What is a GMP Certificate?
APIs, Drugs, Diagnostics, Food, Nutraceuticals, Medical Devices, and Cosmetics fall under the Good Manufacturing Practice (GMP) umbrella. Respective country guidelines specify the standards to be met for the types of goods produced, taking into account the potential effect on product quality. GMP is defined in CFR 21 part 110/111/210/211/820. GMP’s mission is to ensure that goods are produced consistently and regulated manner according to quality standards. To obtain GMP certificate, businesses must meet a number of criteria.
How can my firm Implement GMP Certification?
- Identify the relevant guideline based on the product you manufacturer and country of origin.
- Appoint an experienced consulting company like MedDeviceCorp for guidance, Training, and Implementation support.
- Develop Quality Manual, Procedures, Templets.
- Follow procedures and maintain records for each activity that affects Finished product Quality.
- Conduct Internal Audit to identify GAPS in the Good Manufacturing Practice.
Who will issue GMP Certificate?
Contact any of the government-approved agencies or Certification Bodies.
What will be the tentative cost of GMP Certification?
Costing depends on Shop floor area, Number of Employees, Type of product manufactured, Number of shifts, Number of locations, etc. The major GMP Certification costs are the following.
- Guidance and Consulting Fees.
- Auditing Fees.
- GMP Certificate Fees.
- Auditor Travelling & accommodation.
How long is the process of GMP Certification?
- Documentation & Implementation normally 3-4 months.
- Application Scrutiny, 1 month.
- Auditing and Issue of GMP Certificate, 1 month approximately.
We comprehend your product and plan the facility in accordance with international regulatory standards. The GMP consultation includes documentation and staff training in addition to facility design.
Our GMP consultants, with their rich and varied experience in setting up state of the art manufacturing facilities conceptualizing your dream project according to budget and regulations.
During the initial planning stage, various questions come up like:
- How to design the right layout meeting requirements of men/material movement and at the same time ensure maximum utilization of usually scarce space?
- What should be the correct environmental cleanliness class, which is acceptable?
- How to design an air handling system meeting the requirements of room cleanliness classification and environmental protection?
- What should be the quality of water used?
- What should be the ideal water treatment method?
Based on the above discussion with the client, we will develop:
- Master Site Plan
- Preliminary layouts for facilities
- Size Process Equipment’s and outline basic specifications
- Define Environmental classification and Pressure Differential concepts
- Water treatment concepts
- Civil Finish Concepts
- Room Book
We can create simple engineering prototypes that are tailored to your functional and location needs and recommend cost-effective solutions that comply with regulatory requirements. The following project definitions will be defined during basic engineering:
- Alternative plant layouts which meet GMP requirements
- Men/material flow drawings on the approved layout
- Conceptual design paper on Heating, Ventilation, Air Conditioning, and Pressure Differential system with proposed Air Flow Diagram
- Conceptual design paper on treatment, purification, filtration, and distribution of various utility systems like Water, Steam, Compressed Air, Gases, Solvents, etc.
- Estimate requirements of various utilities
- Develop P&IDs for Process and Utilities
- Estimate Electric Power requirements for the plant and suggest High Tension and Low Tension Distribution schemes
- Conceptual design for ETP and Firefighting Systems
- Prepare civil finishes schedule
Our GMP Consultants will not provide the below services
- Detailed engineering
- Procurement assistance
- Project and construction management
- Qualification & validation
- Quality Assurance Procedures
- Quality Control Procedures
- Raw Material Specifications
- Finished Product specifications
- Packaging Material specifications
- Equipment Cleaning Procedures
- Manufacturing batch records
- In-process test specifications
- Stability Protocols
- Drugs Master File in CTD format
- Site Master file as per PIC/s & Local FDA requirement.
- Liaison with FDA for drug License
- WHO-GMP Product Certification.
- Schedule ‘M’ Requirements & documentation for compliance with Indian FDA’s norms
Training Programs on:
- Standard Operating Procedures –QA/QC/Manufacturing /Maintenance
- The job Training for QA/QC/Shop floor employees
- Process Validation
- Installation Qualification
- Operational Qualification Method Validation
- Facility Qualification
- Purified Water validation
- Current Good Manufacturing Practices (cGMP)
- Good Laboratory Practices
- How to prepare & face Regulatory audits
- WHO guideline
- Technology Transfer
- Statistical Process Control
(Drugs, Medical Device, Cosmetics & Food)
The modern era on the state of art manufacturing facilities (world-class facility) is designed and constructed in accordance with strict cGMP requirements.
Design, construction, and commercialization of cleanroom facilities are expensive processes that require detailed planning and resources. It also dictates the quality and compliance of products that are to be manufactured and their profitability over the long run. Therefore, these activities must be planned in detail with the end in mind, including the regulatory, project funding, the future expansion for the types of products according to intended commercial markets in addition to the facility’s country of location. After all, it would just be too cumbersome and expensive to make any significant changes to the facility design or construction after it is completed and has become operational if errors are found or worse, regulatory agencies deny its approval for manufacturing.
New Manufacturing Facility Layout Design
The GMP consultants are technical persons with many years of real-time work experience in the Pharmaceuticals and Medical Device Industries, so the consultants can understand the product and decide on how it should be followed. The facility is designed for…
- Compliance with leading regulatory Bodies
- Lean manufacturing Compliance
- Space utilization
- Uniflow movement of man, material, and finished products
- Easy access to materials and consumables
New GMP Manufacturing Facility Room Book.
Consultants prepare the room book, which contains correct and specific information about each room in particular.
- Area and Height
- Air classification with pressure differentials
- Cleanroom panel and specification
- Doors and Windows specification
- Room Temperature and Humidity
- Lighting and points
- Electrical connections and points
- HVAC ducts points
- Floor, Wall, Ceiling specification
- Drainage points
- Equipment installation points
Facility Design in Compliance with EU & FDA
Is your manufacturing facility GMP Compliant for future expansion or US FDA or EU regulatory compliance? We are regulatory consultants!
Medical Device EU & FDA Approved GMP Facility Experts
Table 1 ( International clients)
|World-Class Facility Design.
World-Class Facility suitable for manufacturers planning to take US FDA approvals and especially those targeting OEM business worldwide
Food & Cosmetics
0 to 3000 Sq. Ft
3000 Sq.Ft above
GMP Compliant Facility
Suitable for own manufacturing and marketing with GMP compliance
0 to 3000 Sq. Ft
3000 Sq.Ft above
Terms and Conditions refer below
- Site visit by the consultants from Bangalore or Chicago. If so, it will be billed on actuals.
- Payment – 40 % advance, 30 % after concept drawing, and balance after finalizing the layout.
- Method of communication – Telephone / Skype / G talk.
- Language for communication – British English.
- Documentation using an external Cloud server.
- Minimum Timeline – 30 Days.
- Service Tax Applicable as per Govt. rules.
Payment methods will be detailed in the Proposal/ Agreement.
The final Proposal will be sent after our understanding the project in detail by our team.