Unlike quality control, quality assurance is usually focused on how processes are performed or how services are delivered. It focuses on preventing mistakes made by creating and evaluating processes, strategies and brand policies. Typically, your quality assurance function will have a “checklist” ...

1. Head of Quality shall prepare the final market complaint response report (Annexure –III) for products manufactured at site. 2. The market complaint investigation report should be exhaustive, reveal complete facts of investigation, identify the causes clearly in the best possible manner, may contain ...

Before the GCP and similar regulations came into force, clinical trials were largely based on the needs of national governments rather than human rights. The GCP regulates human experimentation in the interest of advancing medical science. It acts as a quality benchmark as well as a moderator that keeps ...

In general, processing records for routine production batches should provide a complete account of the manufacturing process for each batch of biological product that demonstrates that it was produced, tested, and dispensed in accordance with approved procedures. In the case of vaccines, a batch processing ...

If a data integrity issue is found, regulatory agencies take action due to the breach. Actions may include warning letters and import holds. A recent number of warning letters issued by the regulator relate to data integrity issues International regulatory authorities are more concerned with data integrity ...

When the product specification is established based on the product quality defined above, it is necessary to verify that the specification adequately specifies the product quality. (Conformity between standard and specification) In short, conformity between quality and specification is the assurance ...

It is simply a document that describes the quality management principles of a pharmaceutical company The document explains the various regulations, roles, responsibilities performed by the various parties and stakeholders that make up the pharmaceutical industry. This applies to externally affected workers ...

Active pharmaceutical ingredients (APIs) are the main active ingredients of a finished drug product. To ensure product quality and safety, it is important to control the manufacturing process of APIs. In-process control methods are a way to help manage and monitor the manufacturing process. There are ...

1 SOP for preparation of SOP 2 SOP for Data integrity 3 SOP for in house code and numbers 4 SOP for document control, approval, revision, and authorization 5 SOP for market complains for market recalls 6 SOP for market returns and expiration goods 7 SOP for recovery from rejections 8 SOP ...