Quick Overview This procedure pertains to GMP related Audits of suppliers of raw materials, excipients or components, drug products, drug substances ...
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Descripción: sample audit program (ctto)
Quick Overview This Standard Operating Procedure (SOP) describes the program necessary to ensure qualifying a supplier is to assess the supplier’s reliability, continuous quality of products and s...
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This Agreement is used to define the understanding between a supplier of products or merchandise and their client.
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In this Agreement an independent contractor agrees to provide services for a business or an individual. The independent contractor is not an employee of the business or individual that is co…Full description
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Supplier and Contractor Audit An Audit conducted in order to assess the cGMP and/or Technical/Quality Contract compliance of an existing supplier (different material or service).
7.1.3 Re-approval Audit (Time Cycle) A re-approval Audit is an inspection of a previously approved supplier or contract manufacturer, already providing services and/or product. A time cycled Audit is conducted in order to assess the supplier’s facility and services continued cGMP and/or Technical/Quality Contract compliance. Re-approval will be conducted pending the intended use and the frequency of use.
7.1.4
For Cause Audit
An Audit initiated as a result of a recognized problem problem in the services or product provided by a supplier or contract manufacturer. 7.2
Audit cycle time In order to keep a supplier in an approved status, they must be audited on a defined time cycle. Cycle times are based on the type of work performed by the contract firm. Please use this listing as a reference only
Category (A) suppliers must be audited on an annual basis Category (B) suppliers must be audited every two years
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API supplier
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Sterile contract manufacturer
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Non –Sterile Drug product suppliers
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Category (C) suppliers must be Audited every three years
7.3
Key raw material and intermediates suppliers
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Contract testing laboratories
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Raw material suppliers
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Other suppliers
Pre Audit (preparation) activities
7.3.1 Planning of a new supplier Audit It is the task t ask of the Lead Auditor to manage all Audit activities. During the preparation phase he/she ensures that: •
An Audit specific questionnaire questionnaire concerning the product/supplier product/supplier is created and agreed by the team and will be send to the new supplier.
•
All additional agreements must be made with the vendor (e.g. agreeing of Audit date, Audit plan).
7.3.2 Supplier’s Response to the Audit Questionnaire The Lead Auditor ensures that the supplier will answer and send back the Audit questionnaire questionnaire in an appropriate time frame before the Audit is performed. Based on the response of the supplier
