Manufacturing quality assurance responsibilities

As a minimum, the personnel responsible for inspecting manufacturing sites should have relevant qualifications and experience in pharmaceutical manufacturing, quality assurance, GMP, performing inspections and audits, chemistry and quality control. Ideally they should have an inspection background from working with a regulatory authority. 

Key personnel, responsible for managing and supervising manufacture, quality assurance and quality control, should be adequate in number. They should have the managerial and professional or technical skills and experience to assume and discharge responsibility for ensuring that the goods manufactured consistently meet standards and specifications. 

Since SYSCO does not itself manufacture, a quality assurance team of more than 180 professionals determines specifications for each own-brand item and also sets criteria for raw materials and for the standards that manufacturers and processors must follow for food safety, quality, and consistency, as well as for social responsibility and supplier codes of conduct. This quality assurance team identifies and establishes supply sources and audits those suppliers to enforce SYSCO s strict standards for various factors like facility conditions and sanitary measures. Inspectors are at the plants as bacon comes off the production line, or follow produce from field to cooler to assure proper holding temperatures and product integrity. SYSCO s program is unmatched in the food industry. The number of people and level of resources committed to supporting the integrity of the products are far superior to those of other industry competitors, who may devote merely a handful of personnel to these tasks, if they are undertaken at all. 

Pharmaceutical development of a medicinal product must retain the drug s promising in vitro pharmacological activity and provide a predictable in vivo response. The marketed product must be stable, correctly packaged, labelled and easily administered, preferably by self-administration. The product must also be economical to manufacture on a large scale by a method that ensures product quality. In addition, development and eventual production processes must comply with the regulatory requirements of proposed market countries, and all development studies must be performed to acceptable levels of quality assurance. 

The proposed regulations went beyond these basic requirements for a valid study by requiring each study to have a study director who would have ultimate responsibility for implementation of the protocol and conduct of the study [ 3e/31(a)], and each testing facility to have a quality assurance unit to monitor conduct of studies. The concept of a quality assurance unit to monitor study conduct was a new one to most laboratories but a familiar one in manufacturing facilities operating under various GMP regulations. 

The quality assurance department is responsible for providing support to the parent company, affiliates, and contract manufacturers in the development, upgrading, and maintenance of GMP requirements. Validation SOPs is required to give step-by-step direction in performing validation. 

The actions taken in response to alert and action limits are defined in the environmental control program per manufacturing site SOP. Each time an action level is reached, an investigation is performed to determine the cause. If appropriate, product is segregated and quarantined until the cause of the failure has been determined and a decision is made by Quality Assurance regarding release. 

Finally, QA is the effort taken to ensure compliance with government regulations for the systems, facilities, and personnel involved with manufacturing products. Quality assurance audits will be quite varied in scope to achieve this assurance. These responsibilities include batch record reviews, critiques of product design, process validation activity, and, possibly audits of other departments operations. 

It does not end here, however quality assurance must formally increase its monitoring and vigilance of both the laboratory and manufacturing activities related to this product. An active effort should now be mounted to look for trends over time. The FDA expects quality assurance to be proactive and responsible about inconclusive phase II investigations. 

Assembly of the medical device may be partially completed by suppliers before final assembly by the device s registered manufacturer. In such situations, the registered manufacturer is entirely responsible for the work and is expected to assign its own Quality Assurance staff to monitor and perhaps witness supplier assembly. 

Whereas cases such as these are obviously beyond the control of any government entity, educational programs to increase public awareness and improved quality assurance requirements for commercial products may prevent intoxications caused by misidentification. Manufacturers are responsible for assuring that the contents of a package or bottle are accurately represented on the label. Failure to meet this standard causes the product to be adulterated and/or, misbranded and subject to enforcement action by the FDA. A few representative instances of intoxication caused by accidental adulteration of commercial products follow. 

Prequalification of products and manufacturers, purchasing, storage and distribution are complex processes that may involve many offices, procurement agencies, sections or departments and several stages of administration, finance and technical decisions. Pharmaceutical products are not ordinary commodities of trade and require special attention. Support from the offices responsible for quality assurance is crucial. The efficiency of the procedures depends in great part on the use of a proven method in a consistent manner. The use of a standard approach will ensure consistency in all activities involved in procurement of pharmaceutical products of defined acceptable quality. 

Formal approval of the plan, indicating the top-level management for each function, is essential to share the responsibility. The VMP shall be supported with approval signatures from multidisciplinary functions, including Engineering, Manufacturing, Quality Control, Quality Assurance, and Validation at a minimum. 

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