Here are some Examples of Quality Agreements:
Agreement for the Quality Assurance in toll manufacture of clinical trial material
Object of this agreement The following agreement concerns the manufacture and/or packaging and/or testing of the products listed in Annex 1 to the contract (subsequently called products) by CA (Contract Acceptor) or CG (Contract Giver).
This agreement forms an integrated part of the contract dated…, 20....
Specification of the Products The products to be manufactured, packaged and/or tested by CA are defined in product specific enclosures, consisting of
For the evaluation of the compliance of the products with the specification, the test values obtained with the control procedure are binding.
CG has the right to reject a batch if not manufactured according to the agreed procedures, using the agreed plant and equipment, except where prior written approval has been obtained from CG.
Starting Materials
Definition Starting materials are all active ingredients and excipients necessary for the manufacture of the PRODUCTS as well as primary and printed packaging materials.
Procurement / Delivery The competence for procurement of the various starting materials is laid down in the detailed materials list within the product specific enclosures. If the supplier of any material is specified in these enclosures the same may not be changed without written agreement of CG.
Testing and Release Active ingredients, excipients, and printed packaging materials for the manufacture of the PRODUCTS are to be provided as specified in the products specific enclosures.
Starting materials to be provided by CG are to be tested batch-/delivery-wise for identity and are released to CA for processing. A certificate of Analysis will accompany the shipment.
Upon receipt of starting materials and certificates of analysis the containers must be checked by CA for:
CA must maintain records of each batch of raw and packaging materials consisting of:
If the CA orders starting materials direct from an approved supplier then CA is responsible for batch-wise testing and release of material according to control procedure listed in the Product specific annex.
Retained Samples of Starting Materials CA agrees to keep retained samples for any starting material provided by CA except for water, compressed gasses, cleaning solvents and highly volatile compounds such as diethyl ether, for a period of 12 years after initial release. The amount of retained samples must be sufficient for at least three analyses, exclusive of microbiological purity testing.
Retention samples of starting materials provided by CG will be kept by CG.
Storage CA agrees to store the starting materials under such conditions that when used they comply with all quality characteristics with the specifications and current GMP regultions.
If special storage conditions are necessary for starting materials furnished by CG they should be mentioned on the materials list and on the container labels.
Manufacture and packaging of the products Manufacture and packaging of the products are carried out according to the manufacturing and packaging instructions given in the product specific enclosures.
CA agrees to advise CG of any other products or processes which may present a potential hazard to the products (e.g. ß-(L)actam?!/Cephalosporin antibiotics, certain hormones, cytostatics, highly potent drugs or biological preparations from live micro-organisms) and to refrain from any activities which may adversely affect the quality of the products.
CA agrees not to pass to a third party any of the work entrusted to them under the contract without CG prior evaluation and approval of the arrangement.
Batch records
Documentation of Manufacturing and Packaging Records CA will prepare for each batch the complete batch documentation which is necessary for the release of the individual product batches in accordance with the cGMP. The complete batch documentation will be kept on file by CA for a period of 20 years.
The batch documentation is established on the basis of a Project Master that is approved by the QA of CG before manufacturing.
The complete batch manufacturing records comprise the following information
The batch packaging records should provide in addition to above information the following:
CG is to be immediately informed by CA about extraordinary events occurring during manufacture of the products
Documentation supplied for each batch to CG CA will provided to CG for each batch manufactured a copy of
Samples of products The CG will be responsible for maintaining retention samples.
Failure investigations CA agrees to investigate product failure as promptly as possible.
Inspection After suitable advance notice, CG has the right to inspect periodically the manufacture of the products at CA in order to ensure that the manufacture is carried out in accordance with cGMP. CG is always allowed to send a representative to CA during CG products manufacture. CA agrees to co-operate in health authority inspections or in demands for information at any time, even after completion of contract work.
Information CG will be informed well in time of all proposed changes in procedures and changes affecting equipment and materials which could interfere with the quality of the products. All changes may only be implemented after approval by CG. CA agrees to inform CG of any inspections of Regulatory Authorities related to CGs products. CA will inform CG of any change that might affect the regulatory status of the contractor (key personnel, general systems, results of health authority inspections).
Manufacturing Licence of CA CA will provide to CG a copy of the manufacturing licence of the relevant national authority.
Persons to whom Communications should be addressed Persons who should be contacted by CA and CG in matters of quality assurance and contractual agreements are mentioned in Enclosure A.
Changes in the Contract Any changes in this agreement and the relevant Enclosures must be laid down in writing and accepted by both parties.
Product specific annex containing:
Here some more Examples for Quality Agreements:
Contract for preclinical development Contract for manufacture and analysis
Contract for preclinical development
Contract for manufacture and analysis
