Quality by Design

Quality by Design (QbD) is a structured approach to process development that emphasizes science and risk management principles. Applying QbD allows companies to develop manufacturing processes that are safer and more compliant with CGMP regulations. The fundamentals of the Quality by Design approach are: Develop detailed process and product understanding from historical knowledge and product specific experimental data. Use rationally …

Materials Management

Of all the subsystems of a Pharmaceutical Quality System, the Materials Management subsystem may require the most cross-functional collaboration and teamwork. For example, the Materials Management subsystem does not simply apply to warehouse personnel. This subsystem includes the warehouse personnel who receive, store and handle components and raw materials and distribute final products, but it also includes the purchasers who …

Item Specifications

A specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to which a raw material, drug substance or drug product should conform to be considered acceptable for its intended use.  Specifications are chosen to confirm …

FAT / SAT Support

Investing in equipment should never have to be a risk. Testing equipment and reviewing documentation for traceability purposes does a great deal towards lowering the risk of your investment. Accepting the equipment only after completing a Factory Acceptance Test (FAT) is industry standard, but the process can be overwhelming. A few ways to make an FAT run smoothly include: Commissioning: …

Process Validation

Current Good Manufacturing Practices (CGMPs) enforced by the FDA require that all manufacturing processes be validated. Validation ensures that controlling the inputs (i.e. parameters) within an acceptable range will consistently produce outputs (i.e. products) of acceptable quality. The current FDA view of CGMPs emphasizes a risk and science-based approach to biopharmaceutical manufacturing. As a result, Process Validation is viewed as …

Quality Management System Development

A Quality Management System (QMS) is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis. Although a QMS should be created to address an organization’s unique needs, there are …

Quality Risk Management

Quality Risk management (QRM) is a systematic process for the assessment, control, communication, and review of risks to quality of the drug product across the product lifecycle. The approach to managing risk is established via an evaluation of risk to quality. The evaluation is based on scientific knowledge and ultimately linked to the protection of the patient. The level of …

Aseptic Manufacturing

Safety First.  That’s the mantra echoed across almost every industry in the world.  This is especially true in the life sciences industry.  But this safety takes many forms.  The first and foremost is patient safety, the final customer.  For sterile parenteral products, ophthalmic solutions, and medical devices; product sterility is of the upmost importance.  Sterility is achieved in multiple ways, …

Detailed Product and Process Description (DPPD)

In Big Pharma and the life sciences industry, product development is a massive effort that spans several different functions and documents. This process is not only costly, but involves long timelines and requires a breadth of resources to accomplish. Both categories are often being kept in different locations, forcing overall process to depend mainly on tribal knowledge. Despite having a …