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Kerala - Apply for GLP Certificate (Good Laboratory Practice)

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Procedure[edit]




Apply In-Person:

  1. A test facility (TF) desirous of obtaining “Good Laboratory Practice (GLP)” certificate shall approach the office of their respective area range / district / zonal drugs control officer under whose dominion the applicant is operating.
  2. Link for contact details: link1 AND link2
  3. Applicant shall also use the following link for the information on how to apply for this procedure: link but the updated information will be available on the website: [www.dst.gov.in Link] or can be availed from the respective state drug control office of your area.
  4. Go to the respective office and consult with the designated authority to know the updated applying procedure, if any.
  5. Once the advice is sought, please collect the application form or write on a plain A4 sheet as advised.
  6. Application form can be downloaded using the following link: link
  7. Applicant shall get all the required documents as advised. If there is a shortfall in document requirement, the application won’t be processed.
  8. Complete the application form. Make sure that the end of each page of the application is attested by the testing facility in-charge.
  9. Attach the prescribed application fee in the form of a demand draft as prescribed along with all the documents as per our “Required Documents” section of this page in five sets or seven sets as advised.
  10. This application set shall be submitted through mail or by hand to the “National GLP Compliance Monitoring Authority” (NGCMA) as per the following address.
National GLP Compliance Monitoring Authority,
Department of Science & Technology,
Technology Bhavan, New Mehrauli Road,
New Delhi-110 016.
Email: [email protected]
Phone: +91-11-26590 249, 26590 2
Contact link: link
  1. On receipt of the application, the GLP cell will document the application and forward it to the NGCMA secretariat.
  2. An acknowledgement is sent to the applicant on receipt of the application along with the approximate application fees/charges. Please collect it and keep it safe for future reference.
  3. This application will be assigned a unique number to each file. This application file number is used for all correspondence with the applicant (TF).
  4. This application is reviewed and examined by the concerned officer for its correctness and completeness. If there is any shortfall in the details or documents, the department sends notification about the shortfall. Applicant shall follow the guidelines and act accordingly.
  5. If all are in place, an inspection team is constituted for further processing.
  6. ”SMS” triggered update on application status will be sent to the applicant’s mobile.
  7. Applicant will get information on the pre-inspection team and date of the inspection.
  8. Applicant has the privilege to change the date and also the inspection team member if required.
  9. On the scheduled date, the pre-inspection will be conducted. Once the pre-inspection is completed, the inspection team communicates its findings in writing to applicant (TF).
  10. The applicant (TF) is required to take corrective actions to the deficiencies observed, if any, during the pre-inspection and submit an action taken report (ATR) to NGCMA.
  11. Based on the pre-inspection report coupled with ATR, the head office decides on final inspection with the consultation of pre-inspection team.
  12. On the scheduled date, the final inspection will be conducted by a team. The final inspection may take 5 days to complete all the required inspection activities.
  13. The outcome of the inspection team observation will be provided in writing to the applicant (TF).
  14. Observations communicated to the applicant (TF) by the inspection team should be addressed by the applicant(TF) within a period of 45 days from conduct of the final inspection.
  15. The certifying team will evaluate the applicant’s actions and if found satisfactory, the “GLP” certificate will be generated.
  16. The status, viz. Approval or Rejection if any will be conveyed to the applicant through an SMS or through email or as per applicable norms.
  17. If approved, the certificate will be hand delivered or sent through post to the address mentioned while applying or issued as per applicable norms.


Apply Online:

  1. Please use the following online portal to apply online: link
  2. In the given page, please use the “Registration” button to reach registration details page.
  3. Please complete the page prompt as appropriate and click “Send OTP” button.
  4. Applicant will receive OTP in their email ID provided for registration.
  5. Please enter the received OTP against “Enter Email-Id OTP” at the prompted space as applicable and click the “Verify OTP” button.
  6. Now enter the captcha at the given space and click “Register” button for creation of your account and check your registered e-mail for user-name and password to login.
  7. Please revisit the home page. Enter the login credentials as appropriate. Enter the captcha at the prompted space and click “login” button to reach the online applying page.
  8. Please complete the online application form with required mandatory details. Upload required documents as applicable and make payment using the applicable online payment option.
  9. Please submit the application online using the applicable button to get a system generated acknowledgement for successful submission. Please keep it safe for future reference.
  10. Now take the printout of this submitted application. The hard copy should be signed by the management. Attach all the documents that were uploaded online.
  11. Make sure to have this application in five sets or seven sets as advised.
  12. This application set shall be submitted through mail or by hand to the “National GLP Compliance Monitoring Authority” (NGCMA) as per the address given under the “Apply In-Person” section.
  13. From this point onwards, the user shall follow the steps as mentioned under the “Apply In-Person” section to get this certificate.


NOTE:
  • The parameters and regulations for the grant of this certificate are not same across India. It is advised, that applicant shall consult their local drug control authority to get advice on…
    • Any updated rules and regulations in issuance of this certificate which need to be followed.
    • Update on drugs that were included in the list for which “GLP” certificate is not granted.
    • The fee payment for this certificate is accepted in different formats like challan/DD/cheque/cash as applicable. Applicants are advised to take the consultation with the respective drug control authority for your area to prepare fees requirement.


