Most of 483 observations in FDA inspections are repeated frequently in different pharmaceutical companies. The same observation is reported many times in a year but companies are not focusing on the elimination of these issues. These common issues/ mistakes could be easily eliminated before any inspection.
1. Absence of Written Procedures
FDA did not find written procedures 197 times in last one year in different pharmaceutical manufacturing facilities. Companies were not following the thumb rule of pharmaceuticals i.e. “Do that is written and write that is done.” About 50% of these were related to stability studies. Documents like SOPs, protocols, STPs and especially for stability studies must available for every procedure and product in the company.
Most of the companies have written procedures but people don’t follow those procedures and caught in the inspection. To eliminate this issue proper training of the procedures must be provided to all concerned. Employees must be clearly instructed to refer to SOPs before starting any operation.
2. Data Integrity Issues
Data in computer systems was not found secure 125 times during inspection in last one year. Master production and control records and other documents like SOPs, STPs and records must be accessible to authorized personnel only. Digital or physical records must be protected and backed up as per schedule.
Data integrity is a common issue in pharmaceuticals these days. FDA and WHO recently published their data integrity guidelines. This is a frequent issue but very easy to eliminate and don’t require to work hard.
Related: Regulatory Guidelines on Data Integrity
This issue was observed 107 times in last one year during FDA inspections. Firms were failed to investigate batch failure or any component of the batch which was not within the specified limits. FDA says to conduct a proper investigation for each and every incidence, event, deviation or failure that happened in the manufacturing facility. Each failed batch or test must be thoroughly investigated to its actual root cause even though the batch is not released for the distribution.
4. Cleaning, Sanitizing and Maintenance
Cleaning issues in manufacturing are observed 81 times in a period of last one year. Proper cleaning of equipment and utensils used in manufacturing is essential to manufacture a quality product. It is also required to sanitize equipment before its use to remove any microbial contamination. A study must be conducted to find out the hold time period for cleaned equipment during which period equipment can be used without re-cleaning.
5. Environmental Monitoring
Environmental monitoring was not found adequate 76 times in different companies in last one year. Many companies don’t take environmental monitoring seriously especially in oral dosage manufacturing facilities. But FDA takes it seriously too and expects environmental monitoring to be followed in oral dosage forms like sterile facility. A proper environmental monitoring program must be prepared and implemented in all classified areas of the facility.
FDA did not find written procedures 197 times in last one year in different pharmaceutical manufacturing facilities. Companies were not following the thumb rule of pharmaceuticals i.e. “Do that is written and write that is done.” About 50% of these were related to stability studies. Documents like SOPs, protocols, STPs and especially for stability studies must available for every procedure and product in the company.
Most of the companies have written procedures but people don’t follow those procedures and caught in the inspection. To eliminate this issue proper training of the procedures must be provided to all concerned. Employees must be clearly instructed to refer to SOPs before starting any operation.
2. Data Integrity Issues
Data in computer systems was not found secure 125 times during inspection in last one year. Master production and control records and other documents like SOPs, STPs and records must be accessible to authorized personnel only. Digital or physical records must be protected and backed up as per schedule.
Data integrity is a common issue in pharmaceuticals these days. FDA and WHO recently published their data integrity guidelines. This is a frequent issue but very easy to eliminate and don’t require to work hard.
Related: Regulatory Guidelines on Data Integrity
This issue was observed 107 times in last one year during FDA inspections. Firms were failed to investigate batch failure or any component of the batch which was not within the specified limits. FDA says to conduct a proper investigation for each and every incidence, event, deviation or failure that happened in the manufacturing facility. Each failed batch or test must be thoroughly investigated to its actual root cause even though the batch is not released for the distribution.
4. Cleaning, Sanitizing and Maintenance
Cleaning issues in manufacturing are observed 81 times in a period of last one year. Proper cleaning of equipment and utensils used in manufacturing is essential to manufacture a quality product. It is also required to sanitize equipment before its use to remove any microbial contamination. A study must be conducted to find out the hold time period for cleaned equipment during which period equipment can be used without re-cleaning.
5. Environmental Monitoring
Environmental monitoring was not found adequate 76 times in different companies in last one year. Many companies don’t take environmental monitoring seriously especially in oral dosage manufacturing facilities. But FDA takes it seriously too and expects environmental monitoring to be followed in oral dosage forms like sterile facility. A proper environmental monitoring program must be prepared and implemented in all classified areas of the facility.
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Thanks for information sir.
ReplyDeleteWelcome Satish
DeleteKindly suggest us about fungal colonies limit in classified area environmental monitoring. Though all the official pharmacopoeia (like- IP, BP, USP,EU)mentioned only total bacterial count for class-C (50), class-D(100)but not segregated as bacterial & fungal limit separately. It's my opinion fungal colony is most dangerous due to its spore generation rate high as compare to bacterial colony.
ReplyDeletePlease visit
Deletehttps://www.pharmaguideline.com/2014/01/fungal-count-in-air-of-sterile-area.html
Good one
ReplyDeleteAs we know very vital information provided by you while I have one question for all readers, we know all the essential point but how many we follow religiously, only knowing anything is not good enough we need to follow them.
ReplyDelete