How to build up a GMP Quality Manual ?

A quality manual is a document that a company writes to explain which portions of which regulations are applicable to the company
(i.e. which regulations will be followed by the company.)
The regulations that are to be followed are based on the process(es) that are performed at the company.
Not all portions of a regulation may be applicable to all companies.
Sometimes portions of various regulations are applicable (e.g. a medical device company that also performs aseptic processing may follow portions of 21 CRF Part 820, Part 210, and Part 211).

The company’s Quality Manual should outline which parts of which regulations are going to be followed, how they are going to be followed, who is responsible for ensuring that the regulations are followed, and which of the companies approved procedures address the regulations to be followed. If all parts of a regulation are not going to be followed a company may want to include a brief explanation as to why a part of a regulation is not applicable to the company and therefore will not be outlined in the Quality Manual.

The Quality Manual should be written in general terms with minimal specifics. The format of a Quality Manual is usually different than the format used for the company’s other approved documents. The format should still include such things as a company’s logo and name, version control, approval signatures, and confidential markings.

The following are examples of sections that a Quality Manual should contain:

1. Table of Contents
2. Introduction
3. Quality Policies and Objectives
4. Organization and Structure of Documentation
5. Company’s Products
6. References
7. Quality Policies for Specific Regulation Elements

Table of Contents: 

A list of the sections contained within the Quality Manuel and the page each section begins on.

Introduction:

A brief description of the company, the company’s purpose for writing a Quality Manual, and a brief description of the scope of the Quality Manual.

Company Background:

List the name of the company, if it is publicly or privately owned, where the company is located, the size of the facility, how the facility is used, the type of work that the company does, what products are produced at the company, and what the products will be used for.

Purpose:

Provide general statements explaining why and how the Quality Manual will be used.

Example: “This manual will serve as a guide to company X quality policies and key procedures, as well as to describe how these policies will be implemented.”

Example: “This Quality Manuel describes the quality management system that has been established by Company X in order to meet regulatory requirements for the commercial sale of products in the United States and in International Markets.”

Scope:

List the regulations that will be followed by the company as well as any portions of the regulations that will not be followed. Provide a justification for why those portions of the regulations are not going to be followed.

Example: “The system described in this manual is intended to meet general requirements set forth in the United States Food and Drug Administration (FDA) Regulation according to 21CFR Part 210 and 21CFR Part 211 as well as the relevant section of 21CFR Part 820.”

Example: “As a contract manufacturer of phase II materials Company X is not governed by section Y of 21 CRF Part 211 however the company does look to 21 CRF Part 211 for guidance in establishing and maintaining the quality system.”

Quality Policies and Objectives: 

Include a brief statement about the approach that the company is taking in regards to quality, (i.e. a Quality Mission Statement) and list the quality objectives of the company. The quality objectives should not be numerous (five to seven is a typical number) and should be briefly stated.

Example: Customer issues are addressed in a timely, professional, and thorough manner.

Example: Personnel are adequately trained in the job they perform

Example: Products and Services provided by our company are designed, manufactured, and delivered to our customers and meet or exceed our customer requirements.

Organization and Structure of Documentation:

Provide an explanation as to how the documentation structure at your company is organized and managed in relation to the applicable regulations.

Example: Documents related to the quality system are organized in a four level hierarchy structure, are maintained in accordance with applicable regulatory requirements and our company record retention policy, and are managed through a document change control system.

Company’s Products:

This section should include a brief description of the products that are made and distributed by the company including what the intended use of the products is to be. This description should be similar to a marketing type summary in that it does not list proprietary or explicit product information that would be detrimental to the company if persons outside the company read the description. This section should provide enough detail to justify the sections of the regulations that are and are not going to be followed.

References: A list of all the different regulations that were sited within the Quality Manual.

Example: FDA Title 21, Code of Federal Regulations Part 210 & 211, Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs and Finished Pharmaceuticals.

Quality Policies for Specific Regulation Elements: 

This section will encompass the majority of the manual. It will include each regulation that will be followed by the company, a brief description of how the company intends to follow the regulation, and a list of the approved documents (by document name and number) that the company has in place which specifically address/discuss the company’s policies and objectives as stated in this section of the Quality Manual.

Example: Purchasing Controls; Procedures are established and maintained to ensure that materials, supplies, and services impacting the Quality System and procured by Company X purchasing department, conform to specified requirements.

1. Receiving Procedure SOP # XX. 01
2. Vendor Qualification Procedure SOP # XX. 01
3. Release of In-coming Goods Procedure SOP # XX. 01
4. ......

Example: Corrective and Preventive Action; At Company X, Corrective and Preventive Actions are integral in a variety of programs. Whenever possible, these programs make an effort to determine the root cause of the incident and to implement appropriate actions to prevent the reoccurrence of the incident. Quality Assurance approves all Corrective and Preventive plans and tracks their completion and effectiveness.

1. CAPA Procedure SOP # XX. 01
2. Material Review Board SOP # XX. 01
3. Failure Investigation Procedure SOP # XX. 01
4. .......