GMP Certifications
Certify the quality of your production process and minimize the risk of failure
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Within 10-15 days
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What is it? | Why Needed? | Documents Required | Service Package | FAQs
GMP Certifications
GMP (Good Manufacturing Practice) certification is needed to certify that the production processes executed under your business match quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
Good manufacturing practice (GMP), established by WHO, is a system to ensure that the quality standards are matched during the production process in the pharmaceutical products. GMP covers. all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product.
Legal Brother’s helps its clients to obtain the GMP Certificate faster for pan India locations. You may contact us to obtain your GMP Certificate in Delhi, Mumbai, Bangalore, Kolkata, Kanpur, Bareilly, Lucknow, Kanpur, Ghaziabad, Ludhiana, Faridabad, Meerut, Varanasi, Srinagar, Amritsar, Allahabad, Chandigarh, Bareilly, Moradabad, Gurgaon, Aligarh, Jalandhar or any other cities in India.
Why Needed: Reasons & Benefits
The Features and benefits of GMP Certifications are:
Necessity
GMP prevents errors. that cannot be eliminated through quality control of the finished product.
WHO Guidelines
WHO GMP guidelines are available online.
Quality Assurance, Gain trust and improve brand image
GMP testifies and approves the processes at every step. Hence, assures that the quality standards are matched
Documented proof forever
GMP allows to have a proper documented proof of the quality of the products being produced.
Documents Required
- Application for: WHO-GMP certification & issuance of COPP.
- Name of the applicant with address, telephone, fax, e-mail etc.
- Copy of Manufacturing License.
- List of approved products.
- List of products for which the firm has valid CoPP.
- List of products applied for issuance of COPP & their composition.
- Site Master file (as specified under WHO TRs. 823).
- Data on Finished Formulation:
- Master manufacturing formula, manufacturing process.
- Finished product specification and Method of Analysis .
- Stability study evaluation (Accelerated and Real Time) for 3 batches including
details batch size, Batch No., Date of manufacturing, Date of Expiry, stability
study condition (Accelerated/ Real time), Name of Drug etc. (as per Format-A) - Process validation report for 3 batches.
- Validation report of analytical method.
- List of technical staff, their qualification, and experience and approval status.
Frequently Asked Question
What all cities does Legal Brother's offers it's services in?
Legal Brother’s provides its services across India in all cities like Delhi, Noida, Gurgaon, Jaipur, Mumbai, Bangalore, Hyderabad, Chennai, Ahmedabad, Pune, Jaipur, Lucknow, Kanpur, Nagpur and other Indian cities.
Do I need to be physically present for GMP Certifications?
is available 24*7 through its online one-stop platform serving even the most remotest areas of the country. So, Until you wish, You need not physically be available with us. All you need is the necessary documents, an internet connection to share documents, a telephone number, mail id for formal communications. We are there to serve you the best way possible.
