Rapid Methods - Regulatory Considerations

Regulatory Approvals
Celsis Rapid Detection Systems offer proven technologies that have been employed by some of the world's top pharmaceutical and personal care companies for years. Celsis has worked with regulatory bodies in the US, Europe and elsewhere to help educate and refine positions on rapid method detection in the manufacture and development of pharmaceutical products.

Celsis rapid detection products and services have delivered significant cost savings and improved quality control to many organizations within the regulatory parameters of their products and respective agencies. To date, more than 50 pharmaceutical customers have incorporated Celsis Rapid Detection Systems into their regulatory proposals. These submissions cover a variety of agencies, under a number of submission types. Included in these filings are at least 10 successful NDA / sNDA / sBLA submissions and approvals.

FDA Guidance for Industry

"Other suitable microbial test methods (e.g. rapid test methods) can be considered for environmental monitoring, in-process control testing, and finished product release testing after it is demonstrated that the methods are equivalent or better than traditional methods (e.g. USP)."
US FDA, September 2004

Celsis Regulatory Services
Celsis takes an active role in regulatory discussions with agencies and our customers around the world. Celsis has dedicated regulatory personnel and resources available to consult and assist with the implementation of Celsis Rapid Detection Systems within your company.

Validation Services
To ensure that the value of the Celsis system is realized as quickly as possible, Celsis is uniquely positioned to offer the optional services of the Celsis Laboratory Group to perform methods validation work. Since the benefits of rapid methods are not realized until the technology is implemented, the option of outsourcing validation has been increasingly utilized by our customers. Our laboratory facilities are FDA-registered and operate under cGMP standards.

Pharmaceutical Experience

• FDA has accepted two Drug Master Files (DMFs) submitted by Celsis
• Celsis customers can ease the regulatory approval process by referencing the DMF when submitting applications or supplements to the FDA
• More than 50 Celsis pharmaceutical customers have incorporated Celsis Rapid Detection Systems into their regulatory proposals
• Recognized by FDA / EMEA and multiple international regulatory agencies
• 10 successful NDA / sNDA / sBLA submissions and approvals

PDA Technical Report
Celsis led, along with numerous industry leaders and regulators, the Parenteral Drug Association (PDA) Task Force to define guidelines on introducing rapid methods into the pharmaceutical industry. These are published as the PDA Technical Report No. 33, 'The Evaluation, Validation and Implementation of New Microbiological Test Methods', which is used by industry and regulators as the 'best practice guide'. This document has strongly influenced the current draft chapter in the United States Pharmacopeia (USP) 'Validation of Alternative Microbiological Methods'.

Read a review of the report

Purchase a copy of the PDA Technical Report No. 33

Please visit the Celsis Case Studies page to find further regulatory articles