Quality & Technical Agreements.
Defining the responsibilities of production.

What is a Quality or Technical Agreement?

Quality & Technical Agreements fall under the Good Manufacturing Practices guidelines (GMP), and within GMP the terms Quality Agreement, and Technical Agreement, can be considered the same thing.

As companies increasingly outsource the manufacture of APIs, formulations and other manufacturing activities, the need for Quality & Technical agreements becomes more critical for the consistent quality, efficacy, and safety of products for human and veterinary use.

There is clear international direction from both the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use –
“There should be a written and approved contract or formal agreement between the contract giver and the contract acceptor that defines in detail the GMP responsibilities, including the quality measures, of each party”,

and the European Medicines Agency (EMA) –

“A Contract should be drawn up between the Contract Giver and the Contract Acceptor which specifies their respective responsibilities and communication processes relating to the outsourced activities. Technical aspects of the Contract should be drawn up by competent persons suitably knowledgeable in related outsourced activities and Good Manufacturing Practice.”.

The EMA GMP guidelines also specify more detail in relation to what should be in Quality & Technical Agreements, and it is these areas which require oversight by experienced and knowledgeable persons to ensure agreements provide clear responsibilities,

 “The Contract should describe clearly who undertakes each step of the outsourced activity, e.g. knowledge management, technology transfer, supply chain, subcontracting, quality and purchasing of materials, testing and releasing materials, undertaking production and quality controls (including in-process controls, sampling and analysis).”.

There is also another incentive to create well-crafted agreements, and that is for inspections, where they detail key information required on production roles and responsibilities for inspectors, simplifying the inspection process.

Quality & Technical Agreements are usually intertwined with commercial legal agreements because of their interdependency regarding the rights and activities, and best practice is that these are drafted by quality and legal representatives in collaboration because of their specialist knowledge in each area.

Click here for information from the EMA on the ICH GMP Quality System guidelines.

Click here for EMA QA GMP contracting advice.

GMP Quality/Technical Agreement format.

Contract structure.

The party providing the contract should clearly outline their requirements, as the structure of the agreement is inherently influenced by their specifications. A standard quality/technical agreement typically comprises the following sections:

  • Objective and Extent.
  • Definitions.
  • Duties and Obligations.
  • Contact Information.
  • Inventory of Products.
  • Authorisation.
  • Changes & Amendments.
  • Inventory of Subcontracted Analytical Testing Laboratories.

Meeting GMP basic requirements.

Any agreement should also integrate the basic principles of GMP regulations:

  • Ensuring the sourcing of active and excipient raw materials minimises the risk of contamination.
  • Prohibiting contractors from making alterations to the process, raw materials, or formulation without prior written consent.
  • Granting the contract provider and regulatory authorities the authority to conduct audits and inspections of relevant processes, facilities, and documentation.
  • Restricting subcontracting to third parties without mutual agreement.
  • Documenting all deviations from predefined procedures or target test results.
  • Ensuring the contractor retains all batch records for an agreed-upon duration after the product’s expiration.

Production & Testing activities.

The contract should detail various production and testing procedures, including:

  • Product Specification and Master Formula.
  • Process Validation and cleaning procedures.
  • Manufacturing instructions and in-process controls.
  • Management of process deviations and out-of-specification results.
  • Analysis of bulk materials and retention of reference samples.
  • Specifications and testing methods for the finished product.
  • Batch identification system.

Packaging and product release.

Ensure comprehensive coverage in the technical agreement of the following areas:

  • Procedures and criteria for testing packaging materials.
  • Examination of packaging materials.
  • Adequate labelling methods, their assessment, and approval.
  • Packaging instructions, procedures, and documentation.
  • Analysis of finished products and associated documentation prior to release.
  • Conducting annual product reviews.
  • Handling and resolution of complaints.
  • Specifications for product recalls and the determination to initiate them.
  • Management of returned products.
  • Measures to prevent environmental pollution.

Storage and Transportation.

The contract provider defines what are adequate storage conditions, including temperature, light, and humidity requirements for both finished products and bulk materials.

A contract manufacturer may need to transport products to the contracting provider, or to another third party. Additionally, the GMP quality/technical agreement outlines the types of waste materials (solvents, toxic waste, etc.) and specifies the corresponding disposal methods that the contractor is obligated to adhere to.

Batch Documentation.

The contract provider must secure a comprehensive set of batch documentation, including:

  • Production batch record.
  • Packaging batch record.
  • Analytical results for each batch.
  • Production in-process control record.
  • Packaging in-process control record.
  • Bill of materials (BOM).
  • Certificate of analysis for the final product.

Why choose Aegisana for Technical & Quality Agreements support?

Expertise & Experience.

Our GMP Compliance team has the experience to support you with your Quality & Technical Agreements with expert knowledge with the review, improvement, or creation of agreements for different suppliers in the manufacturing process.

Supported by our robust Quality Management System (QMS), we can seamlessly and efficiently adapt to the compliance needs of your manufacturing site.

A detailed & communicative approach.

Our goal is to provide you with peace of mind and confidence by conducting detailed reviews of your quality system agreements, the product and data areas covered within them, and adapting them or creating them for manufacturing improvement and efficiency, compliance, and patient safety.

Through effective communication, reliability, and trust, we aspire to establish a successful and robust strategic compliance and auditing partnership throughout the manufacturing and packaging of your human and animal products.

All of our services adhere to the regulations and principles of the EMA’s guidelines on compliance