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Risk-based Contamination Control Strategy of Manufacturing Non-sterile Pharmaceutical Products

When developing a Contamination Control Strategy for non-sterile pharmaceutical products, it's essential to start by identifying potential causes of contamination. Utilizing tools like the Ishikawa (fishbone) diagram helps structure the thought process and identify various root causes.

Equipment-Related Causes of Contamination

1. Inadequate Equipment for the Process

One of the primary equipment-related causes of contamination is the use of machinery that may not be suitable for the intended process. This can lead to improper containment or handling of materials, increasing the risk of contamination. To address this issue, it is imperative to ensure that equipment is selected and designed with contamination control in mind. Regular assessment of equipment's appropriateness for the processes is essential to prevent contamination.

2. Untrained Personnel for Cleaning of the Equipment

Cleaning is a critical step in preventing contamination in non-sterile pharmaceutical manufacturing. Untrained personnel may not execute cleaning procedures correctly, leaving behind residues or contaminants. Comprehensive training programs should be in place to educate cleaning staff on the importance of their role and the proper techniques for effective cleaning.

3. Non-Existing Plan for Regular Checks of the Laminar Flow

Laminar flow cabinets play a crucial role in maintaining a clean and controlled environment during pharmaceutical manufacturing. Without regular checks and maintenance, the laminar flow's effectiveness can degrade, allowing contaminants to enter the workspace. Implementing a preventive maintenance plan and scheduled checks can help ensure the laminar flow remains efficient.

4. Inadequate Materials of the Parts That Are in Contact with the Product

Inadequate materials may react with the product or degrade over time, potentially leading to contamination. Ensuring that all materials in contact with the product are of the highest quality and compatibility is vital for contamination control.

Equipment-related causes, as identified through the Ishikawa diagram, present a significant area of concern. To address these causes and minimize the risk of contamination, pharmaceutical manufacturers should focus on equipment selection, cleaning validation, personnel training, laminar flow maintenance, material compatibility, cleaning agent selection, and SOPs. By addressing these aspects comprehensively, pharmaceutical companies can enhance product quality, safety, and consumer trust.

Read also: ECA Guideline on Contamination Control Strategy (CCS)

Resource Person: Martina Gjorgjevska

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