| Title: Quality Agreements | |||||
| Guidance Number: 93 | |||||
| Prepared by: | Date: | Supersedes: | |||
| Checked by: | Date: | Date Issued: | |||
| Approved by: | Date: | Review Date: | |||
Introduction
This document provides general guidance to site Quality Teams responsible for writing, revision and maintenance of Quality Agreements with suppliers of materials.
Definition
Quality Agreement – a document between buyer site and a contractor or supplier of material which defines the roles and responsibilities for Quality related functions of the two parties.
Supplier – a firm that manufactures materials for the buyer site. These materials may be excipients, packaging components, RSMs, APIs and operations);
Distributor – those parties involved in trade and distribution, re-processing, re-packaging, transport and warehousing; including forwarding agents, brokers, traders, or suppliers other than the original manufacturer.
GMP – Good Manufacturing Practices
Recommendations
- All materials comprising a finished drug product should have a Quality Agreement in place with the supplier, including suppliers of primary (direct product contact) packaging components.
- All materials should be described by a specification which may include acceptance criteria for attributes and functionality, and methods of evaluation for conformance to the acceptance criteria;
- All materials should be sourced from an approved supplier that has been qualified as acceptable to supply the material via a vendor selection process. The qualification requirements should be established in accordance with the intended use of the material supplied. For example API, critical excipient, drug product, primary packaging component suppliers may be approved via on-site evaluation while non-critical, commodity-type excipients (available from multiple sources with equivalent, recognized specifications such as talc, lactose or microcrystalline cellulose) may be qualified by alternate means (e.g. risk assessment, paper audit, etc.);
- Elements of the selection criteria should include whether the supplier is local (may supply a single location) or global, the number of materials supplied (sole source of a unique material vs. multiple source commodity item), as well as the function of the material in the product formulation or design;
- Any Quality oversight activities (for example surveillance testing, batch record review, audit frequency, on-site visits, etc.) should be determined based on an evaluation of the supplier and the criticality (source of supply, classification of material, safety, etc.) and intended use of the material;
- Any of the recommendations for a Quality Agreement may be revised or overridden with a documented rationale approved by the Site Quality Team.
Essential Elements of a Quality Agreement
1. Scope/purpose statement should contain:
- Description of services expected;
- Material list (where suitable a table format including materials supplied and services performed may be helpful);
- Identification of supplier and client (by name and address);
- Applicable standards (for instance compendia, national/local regulations, laws, guidances, directives, etc.);
- Permissible use of subcontractors. (If included specify that the supplier is responsible for all management and oversight activities, qualification, Quality Agreement, test or material results, etc. provided by sub-contractor. Typical examples of sub-contractors include contract labs, packagers, warehouses, shippers, etc.);
- Agreement terms should include effective period and terms for extension or termination. (Be certain to specify requirements for operations that survive the termination of the Agreement such as stability and complaint handling.)
3. Contacts:
- a listing of essential personnel, their title and contact information(address, phone #, e-mail address, etc.) should be included.
4. Approvals:
- the signatures of identified responsible company officials and the date of approval need be included.