I. PURPOSE OF VALIDATION High-quality water and air are essential for the manufacture of pharmaceuticals. Water is the most commonly used raw material in pharmaceutical manufacturing; it is indirectly used in the manufacture of all dosage forms for cleaning manufacturing equipment, and is also used as a major component which constitutes injectable products. It is […]
Introduction: Heating, ventilation and air-conditioning (HVAC) play an important role the manufacture of quality pharmaceutical products. A well designed HVAC system will also provide comfortable conditions for operators. HVAC system design influences architectural layouts with regard to items such as airlock positions, doorways and lobbies. The architectural components have an effect on room pressure differential […]
About HEPA (High efficiency particulate air) High-Efficiency Particulate Air or HEPA is a type of air filter. It is a type of filter which has high efficiency to filter out about 99.997% that is why they are termed as High efficiency particulate air filter,HEPA filters are made up of a mesh of fiber glass […]
I. INTRODUCTION This article is written to guide and design how to set up validation procedure, one must recognize that for cleaning validation, as with validation of other processes, there may be more than one way to validate a process. In the end, the test of any validation process is whether scientific data shows that […]
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration. The purpose of […]
Cleanroom Classification The current demands in today’s pharmaceutical industry for quality control and quality assurance have been driven by the aspiration to deliver consistently high quality and safe products to the consumer. The standards that are set to meet this goal are exorbitant and tightly controlled both internally and externally. Cleanroom environments are a crucial […]
Pharmaceutical companies and regulatory agencies work together to enhance patient safety when a medicine is first being studied (pre-approval) and after it becomes available to patients and their health care providers as a treatment option, following authorization by regulatory agencies (post-approval). Regulatory agencies are government or non-government authorities, responsible for oversight of the effectiveness, safety, […]
1.0 Overview A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity followed by an organization. The development and use of SOPs are an integral part of a successful quality system as it provides individuals with the information to perform a job properly, and facilitates consistency in […]
Change control is defined as : “A formal system by which qualified representatives of appropriate disciplines review propose or actual changes that might affect a validated status. The intent is to determine the need for action that would ensure and document that the system is maintained in a validated state.” The implementation of a change […]
The F0 value of a saturated steam sterilisation process is the lethality expressed in terms of the equivalent time in minutes at a temperature of 121 °C delivered by the process to the product in its final container with reference to micro-organisms possessing a Z-value of 10. The total F0 of a process takes […]
