Quality Contracts

Contract manufacturer solids - contractor quality questionnaire

Quality Contracts
210,00 EUR
app. 277.20USD
(Non-german customers)

249,90 EUR
(German customers incl. 19% tax)



FDA
EMA
What you will get:
Delivery item: Word Document
You will be able to enter your data into the Word document.
Please note: We do not deliver hard copies.
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Description of the Quality Contracts - Contract manufacturer solids - contractor quality questionnaire

This ready-to-use quality audit questionnaire (audit by mail) has been created to assess potential contract manufacturers and judge their ability to meet current GMP. This questionnaire also includes a covering letter, which needs only a small amount of modification before it can be used.

During any on-site audit preparation, this checklist could be used to draw up the audit agenda and help with a systematic on-site GMP audit. Please remember that as long as your company name is on the product to be manufactured, you are legally responsible for ensuring that the operations carried out on your behalf meet all quality specifications and comply with all legal regulatory requirements imposed on manufacturing and testing.

Table of Content:

1 Document Request
2 Quality Organization and Facility capabilities
2.1 General Information
2.2 Key personnel
2.3 Employee overview
2.4 Facility Size
3 Regulatory and Quality Profile
3.1 Registration
3.2 Authority Inspections and Relationship
3.3 Sub Contracting and Conflict of Interests
4 Quality Systems
4.1 Documentation
4.2 Finished Product batch release
4.3 Complaints and Product recalls
4.4 Training
4.5 Change control
4.6 Cleaning Validation and Cross Contamination Risk
4.7 Validation
4.8 Computer Validation and 21 CFR Part 11
4.9 Supplier qualification
4.10 Self inspection
4.11 Water System
4.12 HVAC - Air Handling System
4.13 Gases (CO2, N2, compressed air)
4.14 Equipment Qualification, Calibration and Maintenance
4.15 Critical Production Steps
4.16 Control of storage areas
5 Quality Control
5.1 Equipment Inventory
5.2 Analytical Testing
5.2.1 QC laboratory water
5.2.2 Expiry dates of solutions
5.2.3 Method validation
5.2.4 Standards
5.3 Out Of Specification (OOS) Results
5.4 Retention Samples / Reserve Samples
5.5 Stability
5.6 Raw Materials purchasing and testing
6 Response Approval

Contract manufacturer solids - contractor quality questionnaire
210,00 EUR
Additional 19% tax for customers from Germany
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