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Auditing an Active Pharmaceutical Ingredient (API) Contract Manufacturing Organization (CMO)

佚名2012-07-19 09:51:23

Active pharmaceutical ingredient (API) manufacturing has similar regulatory GMP expectations as drug products, but not identical in is specific requirements and application. The nature of API manufacturing and its usual purification processes all influence how an API process should operate. Knowing what the FDA expects and how these regulators apply API GMP is important to API purchasers and drug product firms. Reducing risk and protecting the quality of a Drug Product (DP) is critical to the DP firm's success. The webinar will focus on the Q7 and FDA GMP requirements, what are the key contractual requirements and what should be negotiated and documented within quality agreements with a CMO firm.

Why Should You Attend: Attending this webinar will help you identify what you need to know and examine during an audit of your CMO or API suppliers. The webinar leader will help you identify key regulatory and industrial issues associated with API manufacturing. You are purchasing more than a chemical or biological material. You are purchasing a material that can carry with it hidden risks if not properly examined and controlled. Such examination is not always productive if you rely simply on testing protocols. You need to learn where to look and what to focus on during any on-site audit. While understanding the applicable GMP is important, how to apply the GMP and what to establish with a CMO is critical to your supply chain.

Areas Covered in the Session:

Examine key elements of an API audit

Audit preparation

The audit itself

Opening Session

Audit itself

What to look for?

Discussion of findings

Suggestions and experience

Closing Meeting

Who should participate in audit

Who should attend openning and closing sessions

Audit Reports

Follow-up Actions

Agreed upon Schedules

Follow-up Audits

Who Will Benefit:

Supervisors and Managers in Manufacturing

Supervisors and Managers in Quality


Maintenance Supervisors and Managers

Warehousing and Materials Management Supervisors and Managers

Overview: Auditing an API CMO or any API supplier is a specialty that requires knowledge and experience that is gained through exposure to the unique attributes associated with API manufacturing.

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