GMP OTC Lot Release

GMP OTC Testing Services

Compliant quality testing is crucial for manufacturing Over-the-Counter products (OTCs) to ensure safety, efficacy, and regulatory adherence. As an FDA-registered GMP drug facility and ISO 17025 accredited laboratory, Microchem is dedicated to maintaining the highest standards of quality and reliability. Our comprehensive testing suite provides confidence to manufacturers and consumers alike that OTC products are rigorously evaluated and meet all necessary regulatory requirements.

 

OTC Testing

• USP 61: Standard Microbial Enumeration
• USP 62: Detection of Specified Microorganisms
• USP 61 and 62 Validated Analog: Hybrid and rapid method for routine microbial testing
• USP 60: Detection of Burkholderia cepacia complex (BCC)
• USP 51: Preservative Efficacy Test for OTCs
• DNA Sequencing: Contaminant Speciation

Method Suitability

Suitability tests are a critical step in the testing of Over-the-Counter (OTC) products. This process guarantees that the testing method is appropriate for the specific product, providing assurance of the microbial safety and overall quality of OTC products for consumers.

In a suitability test, a known concentration of microorganisms are intentionally introduced into finished products and ingredients in controlled, low quantities. The inoculated sample is then put through its applicable test and the recovered microbial counts are compared to the expected counts. If the results are consistent, the method is confirmed to be compatible with the OTC product, ensuring it meets the FDA’s requirement for method verification.

We recommend conducting the suitability step once per formula.

Preservative Efficacy for OTC Products

Ensuring a product’s preservative system can withstand microbial contamination over time is essential for consumer safety and regulatory compliance. Preservative Efficacy Testing (PET) plays a crucial role in product development, particularly for liquid OTC products. The standard USP 51 test challenges the product with five representative microorganisms and assesses its ability to inhibit their growth over a specified period. This rigorous analysis ensures that the product remains safe and effective throughout its shelf life, providing confidence to both manufacturers and consumers.

Facility Environmental Monitoring Support for OTC Manufacturers

Routine monitoring of a manufacturing facility involves air sampling, water sampling, and swab studies to ensure a controlled environment. Microchem excels in comprehensive environmental monitoring services, offering everything from complete cleanroom disinfection validations to settling plate analysis. Implementing thorough and routine facility microbial monitoring plans is essential for detecting and addressing any vulnerabilities in your manufacturing process, ensuring consistent product quality and consumer safety.

Working with Microchem

For 30 years, Microchem has been a key player in the testing industry, successfully guiding clients to market and navigating microbial contamination challenges. Trust Microchem’s skilled microbiologists to bring your products to market with confidence. Whether you are in the product ideation phase or ready for distribution, maintaining microbial vigilance is crucial to prevent adverse events and ensure product safety. Contact our lab today to learn more.