12 Respiratory system Introduction Respiration is a term used to describe two different but interrelated processes: cellular respiration and mechanical respiration. Cellular respiration is the series of intracellular biochemical processes…
13 Oral tissues Introduction The digestive process commences in the oral cavity with the ingestion, fragmentation and moistening of food but, in addition to its digestive role, the oral cavity…
18 Male reproductive system Introduction The male reproductive system is responsible for the production of spermatozoa and their delivery into the female reproductive tract and may be divided into four…
2 Cell cycle and replication Introduction The development of a single fertilised egg cell to form a complex multicellular organism involves cellular replication, growth and progressive specialisation (differentiation) for a…
When it is necessary to control the environment, specifications for parameters such as temperature, humidity, colony-forming units (CFUs), and particulates per cubic foot should be…
Inactive Ingredients (Excipients) Excipients are defined as ingredients added to the drug formulation for purposes other than the therapeutic or medicinally active effect. They are largely inert substances that…
Content of Site Master Files Chapter 1. General Information • Name, address, and company description (C.1.1): Includes a brief description of the company, relation to other sites, and…
GMP regulations place responsibility for ensuring the quality of the materials used to manufacture drug products squarely on the shoulders of the pharmaceutical company. The globalization of the pharmaceutical…
At the highest level of the documentation hierarchy in most companies sits the quality manual, which defines the corporate objectives related to quality and compliance. It establishes a figurative…
