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Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, details regulatory requirements for developing a quality manual.
Q. I work for a small start-up company and have been tasked with writing the quality manual for my company. I have searched but have been unable to find regulations that define what is contained in this document. Can you help?
A. The short answer is there is little guidance on what the actual content of a quality manual should contain. It is clear, when reviewing the regulations, there is an intent to have documentation regarding a company’s overall quality approach. In Europe, EudraLex Volume 4, Chapter 1, titled Pharmaceutical Quality System, section 1.7, states, “the Pharmaceutical Quality System should be defined and documented. A Quality Manual or equivalent documentation should be established and should contain a description of the Quality Management System including management responsibilities” (1). The United States Code of Federal Regulations (CFR) doesn’t mention a quality manual but does mention a need for a quality policy in the medical device regulations. US 21 CFR 820.3 states, “Quality policy means the overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility” (2). And in section 21 CFR 820.20, the regulation states a “Quality policy.Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization” (3). The best source for what you should include in your quality manual comes from the International Council for Harmonisation (ICH) in the ICH Q10 document titled Pharmaceutical Quality System (4). Section 1.8 of this document states, “A Quality Manual or equivalent documentation approach should be established and should contain the description of the pharmaceutical quality system. The description should include: (a) The quality policy (see section III (2)). (b) The scope of the pharmaceutical quality system. (c) Identification of the pharmaceutical quality system processes, as well as their sequences, linkages, and interdependencies. Process maps and flow charts can be useful tools to facilitate depicting pharmaceutical quality system processes in a visual manner. (d) Management responsibilities within the pharmaceutical quality system (see section III (2)).” Just to be clear, the quality manual applies to the entire company
and not just the quality department, similar to how the term quality culture is not referring to the culture of the quality department but the entire company’s approach to culture.
Because the quality manual governs the entire company, it is advisable that it be constructed with representatives from various functions in the company. This collaboration helps ensure the overall purpose and scope of the document is representative of the company’s philosophy. A simple purpose statement might say something to the effect, “The quality system described is intended to ensure the facility is compliant with [list regulations] and serves as the basis of the Quality Systems that apply to [list company name], products, and current good manufacturing practice (CGMP) activities.” The scope statement can be just as simple and state something to the effect that the quality systems described apply to all products, personnel, and manufacturing operations to ensure products meet the requirements for safety, identity, strength, and purity.
Another section to consider adding is a section of definitions. It is my experience that each company/facility utilizes their own acronyms. Any special acronyms being used at the facility should be defined in the definitions section along with common acronyms such as CGMP, FDA, EU, SOP, etc. Having a definition section helps everyone (employees, auditors, clients, regulators) understand the overall quality system as it applies to your facility. The next section I would recommend be included is an organizational chart. The organizational chart should demonstrate the reporting hierarchy of the company to demonstrate the independence of the quality organization.
One of the most critical sections to include in your quality manual, in my opinion, is the section on management responsibilities. In this section, you should introduce the company’s management review responsibilities as well as the senior management titles that are responsible for overseeing the pharmaceutical quality system and the management review meetings. The next critical section to include is an overall description of the quality management system in effect at your company. In this section, you can describe your company’s approach to all the applicable systems utilized by your company for planning, documenting, implementing, and monitoring the activities that potentially impact product quality and patient safety. These processes included but are not limited to quality by design, quality risk management, corrective and preventive actions (CAPA), change control management, management of materials, and maintenance of facilities. In describing the quality management system, you should discuss how it relates to manufacturing, facilities and equipment, materials, packaging and labeling, and laboratory controls. If you outsource an activity, you should note that the activity is outsourced and your oversight responsibilities.
The last element of the quality manual is its approval. In my opinion, the quality manual should be agreed to and signed off by representatives from the various departments it governs. The final step in the process is to ensure that everyone, from senior leadership on down, is trained and understands the quality manual and how it relates to their job responsibility. If you follow this simple approach to constructing a quality manual you will have an easy-to-follow, comprehensive document that communicate the company’s commitment to manufacturing safe and effective pharmaceutical products.
Susan J. Schniepp is distinguished fellow at Regulatory Compliance.
Vol. 35, No. 2
Pages: 42, 41
When referring to this article, please cite it as S. Schnipp, “What’s in Your Quality Manual?,” BioPharm International 35 (2) (2022).