Product Quality Analysis: Quality And Quality Control

Product Quality Analysis-QA and QC: Quality assurance (QA) and quality control (QC) are a division with the responsibility of quality testing and ensuring proposed changes do not impact the quality of any aspect of the process. Pharmaceuticals must be marketed as safe and therapeutically predictable and consistent. This is quality control. QC's role includes evaluation throughout the process, including but not limited to raw material and API, drug product, packaging components and finished product. The responsibilities of this job are to ensure efficacy, safety, quality and compliance with the relevant authority. QC in short is focused on process output. Quality assurance is about assuring that all operations associated with the manufacturing

It primarily reviews the regulations and guidelines relating to the manufacturing and development of the product in question and gives guidance and clarity on what is required. (Brady, 2013)

There are 4 specific elements to a quality systems model in bio/pharmaceutical manufacturing that can help manufacturers comply with GMP regulations and guidelines.

1. Management Responsibilities
2. Resources
3. Manufacturing Operations
4. Evaluation Activities (Brady, 2013)

1) Management Responsibilities

In a quality management system the management are responsible for establishing the structure of the system. The system must be built to meet the requirements, both of the company to keep it a viable business and to comply with all necessary regulations. It must be established in an easily understood format so that each employee can comprehend and implement it. Conformation of all employees in essential to the success of a quality management system so effective communication is crucial. This allows communication and documentation easier for all personnel to ensure complete awareness. Management’s involvement

This is the structured approach used to continual improvement of a process. Performance and monitoring of operations allow the technical experts to efficiently and effectively validate all data and product information obtained through the process, allowing the appropriate technical expert to implement any changes they feel necessary to ensure consistent quality and purity in the finished product. The term CAPA also comes into the equation here as this documentation and continual monitoring of operations allow the technical experts to see any nonconformity with the product or process and can assist in introducing improvements and preventing any unwanted actions from occurring. Continually monitoring trends and data provided throughout production allows us to facilitate improvement upon the system. By collecting data from monitoring, measuring and other activities this allows the appropriate person to identify and resolve problems before they lead to breakdowns or impact the product or process in a negative way. It can also help to anticipate and prevent problems from occurring in the first place, this is the preventative action in CAPA. Internal audits are also an excellent way of evaluating the effectiveness of the implementation of procedures and process changes. As with every other procedure, documentation is of the utmost important and this is no different for internal audits either. It is not enough