Pharma Plant Setup consultant for all over India.

 Pharma Plant Setup consultant all over India.

Laafon Galaxy provides pharma plant setup scientific consultancy for all of India. It has a team of technical experts in the field of pharma plant setup. The company provides every service for pharmaceutical companies, cosmetics plants, Ayurvedic manufacturing companies, Food plant FSSAI, and Medical Devices Companies. 

Laafon Galaxy has experience in setting up more than 200 pharmaceutical companies in India with different dosage forms, they have a vast service base in this field. They have a team of experts who possess extensive knowledge and experience in the field of pharma manufacturing. 

They have deep knowledge of the various processes involved in pharmaceutical manufacturing plant setup. They are able to provide valuable insights and helpful guidance to ensure the project will be executed successfully.

Pre Project Planning

Laafon Galaxy team provides pre-project planning to the business owner so that they can modify their project in the best way. Some key aspects are covered in Pre-Project Planning:

• Market Research
• Site Selection
• Budgeting
• Feasibility Study
• Regulatory Compliance

Design and Engineering

A good consultant is one who starts with a perfect design. Every successful project was built upon an error-free design. Design and Engineering are significant factors in the plant setup process. Laafon Galaxy works in the following manners while the inception of plant setup:

1. Conceptual Design
2. Basic Engineering Design
3. Detailed Engineering Design
4. Procurement

Construction of building and plant

Construction of the building is a time taking and lengthy process. This process requires a high level of supervision and a lot of effort by the consultancy team. Generally, the construction process is based on the following steps:

• Layout Maps
• Designing
• Civil work
• Mechanical work
• Electrical Work
• Commissioning

Validation and Qualification

After completion of civil work installation of machinery takes place. Simultaneously Validation and Qualification of machines, HVAC system, and documentation starts. It is an essential job in the view of Regulatory compliance for obtaining the manufacturing license. It is a core scientific process that requires a high level of expertise in the subject.

Qualification of manufacturing and laboratory equipment is also associated with the above process. To meet the norms of compliance each machine needs its IP/PQ/OQ before going to License audit. The IP/PQ/OQ record is to produce before the auditing team to ensure that the equipment meets the GMP guidelines. 

Process Validation is also a due process before Drug License final audit by FDA officers. Similarly, cleaning validation of all machines and premises is also carried out. A documented proof of all processes is maintained for the reference of audit compliance. 

Operation and Maintenance

Pharmaceutical plant setup is a scientific job that needs a bunch of documentation along with supervision. Many operations and maintenance tasks are completed for a successful project setup. Some of the key processes are:

1. Training of staff is an essential part of the consultancy team. A competent team of manufacturing, quality control, and quality assurance departments is required to run a pharma unit.
2. Maintenance of machines, AHUs, HVAC systems, Utility, and Quality Control equipment is performed by the consultancy firm.
3. Documentation is another duty of the team to help obtain the manufacturing license and other accreditation certificates. A long list of documents is to prepare including SOPs, Validations, MFRs, IQ/OQ/PQ, calibration of equipment, product list, and application of FDA license, etc.

 All consultancy services for the setup of the plant:

All plant premises are designed as per the client’s product and production capacity needs.

• Civil Architect Plan.
• Clean Room Plan.
• HVAC plan for a pharmaceutical plant.
• Complete Plumbing plan.
• Whole electrical Plan
• Equipment/Machinery Plan
• The special design of the facility is as per US-FDA, EUdraLex, PICS-GMP, CE, MDR Rules 2017, and WHO-GMP Guidelines.

You will get the design of the facility in such a way no cross-contamination or mix-up of products can happen. and the process can take place in areas connected in a logical order corresponding to the sequence of operations and to the requisite cleanliness levels.

Regulatory Services for all industries are available here:

A well-trained team of Regulatory affairs officers is available for all regulatory services required in pharmaceutical companies.  following services are provided here:

• For grant of Drug Mfg. License on Form 25 & 28.
• Cosmetic mfg. License on Form 32.
• Ayurvedic (Ayush) License on Form 25D.
• Drug Loan License
• Medical devices License on Form MD-5 & MD-9

Also Read: Pharmaceutical formulation plant for Sale in North India

All certification services for different types of companies.

If you are looking to register your company in an overseas market or like to export your products to many Asian countries including Russia, we provide all consultant services to prepare plans and documents for the particular services like:

1. WHO-GMP certification
2. GMP certification
3. US-FDA
4. UK-MHRA
5. Documents service for pharmaceutical plants
6. All SOPs for process and types of machinery and Lab equipment
7. Validation of Lab equipment, mfg. machinery, and Process Validation
8. MFR for all dosage forms in Pharmaceutical companies.
9. AHU process validations 
10. HVAC system validation and Qualifications.
11. Calibration of Instruments documents
12. Site Master File
13. Products Stability studies data and reports.
14. COPP for the export of products
15. Products Dossiers for export purposes
16. WHO-GMP audits checklist compliance
17. Renewal and new GMP certifications

Related Post: Pharma units for sale in Baddi

Summary

The pharma plant setup process is a purely scientific task, and hiring a consulting team is crucial work. A good consultancy firm will work from Pre-Project planning to the final audit for Drug licenses in a systematic way. Each step in the plant setup process is equally important.

The construction of the building is not less important than Validation and Qualification or documentation. Therefore, consistent focus and supervision by consulting agencies are primarily important. 

Business owners should never underestimate the role of the consultancy in the pharma plant setup project. It will cost very high if you skip hiring a consultant for your project. The duration of the project will increase and the total cost will also increase. 

References

1. Pharmaceutical Manufacturing Handbook: Production and Processes" by Shayne Cox Gad
2. "Handbook of Pharmaceutical Manufacturing Formulations: Semisolid Products" by Sarfaraz K. Niazi
3. "Pharmaceutical Production: An Engineering Guide" by Ellis Horwood
4. "A Practical Guide to Pharmaceutical Facilities Design" by S. Kayser and S. Seddon
5. "Pharmaceutical Process Validation: An International Third Edition" by Robert Nash and Alfred H. Wachter
6. "GMP-Qualifizierung und Validierung von Wirkstoffanlagen" by Wilhelm W. Huisinga (German language)
7. "Pharmaceutical Engineering: Practical Pharmaceutical Engineering for Chemists, Chemical Engineers, and Pharmacists" by James H. Black and Michael J. Groves
8. "Pharmaceutical Dosage Forms and Drug Delivery Systems" by Howard C. Ansel and Mitchell J. Stager
9. International Society for Pharmaceutical Engineering (ISPE) - https://ispe.org/
10. Pharmaceutical Online - https://www.pharmaceuticalonline.com/
11. Pharmaceutical Technology - https://www.pharmtech.com/
12. Journal of Pharmaceutical Sciences - https://www.jpharmsci.org/

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