cGMP MANUFACTURING FACILITY DESIGN FEE




Facility design by the expert in the industry with different options, no additional charges if you change the design for first three times,

Sr.No. Stage Scope
1 Layout Preparation To Prepare Layout to meet the FDA regulations. The Layout will be given the excel format with dimensions. This activity involves offsite work.
2 Exterior structure built up To monitor and guide the exterior workout of all set up excluding clean room.
3 Manpower recruitment as per FDA requirement. To interview and recruit manpower as per FDA requirement. This do not involve locating of the personnel.
4 Documentation structure built up for Production, QA/QC, Warehouse, Engineering etc. To guide for the built up of the documentation structure as per FDA requirement. This activity involves offsite work.
5 Clean room built up for Production and QC. To locate and finalise the competent clean room, HVAC and the epoxy system provider. This activity involves offsite work.
To monitor the clean room built up as per requirement.
Review of URS, IQ, OQ and Clean room Validation protocol and execution of validation. This activity involves offsite work.
6 Site Mater file preparation as per requirement To prepare the site Master file for the facility. This activity involves offsite work.
7 Equipment purchase To finalise the equipment for Warehouse, QC, Microbiology etc. This activity involves offsite work.
To guide for the preparation of URS, IQ, OQ of the equipment and review of same. This activity involves offsite work.
8 Equipment validation guidance To guide for the validation of the equipment to be carried out from third party. This activity involves offsite work.
9 Equipment validation report To guide the preparation of the report of the equipment validation and review of the same. This activity involves offsite work.
10 ETO steriliser validation To finalise the ETO validation protocol and the execution of ETO validation as per load pattern. This activity involves offsite work.
11 Consumable purchasing Guide to purchase the consumables, locating the suppliers. This activity involves offsite work.
12 Microbiological laboratory set up To set up the microbiological laboratory.
To guide the routine follow up of microbiological SOP’s and the review of activities.
13 Microbiological validations To guide the preparation of protocol of Microbiological validations. This activity involves offsite work.
To get the microbiological validations done and review of activities. This activity involves offsite work.
Guide for the preparation for Microbiological validation reports
14 Training Training of Personnel for execution of batches
15 Process validation To guide for Process validation protocol preparation.
To guide for Execution of process validation.
To guide for process validation report.
16 FDA audit FDA audit preparation
To be available during FDA audit


For “***”, Please contact us for proposal, Please mention about the product in detail (Technical name of the product and its intended use and details of models and related process), so that we can send you the proposal.

Note:
  • Payments accepted in Indian rupees. Govt. taxes additional as applicable
  • for all the visits including site visit for technical discussion, travelling will be chargeable at actual.
  • Fee to be paid in 4 equal Instalments.
  • Method of communication - Telephone /e-mail
  • Language for communication – English.
  • Minimum Timeline - 90 Days for Submission file preparation from getting all necessary inputs from your side.

Training fees:
Regarding the training on the use and maintenance of the facility, Please send us an e-mail about the requirements in detail; we will reply you with our proposal.

Contact us

A1-101, Ankur,
Near Cipla Foundation,
Warje, Pune- 411058

E mail :- info@avscertification.com
Telephone :- +91 - 9881946595



Design & Developed By : Logic Palace Systems and Softwares
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