Quality Technical Agreement - Cryopreserved Advanced Therapy Medicinal Products (ATMPs) Receipt, Storage, and Onward Supply

Aug 31, 2026

Upload by Jake

Quality Technical Agreement defining roles and responsibilities between a Contract Giver (CG) site pharmacy and a Contract Acceptor (CA) service provider for the receipt, storage, and onward supply of cryopreserved Advanced Therapy Medicinal Products (ATMPs) with marketing authorisation. The agreement establishes compliance expectations under GMP, GDP, and Human Medicines Regulations 2012, including subcontracting controls, required contact persons, and capability/authorisation requirements. It also sets regulatory information, product ownership by CG, term and review cadence, change and variance approval, termination notice, and availability to relevant authorities, with annual joint compliance review and noncompliance resolution timelines.

LanguageEnglish

CategoryLetters

FormatDOCX

Pages20

Reading Time7 min

AccessFree to download

Definitions

Scope of agreement

Regulatory information

The Technical Agreement (including termination)

QUALITY TECHNICAL AGREEMENT FOR THE RECEIPT, STORAGE, AND ONWARD SUPPLY OF CRYOPRESERVED ADVANCED THERAPY MEDICINAL PRODUCTS (ATMPs) which hold a marketing authorisation (MA) SITE DOCUMENT REFERENCE NUMBER Between SITE PHARMACY And VENDOR PROVIDING SERVICE QUALITY TECHNICAL AGREEMENT FOR THE RECEIPT, STORAGE, AND ONWARD SUPPLY OF CRYOPRESERVED ADVANCED THERAPY MEDICINAL PRODUCTS (ATMPs) ON BEHALF OF SITE PHARMACY Contents TOC \o "1-3" \h \z \u QUALITY TECHNICAL AGREEMENT (Site Document Ref. xxxxxx) FOR THE RECEIPT, STORAGE, AND ONWARD SUPPLY OF CRYOPRESERVED ADVANCED THERAPY MEDICINAL PRODUCTS (ATMPs) ON BEHALF OF SITE PHARMACY This Technical Agreement is made between: SITE PHARMACY Site Address Site Address Site Address Site Address Site Address hereinafter referred to as Contract Giver ‘CG’ and SERVICE PROVIDER Provider Address Provider Address Provider Address Provider Address Provider Address hereinafter referred to as Contract Acceptor ‘CA’ List any additional sites if more than one here List any relevant regulatory authorisations if the activity is carried out under those authorisations Definitions Scope of agreement This Technical Agreement defines the roles and responsibilities between the CG and CA in ensuring compliance with GMP, GDP and the Human Medicines Regulations 2012 (SI 2012:1916 as amended) with regard to the provision of pharmaceutical services as specified in ‘ REF _Ref90299980 \h Appendix 1: Services’, of this agreement. All parties will strictly observe the detailed pharmaceutical responsibilities which are specified in ‘ REF _Ref90300277 \h Appendix 2: Responsibilities of each Party’, of this agreement. All parties must appoint Contact Persons as named in ‘ REF _Ref90301766 \h Appendix 3: Key Contact Persons’ of this agreement. In circumstances where CA subcontracts certain activity, this is permitted where agreed in advance and accepted by CG. Any providers to whom activity is sub-contracted by CA will be listed in ‘ REF _Ref90301883 \h \* MERGEFORMAT Appendix 4: List of Subcontractors’, of this agreement. The responsibilities defined in this agreement apply to the sub-contractor as they do to CA. Additionally, CA must ensure appropriate agreements are in place with sub-contractors which compliment those contained in this TA. This agreement covers activity relating to the receipt, storage and onward supply of cryopreserved ATMPs holding a marketing authorisation on behalf of CG. Any additional ‘preparation activities’ subcontracted remain the responsibility of CG and may either be added to this agreement where required, or managed via a separate TA. Any such arrangements must take into account the requirements of the SmPC and GMP as it relates to the activities involved. Where these services are provided, the provider must operate within the regulatory framework which applies (for example, compliance with GMP and operating under an MS licence). Finally, where additional services beyond receipt, storage and distribution are included, a thorough review of the content of this TA is recommended to ensure it covers the necessary activity. Regulatory information The parties acknowledge that CG shall procure the ATMP, and arrange for its delivery directly to CA. Thus, will perform all the obligations and responsibilities of a purchaser of authorised medicinal products. CG will own the product throughout the activity. This TA is supplementary to any agreement between the manufacturer of the ATMP and CG. This TA can be shared with manufacturers in support of their assessment of appropriate arrangements when conducting site qualification assessments of prospective clinical sites. The CG responsibilities contained in this TA cannot be delegated to the manufacturer. CA has the full capability and appropriate authorisations to carry out the activity described in this TA as described in Appendix 1 of this agreement. Any services will be at all times processed and controlled in complia

FAQs

What is the scope of this Technical Agreement for ATMPs?

It covers the receipt, storage, and onward supply of cryopreserved ATMPs with marketing authorisation on behalf of the site pharmacy (CG). Any additional preparation activities are addressed separately or remain CG’s responsibility.

How do CG and CA ensure regulatory compliance?

Both parties must ensure compliance with GMP, GDP, and the Human Medicines Regulations 2012, and observe detailed pharmaceutical responsibilities listed in the appendices. CA must operate within the applicable regulatory framework, such as a WDA(H) under an appropriately experienced RP.

What are the agreement term, review, and termination conditions?

The agreement becomes effective on the final signature date and remains valid for 5 years, with review and updates every five years unless amended earlier by mutual written consent. Either party may terminate with 3 months’ written notice, and variances must be written and approved by all parties.

Aug 31, 2026

Upload by Jake