GMP Violations Affect Manufacturers
If many GMP violations happen, this can have a huge impact on the business of the pharmaceutical industry in India. GMP violations can harm pharmaceutical companies in four ways.
1. Suspension of production: Violation of GMP may lead to suspension of production if the violation is serious. It means that ...
Trends in GMP Violations in Pharmaceuticals
All pharmaceutical companies have established strict guidelines and regulations according to current good manufacturing (cGMP) guidelines. These guidelines help the manufacturers to ensure the quality of manufactured pharmaceutical products. Despite these efforts by the companies, there are a lot of ...
Common GMP Violations
According to GMP inspections by various regulatory agencies, more than 100 types of GMP violations are found in Indian pharmaceutical manufacturing facilities. Some frequently found violations are as follows.
1. Data Integrity
Data integrity issues are the most common GMP violations found in Indian ...
To Avoid GMP Violations
GMP violations can be easily avoided by keeping the following key points in mind.
1. Follow all guidelines provided by regulatory agencies.
2. Ensure that all processes conform to GMP requirements.
3. Ensure products are safe and effective.
4. Keep records of procedures and activities to ensure compliance ...
What can be done to prevent GMP violations?
GMP regulations are important to prevent contamination of pharmaceuticals with harmful toxins and organisms. However, despite many pharmaceutical companies complying with GMP regulations, GMP violations have increased recently. What can be done to prevent this breach?
One solution is to increase the ...
Who is Responsible for GMP Violations
Following GMP regulations is not the responsibility of any individual in the facility but is a collective effort from junior staff to senior management. All departments have to play their important role to comply with GMP regulations. Quality Assurance Head of Quality Assurance is mainly responsible ...
Types of GMP Violations
Various types of GMP violations can occur in the pharmaceutical industry. Some of the most common include:
1. Failure to follow proper manufacturing procedures – This is one of the most common GMP violations and can occur for a variety of reasons. For example, if production equipment is not properly ...
