The sheer volume of pharmaceuticals developed, tested, manufactured, processed and packaged both domestically and abroad demand strict adherence to Current Good Manufacturing Practices (CGMPs). The numbers are mammoth. According to current reports:
- The US pharmaceutical industry had a 40% share of the global market
- Estimated sales of $333 billion, the largest in the world
- Directly or indirectly supports over 3.4 million jobs across the U.S.
- Total healthcare expenditures $3.12 trillion
- Total healthcare expenditures equal 17.4 % of the GDP
Maintaining pharma data integrity – accurate electronic records, paper records or a mix of gathered data – during the entire development process of data is essential. Pharmaceuticals must place a high priority on maintenance, keeping complete records 100% of the time. Their reputation is on the line by both the national and international media networks and various social media outlets, impacting the bottom line, but the issues are far more significant than mere reputation.
In the Pharmaceutical field, A non-compliance error or data mistakes can adversely affect a drug company’s bottom line. At best, it can cause a costly delay in a drug coming to market or allow an inferior-quality drug on the market, resulting in massive and costly recalls. At worst, a faulty drug reaching the market can cause devastating issues for patients or even death.
Challenges to data integrity come from a myriad of sources and include an intricate system of outsourcing various parts of the manufacturing process to other countries. Mergers and acquisitions can make it difficult for manufacturers to ensure CGMPs compliance. Interestingly, emerging technology in the form of mobile devices used for calibration can also test data integrity compliance.
Typical CGMP data violations include the responsibilities and procedures regarding quality control. The FDA found these procedures were not in writing or were not being followed; likewise, written procedures focusing on production and process controls were non-existent.
When CGMP violations are uncovered, regardless of the nature of the violation, the FDA issues warning letters to pharmaceuticals worldwide. From China to Germany to Hungary and other countries; a small sampling of violations spans everything from blatant data manipulation to discarding written documents in a wastebasket.
The United States Food and Drug Administration (FDA) has issued mandates and recommended guidelines covering all aspects of the pharmaceutical industry including using best practices initiatives for achieving Pharma data integrity. Any breach in data integrity renders the entire process of drug development and manufacture suspect as the quality of the drug cannot be verified if the data does not reflect a precise accounting from start to finish.
According to the FDA, system controls, procedures and documentation must all follow CGMP protocols to assure product quality. To clarify these controls and procedures regarding documentation and to ensure compliance the FDA has issued the following minimum data integrity requirements:
- Store data securely prevent inadvertent tampering by erasure.
- Backup data should be exact and complete.
- Store data to ensure against loss or deterioration.
- Document certain activities as they occur using scientifically sound laboratory practices.
- Retain records in an acceptable form, whether original or copies.
- Record completely all information with no tests or data omitted.
- Store metadata throughout the record’s retention period.
Tips to CGMP Compliance
The FDA has issued a list of rules, regulations, and prohibitions concerning the data integrity throughout the development, manufacture, processing and packaging of drugs. These six tips will help you increase your compliance.
- Don’t write data on paper – it can be thrown
- Don’t store it in temporary memory. It is a permanent record.
- Don’t sample and test to obtain or overcome a specific goal.
- Do adhere to CGMP
- Do run system suitability tests using established written procedures
- 6. Do record data for scientific justification for
Pharma regulations matter. Establishing and upholding them begins with hiring the right people. People who are not only talented but are also committed to regulation and data integrity. RomAnalytics understands. We specialize in connecting the best pharma talent with the best pharma companies. Contact us today.