Cleaning of equipment was first published in the Code of Feral Regulations (CFR) as 21CFR211.67 Equipment Cleaning and Maintenance in 1978. After that a lot of document guidelines are published on cleaning validation and nowadays cleaning validation is the main focus area of FDA inspections.
Identification of Worst Case in Cleaning Validation
It is not possible to carry out cleaning validation of all products manufactured in the facility. Therefore, products are selected on the basis of the worst case. Worst case is the condition when it is difficult to clean the residues of the manufactured product from the equipment surface.
Build a Quality Culture in Pharmaceuticals
Quality of pharmaceutical products is a major concern in the pharmaceutical industry. Quality of product indicates the seriousness of the manufacturer towards the safety of the patients. It means defects in product quality may harm the user of the product.
Control of Contamination at Different Manufacturing Stages
One of the most critical aspects of dosage form manufacture is the vigilance and care required ensuring the complete absence of any form of cross-contamination. Contamination may occur at any stage of the manufacturing process. Personnel, equipment, area and raw material all may have contamination …
Favourable Conditions for Microbial Growth in Cleanroom Area
In the pharmaceutical industry, the end is to produce a drug that will help humanity in either promotion of health status, amelioration of the disease condition or palliating a chronic illness. For this cause, the pharmaceutical companies provide for themselves a conducive place to make drugs. Thes…
Determination of Data Integrity Compliance in Pharmaceuticals
Data integrity is the principle of generating, maintaining and assuring the consistent accuracy and completeness of data in a company or manufacturing plant through the entire life cycle complying with the regulations set within the pharmaceutical industry by the Food and Drug Administration (FDA).…
Validation of Utility Systems in Pharmaceutical Facilities
This chapter provides a summary of the key validation test functions and acceptance criteria for each utility system. These are provided as a guideline for those involved in the validation of ABC Pharmaceutical. Approval of this Master Plan neither provides approval of these test functions and acce…
Computerized System Validation Planning and Execution
Computer validation planning consists of a Computer Validation Plan (approach), specific activities required to carry out the plan, and a Computer Validation Report as documented assurance that all activities required to validate the computerized system have been successfully completed.
How to Write a Validation Master Plan?
A Validation Master Plan (also referred to as the VMP) is a document which outlines the principles tied to the qualification of a certain facility, defining the systems and areas which need validation and provides a written guideline on how to achieve and then maintain a qualified facility. VMP is …
Validation Program in Pharmaceutical Industries
Validation is defined as:
Establishing documented evidence that provides a high degree of assurance that a process, system, equipment or assay will consistently produce the desired results according to predetermined specifications and quality attributes. Qualification is defined as:
The documented …
Establishing documented evidence that provides a high degree of assurance that a process, system, equipment or assay will consistently produce the desired results according to predetermined specifications and quality attributes. Qualification is defined as:
The documented …
HPLC System Software Validation Plan
Introduction
Softwares are used to operate and interpret the analysis results in HPLC systems. There are many softwares those are used in different HPLC systems. All softwares are required to validate to ensure the accuracy of the produced data.
Software Validation is a requirement of GxP system. …
Software Validation is a requirement of GxP system. …
Difference between Process Validation and Product Validation
Pharmaceutical products need to follow a set of standards as a means of assurance of quality. Such a standard is validation, whether process or product validation, it is well known that the validation is made as an essential building block of good manufacturing practices (GMP) process or a guidelin…
Quality Manual and Quality Policy
The pharmaceutical industry is one of the fastest growing and sensitive sector dealing with medicins, patients, medicinal drugs and pharmacists. It needs to be handled with care to avoid the risk for the people living at stake. Thus the rules and regulations governing the operations within the phar…
Difference between Generic and Branded Medicines
A lot of persons have misperceptions regarding the quality of the generic and branded medicines. Generic and branded medicines both are prescribed by the doctors. Both of these medicines have the same drug but both have some difference in other ingredients.
Difference Between HEPA and ULPA Filters
The two main types of air filters employed in biosafety cabinets, pharmaceutical manufacturing, electronic goods manufacturing, room air purification, and vacuum cleaner filters are High-Efficiency Particulate Air (HEPA) filters and Ultra-Low Particulate Air (ULPA) filters. Both these filters are d…
