Softgel manufacturing is a regulated industry that requires strict adherence to various regulations and compliance requirements. These regulations and requirements are in place to ensure that the softgel capsules produced are safe, effective, and of high quality. Here are some of the main regulations and compliance requirements that softgel manufacturers must follow:
- Good Manufacturing Practices (GMP)
GMP is a set of regulations and guidelines that ensure that pharmaceutical products, including softgel capsules, are consistently produced and controlled according to quality standards. Softgel manufacturers must comply with GMP regulations, which cover all aspects of the manufacturing process, including facility design, equipment maintenance, personnel training, and documentation.
- Quality Control (QC) Testing
Softgel manufacturers must perform rigorous quality control testing on their products to ensure that they meet the required quality standards. QC testing includes testing for identity, potency, purity, and dissolution rate. Softgel manufacturers must also perform stability testing to ensure that their products remain stable and effective throughout their shelf-life.
- Record Keeping and Documentation
Softgel manufacturers must maintain detailed records and documentation of their manufacturing process, including batch records, validation reports, and QC testing results. These records and documents must be maintained for a specified period and must be available for inspection by regulatory authorities.
- Regulatory Authority Inspections
Regulatory authorities, such as the FDA in the US, conduct regular inspections of softgel manufacturing facilities to ensure compliance with regulations and guidelines. Inspections can be scheduled or unannounced and can cover all aspects of the manufacturing process, including facility design, equipment maintenance, personnel training, and documentation.
- Environmental and Occupational Health and Safety (EHS) Regulations
Softgel manufacturers must comply with environmental and occupational health and safety regulations to ensure the safety of their employees and the environment. EHS regulations cover aspects such as waste disposal, air and water quality, and the use of hazardous materials.
- International Standards
Softgel manufacturers must also comply with international standards such as the International Conference on Harmonisation (ICH) guidelines. These guidelines provide a harmonized approach to the development, testing, and registration of pharmaceutical products, including softgel capsules.