Introduction
Certain pharmaceutical products are inherently light-sensitive, meaning they degrade or lose potency upon exposure to light, especially UV and visible wavelengths. This sensitivity can affect both active pharmaceutical ingredients (APIs) and finished dosage forms, resulting in chemical instability, loss of efficacy, or the formation of harmful degradation products. Ensuring the protection of such products from light exposure throughout the product lifecycle is critical to maintaining quality, safety, and regulatory compliance.
International guidelines, such as ICH Q1B (Photostability Testing of New Drug Substances and Products), USP <1079>, EU GMP, and WHO TRS, mandate appropriate controls and validation for handling, packaging, and storing light-sensitive products. These include the use of light-protective primary packaging (e.g., amber vials, aluminum strips), controlled lighting in production areas, and transport/storage protocols that prevent unintended light exposure.
Risks associated with poor handling of light-sensitive products include:
- API degradation during sampling, manufacturing, or filling
- Reduced potency or therapeutic effect due to prolonged light exposure
- Appearance changes, such as color shifts, that indicate instability
- Formation of toxic degradation products
- Regulatory non-compliance, leading to product recall or rejection
This risk assessment is designed to evaluate the potential hazards, failure points, and control weaknesses related to the management of light-sensitive products across the pharmaceutical workflow. By using tools such as 6M analysis (Man, Machine, Method, Material, Measurement, Milieu) and FMEA (Failure Modes and Effects Analysis), this assessment will:
- Identify risk points in material handling, processing, sampling, and storage
- Review packaging suitability and photostability data
- Evaluate equipment lighting, personnel training, and environmental controls
- Assess the adequacy of SOPs, labeling, and transport protocols
- Recommend mitigation strategies, including engineering controls and validation enhancements
The goal is to ensure that light-sensitive products are consistently protected from light exposure through robust procedural and technical controls, safeguarding their quality, stability, and patient safety in line with global regulatory expectations.
