Technical Quality Agreement For Contract Manufacturing (Technical Agreement, Quality Agreement)

From both a regulatory and commercial perspective, companies should work with their suppliers (contract manufacturers) to ensure that they receive materials and services in line with predetermined specifications covering quality, volume and delivery. Some companies limit the Supplier Qualification process to the creation of a supplier contract. However, this approach is usually insufficient when it comes to specifying the tasks, responsibilities and duties of each party as regards product quality and testing.

“Contract manufacture and analysis must be correctly defined, agreed and controlled in order to avoid misunderstandings which could result in a product or work of unsatisfactory quality. […] The contract must clearly state the way in which the Qualified Person releasing each batch of product for sale exercises his full responsibility” (extract from the Rules Governing Medicinal Products in the European Union, Volume 4, Good Manufacturing Practice, Chapter 7, Contract Manufacture and Analysis).

This master document template for technical quality contract manufacturing, which is over 35 pages in length, clearly defines the duties of the Contract Giver and the Contract Acceptor and is extremely beneficial for both parties. The template specifies all the arrangements, agreements and controls needed to avoid misunderstandings that could result in a product or work of unsatisfactory quality.

It includes nine attachments that cover the details of processes, materials, IPC, product specifications, stability, customers and labels. This ready-to-use template only needs a small amount of site-specific modification before you can adopt it in its entirety for your operations. All you need to do is enter your site-specific information in the coloured fields that are marked.

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Description

Table of Content:

1 Subject of this Agreement
1.1 Scope
1.2 Technical Information
2 Administrative Information and Responsibilities
3 Supply and Manufacture
3.1 Premises
3.2 cGMP Guidelines
3.3 Materials
3.3.1 Materials procured by SUPPLIER
3.3.2 Materials provided by the CONTRACT GIVER
3.4 Master Batch Record
3.5 Production Process
3.6 Batch Numbering
3.7 Date of Manufacture
3.8 Rework and Reprocessing
3.9 Manufacturing and Equipment Data
4 Quality Assurance and Control
4.1 Sampling/Samples
4.2 Testing
4.2.1 Raw Materials, and Packaging Components
4.2.2 In-Process Testing
4.2.3 Finished Product
4.3 Release Procedures
4.4 Documentation
4.4.1 Batch Documentation
4.4.2 First three Batches
4.4.3 Requests for complete Documentation
4.4.4 Document Retention
4.5 Retained Samples
4.6 Stability
4.7 Rejection of PRODUCT by CONTRACT GIVER
4.8 Conflict Resolution
4.8.1 Analytical Issues
4.8.2 Quality Assurance and Environmental Issue
4.9 Regulatory Inspections
4.10 Annual PRODUCT Review
4.11 Right to Audit
4.12 Corrective Actions from Audits
4.13 Post Marketing Issues
4.13.1 Defects discovered after approval by SUPPLIER
4.13.2 Product Complaints
4.13.3 PRODUCT Recall
4.13.4 Medical Surveillance and Adverse Drug Reactions/Events (ADR/E)
4.13.5 Contact with registration agencies
5 Deviations and Investigations
5.1 Deviations
5.2 Failure Investigations
6 Change Control
7 Process and analytical Capability - Validation
7.1 Analytical Method Validation and Equipment Qualification
7.2 Cleaning
7.3 Facility and Utilities Qualification (DQ, IQ, OQ)
7.4 Process Validation (PQ)
8 Laboratories
8.1 Compliance
8.2 Equipment
8.3 Documentation
8.4 Contract Laboratories
9 Personnel, Health & Safety
9.1 Personnel
9.2 Health, Safety and Environment
10 Storage and Shipping
10.1 Shipment to CONTRACT GIVER
10.2 Shipment to CONTRACT GIVER’s Customers
11 Confidentiality, Restriction of Use
12 Warranties - Liabilities- Indemnification
12.1 Warranties
12.2 Warranty Disclaimer
12.3 Limitation of Remedies
12.4 Indemnification
13 Insurance
14 Term, Termination, Effects upon Termination
15 Force Majeure
16 Miscellaneous
16.1 Headings
16.2 Severance
16.3 Waiver
16.4 Assignment
16.5 Notice
16.6 Entirety
16.7 Counterparts
16.8 Authority
17 Governing Law - Disputes
17.1 Governing law
17.2 Jurisdiction
18 TECHNICAL INFORMATION with 9 Attachements

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SKU Technical quality agreement for contract manufacturing

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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Answer:
Dear Mr. Raindl, we are constantly updating our templates according to new and updated regulatory requirements or costumer feedback.
By GMP7.com on 26,March,2019

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