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| Grant of Approval for Public Testing Laboratory and Blood Storage Centre |
| Food and Drug Administration M.S. grants approval for Public Testing
Laboratory in form 37 and for Blood Storage Centre. |
| Procedure to obtain Approval. |
Stage 1
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For Approval of Lay out Plan the Applicant has to submit 3 Blueprint copies of plan
to the concerned licensing Authority.
- The plan should be as per the requirements prescribed in the Drugs
and Cosmetics Act 1940.
- The plan is scrutinized by panel of officers as per the requirements
of the Drugs and Cosmetics Act 1940.
- Finally after scrutiny and compliance as per requirements of the Act the
Layout plan is approved and a copy is given to the Applicant.
Stage 2
| Application for Approval of Public Testing Laboratory and Blood Storage Centre |
The applicant has to make application in the form 36 for approval for Public Testing Laboratory and for Approval for Blood Storage Centre Application in the Form of covering letter is to be submitted. The applicant has to pay Necessary fees as given in Appendix A.
Fee can be paid in cash at Head Office/Division as well as any other District Office. The fee can also be paid through challan at Government Treasury, Reserve bank of India, State Bank of India and State Bank of Hyderabad for Maratha Wada Region under Head Account----- |
| 0210 - Medical and Public Health. |
| 04 - Public Health |
| 104 - Fees and Fines, etc. |
| Documents to be attached along with the application: |
- Receipt for the fees paid or challan, (the fees are as given in Appendix A) as the case may be or their attested copies.
- Copy of Approved layout plan.
- Documents viz. Rent receipt, purchase documents or its attested copies showing lawful possession of the premises
- List of machinery and equipments.
- Documents relating to the constitution of the firm viz. Partnership-deed, Memorandum and article of association etc.
- Full particulars of the competent technical staff employed for manufacturing and testing of drugs and cosmetics along with copies of their educational qualifications and experience certificates approval letter as competent staff. The competent technical staff is required to furnish consent letter for full time employment with the applicant firm.
- Full name of the proprietor or the partners, as the case may be shall be provided in the application.
- In case of private or public limited concerns, full name of the Directors who sign the application and the authorized signatory, if any, shall be provided in the application.
- List of products in duplicate along-with undertaking to be submitted for Blood Storage centre.
- Agreement between the Blood Storage Centre and the Mother Blood Bank (Appendix I )
Stage 3
| The application is scrutinized and premises inspected. |
Stage 4
| If all conditions as prescribed by the act are complied approval is granted. |
| Procedure to Renew Approval |
| Approval of Public Testing Laboratory and Approval for Blood Storage Centre can be renewed. |
Stage 1
| Application |
| The applicant has to make application in the form 36 for renewal of approval
for Public Testing Laboratory. In case of Approval for Blood Storage Centre.Application in the Form of covering letter is to be submitted. The applicant has to pay Necessary fees as given in Appendix A . |
| The mode of payment of fees is same as fresh approval. |
| Documents to be enclosed along with application of renewal of approval :- |
- Copy of cash receipt or challan for payment of fees.
- Xerox copy of previous approval certificate. .
- Xerox copy of the list of Drugs previously approved.(in case of Blood Storage Centre.)
- Full particulars of the competent technical staff appointed for manufacturing and testing along with their educational qualification and experience certificates.
- Agreement between the Blood Storage Centre and the Mother Blood Bank.
Stage 2
| Inspection |
| The application is scrutinized and premises inspected. |
Stage 3
| Grant of Approval |
| If all conditions as prescribed by the act are complied approval is granted |
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