What is IPEC PQG GMP?

The Joint IPEC-PQG Good Manufacturing Practices Guideline – Updated version. This document covers the quality management system and the extent of GMP required for the manufacture of excipients intended for use in drug products.

What is ICH Q8 Q9 Q10?

ICH Q8, Q9 and Q10 provide a structured way to define product critical quality attributes, design space, the manufacturing process and the control strategy. This information can be used to identify the type and focus of studies to be performed prior to and on initial commercial production batches.

What is OOS and OOT?

OOS (out of specification) is the comparison of one result versus predetermined specification criteria while OOT (Out of Trend) is the comparison of many historical data values versus time.

What is required for excipient?

In order to market an excipient, there is no regulatory requirement that there must be a compendial monograph for the material. However, other regulations may define a suitable quality which could be used (e.g. Food Chemical Codex).

Are pH adjusters excipients?

pH modifier excipients are used in the pharmaceutical industry due to their antioxidant properties. pH modifiers can help maintain the stability of pharmaceutical and can also be used as preservatives. For pH-modification, the addition of a base or an acid is often preferred over the use of buffers.

What does ICH Q9 stand for?

Quality Risk Management
International Conference on Harmonisation (ICH) guideline Q9, Quality Risk Management, represents the first internationally recognized guideline specifically addressing QRM for the pharmaceutical and biopharmaceutical industries. …