THANKS FOR HELP IN PHARMA

1. Clean Room Handbook
2. Cleaning Methodology & Validation (Best Practices Documents)
3. Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs
4. Installation Qualification Protocol for Automatic Polarimeter
5. Operating Procedure for Air Handling Units, Exhaust, Supply and Ventilation Units
6. SOP for Preparation of Media
7. Study Title PDE Determination for Benzyl Penicillin
8. Problem in Tableting
9. Flow diagram of water pre-treatment-plant
10. Qualification of Analytical Instruments
11. SOP for Validation Master Plan
12. US FDA 483 observations on Microbiology
13. BMS

Our pharmaceutical manufacturing facility is designed to produce high-quality medicines in a safe, controlled and compliant environment. The plant is divided into clearly defined areas for material receipt, dispensing, granulation, compression, coating, primary and secondary packing, with unidirectional flow of men and material to minimise mix-ups and cross-contamination.

All critical operations are performed under classified HVAC conditions with validated temperature, humidity and differential pressure controls. HEPA-filtered air, pressure cascades and restricted access help maintain the required cleanliness levels. Cleaning and line clearance procedures are documented and followed before every batch, as per Good Manufacturing Practices and approved SOPs.

Raw materials and packaging materials are sourced from qualified vendors and quarantined until they are sampled, tested and released by Quality Control. In-process checks are carried out at defined stages to ensure that products consistently meet predefined specifications. Finished products are released only after thorough review of batch manufacturing records, analytical reports and deviation or change control, if any, by Quality Assurance.

All equipment, utilities and computerized systems are qualified and maintained through planned preventive maintenance and calibration programmes. Personnel are trained regularly on GMP, safety, data integrity and hygiene practices, with training effectiveness monitored and documented.

Comprehensive documentation, internal audits and management review ensure ongoing compliance with applicable regulatory requirements and company standards. The facility promotes a strong quality culture where each employee is aware of their role in protecting the patient and the product. Environmental, health and safety aspects are managed through appropriate controls, emergency preparedness and continuous monitoring, with emphasis on reducing risks at source and promoting safe behaviour.

The overall focus of the facility is to ensure patient safety, product quality and regulatory compliance through a robust quality management system, risk-based thinking and continuous improvement.