Every business owner wants to produce more products to achieve the new milestones in manufacturing. The pharmaceutical field is different from the others in the quality of products. It is a great idea to scale up the production but at the same time, product quality must not be compromised. Following ...

OBJECTIVE The objective of carrying out Product Quality Review (PQR) is to establish that the product is manufactured as per approved procedures and the trends of results of critical quality attributes are well within acceptable limits. PQR will also address the review of raw and primary packaging materials ...

Principle 1 Customer focus: organizations depend on their customers and therefore should understand current and future customer needs; meet customer requirements and strive to exceed customer expectations. Principle 2 Leadership: leaders establish unity of purpose and direction of the organization. They ...

The Quality System covers the following areas of operation: 1 Human Resources – to ensure that staff of appropriate educational level, experience and health are recruited, that their roles and responsibilities are clearly defined and that they are adequately trained, supervised, assessed and their ...

Quality management in pharmaceuticals or in other words quality assurance is a dynamic process of understanding the norms of this industry. Medicines administered to consumers must be safe and not cause long-term effects on the recipient. A quality management system is a set of interacting elements based ...

Purpose: To lay down the procedure for conducting management review meeting to evaluate effectiveness of Quality management system, and to identify the area of improvement. Procedure >> QA Personnel or Designee shall prepare the agenda for management review meetings and share with management review committee. >> ...

Quality by Design: A concept that quality should be built into a product with a thorough understanding of the product and process by which it is developed and manufactured along with a knowledge of the risks involved in the manufacturing of the product and how to best mitigate those risks.

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 ...