO GMP
standards. Identify deficiencies and areas
needing improvement. www.cubitlifescience.com
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03
04
TRAINING
FACILITY AND EQUIPMENT
Provide training for all personnel involved in
the manufacturing process on WHO GMP
guidelines. Implement on-going training programs
to keep staff updated on best practices and new
regulations.
Ensure that manufacturing facilities and
equipment meet the necessary standards. Regularly
maintain and calibrate equipment, keeping
detailed records of all activities.
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06
APPLICATION PROCESS
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Prepare and submit an application to the relevant
health authority, including all required
documentation. This includes internal audit
results, SOPs, training records, and quality
control data.
QUALITY CONTROL
Implement a robust quality control system to test
raw materials, in- process items, and finished
products. Maintain thorough records of all
quality control procedures and results. www.cubitl
ifescience.com
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07
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INSPECTION

• Undergo an inspection by WHO or a designated
  authority to assess compliance with GMP
  guidelines.
• Promptly resolve any issues identified during the
  inspection.

CERTIFICATION

• If the inspection is successful, the company will
  receive WHO GMP certification.
• Regular audits are conducted to maintain on-going
  compliance.

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WHO GMP Certified Companies in India
Cubit Lifesciences LLP is committed to upholding
the highest standards of quality in
our manufacturing processes. By adhering to WHO
GMP guidelines, we ensure that our products are
safe, reliable, and effective, meeting
the stringent requirements of global health
standards.
India boasts a significant number of WHO GMP
certified companies in India, highlighting the
countrys strong pharmaceutical sector. These
companies adhere to high-quality manufacturing
standards, ensuring their products meet
international benchmarks. www.cubitlifescience.com
The presence of numerous WHO GMP approved
manufacturers in India underscores the countrys
capability in producing safe and effective
pharmaceutical products for global markets.
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Conclusion
WHO GMP certification is a testament to a
companys commitment to quality and safety in
pharmaceutical manufacturing. It involves a
meticulous process of assessment, documentation,
training, and compliance with rigorous
guidelines. For companies in India and around the
world, achieving WHO GMP certification is a
significant milestone, signifying their
dedication to excellence in producing high-
quality pharmaceutical products.
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CONTACT US

• 91 9426068836
• info_at_cubitgroup.in www.cubitlifescience.com
• Unit 1, Plot no 39 40 Ozone Industrial Park,
  Near Kerala GIDC, Village Bhayla, Bavla- Rajkot
  Highway, Taluka Bavla, Ahmedabad, Gujarat 382220,
  India

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