1. Environmental Monitoring  

This involves the testing and monitoring of the manufacturing and storage environment to ensure that it is free from any potential sources of contamination that could adversely affect the quality and safety of the products being manufactured. Environmental monitoring involves the collection and analysis of various samples, including air, surfaces, and water. 

Air Sampling: It involves the collection of air samples from various locations within the manufacturing and storage areas using specialized air samplers. The air samples are then analyzed for the presence of microbial contaminants, such as bacteria and fungi, which can pose a significant risk to product quality. 

Surface Sampling: This involves the collection of swab or contact plate samples from various surfaces within the manufacturing and storage areas, including walls, floors, and equipment. The samples are then analyzed for the presence of microbial contaminants, which can indicate the presence of potential sources of contamination. 

Water Sampling: It involves the collection of water samples from various sources, including purified water systems, cooling water systems, and process water systems. The samples are then analyzed for the presence of microbial contaminants, as well as chemical and physical parameters, such as pH, conductivity, and total organic carbon.  

2. Equipment Calibration 

The calibration process involves comparing the measurements produced by the equipment being calibrated to a known standard or reference value. If the measurements produced by the equipment are not within an acceptable range of the reference value, adjustments are made to the equipment to bring it into compliance. The calibration process also involves documenting the results of the calibration and any adjustments made to the equipment. 

The calibration process should be carried out by trained personnel using calibrated reference standards and appropriate calibration procedures. The calibration process should also be carried out in a controlled environment to minimize the impact of external factors, such as temperature and humidity, on the calibration results. 

3. Pest Control 

Effective pest control in the pharmaceutical industry involves the implementation of a comprehensive pest management program that includes several key components 

To perform this identifying the types of pests present in the manufacturing and storage areas is crucial. After this Prevention measures may include sealing entry points, eliminating sources of food and water, and implementing good sanitation practices. Then chemical control is performed and this may include the use of insecticides, rodenticides, and bird repellents. Chemical control measures should be carried out by trained personnel and should be used in accordance with industry standards and regulatory requirements. 

4. Safety Audit  

The audit involves a comprehensive assessment of the electrical installations and equipment in the facility to identify such as faulty wiring, overloaded circuits, and equipment malfunction, that can pose a significant risk to personnel and property. The audit can also ensure compliance with industry standards and regulatory requirements, such as the National Electrical Code (NEC) and the Occupational Safety and Health Administration (OSHA) standards. 

These audits include reviewing documentation, visual inspection, electrical testing, analysis of results, reports and recommendations 

5. Fire Safety Audit 

A fire safety audit involves a comprehensive assessment of the facility to identify any potential fire hazards and ensure compliance with industry standards and regulatory requirements. 

This audit includes reviewing documentation, visual inspection, evaluation of fire protection equipment, analysis of results, report and recommendations.  

6. Water Management Audit  

A water management audit involves a comprehensive assessment of the water systems in the facility to identify any potential water quality issues and ensure compliance with industry standards and regulatory requirements.  

This audit includes reviewing documentation, visual inspection, water sampling, evaluation of water treatment processes, analysis of results, report preparation and recommendations.  

7. HVAC System Audit 

The HVAC (heating, ventilation, and air conditioning) system is a critical component of the facility’s infrastructure, providing controlled environments for the manufacturing, testing, and storage of pharmaceutical products. An HVAC system audit involves a comprehensive assessment of the HVAC system to identify any potential issues and ensure compliance with industry standards and regulatory requirements, such as the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) standards and the Occupational Safety and Health Administration (OSHA) standards. 

This audit includes reviewing documentation, visual inspection, Airflow and temperature testing, evaluation of air filtration, analysis of results, report and recommendations.  

8. Chemical Handling Audit 

The audit involves a comprehensive assessment of the processes and procedures involved in the handling, storage, and disposal of chemicals in the facility. The goal of the audit is to identify any potential hazards and ensure compliance with industry standards and regulatory requirements. This involves reviewing documentation, visual inspection, monitoring chemical inventory, training personnel, analysis of results, report preparation and recommendations.  

9. Microbiological Testing  

It involves the analysis of microbial contamination in various pharmaceutical products, including raw materials, finished products, and manufacturing equipment. The goal of microbiological testing is to ensure that the products are free from microbial contamination and meet industry standards and regulatory requirements. 

This involves sample collection, preparation of samples, microbial identification, analysis of results, report preparation and recommendation.