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Pharmaceutical Services

To enter the US market, a supplier of Active Pharmaceutical Ingredients (APIs) must fully comply with US Food and Drug Administration (FDA) regulations. While the DMF submission is a key milestone, this alone does not permit sale of an API in the US. The DMF supports the market application of the dosage form manufacturer. Only after a prospective customer's market application is approved by the FDA can the API manufacturer sell the API in the US.

A number of consulting firms are supplying low cost services to help companies compile and submit DMFs without having the requisite cGMPs and QA systems in place. This is particularly true in China which is presently adding DMFs at incredible pace only to see the first round of FDA scrutiny and QA failure. See Shanghai 15. Helping companies submit DMFs without the required QA systems is clearly unethical. Betterchem introduces a better solution… USActives.

cGMP Audits - Facility and Process Assessment

Our time-line begins with an audit/assessment of the manufacturing facility, processes, and controls. The audit has two principal objectives: 1. To assess the facility, equipment, and services from a design and engineering perspective, and 2. To evaluate cGMP compliance.

An API facility audit usually lasts 4 days with a fifth day devoted to a discussion of the findings. At that time, the client is advised to give the auditor a detailed summary of planned activities with estimates of time required to correct each compliance deficiency.

Audit Report/Recommendations

An audit report is prepared within 2 weeks of the assessment. The report includes findings and recommendations for corrective actions. A list of references to FDA and industry guides is provided by USActives.

API Manufacturer's Response

The API manufacturer typically takes 1-3 months to respond to the audit findings. The response should include a time-line for corrective actions which can be incorporated into the overall plan.

Action Plan

USActives takes the information provided above to revise the overall time-line. Our companies collaborate to develop an action plan which incorporates recommendations from the audit, the API manufacturer's course of action, and their plans for selling to specific US customers. USActives also develops a regulatory strategy for consideration by the API manufacturer. This phase should take 1 month to complete.

Know-How Transfer: Protocols, Prototypes, Guidances

With the cGMP baseline established and planning completed, USActives oversees the 2-way transfer of know-how. The first phase emphasizes the review of API procedures, protocols, and reports. USActives supplies guidance and guidelines, where needed. When possible, prototypes are provided to ensure appropriate format and content. The transfer phase typically lasts 6 months.

Data Review

USActives provides a list of records, reports, analyses, and studies that would be reviewed as the first step toward drafting a DMF. This includes master and batch production records, validation reports, release analyses, and stability studies. Upon receipt, USActives makes recommendations to improve compliance with FDA policy. Data review and revision typically takes 1-2 months.

This work leads directly to…

Type II DMF Drafting, Review, and Verification

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