Well, this is the hot water's topic in the pharma industries. Skip testing is aligned with regulatory guidelines (e.g., ICH Q6A, FDA) which supports reduced testing frequency for products with established consistency.
Now come back to the question, "What is Skip Testing"?
Skip testing is a strategy where routine testing of batch-to-batch is reduced or omitted based on strong historical data, validated processes and a risk-based approach.
Skip testing in Microbial Limit Test (MLT) is implemented to optimize resources while ensuring consistent product quality and compliance with regulatory standards.
Why does ICH Q6A & FDA support Skip Testing?
Validated and Controlled Processes:
Pharmaceutical products, especially non-sterile forms, are manufactured using validated processes with robust quality controls, reducing the likelihood of microbial variability.
Consistent compliance in microbial limits over time can justify reduced testing frequency.
When should Skip Testing be used?
Consistent Compliance:
Applicable to products or materials with a strong record of meeting microbial limit requirements.
Low-Risk Products:
Products with low microbial growth potential (e.g., capsule pellets, tablets).
Robust Monitoring:
Environmental monitoring and periodic verification of microbial limits are required to ensure continued compliance.
Periodic Review:
Skip testing practices must be periodically reviewed to ensure ongoing suitability LIKE EVERY 3RD, 5TH OR 10TH BATCH should be reviewed.
Skip testing is a strategic tool but must be applied judiciously to ensure product safety and compliance.
Rationale for Skip Testing in Non-Sterile Products
Low Microbial Risk Profile:
Non-sterile products often have intrinsic properties (e.g., low water activity, antimicrobial preservatives) or process controls that reduce microbial risks significantly.
Historical Data and Process Validation:
Long-term historical testing data from the same product, raw materials or process consistently meeting microbiological limits confirms the predictability of outcomes.
Regulatory Flexibility:
Regulatory agencies (ICH Q6A, FDA) recognize that certain low-risk products do not need batch-by-batch microbiological testing, provided robust scientific evidence supports this approach.
Any proposal to implement skip testing must ensure it does not conflict with these regulatory requirements.
Limitations of Skip Testing:
Skip testing should only be applied after thorough risk assessment and justification. If there are process changes, deviations or OOS results, full testing must be reinstated until stability is re-established.
Read also: Interview Questions and Answers On Microbiology In Pharmaceutical Industry
