The Active Pharmaceutical Ingredient (API) end user supply chain security is a critical component to getting the finished dosage to market. Not only is this an expectation of the FDA, and US Customs, but supply chain security maintains continuity of product supply and uninterrupted business.
A full-service generic API supplier like ChemWerth fully understands the importance a well-documented API has in getting customers to market. It takes years of experience to create robust systems to ensure supply chain security — from processes and procedures used to move the product globally in a traceable and GMP-compliant manner, to ensuring the manufacturer of the API is fully GMP compliant at all times. Excellent documentation is paramount to success.
ChemWerth’s regulatory team has nearly 40 years of experience in all facets of Drug Master File (DMF) documents. We understand that DMFs filed with the FDA need to be accurate and current, and that finished dosage users referencing approval documents have to work with speed and urgency, but can’t afford a misstep with the DMF.
Securing the supply chain means that discipline, diligence, expertise and compliance are applied from start to finish. Consider the ChemWerth processes and protocols that are implemented to secure the chain: from regulatory affairs to product manufacturer GMP compliance to ChemWerth’s proprietary GMP compliance to logistics.
Below is a breakdown of ChemWerth’s detailed approach to securing the supply chain.
- ChemWerth’s regulatory experts have the knowledge to file and maintain API regulatory submissions in virtually any regulated market in the world. In fact, ChemWerth has filed DMFs in 38 countries.
- ChemWerth’s speed to market is unmatched in the industry, with our average end user supported ANDA approval occurring in only one regulatory review cycle. The industry average is more than two cycles.
- The experience of our regulatory staff and good working relationship with the FDA enable ChemWerth to address regulatory issues and expedite regulatory approvals quickly.
- Our close relationships with our represented manufacturers allow us to respond quickly and accurately in all aspects of regulatory submissions. We often solve customer problems within 24 hours.
- Regulatory submissions filed by ChemWerth are prepared by our regulatory teams in coordination with product manufacturers. This ensures the most accurate and technically sound submission possible.
- ChemWerth’s regulatory group is well-versed in the GDUFA law and ensures that all required ChemWerth-represented API suppliers are self-identified with the FDA and that facility fees are paid. In addition, ChemWerth ensures that all submitted DMF fees are paid and that they pass initial FDA review in a timely manner.
Product Manufacturer GMP Compliance
With more than 500 GMP audits performed, ChemWerth has an experienced compliance auditing staff, which ensures that all of our represented manufacturers are in compliance with applicable GMP regulations.
- ChemWerth has internal procedures that are used to perform routine GMP audits of our represented manufacturers. Typically, each manufacturer is audited on a 3-, 6-, 9- or 12-month audit cycle. This auditing program is based on the FDA’s six system quality inspection approach and significantly reduces the risk that our API manufacturers will fail an agency inspection, which would interrupt API supply to our customers.
- ChemWerth’s audits include an Audit Agenda, Audit Report and a Corrective Action Report (CAR), which includes major and minor recommendations. This CAR is issued at the conclusion of our audit and manufacturers are required to respond in full within 30 days. Based on the result of our audit, manufacturers are classified for acceptability by ChemWerth. ChemWerth will not supply from a manufacturer that does not have adequate controls in place to ensure overall product quality.
- In addition to performing our own internal GMP audits, ChemWerth welcomes the opportunity to arrange, work with and accompany an audit by one of our customers of a represented manufacturer. ChemWerth provides a GMP-trained staff member to coordinate all audit logistics and accompany the customer auditor during the audit. We work with the manufacturer to ensure that all CAPAs are carried out in a timely manner.
- ChemWerth works with FDA inspection teams to coordinate their inspection of our represented manufacturers. We also attend regulatory agency inspections (FDA, EDQM, etc.) as needed and act as a liaison to ensure inspections proceed as smoothly as possible. ChemWerth works with manufacturers to respond to any audit observations in a complete and effective manner.
ChemWerth Internal GMP Compliance
ChemWerth realizes that as part of the supply chain, our company is also responsible for maintaining applicable GMP compliance in addition to our product manufacturers’ GMP compliance. ChemWerth’s internal global operations are fully GMP compliant according to requirements set forth in ICH Q7: “GMP Guide for Active Pharmaceutical Ingredients” for pharmaceutical distributors, as well as USP’s “Good Distribution Practices”. This internal GMP control includes the following:
- Global operations are completely controlled by internal Standard Operating Procedures (SOPs) and quality systems, which include control of logistics and all regulatory-, compliance- and quality-related activities. These include, but are not limited to, the following:
– Customer change communication
– Product recall
– Quality complaint handling
– Product labeling control
- Logistics procedures are fully maintained to ensure complete traceability of all distributed material.
- Quality agreements are in place with all of our API manufacturers.
A major part of our internal SOPs and systems involves product logistics, which ChemWerth knows is a very crucial aspect of a supply chain. The following activities are critical:
- The ability to move product from one location to another in a seamless fashion, especially from one country to another with the varying import requirements of each country.
- The ability to perform product return and replacement functions quickly.
- The ability to limit FDA custom “Holds” and get shipments cleared as quickly as possible.
- The ability to ensure that all API products meet their applicable monograph/standard and are always labeled and packaged correctly. Any product damage is dealt with swiftly.
- The ability to maintain logistics procedures, ensuring complete traceability of all distributed material.
- The ability to track all product inventory at all of our global API suppliers. This ensures that API is restocked when inventory runs low, thus ensuring efficient delivery lead times.
- ChemWerth is C-TPAT certified, which enables us to streamline and shorten delivery lead times even further. It also provides heightened security of all shipments.
For nearly 40 years, ChemWerth has earned the trust of some of the largest generic pharmaceutical companies in the world. We invite you to compare and contrast your current API supplier’s knowledge and expertise with ours. We’ll get you to market … and keep you on the market.