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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 pharmaceutical manufacturing facilities. Missing data and data manipulation are commonly found data integrity issues. Data falsification in some companies was also observed by regulatory bodies where false analytical data was created to advertise the product.
2. Procedures are not written or fully followed
It is also very common where the procedures followed in quality control are not written down in SOPs and STPs. In other cases, quality control or production personnel do not follow written procedures.
3. Cleaning and sanitization
Equipment and containers are not cleaned, maintained, or sanitized at appropriate intervals to prevent contamination that alters the safety, identity, potency, quality, or purity of the drug product. Area cleaning and sanitization is found unsatisfactory in some facilities.
4. Failure to store medication properly
Proper drug storage is essential for the safety of drug products. Some facilities failed to maintain the temperature and humidity required to store drug products. This can reduce the effectiveness of the product and cause degradation of the active ingredients.
5. Improper packaging
Improper packaging is another violation found in drug manufacturing facilities. In some cases low quality packaging materials are used or products are not labeled properly. In some other cases packaging materials are not sampled, tested or used after receipt and prior to packaging and labeling of the drug product.
6. Failure to investigate discrepancies
Failed to thoroughly review or investigate whether an incident or batch had already been delivered or had any unexplained discrepancies. Some companies fail to implement proper corrective and preventive actions.