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Required Documents[edit]

  • Application form.
  • Covering letter indicating the purpose of GLP certificate.
  • Copies of manufacturing licence.
  • Recent organization charts.
  • List of personnel along with their qualifications and training (especially GLP training if any).
  • Floor-plans with GLP marked-area.
  • List of instrument(s)/equipment(s) including number of computers.
  • Procedures being followed to maintain security and integrity of computerized data and records.
  • Details of test systems.
  • List of standard operating procedures (SOP’s).
  • SOP’s of general procedures for drafting, authorizing, modifying, distributing and archiving SOP’s.
  • Brief description of the working of the quality assurance unit with list of SOP’s for this purpose.
  • Demand draft for the advised amount.
  • Authorization of the signatory of the application form as per requirement.
  • Company PAN card.
  • Aadhaar card of directors.
  • Self-declaration.
  • Self-addressed envelope with stamp.



Note:
Apart from the above listed documents, authorities may ask for additional information or document. Please provide them for smooth processing.



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Office Locations & Contacts[edit]

Office of the Drugs Controller,
Red Cross Road, Vanchiyoor PO,
Thiruvananthapuram – 695035.
Phone: 0471-2471896
Email ID: [email protected]
Contact link: link



Department of Science and Technology,
Technology Bhavan, New Mehrauli Road,
New Delhi - 110 016.
Telephone: +91-11-26562122/25/33/44, 26567373, 26962819
Fax +91-11-26863847, 26515637
Email: [email protected]
Contact Link: link

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Eligibility[edit]

  • A testing facility is eligible for seeking “GLP” certification, if it is involved in conducting scientific study or research related to non-clinical health or environmental safety studies. Such TF’s can be:
    • Contract research organization.
    • R&D institution.
    • University/Deemed to be university/Institute of national importance.
    • Industry/Company.
    • Government organization/Public sector enterprise.


*Applicant (company) having competent technical staff on roll are eligible to apply.
  • Manufacturer or a formulator with a valid licence of manufacture of drugs is eligible to apply.



Fees[edit]

  • Rupees 1,500/- per certificate or as per authorities quote.
  • Applicant shall pay the applicable inspection charges and other charges as per authorities quote.



Validity[edit]

  • The validity of the certificate shall be for three years from the date of grant of the Certificate or as per the period mentioned on the certificate.



Documents to Use[edit]

  • Application form can be downloaded using the following link: link



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Sample Documents[edit]

Please attach sample completed documents which would help other people who would like to follow this procedure.


Processing Time[edit]

  • The whole process can be completed within 5 months from the date of acceptance of the application.



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Related Videos[edit]

Videos explaining the procedure or to fill the applications.
Attach videos using the following tag <&video type="website">video ID|width|height<&/video&> from external
websites.
Please remove the "&" inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe,
myspace, revver,
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url "http://www.youtube.com/watch?v=Y0US7oR_t3M%22 Video ID is "Y0US7oR_t3M".


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Instructions[edit]

  • As per pre-inspection, the inspection will be conducted to assess the competency of the testing facility with respect to the “OECD” principles of the “GLP” and also to have a clear idea about the organization, infrastructure and operational aspects of the testing facility.
  • Please follow the below guidelines for the “GLP” certification.
    • Maintain “SOP” documents.
    • Operating and instruction manuals of instruments and equipment’s.
    • Facility design from start to end.
    • Maintenance of records.
    • List of equipment’s.
    • Training records of personnel.
    • Contract documents.
    • Trained and skilled staff.
    • Maintain good hygiene.
    • Proper maintenance of production facility and equipment.
    • Performing regular audit.
  • Don’t forget to take all the originals of the document along with copy for applying.
  • Ensure that application is complete before submission.


Required Information[edit]

  • Name of the test facility (TF)
  • Address of the test facility (TF)
  • Names of the drugs
  • Date of application
  • Type of the test facility (TF)
  • Details of the parent organization (of the test facility (TF)) if any
  • Type of test items
  • Email ID
  • Mobile number
  • Telephone number of the test facility (TF)
  • Fax number of the test facility (TF)
  • Company letter head



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Need for the Document[edit]

  • The ”Good Laboratory Practice” (GLP), are regulations that require implementation of a robust quality management system to ensure the validity, integrity and reliability of non-clinical safety data submitted for regulatory evaluation and approval.
  • The “GLP” is intended to minimize adverse drug effects and improve human health and environmental safety profiles.
  • The certification helps in ensuring maintenance of the best level of hygiene and quality of the products, which further helps in increasing the confidence of customers in the quality of the products.
  • GLP is required…
    • To reduce malpractice in the production/formulation of the products.
    • To access the quality of the products.
    • To minimize the use of toxic ingredients.



Information which might help[edit]

  • Adhere to good laboratory practices and techniques.
  • The “GLP” certification increases the business worth and business value.
  • The “GLP” certification enhances the company reputation in international market for doing business.



Other uses of the Document/Certificate[edit]

Please explain what other uses of obtaining this document/certificate are.

e.g. Birth Certificate can be used as proof of identity.


External Links[edit]

  • Please follow the link for additional information: link


Others[edit]

More information which might help people