Quality Agreement（part Ⅱ）

What are the elements of a quality agreement? 

A quality agreement includes several components essential to the pharmaceutical industry, including the following:

Manufacturing Activities 

These are the everyday activities performed as a part of product manufacturing. In it, every party's responsibility must be mentioned and pre-defined. It must also be noted whether the owner or contractor handles any particular activity or whatever the case may be.

Some activities included in manufacturing include the following.

Quality Unit Activities

It describes the function of a quality control unit in ensuring cGMP compliance for both the owner and contractor. In addition, it must also explain how the owner and contractor will communicate with each other, including verbally or in writing, and identify the contact person. 

Despite framing and agreeing upon terms of quality unit activities, both parties remain responsible for ensuring quality in the process and final product.

Regarding product release, the contractor is responsible for approving or disapproving products or their manufacturing activities.  At the same time, owners are responsible for approving or disapproving products manufactured by contractors.

Some additional scopes related to quality units include but is not limited to

• Audits, communication, and findings

• Auditing contract facilities to ensure cGMP compliance, including routine  and case-specific audits

• Owners and contract facility expectations for FDA inspection

• Agreed upon provisions for communicating observation and findings

• Relevant FDA inspection and correspondence 

• What information will be presented to the product owner during inspection and audits of the contract facility?

Facilities and Equipment

It describes the specific site and its address where the contractor will perform the manufacturing operation. Information regarding equipment validation & maintenance and each part's responsibility is also defined. 

It should include all equipment and facilities used in the contract manufacturing. 

• IT and automated control systems

• Environmental monitoring

• Room classification

• Utilities

Materials Management

In this specification, both parties should define clear roles regarding which party will be responsible for establishing specifications for components used in manufacturing and which party will be responsible for auditing, qualifying, and monitoring suppliers, including the testing and sampling.

This section should also include details for inventory management, including labelling, inventory reconciliation and product status identification.

This agreement should also define the party responsible for physical material control at different points.

Product-specific considerations

This section includes considerations related to a specific or individual product. It contains expectations of each party related to  

• Product/component specifications

• Defined manufacturing operations, including batch numbering processes 

• Responsibilities for expiration/retest dating, storage and shipment, and lot disposition 

• Responsibilities for process validation, including design, qualification, and ongoing verification and monitoring

• Provisions to allow owner personnel access to the contract facility when appropriate 

It must also include how technology transfers to contract facilities for manufacturing purposes  complies with cGMP. 

Laboratory Controls

In this section, drug testing to ensure the quality of the product is defined by defining the roles and responsibilities of the owner and contractor, and includes the following elements

• Procedures delineating controls over sampling and testing samples

• Protocols and procedures for communicating all laboratory test results conducted by contract facilities to the owner for evaluation and consideration in final product disposition decisions

• Procedures to verify that both owner and contract facilities accurately transfer development, qualification, and validation methods when an owner uses a contract facility for laboratory testing

• Routine auditing procedures to ensure that a contract facility's laboratory equipment is qualified, calibrated, and maintained in a controlled state by CGMP

• Designation of responsibility for investigating deviations, discrepancies, failures, out-of-specification results, and out-of-trend results in the laboratory and for sharing reports of such investigations 

Documentation

Documentation and record keeping are an integral part of the pharmaceutical industry, and it must also be ensured when outsourcing your manufacturing activities to external contractors.

The documentation section of the quality agreement should include expectations between the owner and contractor when reviewing and approving documents. It should also include

• How changes may be made to 

               ◆ Standard operating procedures

               ◆ Manufacturing records

               ◆ Specifications

               ◆ Laboratory records,

               ◆ Validation documentation

               ◆ Investigation records

               ◆ Annual reports

               ◆ Other documents related to products or services provided by the contract  

Change Control

This section of the quality agreement describes changes in processes, equipment, test methods, specifications, and other methods, including responsibility allocation

The quality agreement must include the change control for the flowing process 

• Components and their suppliers 

• Established locations

• Manufacturing processes 

• Products or product types that use the same production line, equipment train, or facility 

• Testing procedures 

• Major manufacturing equipment 

• Shipping methods 

• Lot numbering scheme 

• Container closure systems 

• Tamper evidence features.

• Product Distribution