Contamination and Cross Contamination in Pharmaceutical Industry

Contamination or Cross-contamination could be an outcome of accidental mix-up of starting material, intermediate, or finished product with foreign material, with other products’ starting material or other product.

The contributory factors for contamination or cross-contamination could be human, facility, procedure, equipment, or utility. The contamination and cross-contamination could occur at any stage, starting from raw material sources to the packaging of pharmaceutical products.

Contamination or cross-contamination chance in pharmaceutical industry is a major regulatory observation. It may comes from lack of cleaning validation and verification studies and/or inaccurate facility design.

Read also: Cleaning Validation in Pharmaceutical Industry

The contamination or cross-contamination could occur during:

1. Material transportation and receipt at a manufacturing facility

2. Storage

3. Sampling

4. Dispensing

5. Manufacturing

6. Packaging

The outcome of the Quality Risk Management process should be the basis for determining the extent of technical and organizational measures required to control risks for cross-contamination. For example, cross-contamination can be prevented within a manufacturing facility by;

1. The robust design of the facility

2. Equipment

3. Utility

4. Material movement

5. Personnel movement

6. Manufacturing procedure

7. Cleaning procedures

Read also: GMP Facility Design and GMP Golden Rules

Resource Person: Rizwan Naqvi