Dear Sirs,
I am working in a small API manufacturing unit, recently I audited (Internal Quality Audit)our purchase department, during the course of audit, found one of the key raw- material (a solvent) was procured from an imports and exports agency, the material manufacturer is unknown and a third party Certificate of Analysis is available. When we requested the supplying agency to give the details of manufacturer, the supplier says that traders are buying materials from different manufacturers and unloading the materials in one container and the same is certifying by third party laboratory, hence it is difficult to find out the manufacturer of the material. Now In this circumstances I would request the forum members,
How to qualify the supplier without knowing the manufacturer details for the key raw-materials?
And is it sufficient a third party Certificate of Analysis for the materials.
Kindly suggest.
T.Nageshwar
[quote=nageshwar]Dear Sirs,
I am working in a small API manufacturing unit, recently I audited (Internal Quality Audit)our purchase department, during the course of audit, found one of the key raw- material (a solvent) was procured from an imports and exports agency, the material manufacturer is unknown and a third party Certificate of Analysis is available. When we requested the supplying agency to give the details of manufacturer, the supplier says that traders are buying materials from different manufacturers and unloading the materials in one container and the same is certifying by third party laboratory, hence it is difficult to find out the manufacturer of the material. Now In this circumstances I would request the forum members,
How to qualify the supplier without knowing the manufacturer details for the key raw-materials?
And is it sufficient a third party Certificate of Analysis for the materials.
Kindly suggest.
T.Nageshwar[/quote]
Dear Mr.Nageshwar
Please note key starting material is a structural fragment in the final product, So utmost care shall be taken for procurement of key starting material. All the Agents, brokers, distributors, re packers, relabelers which are involved in the KSM supply chain should be qualified as per regulations. Distributor doesn’t have the rights to blend the materials with two different manufacturers the blended material third party analysis becomes invalid.
The distributor/trader should have the traceable information of supplied product and manufacturer details, there is no exemptions for the same.
To avoid this type of incidents the risk in the supply chain should be evaluated and mitigated. The shorter supply chain will be more secure.
Pls refer the following attachment to know the role of supply chain in the sourcing.
[attach]329[/attach]
Thanks and regards
Quick guide for API sourcing.pdf (70.6 KB)
Congress must grant the FDA additional powers to bring oversight of manufacturing inline with shifts in production practices, according to a report.
In a report titled After Heparin , Pew Health Group breaks down current weaknesses in the supply chain and proposes fixes. Empowering the US Food and Drug Administration (FDA) is one of the main themes of the Pew report.
“Congress must institute reforms to ensure that the FDA’s oversight of overseas manufacturing is increased, and that industry is held accountable for the security and safety of increasingly globalised and outsourced supply chains”, concludes the report.
Giving the FDA the power to force a drug recall is one of the extra regulatory authorities called for by Pew. The other is the power to subpoena witnesses and documents to quicken investigations into drug product quality.
Pew also calls on the FDA to significantly increase the rate of foreign inspections and, if possible, make unannounced visits. Ideally, the FDA will be given resources to conduct these inspections but, acknowledging this is unlikely in the short-term, Pew proposes some workarounds.
Manufacturer registration fees could be an extra income source to support an uptick in overseas inspections. Using this extra funding the FDA could pay independent third-party inspectors to visit overseas production plants. Collaboration with other regulators could also help.
“The FDA could immediately alleviate resources by reducing its inspectional activity in the EU by relying on the results of inspections carried out by European regulators”, one person told Pew. As in-PharmaTechnologist revealed last month , Europe has made this proposal to the FDA.
Industry action
Industry also has a significant role to play. Many experts told Pew “you cannot inspect quality into a product; it must be built in to every process”. Improvements in quality systems, subcontractor agreements, supplier audits, supply chain documentation and testing can help meet this goal.
“There was strong agreement that manufacturers must be held accountable for their full supply chain and that they need to have concrete knowledge of suppliers when they are selected”, said Pew.
Greater transparency is also needed. Sharing of information on suppliers, risk signals and other data is one element. A requirement for drug companies to list the country of origin of finished products and active pharmaceutical ingredients (API) on their websites is another proposal.
Report methodology :Pew based its report on conversations with: the FDA, US Pharmacopeia (USP), pharmaceutical manufacturing and distribution trade associations, the retail pharmacy industry, medical and pharmacy professional associations, consumer groups and supply chain experts.
FDA documents, US Government Accountability Office (GAO) reports, Congressional testimony, peer-reviewed journal articles and commercial publications were also sources of information. Video footage of a two-day roundtable discussion hosted by Pew is available .
Dear Sirs,
Thanks for your promt reply suggestions.
T.NAGESHWAR