LVP (LARGE VOLUME PARENTERALS)

General

Large Volume Parenterals (LVP) are single dose injections for administration through the intravenous route. These products should be in volumes of 100 ml or above. Products like Dextrose injection I.P., Sodium Chloride injection I.P., Ciprofloxacin injection etc. are some LVPs. Any injection having volume less than 100 ml and for multi dose administration falls under the category of Small Volume Parenterals (SVP).

Licensing

The procedure of licensing of LVPs has been modified in the Drugs & Cosmetic Rules by GSR No. GSR923 (E) dated 14/12/1992, whereby it falls under the category of drugs that are to be approved by the Central Licensing Approving Authority (CLAA) which is the CDSCO. Licenses issued by the State Licensing authority have to be approved by the CLAA before they are issued to the applicants.

Procedure

 Application for the Grant or renewal of license for the manufacture of LVPs is to be submitted on form 27D along with the required information to the State Licensing authority and a copy to the respective Zonal office of the CDSCO and CDSCO, HQ, New Delhi.. The data submitted should be printed/typed on A4 paper with arial font. All photocopies should be legible and authenticated. The Licensing authority of the State in co-ordination with the CDSCO Zonal Office will carry out a joint inspection of the applicant’s premises to examine in detail the capacity of the applicant to manufacture and test the products it intends to manufacture. A copy of the report will be handed to the applicant. If the report is satisfactory further action will be taken by the licensing authority for sending the same to the CLAA for approval. If the report indicates that there are deficiencies, the applicants premises may be reinspected jointly or independently, depending on the criticality of the deficiency, after the removal of the same.

Requirements

The manufacturing premises must be as per the requirements of Schedule M, Good Manufacturing Practices. The applicant should have documentation in place as per the requirements of Schedule M and Schedule U. It is recommended that the applicant does not apply for license until the premise is ready with respect to most of the requirements, as unfinished premise inspection cannot be a final inspection and there may be delay in reinspection.

Documents to be submitted:

The following documents are to be submitted at the time of submitting the application. The documents may also be submitted as soft copies in floppies or CDs for easy storage:

  1. Site Master File
  2. Plan of the premises, blueprint along with details of the areas of each section
  3. Name, address, qualification, and experience of the technical staff responsible for manufacture and

     testing. The qualification and experience should be backed up with attested proof.

  1. Name and address of the Directors, Partners, or Proprietor

5.Proof of Payment of fee (Challan)

  1. Ownership, rent or lease details of the premises*
  2. List of drugs intended to be manufactured. This should include formula, pack size and details of

     primary packing material (glass or plastic), Literature and insert/insert (if any), draft level of product

     intended to manufacturer)

  1. Stability Studies data of the applicants products1
  2. List of machinery installed
  3. List of laboratory equipments
  4. Validation and calibration of essential and critical equipment and instruments
  5. Validation of HVAC system
  6. Copies of procurement documents of machinery and equipments (bills etc)*
  7. Description of the manufacturing process*
  8. Any other document requested by the inspecting authorities

1 Stability Studies for all products is to be submitted in case of renewal of license.

In case of grant of license only established pharmacopoeial products will be allowed. However real time/accelerated stability studies has to be commenced immediately after the products are manufactured.

* These may not be submitted during renewal of license

We at Raj Pharma Consultancy are ready to help you for the process of this application & get you the approval with minimum possible timelines