QMS-110 Management and Control of Contract Work

Document Owner

Quality Assurance /Supply Chain Manager

Affected Parties

All colleagues in QA/Procurement/Operation/Technical service teams.

Purpose

This SOP describes the different aspects of Contract Work with reference to the gmp site:

a. Control of contract manufacture and packaging for the site’s products.

b. Contract manufacture and packing by the site on behalf of other Companies

c. Contract Supply Procedure.

Scope

Responsibility for the procedures set out in this SOP is as follows:

a. Quality Assurance Manager

b. Technical Service Manager

c. Operations Manager

d. Procurement Manager

Definition

Related Documents

EHS Statement

There is no EHS impact by this documented procedure, however EHS issues need to be reviewed in the selection of new contractors.

Procedure

cGMP and all aspects of this procedure must be adhered to ensure production of a quality product.

Separate documentation is to be prepared for each presentation of each type of product, but repeat operations are referenced to the original documentation as long as there has been no change in items listed.  However any changes to established contract work are to be handled in a similar manner to new contract work.

Contractors must be advised of any planned significant changes, which can affect the quality of the products subject to the Agreement, e.g. changes in site of manufacture, formulation, processing equipment.

Technical Service Department will liaise with Regulatory Department to determine if Regulatory approval is required for manufacturing or packaging at an external site.

1.            Control of Contract Manufacture and Packaging for finished Products

1.1.         Scope

Documentation: Several forms of documentation are associated with contract manufacture:

1.1.1        Master File.  This file may contain the following documents: Specifications, Formulation, Manufacturing Instruction, Control Methods, Raw Material/Packaging specifications.

1.1.2     Quality Assurance Agreement

A written and binding agreement between Contract Giver and the Contract Acceptor that clearly defines the roles and responsibilities of both parties for a service, product, project or study and covers the following areas:

a. Definition

b. Introduction and Scope

c. Processing, Analysis, Packing and Release

d. Quality Assurance and Quality Control

e. Release Procedure and Transportation

f. Product Recall

g. Product Quality Complaints

h. Post Marketing Stability Studies

i. Annual Product Review

j. Quality Management

A Quality Assurance agreement is to be drafted by Quality assurance Department, using TEM-100and checked by the Technical Service Department.

The Quality Assurance Manager will sign the QA Agreement.

The signed QA Agreement is forwarded by the Quality assurance Manager to the Contractor and confirmation of the requirements of the Agreement obtained from the Contractor, (usually by signing and returning an extra copy of the Agreement).

The signed Quality Assurance Agreement is to be logged into the Register of Contracts and stored in the Manufacturing safe.

1.1.3      Toll Agreement, which will outline the cost associated through Supply Chain and a Service Level Agreement, which is raised at the discretion of the Supply Chain area.

1.1.4      Third Party Manufacture Dispatch Report (TEM-105), is to be raised by the Supply Chain area.

1.1.5      Purchase Order

A Purchase Order must cover all contract work.

The Procurement staff will ensure that:

(a)       Every Purchase order for the work described contains the appropriate information.

(b)       Every purchase order for the work described in the agreement makes reference to the appropriate Material Code number.

(c)       Any alteration in the process becomes the subject of an amendment of the agreement.

(d)       No external work on products is carried out without the requirements of this SOP being met.

(e)       The work order specifies guidelines to yield required, efficiency of the work, overall cost/unit, delivery details and time.

1.1.6      Material Code number

The Technical Service Department will allocate a Material Code number for the goods or service being ordered. This Material Code number is to be featured on the order.

1.1.7      Production Documents

The contractor is responsible for devising suitable Production Documents on which the operations of packing for shipping to the contractor, counts, bulk batch numbers, shipping details, etc., together with received details of the completed work, together with a reconciliation can be recorded.  The originals of these documents are to be approved by the contract giver.

1.1.8      Warehouse

On receipt of the finished goods from the Contractor, the Receiving Warehouse books in the material.

The documentation must be tallied and include reconciliation of reject materials.  This reject material is not returned (unless requested), however should unusual quantities of rejects be associated with the batch, Contract giver should be advised and may examine these rejects before their destruction by the Contractor.

It is critical that care be taken to maintain the segregation of any separately packed material or batches.

1.1.9      Quality Assurance examines, passes and/or rejects material on the basis of approved specifications.

2.            Figure 1: Flow Chart – Process of Contract Work

3.            Contract Manufacture by Sponsor GMP site on behalf of Other Companies

3.1.         Sponsor site may accept contract work in its field of competence, providing the product presentations are compatible with existing equipment, not in direct competition with Sponsor site products and capacity exists.

3.2.         Should Bulk unlabeled or site‑labelled product be required, this is ordered on a Purchase Order, and does fall under this SOP.

3.3.         If the product is to have the Contract Givers’ name on the label, a written GMP/Toll Agreement is required.  This is to be signed by responsible personnel at the Contract Giver site and by the site.

3.4.         The Company Secretary will hold a copy of this Contract.

3.5.         Site will supply tested, passed product as per the Agreement together with a Certificate of Analysis.  (Production documents will only be supplied where requested.)

Summary of Changes